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Volume VIII, Number 1 Sabin Spring 2005 EPORT The newsletter of the Albert B. Sabin Vaccine InstituteR — dedicated to disease prevention www.sabin.org FDA Clears Human Vaccine for Phase I Safety Trials Sabin/GW Researchers Receive Word on Investigational New Drug Status for Vaccine

Clinical trials to test the safety of a gin safety trials is a major milestone for in individuals who suffer from hook- first-of-its-kind human hookworm vac- the human project,” worm .” cine will begin in the Washington, DC Hotez said. “It has taken an amazing Human is caused area in the coming weeks after the U.S. amount of our team’s effort to get us to by parasitic worms that fasten onto the Food and Drug Administration conferred the current stage of vaccine develop- inner layers of the small intestine using investigational new drug status on the ment. Of course, our ultimate goal is to their teeth-like projections and cause vaccine this past January. No current take this to developing coun- loss at the attachment site. vaccine is available to prevent hook- tries where the vaccine will be tested Hookworm disease refers to the iron worm disease, which is one of the most Continued on page 4 common chronic of humans with an estimated 740 million cases in The village of Americaninhas, areas of rural poverty in the tropics in a rural part of Minas Gerais and subtropics. state in , is the focus of a The Human Hookworm Vaccine Ini- field study of hookworm dis- tiative (HHVI) is sponsored by the ease burden, being conducted Albert B. , and by the Human Hookworm Vac- is funded by the Bill & Melinda Gates cine Initiative. The members of Foundation. The research is conducted one village family posed for a at The George Washington University photo during an HHVI Team site visit in March. SVI program Medical Center. Peter J. Hotez, MD, manager of the HHVI, Kari PhD, professor and chair of GW’s De- Stoever, furnished the photo and partment of Microbiology and Tropical participated in the site visit. Medicine leads the scientific team and has been responsible for the develop- ment of the vaccine. “Approval to be- Albert Z. Kapikian, MD, to be Awarded the Sabin Gold Medal I nside May 10 Ceremony in Baltimore for SVI’s Highest Scientific Award ViewPoint...... 2 Albert Z. Kapikian, MD, physician, nual Conference on Vaccine Research President’s Message...... 3 medical pioneer and viral diseases re- at the Marriott Inner Harbor hotel in SVI and Elimination ...... 3 searcher, will receive the prestigious Baltimore, Maryland. The ceremony Routine Albert B. Sabin Gold Medal at a cer- will begin at 7 pm. Recommendation ...... 6 emony on May 10, 2005. Kapikian is the Kapikian’s career of more than 47 Sabin Gold Medalist ...... 1, 7 13th recipient of this recognition, years, with groundbreaking medical re- Vaccine Consortium News.... 8 awarded annually by the Sabin Vaccine search contributions, is distinguished by Named Public Institute to honor achievements by the development of the first licensed Health Hero ...... 9 vaccinologists and infectious disease . “Albert Kapikian’s Vaccine Anniversary ...... 10 experts. The ceremony will be held in contribution to mankind through the Book Corner ...... 11 conjunction with the National Founda- tion for Infectious Diseases Eighth An- Continued on page 7 2 SPRING 2005 SABIN VACCINE REPORT

The Sabin Vaccine Report VIEW is published by the POINT Albert B. Sabin Vaccine Institute Subscriptions are free, but tax deduct- ible contributions are appreciated to The following message from the Sabin Vaccine Institute is timed to mark National Infant support the SVI’s many programs. Week (NIIW), April 24-30, in the and as members of the Please direct inquiries to: Americas mark Week in the Americas, April 23-30. NIIW is an annual SABIN VACCINE REPORT observance that highlights the importance of timely immunization for children and infants. 161 Cherry Street This year more than 500 events are expected to take place across the nation to increase New Canaan, CT 06840-4818 awareness of the importance of vaccination. NIIW was established 11 years ago by the U.S. phone: 203.972.7907/fax: 203.966.4763 www.sabin.org Department of Health and Human Services and the Centers for Disease Control and Prevention. email: [email protected] Vaccination Week in the Americas is coordinated by the Pan American Health Organization, EDITOR ASSOCIATE EDITOR focusing on the children normally left behind, those living in rural border regions, indigenous Raymond MacDougall Veronica Korn people and vulnerable groups, including women of childbearing age and the elderly. We offer

COPY EDITOR thoughts on the importance of immunization in a spirit of solidarity with these efforts. David Bedell OFFICERS OF THE SVI BOARD OF TRUSTEES H. R. Shepherd, DSc, Chairman William R. Berkley, Co-Chairman Michael E. Whitham, Esq., Secretary/ The Childhood Immunization Schedule: Treasurer Why Are So Important? SVI STAFF Dean D. Mason, President/CEO As parents, we are constantly concerned about keeping our children safe and healthy. Fran G. Sonkin, Executive Vice President To protect them, we put them in child safety seats and install childproof door latches. One Ciro de Quadros, MD, MPH, Director, of the most important ways we protect our children is to follow the childhood immunization International Programs schedule and get them vaccinated against serious but preventable diseases. Raymond MacDougall, Director of are one of medicine’s greatest triumphs because they prevent serious disease Communications David Bedell, Director, Educational and death. Many once common infectious diseases such as polio, , whooping Programs cough, and rubella (German ), are now only distant memories for most Americans. Kari Stoever, CCRP, Program Manager, Today in the United States, we have few reminders of the suffering, disabilities, and premature Human Hookworm Vaccine Initiative deaths caused by these vaccine-preventable diseases. Jean Mitchell, Development Officer Many of today’s parents have never even seen the diseases that vaccines prevent and Bruce Baiter, Assistant to the Chairman Karen Bodick, Assistant to the President don’t fully understand the significance of following the childhood immunization schedule. Vanessa Santiago, Assistant to the Instead, a parent may ask, “Why does my baby need so many shots?” Executive Vice President Before age two, every child should be immunized against 12 potentially serious vaccine- Ana Carvalho, Assistant to the Director, preventable diseases: measles, mumps, rubella, diphtheria, tetanus, pertussis (whooping International Programs cough), polio, type b (Hib disease), , varicella Veronica Korn, Research Associate (), pneumococcal disease and . At least one shot is needed for each Christel Lane, Receptionist/Staff Assistant of these diseases, and for a few diseases, several doses are needed for the best protection. Jean-Serge Valcourt, Accounting Vaccines are given at this early age because the diseases they prevent are far more SVI ADVISORS serious or common among babies or young children. Up to 60 percent of severe disease Philip K. Russell, MD, Senior Advisor to caused by Hib in children is among babies less than 12 months of age. Moreover, 90 the Chairman percent of all deaths from whooping cough are among children under six months of age. Peter J. Hotez, MD, PhD, Senior Fellow & Chair, Scientific Advisory Council The ages that doctors recommend vaccines in the immunization schedule are not arbitrary. Anne Gershon, MD, Co-chair, Scientific They were chosen to give our children the earliest and best protection against disease. Advisory Council Vaccinating a child according to the immunization schedule protects not only that child Hugh E. Evans, MD, Sabin Fellow but also the entire community. Every day in the United States, there are 11,000 children William Muraskin, PhD, Sabin Fellow born who need to be fully immunized before two years of age. The 12 diseases that infant Patricia Thomas, Sabin Fellow Nancy Gardner Hargrave, Development immunizations prevent still exist and circulate in many parts of the world. For children Counsel who are not immune these diseases can still lead to pneumonia, blood infections, brain damage, liver, kidney or heart problems, skin deformation and blindness. VOLUNTEER Maria Maunahan, Website Updates Talk to your child’s health care provider about the childhood immunization schedule. Following it is one of the best ways parents can protect their children’s health. dedicated to disease prevention www.sabin.org 3

It Is Time for a Vaccines for Adults Entitlement Program Message from Dean Mason, President and Chief Executive Officer, SVI One of the most immediate and cost-effective government investment mea- Since the initiation of the VFC program the country has sures that could be taken to protect almost all Americans would be to establish sustained high levels of immunization coverage among a “Vaccines for Adults” (VFA) entitlement program. infants and children and record lows in vaccine prevent- In the early to mid-1990s, both the Bush and Clinton administrations and able disease morbidity in the same age groups. Congress responded to a problem. The measles epidemics of Unfortunately, the same cannot be said for adults. An estimated 114,000 1989-1991 provided the impetus. There were 55,622 reported cases of measles excess hospitalizations and 36,000 deaths attributed to influenza occur annu- and 123 deaths. A full 90% of the deaths occurred in people not vaccinated ally with the highest morbidity and mortality occurring in adults 65 years-of-age against measles. Morbidity from diseases preventable by vaccination, lower and older. coverage in ages 18-49 years in 2002 was only immunization coverage among indigent and minority children, and “pockets- 20%. It is estimated that 3500 people ages 65 years or younger die each year of-need” were contributing to a crisis in public health. The 64 deaths in 1990 from pneumococcal disease that is vaccine preventable. In the 18-49 year age were the largest number reported in almost 20 years. group, in those with defined risk factors, coverage is Healthcare providers who negotiate their own prices were increasingly only 12%. Vaccine coverage rates among adults is woefully inadequate for other referring their young patients to public health clinics for all or some of their diseases. Additional vaccines to benefit adults, including possibly a vaccine recommended vaccines. Not only were these children not receiving compre- against shingles that is now in clinical trials and awaiting FDA review, are on the hensive health care, but the practice of referring children often meant they horizon. did not receive their until required to do so for day care, Head Vaccine protection against influenza, pneumonia, , hepatitis B, Start, or school entry. Some insurance companies were scaling back on tetanus, diphtheria, pertussis and in some instances against meningococcal vaccines as a covered benefit while others were making it difficult for the diseases should be offered to all adults. There is an occasional need to vaccinate “working poor” by raising the deductibles or limiting the amount of cover- susceptible adults against measles, mumps, rubella, and chickenpox. A govern- age for vaccines. ment commitment to assure equal access to life saving vaccines for all adults at The response included the Infant Immunization Initiative, the development no cost, or at a reasonable cost if they can afford it, should be a guarantee. The of Immunization Action Plans in all states and the legislative enactment of the cost savings of such a disease prevention program would more than justify the Vaccines for Children (VFC) program. The public health community has ben- taxpayer expense. efited from more than a decade of the VFC program. Established through Title A VFA program would guarantee the government’s commitment to the pur- XIX in August, 1993, VFC was implemented nationwide in October, 1994. The chase of vaccines at fair prices and as recommended by the authoritative bodies. VFC program guarantees the federal purchase of vaccines for children who are It would expand and guarantee market share to industry, allow for vaccinations Medicaid eligible, without health insurance, American Indian, or Native Alas- of all persons in need, encourage increases in vaccine production and supply kan. It is one of the largest public and private healthcare partnerships, with and stimulate competition. Every adult should have the benefit of vaccines that over 80,000 private providers participating. It guarantees an open market for can protect against certain diseases. Such a program would be a true example all vaccine manufacturers who negotiate through CDC’s contracts. of government commitment to the protection and well being of its citizenry. Sabin Vaccine Institute Supports PAHO Project Targeting Rubella and CRS One-Year Project to Contribute to Elimination of Rubella and Congenital Rubella Syndrome in the Americas The Sabin Vaccine Institute partnered dicated that as many as 20,000 infants CRS elimination that might be adopted with the Pan American Health Organi- were born with CRS in the Americas and applied in other regions of the world. zation (PAHO) to launch a one-year each year. Today, with strong immu- project contributing to elimination of ru- nization programs, rubella incidence, bella and congenital rubella syndrome and consequently CRS, has declined (CRS) in the Americas. An agreement significantly. It is estimated, however, signed in March defines a project that that it will take more than 20 years will focus on four countries: Guatemala, for CRS to be controlled by routine Nicaragua, Bolivia, and Paraguay. childhood immunization. This project The project will emphasize adult vac- will accelerate the interruption of ru- cination and supplemental immunization bella transmission by a one-time adult activities. “Rubella, sometimes referred mass campaign to achieve more rapid to as German measles, has rather be- decrease of the number of rubella nign symptoms in adults,” said Ciro de cases and infants born with CRS. Quadros, director of international pro- PAHO adopted a resolution in 2003 grams, SVI. “For a developing fetus, to eliminate rubella and CRS by 2010. Ciro de Quadros, MD, MPH, director of international whose mother is exposed in early preg- The project is aimed at speeding up programs, SVI, and Mirta Roses Periago, director of nancy, the consequences can be devas- the progress towards this goal and will PAHO, signed the agreement for the Rubella Elimina- tating.” Surveillance in the mid-1990s in- serve as a pilot program in rubella and tion project. 4 SPRING 2005 SABIN VACCINE REPORT

Human Hookworm Vaccine Initiative Receives Vaccine IND Several More Years of Rearch on the Horizon from page 1 deficiency that results from This first phase of clinical research will zil is now assembling baseline data in a moderate and heavy infections. Because assess the initial safety of the new hook- rural area impacted by hookworm dis- women and young children have the low- worm vaccine, as well as the immune ease. In just more than a year, that data est iron stores, they are the most vul- system’s response to vaccination. Sev- and data from safety and tolerability tri- nerable to chronic hookworm blood loss. eral more years of subsequent research als in the United States will serve as In children, chronic hookworm disease on the vaccine’s effect will be required required groundwork for a wider clini- contributes to physical growth retarda- before it can be licensed for use. Look- cal trial, to ascertain the efficacy and tion and cognitive impairment. Hook- ing towards the future, the Sabin Vac- safety of the new vaccine. worm is considered a major health threat cine Institute signed a memorandum of The HHVI received past funding from to adolescent girls, women of reproduc- understanding this past fall with federal the National Institutes of Health, the tive age, and to outcomes in pregnancy and state vaccine production facilities in , and the Medi- and is a major contributor to misery and Brazil for clinical development of the cal Board of New York. For more infor- suffering in the poorest of the poor. vaccine. An HHVI team based in Bra- mation, visit www.sabin.org.

BBC World Broadcast Features HHVI Kill or Cure Segment Depicts Hookworm Disease, Vaccine Development

The diseases covered in this season’s series are river blindness, measles, multi- drug resistant TB, pneumococcal meningitis, Chagas, worms, rotavirus, diphtheria, STDs and trachoma. The programs were filmed around the world in loca- tions that included Tajikistan, Cameroon, Bolivia, Tanzania and South Korea. Pro- ducers of the series write, “Although many of these diseases have been ne- glected by modern medical science for Filming of BBC’s Kill or Cure series took place this past December at The George Washington University decades, this is a documentary series lab of the Human Hookworm Vaccine Initiative. Pictured with the film crew are, at right, HHVI’s Peter about hope. While millions of lives are Hotez and Maria Elena Bottazzi. The segment on hookworm was aired in February. lost every year, there are people work- ing on new life-saving treatments. The The plight of hookworm-infected poor The Human Hookworm Vaccine programs focus on the diseases, the vic- and the potential for a vaccine head- Initiative’s , MD, PhD, pro- tims and the handful of scientists search- lined a segment of Kill or Cure, a sci- vided an in-depth understanding of ing for the answers. Kill or Cure ex- ence and health broadcast of BBC hookworm and efforts underway to amines the development of new drugs World. The documentary series, pro- develop a hookworm vaccine. The and new ways of preventing infection.” duced in 10-part installments, is currently story line was complemented by a pro- The filming provided an opportunity to examining diseases that blight millions file of a Vietnamese girl whose life and explain the immense problem of para- of lives, and looks at the science behind the lives of those around her are pro- sitic worm disease to a wide audience. the hunt for new treatments. The hook- foundly affected by hookworm infec- “Worm infections are the most common worm program aired in February. tion indigenous in their community. infection of all human kind,” Hotez said. dedicated to disease prevention www.sabin.org 5

Sabin Fellow, Patricia Thomas, Named Knight Chair in Health and Medical Journalism

Author of Big Shot to Begin Project at University of Georgia The University of search for more than 30 years, will take flow of health news to the Southern Georgia’s Grady up her new post in August. The Univer- Black Belt, a rural strip of hundreds of College of Journal- sity is located in the center of the bio- counties winding through 11 states. ism has named science corridor between Atlanta and Thomas was the first nonphysician to Patricia Thomas its Augusta. As holder of the Knight Chair, serve as editor of the Harvard Health first Knight Chair in Thomas will partner with the Centers Letter. She has been a Knight Science Health and Medical for Disease Control and Prevention, the Journalism Fellow at the Massachusetts Journalism. Thomas, Medical College of Georgia, the Institute of Technology, and in 1998 was Patricia Thomas a Sabin fellow for Morehouse School of Medicine, and awarded the Leonard Silk Journalism the past several Emory University to develop programs Fellowship for her book Big Shot: Pas- years, will be responsible for an outreach to improve media coverage and commu- sion, Politics, and the Struggle for project to improve the flow of public nication of health issues. She will de- an AIDS Vaccine. She was also health news in the impoverished South. velop and teach courses in health and among the first healthy volunteers to Thomas, who has written about medi- medical journalism and create an out- be injected with an experimental DNA cine, public health and life science re- reach program aimed at improving the vaccine for AIDS.

In Memory of Vaccinologist of the 20th Century A long-time colleague of the Sabin medicine is based on his work. He is , in col- Vaccine Institute, Maurice R. Hilleman, credited with having developed more laboration with the PhD, DSc, 85, died April 11 at a hospi- human and animal vaccines than any Merck Company tal in Philadelphia where he was being other scientist, helping to extend human Foundation, an- treated for cancer. Hilleman was a mi- life expectancy and improving the econo- nounced the cre- crobiologist who developed vaccines for mies of many countries. He retired from ation of the Maurice mumps, measles, chickenpox, pneumo- Merck in 1984 as senior vice president. R. Hilleman Chair in nia, meningitis and other diseases. His Hilleman pioneered the development Vaccinology. discoveries have saved tens of millions of numerous vaccines, including The Hilleman of lives and reached into every home. measles, mumps, rubella, varicella, Chair will be occupied by a physician/ Though he was not as widely known Marek’s disease, hepatitis A, hepatitis scientist contributing to vaccinology on among the general public as some other B, and adenoviruses, and he participated the faculty of Penn and the post will scientists of note, his achievements in the evolution of vaccines against men- serve to accelerate the pace of vaccine match or exceed many of the greats. ingitis and pneumonia. research there. Hilleman was the fourth scientist to re- Another important aspect of his ceive the prestigious Sabin Gold Medal, work was advancing the science which he was awarded in 1997. He of combination vaccines. For in- maintained a close association with the stance, the combined measles, Sabin Vaccine Institute since then, lend- mumps, and pre- ing his expertise to Institute programs vents three diseases with only one as a member of the SVI Scientific Ad- vaccination. Children therefore re- visory Council. ceive fewer painful injections and Raised on a farm in , parents and children face less anxi- Maurice Hilleman Hilleman credited much of his success ety. Pediatricians require less stor- to his boyhood work with , age space for vaccines and less whose eggs form the foundation of so handling is required. many vaccines. He pioneered the de- In March 2005, the University of Six lucite-encased vials contain vaccines of which Maurice velopment of eight of the 14 routine vac- School of Medicine Hilleman led the development, a replica of an artifact cines and much of modern preventive and the Children’s Hospital of included in the National Millennium Time Capsule. 6 SPRING 2005 SABIN VACCINE REPORT

Routine Meningococcal Vaccination Recommended by U.S. Advisory Committee New Recommendation for Vaccination at the Pre-Teen Medical Visit

New Routine MCV4 Recommedation recognizes that vaccine supply may be cent of people with meningococcal dis- The Advisory Committee on Immuni- an issue in the first few years after li- ease die, and 11-19 percent of survivors zation Practices (ACIP) to the Centers censure of MCV4. Adolescents in other have permanent disabilities (such as for Disease Control and Prevention age groups who wish to decrease their mental retardation, hearing loss, and loss (CDC) recommends routine vaccination risk of meningococcal disease may elect of limbs). The disease often begins with of young adolescents with meningococ- to receive vaccine. symptoms that can be mistaken for com- cal (MCV4) at the College freshmen who live in dormi- mon illnesses, such as influenza. Men- pre-adolescent (11-12 year old) visit. The tories are at higher risk for meningococ- ingococcal disease is particularly dan- recommendation was announced Feb- cal disease compared to other people of gerous because it progresses rapidly and ruary 10, 2005. the same age. Because of the feasibil- can kill within hours. According to CDC, recommending ity constraints in targeting freshmen in The new meningococcal vaccine was MCV4 vaccination in pre-adolescents dormitories, colleges may elect to tar- licensed by the U.S. Food and Drug Ad- may strengthen the role of the pre-ado- get their vaccination campaigns to all ma- ministration (FDA) on January 14, 2005 lescent visit and have a positive effect triculating freshmen. The risk for men- for use in people 11-55 years of age. It on vaccine coverage. ACIP recom- ingococcal disease among non-fresh- is manufactured by Sanofi Pasteur and mends that pre-adolescents see a men college students is similar to that is marketed as Menactra™. healthcare provider at age 11-12 for a for the general 18-24-year-old popula- The vaccine is highly effective, con- routine visit, at which time appropriate tion. However, the vaccines are safe ferring protection against invasive dis- immunizations and other preventive ser- and immunogenic and can be provided ease caused by four meningococcal vices should be provided. to non-freshmen college students who serogroups—A, C, Y, and W-135. How- Expanding the MCV4 Recommendation want to reduce their risk for meningo- ever, it does not protect people against In order to extend the benefit of coccal disease. meningococcal disease caused by “type MCV4 vaccination for older adoles- Meningococcal disease is caused by B” . This type of bacteria cents, the ACIP recommends vaccina- bacteria that infect the bloodstream and causes one-third of meningococcal tion before high school entry (~15 years the linings of the brain and spinal cord, cases. More than half of the cases old). Within 3 years, the goal is routine causing serious illness. Every year in the among infants less than one year old are vaccination with MCV4 of all adoles- United States, 1,400 to 2,800 people get caused by “type B,” for which no vac- cents beginning at 11 years of age. ACIP meningococcal disease. Ten to 14 per- cine is available.

Vaccination of the Elderly Remains a Key Goal of Influenza Prevention “Impact of Influenza Vaccination on Seasonal Mortality in the U.S. Elderly Population” by Simonsen et al. (2005) Indicates the Need for Improved Vaccines and Influenza Treatments

A study published in the February 14 older get vaccinated against influenza improvement in influenza prevention Archives of Internal Medicine reported each year. They are at highest risk for efforts, including research into that vaccination of the elderly population complications, hospitalizations, and developing more effective vaccines for against influenza may be less effective deaths from influenza. Vaccination the elderly and the increased use of in preventing death among the elderly remains the best protection from medicines to treat influenza. than previously assumed. The study’s influenza available for the elderly and In addition, recently published studies findings caused some confusion about their loved ones. raise the possibility that it may be whether people 65 years and older In the current study by Simonsen et beneficial to vaccinate larger numbers should receive an influenza vaccination. al., the authors in no way imply that the of healthy persons, including children, to The Centers for Disease Control and elderly should not receive influenza prevent transmission of influenza Prevention (CDC) and National vaccine. Rather, the study concludes that to high risk persons such as the elderly. Institutes of Health (NIH) continue to the vaccine may prevent fewer deaths The ACIP and CDC continue to support the Advisory Committee on among the elderly than previous studies consider whether to expand the influenza Immunization Practices (ACIP) would have suggested. Therefore, the vaccine recommendation to other recommendation that people aged 65 and authors note that there is room for groups pending ample vaccine supply. dedicated to disease prevention www.sabin.org 7

Vaccine Developer Albert Z. Kapikian, MD, to be Awarded the Sabin Gold Medal NIH Officer John La Montagne, PhD, to be Recognized with Posthumous Award

vaccine strategy involved mating outer College in 1956 and in 1957 joined the proteins from different human rotavirus National Institutes of Health (NIH) as strains with a monkey rotavirus that is a commissioned officer of the U.S. Pub- attenuated (weakened) for humans and lic Health Service. In 1967 he was ap- combining the resulting hybrid viruses into pointed head of the Epidemiol- one vaccine. From a single-strain ogy Section of the Labo- vaccine in 1984, the vaccine ratory of Infectious was gradually made protective Diseases, a position against the four most impor- he holds today as a tant clinical strains of member of the Civil rotavirus. In 1998, this vac- Service. He has re- cine became the first ceived numerous rotavirus vaccine licensed in honors and is the the United States. author of many Kapikian graduated from Albert Kapikian scholarly papers. Cornell University Medical Continued from page 1 field of vaccines is truly extraordinary,” said H.R. Shepherd, chairman of the In- John La Montagne to be Posthumously Honored stitute. “It takes a great vision and dedi- cation to achieve such progress for hu- John R. La Montagne, PhD, who manity.” served as NIAID deputy director from In the 1950s Kapikian began studying 1998 until his sudden death this past the and causes of various November, will be posthumously recog- viral diseases. He is renowned for pio- nized at the Sabin Gold Medal ceremony. neering studies using electron micros- He was a presenter of the Sabin Gold copy to discover and characterize vi- Medal at last year’s ceremony. During ruses causing major diseases in humans. his 30-year career at NIH, La In 1972, Kapikian identified the Norwalk Montagne was a noted scientist and an , the first virus associated with acute influential leader in the field of infec- epidemic gastroenteritis, gaining recog- tious diseases. His contributions to do- nition as “the father of human gastroen- mestic and global efforts to fight emerg- John La Montagne teritis virus research.” In 1973, he and ing and re-emerging infectious diseases two colleagues identified the virus that included biodefense. He received numerous awards for his causes hepatitis A. He also became the John R. La Montagne received his PhD first person in the United States to de- scientific accomplishments, including the from Tulane University in 1971. In 1976, Public Health Service Special Recogni- tect and visualize human rotavirus, which he came to NIH as the Influenza Program was discovered by others in Australia. tion Award for leadership in childhood officer at NIAID. He became the pro- vaccine research programs, the Surgeon He dedicated his efforts to studying this gram officer for the Viral Vaccines Pro- leading cause of severe diarrhea in in- General’s Certificate of Appreciation, gram in 1983, and the Influenza and Viral and the Secretary’s Award for Distin- fants and children, which accounts for Respiratory Diseases program officer in more than 500,000 deaths annually, pre- guished Service for design and imple- 1984. Beginning in 1986, La Montagne as- mentation of critically important dominantly in the developing world. sumed the role of director of the AIDS Working with the National Institute of biodefense strategies. His longtime col- Program. In 1987 he was appointed di- league, Regina Rabinovich, MD, MPH, Allergy and Infectious Diseases rector of the Microbiology and Infectious (NIAID), Kapikian led a nearly 25-year director, Infectious Diseases, Bill & Diseases Program, which became a divi- Melinda Gates Foundation, will present effort to develop an oral rotavirus vac- sion in 1988. He was appointed deputy di- cine. The team’s neo-Jennerian rotavirus the special award to his widow, Mary rector of the NIAID in February 1998. Elaine Elliot La Montagne. 8 SPRING 2005 SABIN VACCINE REPORT

Cancer Vaccine Consortium Breaks New Ground in ELISPOT Testing ELISPOT Proficiency Panel Project is Launched

Validation is essential for all immuno- This project further allows comparison 1. Establishing leadership in shaping logical assays that are used to monitor of individual ELISPOT protocol details assay standards patient’s immune response to vaccines, with those of the entire panel, without 2. Initiating the process of working and validation efforts need to include ex- compromising anyone’s confidentiality. with the FDA on common assay stan- ternal proficiency testing. The Cancer To protect the intellectual property of dards Vaccine Consortium (CVC) has orga- each participant, the panel will be per- 3. Reducing time and cost of assay nized a groundbreaking project to help formed and results will be shared in development establish validation standards for an coded format. 4. Preserving current standards of ELISPOT assay for interferon-gamma. This panel is planned to be the first in practice while providing a basis for im- This project, an ELISPOT proficiency a series of validation and standardiza- proving individual protocols panel, will, for the very first time, bring tion projects to address the various com- 5. Building connections to other re- many members of biotech companies plex setup modalities for ELISPOT test- search groups and academia together to compare and ing in the community. 6. Providing support for broader as- test ELISPOT performance and various Various other follow-up panels are be- say development efforts protocol approaches. This effort will join ing discussed, for instance testing of This initiative was first presented at 34 laboratories working on a wide vari- weak , in vitro stimulation the CVC’s San Francisco meeting in ety of , and with a broad range strategies before ELISPOT testing, November 2004. In response to the high of vaccine types. various presentation strategies, level of interest shown by Consortium There are currently no such testing and more. members, the CVC went forward with programs set up for repeated use This project fits the CVC’s mission, the plan. Dennis Panicali, PhD, co-chair through any agency or institution. Typi- which is to help its members pursue com- of the Consortium’s Assay Working cally, they are run in small collaborative mon goals and overcome common Group, is overseeing the project. Sylvia efforts of groups working in a similar hurdles in the development of cancer Janetzki MD, PhD (ZellNet Consulting), scientific environment. For example, the vaccines. Overall Consortium goals in- an ELISPOT specialist, is managing the CVC proficiency panel is based on re- clude accelerating the development of project. The Consortium has also en- cently completed work by the ELISPOT cancer vaccines through interaction with gaged the services of BBI Biotech Re- Collaborative Study Group, a network of the FDA and other regulatory agencies; search Laboratories and statistician 11 labs involved in HIV vaccine trials. establishing communication networks Kathy Panageas, PhD, of Memorial This validation project offers an ef- among public and private organizations Sloan-Kettering Cancer Center. fective tool for testing the proficiency in pursuing cancer vaccines; and educat- For more information about the performing an ELISPOT assay. It also ing the public, media and other constitu- ELISPOT proficiency panel, please provides documentation for regulatory encies about cancer vaccines. email Susan Geiger, Executive Director and sponsoring agencies about the par- The Consortium has a number of goals of the CVC, [email protected] ticipants’ approach to this technique. for this proficiency panel. They include: or call 414-918-3199.

Save the Date Celebrating Leadership in Global Health 2005 Albert B. Sabin Vaccine Institute Awards Wednesday, June 29, 2005—The University Club, 6:30 PM Reception—7:30 PM Dinner and Awards Presentation

Ticket information, (212) 997-0100 or (203) 972-7907 dedicated to disease prevention www.sabin.org 9

Ciro de Quadros Honored by UC Berkeley with Public Health Hero Award International Award Recognizes Efforts to Rid the World of Infectious Diseases

The School of Public Health at the one whose name is “synonymous with Four additional honorees were Sarah University of California (UC), Berke- successful immunization.” He added, Weddington, JD (National Hero); former ley, celebrated the 9th annual Public “Ciro showed the countries how to get California state senator John Health Heroes Awards Ceremony on political commitment, secure interna- Vasconcellos, JD (Regional Hero); and March 18. SVI’s Ciro de Quadros, tional and external resources, and build the Pacific Business Group on Health MD, MPH, was presented with the In- effective programs.” (Organizational Hero). ternational Public Health Hero award for his work to rid the world of infec- tious diseases at the event at San Francisco’s Exploratorium. The Public Health Heroes honor was established by the UC Berkeley School of Public Health to broaden awareness and understanding of the public health field by recognizing individuals and or- ganizations for their significant contri- butions and exceptional commitment to promoting and protecting the health of the human population. “I am deeply honored by this special award,” de Quadros said. “I am pleased that it draws attention to impor- tant public health efforts being carried out around the world.” De Quadros has dedicated his career to freeing the world Dr. Ciro de Quadros, right, is presented the International Public Health Hero award by David of infectious diseases, especially those Brandling-Bennett, MD, senior program officer, Infectious Diseases Division, Global Health Program, that disproportionately affect the health Bill & Melinda Gates Foundation. Photo: Peg Skorpinski and social development of the world’s poorer countries. A pioneer in developing effective strategies for surveillance and contain- Vaccines Wins Acclaim Among Publishers ment, de Quadros served as the World Book Edited by de Quadros Merits Excellence Award Health Organization’s chief epidemiolo- gist for eradication in Ethio- Vaccines: Preventing Disease and Protecting Health, a publication of the pia in the 1970s. Following the global Pan American Health Organization, edited by Ciro de Quadros, SVI director of eradication of smallpox, he became di- international programs, won an award from the Association of American rector of the Division of Vaccines and Publishers in the medical science category. The award, presented February 8 Immunization for the Pan American at the annual conference of the group’s Professional and Scholarly Publishing Health Organization, for whom he suc- Division, is given “to acknowledge excellence in book, journal and electronic cessfully directed efforts to eradicate publishing in all the disciplines represented by professional, scholarly and poliomyelitis and measles from the reference publishing.” Western Hemisphere. The publication recounts the various ways vaccines have played a role in Since 2003, de Quadros has led SVI’s improving the health of the world’s populations, ranging from early efforts against international programs. Upon present- yellow fever at the turn of the century to the eradication of smallpox and polio ing the award, David Brandling- from the Americas to the challenges of vaccines for emerging and re-emerging Bennett, MD, senior program officer, diseases, such as HIV/AIDS and malaria. Infectious Diseases Division, Global The publication may be ordered from the PAHO publications website, Health Program, Bill & Melinda Gates publications.paho.org. Foundation, described de Quadros as 10 SPRING 2005 SABIN VACCINE REPORT

Smithsonian’s Museum of American History Marks 50th Anniversary of the New Exhibition Explores Extraordinary History of a “Medical Miracle”

Last Spring, The Sabin Vaccine Re- nities and individuals and in unexpected the Americas with Ciro de Quadros, port reported on the celebrations com- places in American society.” MD, MPH, director of international pro- memorating the polio vaccine trials that Those over 55 years of age probably grams at the Sabin Vaccine Institute. commenced in 1954. The results of the remember summers when whole com- The exhibit is a one-year display that trials were announced with jubilation in munities shut down as families kept chil- will explore some of the changes in April 1955. So, new commemorations dren home out of fear of exposure to American medicine in the 20th century have begun this month for the 50th an- polio. Today, transmission of polio world- and the impact a disease can have on niversary of the announcement of a safe wide has nearly ended. society as a whole. and effective vaccine, including a spe- Poliomyelitis is a viral disease that pri- According to the Smithsonian, the cial museum exhibit. marily affects the motor neurons that show draws upon the themes of com- The exhibit at the Smithsonian’s Na- control muscles, especially those of the munity activism, human resilience, the tional Museum of American History in limbs, breathing and swallowing, and can development and use of medical tech- Washington, DC, evokes the dread fear cause paralysis and sometimes death. nologies, medical science, and competi- of polio that preceded a vaccine and de- The inactivated (killed) polio vaccine tion and rivalry in science. By examin- lineates the years of its use to the point (IPV) was developed in 1955 by Jonas ing the complicated and where many young people have no rec- Salk, MD. A live attenuated (weakened) the vaccine that was hailed as a “medi- ollection of the disease. “Whatever Hap- oral polio vaccine was developed by Dr. cal miracle” in the 1950s, the exhibition pened to Polio?” tells the story of polio in 1961. As a result of the provides a better understanding of sci- disease in the United States, the vac- Salk and Sabin vaccines, the last case ence, health and the impact of collec- cine development, current world efforts of wild polio occurred in the United tive action on society. to eradicate polio and the stories of sur- States in 1979. A massive international Significant objects in the exhibition in- vivors and the influence they have had public-private sector collaboration began clude a syringe used during the clinical on American society. in the 1980s with the goal of eliminating trials 1954 and 1955 by ; an “The introduction of a successful po- transmission of poliovirus everywhere in iron lung; a chest respirator; objects from lio vaccine in 1955 was one of the most the world. disability activists Justin Dart, who was significant events of the 20th century,” During their exhibit preparation, the instrumental in passing the Americans said Brent D. Glass, director of the mu- Smithsonian curators conducted exten- with Disabilities Act and received the seum. “The disease has had far-reach- sive research, including an interview Presidential Medal of Freedom, and Ed ing effects both in the lives of commu- about polio elimination achievements in Roberts, who integrated the UC Berke- ley campus in the 1960s and was a founder of the independent living move- ment. Other exhibits include a gene syn- thesizer, equipment used today by vac- cinators in India and Africa, and leg braces worn by President Franklin D. Roosevelt—the most famous polio sur- vivor in America. A particularly intrigu- ing object from the museum’s collections is a piece of 70-year-old cake from one of the Birthday Balls held by the March of Dimes in honor of Roosevelt. The Smithsonian website includes in- formation related to the exhibit at americanhistory.si.edu/polio. The Jonas Salk, MD(1914-1995) developed the Albert Sabin, MD (1906-1993) developed National Museum of American History inactivated polio vaccine licensed in 1955, the live attenuated oral polio vaccine is located at 14th Street and Constitu- a version of which is used in the United licensed in 1962 and extensively used tion Avenue N.W., Washington, DC, with States today. around the globe. daily hours from 10 am to 5:30 pm, ex- cept Dec. 25. dedicated to disease prevention www.sabin.org 11

Vaccine Meetings on Influenza, Rotavirus, Cancer Yield Insightful New Releases BOOK Pandemic Influenza Threat Examined, that a new pandemic is likely to occur in the not-too-distant future and called for Global Response Plan Explored in SVI CORNER a global response plan and vaccine Proceedings Report policy to avoid the potentially over- These proceedings documents can be Pandemic influenza outbreaks (when whelming death toll that such a pandemic downloaded from www.sabin.org. a novel strain emerges to which humans could pose. These leading stakeholders Limited copies are available from the are not sufficiently immune) occur three probed different aspects of pandemic Sabin Vaccine Institute upon request. or four times a century. In these early planning, from initial source recognition days of the new millennium, scientists and surveillance to the international co- and Dendritic Cell Based Therapies,” are closely watching avian or “bird” flu ordination and political considerations of and “Clinical Trials and Immune Assess- outbreaks in Asia for signs of an impend- an emergency plan. ment of Response.” Also included are ing catastrophe. The last great epidemic participants’ submitted abstracts and a of 1918-1919, resulting in a worldwide Proceedings of 2004 Cancer Collo- death toll of between 40 million and 100 glossary. quium Published million people, is a grim reminder that The Proceedings of the Sixth Annual history could repeat itself. Better under- Rotavirus and Vaccine Development Walker’s Cay Colloquium on Cancer standing of novel influenza viruses and Appraised in Symposium Proceedings Vaccines and are now coordinated global health strategies may The rapid introduction of safe, effec- available. The 70-page document is an thwart or reduce the impact of another tive, and affordable rotavirus vaccines edited commentary encapsulating the pandemic outbreak. These consider- is urgently needed in developing coun- presentations and discussion which took ations are the subject of a new SVI pub- tries, where nearly 500,000 children a place at the March 2004 international lication, Pandemic Influenza: Can We year die from the disease, according to gathering of scientists from academia, Develop a Global Vaccine Policy? the most recent mortality estimates re- industry, and government in the field of An alarming trend in novel infectious ported at the Sixth Interna- cancer vaccines. diseases such as SARS in 2003 and in- tional Rotavirus Sympo- Following a keynote creasing cases of avian influenza abroad sium. The symposium address by Rolf has heightened the attention of the marked a watershed in the Kiessling of the world’s scientific community to imminent decades-long effort to bring Karolinska Institute dis- pandemic. While SARS was relatively such vaccines into use. cussing the Her-2/neu easily contained, its severity and new- The Proceedings of the oncogene, 27 presenta- ness surprised many. In recent months, Sixth International tions offer news of ba- avian influenza, once restricted to poul- Rotavirus Symposium de- sic and clinical re- try and wild birds, has “jumped species” scribes how, for the first search, with lessons and is now known to have infected hu- time, scientists, policy mak- and insights applicable mans both through direct animal to hu- ers, economists, public to future research and man transmission and, most alarmingly, health experts and the do- trial design. Reports in probable human-to-human cases. nor community together range from basic ques- SVI convened the 11th Annual Vac- tackled the scientific, social, tions in to prod- cine Policy Collo- and economic issues that must be re- ucts in an advanced stage of quium in the fall of solved for rotavirus vaccines to become development such as 2004, bringing to- widely accessible to the children who GVAX®, Provenge® and gether government need them most—those living in impov- Theratope®. These presen- officials, academic erishment or in developing nations. tations are grouped under scientists and industry First discovered by Dr. Ruth Bishop session titles “Target Antigen representatives to ad- in 1973, rotavirus is described as a Discovery and Validation,” dress and tackle key “democratic infection” afflicting nearly “Platforms of Vaccine Devel- issues surrounding all children, whether rich or poor, by the opment,” “Tolerance, Immu- pandemic influenza. age of 5. Yet it is the world’s poorest nosuppression, and Tumor The expert group children who are most likely to die from Escape Mechanisms,” cautiously predicted “Adoptive T Cell Therapy Continued on page 12 12 SPRING 2005 SABIN VACCINE REPORT

Book Corner SABIN June 1 – 3 North Bethesda, Maryland CALENDAR Accelerating Anticancer Agent Development and Validation Workshop APRIL-SEPTEMBER 2005 www.acceleratingworkshop.org June 7 – 8 Washington, DC April 18 – 20 Arlington, Virginia National Vaccine Advisory Committee Bio-Chem Defense Vaccines and Meeting www.hhs.gov/nvpo Therapeutics June 8 – 10 Prague, Czech Rep. www.infocastinc.com/biovac.html Plant-Based Vaccines & Antibodies Continued April 19 – 20 Montreal, Canada www.meetingsmanagement.com/pbva_2005 from World Vaccine Congress Montreal 2005 June 14 – 15 San Diego, California page 11 www.lifescienceworld.com/2005/ From Innate Immunity to Vaccines wvcm_CA www.infocastinc.com/vac.html April 24 – 30 USA Nationwide June 15 - 18 Lisbon, Portugal rotavirus. More than 80 percent of 2004 National Infant Immunization 12th International Congress on rotavirus deaths occur in developing Week Infectious Diseases countries where resources are scarce www.cdc.gov/nip/events/niiw www.isid.org and health care systems inadequate. By May 1 – 5 Lisbon, Portugal June 21 – 24 Cold Spring Harbor, NY breaking with past practices and focus- International Society of Travel Medicine 7th Annual Sabin Colloquium on Cancer ing clinical trials and licensure efforts in Conference 2005 Vaccines and Immunotherapy middle- and low-income countries, the www.istm.org www.sabin.org/pub_cancer.htm global health community would save and May 9 – 11 Baltimore, Maryland June 27 – 29 Bethesda, Maryland change the lives of children too chroni- Eighth Annual Conference on Vaccine 2005 Annual Conference on Research cally sick and weak even to attend Antimicrobial Resistance www.nfid.org/conferences www.nfid.org/conferences/resistance05 school. With a new vaccine just having en- May 10 Baltimore, Maryland June 29 New York, New York Albert B. Sabin Gold Medal Ceremony Sabin Awards Celebration tered the market and another nearing www.sabin.org/awards_gold.htm The University Club completion of clinical trials, the global May 12 – 13 Mainz, Germany www.sabin.org/awards.htm rotavirus community finds itself at a piv- 2005 June 29 – 30 Atlanta, Georgia otal juncture in the effort to overcome www.c-imt.org Advisory Committee on Immunization the devastating mortality caused by May 23 – 25 Amsterdam, Neth. Practices (ACIP) rotavirus. Successful, widespread intro- Phacilitate Vaccine Forum Spring 2005 www.cdc.gov/nip/acip duction of these vaccines will hinge on www.phacilitate.co.uk July 12 – 15 Boston, Massachusetts the answers to three fundamental ques- June 1 – 2 Rockville, Maryland NACCHO-ASTHO 2005 Joint Meeting tions: 1. Efficacy: will the new vaccines Advisory Commission on Childhood www.astho.org work equally well for children in lower Vaccines (ACCV) Meeting September 5 – 7 Lisbon, Portugal income countries as in upper- and www.hrsa.gov/osp/vicp/accv.htm Cancer Vaccines/Adjuvants/Delivery middle-income countries? 2. Safety: will www.meetingsmanagement.com/cvadd_2005 a few adverse events lead to the with- drawal of the vaccines? 3. Cost: will the new vaccines be priced and financed NON-PROFIT ORG. in a way to ensure long-term affordability U.S. POSTAGE and sustainability? PAID In a declaration signed by health offi- MONTROSE, PA cials from 16 Latin American countries PERMIT NO. 2 during the symposium, delegates agreed 161 Cherry Street RETURN SERVICE REQUESTED “to continue to support immunizations in New Canaan, CT 06840-4818 U.S.A. the region as a common good in the re- gion, as the highest political priority” and “to facilitate the introduction of the rotavirus vaccine, as soon as it becomes available at affordable prices for the countries in the region.”