New Smallpox Vaccine Found Safer Than Existing Vaccines
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APRIL 2009 • WWW.SKINANDALLERGYNEWS.COM INFECTIOUS DISEASES 37 Gardasil Prevents Warts, HPV Misunderstood, Feared HPV Infection in Males In One Border Community BY PATRICE WENDLING diagnosis of HPV as a diagnosis of BY MIRIAM E. TUCKER ACIP from the American Academy of Fam- cancer. They expressed their fears of ily Physicians. ispanic men and women liv- cancer and their belief that, once di- ATLANTA — The human papillomavirus In the randomized, double-blind, placebo- Hing on the United States–Mex- agnosed, it is “essentially a death vaccine was efficacious in preventing persis- controlled trial, three doses of Gardasil or ico border have little understanding sentence.” The women said they tent infections and genital warts caused by placebo were given at 0, 2, and 6 months. about the human papillomavirus would be reluctant to disclose their HPV strains 6, 11, 16, and 18 in a Merck-spon- Mean follow-up for this analysis was 30 and its role in the etiology of cer- HPV status to their partners be- sored study of 4,065 males aged 16-26 years. months of a planned total of 36. The study vical cancer, according to a small cause they believed they would be The findings were presented by Dr. Richard population, which came from 18 different prospective study. accused of infidelity. Men initially M. Haupt at a meeting of the Centers for Dis- countries, included 3,463 heterosexual males Not only were there very low lev- expressed anger at the possibility of ease Control and Prevention’s Advisory Com- aged 16-23 years and 602 males aged 16-26 who els of knowledge among these res- an HPV diagnosis, attributing it to mittee on Immunization Practices. Merck have sex with men. Because of problems in en- idents, but their misconceptions infidelity, Dr. Fernandez said. After had previously reported immunogenicity and rollment, data collection for the latter group and confusion continued even after a brief explanation about the ambi- safety data for its HPV lags behind by about a they were given some basic infor- guity of HPV transmission, they vaccine (Gardasil) in Vaccine efficacy year, Dr. Haupt noted. mation about HPV and cervical ascribed their initial reaction to cul- younger males aged 9- was 90.4% At baseline, 12% of cancer, Maria Fernandez, Ph.D., tural ideals of machismo. 15 years, but these are against external the entire group was said in Carefree, Ariz., during a Dr. Fernandez acknowledged the first data on effica- genital lesions polymerase chain reac- press conference sponsored by the that the border communities and cy in males and the first and 85.6% in tion–positive to at least American Association for Cancer colonias face unique challenges, findings in older ado- preventing one of the four vaccine Research. For example, participants and that the findings of this small, lescent and adult males. infection. virus types. By serology, tended to compare HPV with HIV qualitative study should not be The rationale for use 8% were seropositive to and other sexually transmitted in- generalized. of Gardasil in males is DR. HAUPT at least one type. With fections, and were confused or un- “On the other hand, it raises twofold. There is in- the results of PCR and aware that men could have HPV some interesting questions about trinsic benefit to males themselves since serology combined, 83% of the group was and transmit it. what we’ve heard in many other HPV strain 18 causes penile, anal, and naive to all four types. Moreover, most who She reported on 30 Hispanic studies about cultural norms, such oropharyngeal cancer and HPV 6 and 11 are were infected had just one type, suggesting women and 11 Hispanic men with- as things like machismo and the associated with genital warts. There is also that “the vast majority would benefit from the out a diagnosis of HPV who lived way we’ve traditionally interpret- a public health benefit to vaccinating males vaccine,” Dr. Haupt said. in Rio Grande Valley colonias (un- ed this concept,” she said. “As we against HPV since coverage among girls is Per protocol, efficacy of the vaccine was incorporated border settlements) saw in these focus groups, there’s likely to be incomplete, transition of HPV 90.4% against external genital lesions, 85.6% and participated in focus groups in sort of an initial reaction, but then occurs efficiently between sexual partners, in preventing persistent infection (from two Brownsville, Tex. The mean age people talked about standing by and “gender-neutral” vaccination would be or more consecutive visits), and 44.7% against was 41 years among the women their partner.” expected to reduce overall viral transmission DNA detection of a vaccine virus strain in (range, 20-74 years) and 39 years Clues about these cultural in the entire population, noted Dr. Haupt of anogenital specimen from one or more vis- among the men (range, 19-76 norms and beliefs are essential to Merck Research Laboratories, Whitehouse its. All three of those results were statistical- years). The average annual income the design and implementation of Station, N.J. ly significant, he said. for a family of four in these semi- successful and badly needed inter- ACIP is expected to recommend the vac- Safety analysis showed similar findings to rural neighborhoods was $13,000. ventions for HPV prevention. cine for use in males aged 11-12 at the ado- those seen in females. Local site reactions About 60% of participants had not “You have to be very cautious in lescent visit, just as it is now given to girls. were the most common adverse event, oc- completed grade school. terms of generalizing these find- This should simplify implementation, Dr. curring in 60% of the 2,020 Gardasil recipi- Analysis of the Spanish-language ings, but many of the populations Doug Campos-Outcalt, of the University of ents and 54% of the 2,029 placebo recipients. focus group transcripts revealed that that are suffering increased inci- Arizona, Phoenix, said in an interview. Systemic reactions, serious adverse events, attitudes and concerns about HPV dence of HPV and cervical cancer “There are now four vaccines recom- and discontinuations were uncommon and differed by gender, said Dr. Fernan- and increased mortality are in this mended for adolescents. I think there will be were not different between the Gardasil and dez of the division of health pro- area,” Dr. Fernandez said. a period of time before we get high accep- placebo groups, Dr. Haupt reported. motion and behavioral sciences at The study was funded by the tance rates, but it will help to have other vac- Merck has filed an application with the the University of Texas in Houston. National Institutes of Health. The cines being offered at the same time,” said Dr. Food and Drug Administration for licensure Women in particular viewed the authors reported no conflicts of Campos-Outcalt, who serves as the liaison to of Gardasil in males aged 9-26 years. ■ disease with fatalism, interpreting a interest. ■ New Smallpox Vaccine Found Safer Than Existing Vaccines BY MARY ANN MOON than first-generation vaccines yet highly such as autoinoculation/ contact immunogenic is crucial to constructing inoculation, eczema vaccinatum, he third-generation smallpox vac- a prevention plan in the event of a bioter- progressive vaccinia, generalized Tcine LC16m8 was found to be as im- rorist attack,” the investigators noted. vaccinia, encephalitis, or the myo- munogenic as existing smallpox vaccines They assessed the LC16m8 vaccine in pericarditis that has been “a major but appeared to be safer in a study of healthy personnel in the Japan Self-De- concern” in the U.S. vaccination over 3,000 Japanese adults. fense Forces inoculated in 2002-2005. program. The researchers noted . R The live, attenuated, tissue-cultured Nearly 99% were men, and all were J that while the total sample size in LC16m8 vaccine proved to be immuno- Asian. A total of 1,529 had never been the study limited their ability to OBLE genic in adults who had never received vaccinated, and 1,692 had previously N “conclusively confirm that ab- any smallpox vaccination, and it pro- been vaccinated against smallpox (JAMA OHN sence of severe adverse events,” . J duced an adequate booster response in 2009;301:1025-33). R their results support the conclu- those who had been vaccinated. The proportion of “takes”—the visible sion that LC16m8 “causes minimal As important, the LC16m8 vaccine skin reactions to a single intraepidermal CDC/ D local manifestations and systemic produced minimal local reactions and no scarification—was comparable to that The lesions on this patient’s arm were adverse effects.” severe adverse events, said Dr. Tomoya seen with other vaccines, as were serum caused by the smallpox virus, variola major. The study findings suggest that Saito of the department of tropical med- levels of neutralizing antibodies. LC16m8 is “a viable alternative to icine and parasitology, Keio University, The seroconversion rate was over ously vaccinated, Dr. Saito and col- first-, second-, and other third-generation Tokyo, and associates. 90% in those who were never vaccinat- leagues wrote. vaccines in a smallpox preparedness pro- “Developing a vaccine that is safer ed and 60% in those who were previ- There were no severe adverse events gram,” they added. ■.