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Accidental Vaccinia Virus Exposure: Information Sheet for Laboratory Workers
The University of Iowa Vaccinia Vaccination Information Form I understand that due to my occupational exposure to vaccinia virus, I may be at risk of acquiring infection from vaccinia. I have been given the opportunity to be vaccinated with the smallpox vaccine, at no charge to myself. After reading the Medication Guide and information packet from the Centers for Disease Control and Prevention (CDC) I understand there are risks involved in working with vaccinia virus, in addition to risks in receving the vaccination. My signature below indicates that I have: 1. Read the CDC’s Medication Guide that has been provided to me (follows this informational form). 2. Read the CDC’s "Important Information about Vaccinia (Smallpox) Vaccine For Laboratory Workers" that has been provided to me (follows this informational form). 3. Had an opportunity to ask questions about vaccinia with Biosafety Staff in the Environmental Health and Safety Office (EHS) at 335-8501. 4. Had the opportunity to ask questions about the vaccine with University Employee Health Clinic staff at 356-3631. I have decided to: Decline the vaccination at this time. I understand that by declining this vaccine, I continue to be at risk of acquiring an infection from vaccinia. If I continue to have occupational exposure to this virus and decide to be vaccinated in the future, I may request and receive the vaccination, at no charge to myself. Receive the vaccine, provided through the University Employee Health Clinic (UEHC). Signature: Please print name: Date: University ID number: Principal Investigator/Lab Director Name: If consenting, please also complete: Date of Birth: Job Title: List of duties and/or viruses used in lab that may cause exposure to vaccinia virus: Return page 1 of this form to: Associate Biosafety Officer, 100 EHS. -
ACAM2000 Clonal Vero Cell Culture Vaccinia Virus (New York City Board of Health Strain) — a Second-Generation Smallpox Vaccine for Biological Defense
International Journal of Infectious Diseases (2004) 8S2, S31—S44 http://intl.elsevierhealth.com/journals/ijid ACAM2000 clonal Vero cell culture vaccinia virus (New York City Board of Health strain) — a second-generation smallpox vaccine for biological defense Thomas P. Monatha,*, Joseph R. Caldwella, Wolfgang Mundtb, Joan Fuscob, Casey S. Johnsonc, Mark Bullerd, Jian Liua, Bridget Gardnera, Greg Downinga, Paul S. Bluma, Tracy Kempa, Richard Nicholsa, Richard Weltzina aAcambis Inc., 38, Sidney Street, Cambridge, MA 02139, USA bBaxter BioScience, USA and Austria cPRA International, Lenexa, KS dSt. Louis University Medical School, St. Louis MO Summary The threat of smallpox as a biological weapon has spurred efforts to create stockpiles of vaccine for emergency preparedness. In lieu of preparing vaccine in animal skin (the original method), we cloned vaccinia virus (New York City Board of Health strain, Dryvax1) by plaque purification and amplified the clone in cell culture. The overarching goal was to produce a modern vaccine that was equivalent to the currently licensed Dryvax1 in its preclinical and clinical properties, and could thus reliably protect humans against smallpox. A variety of clones were evaluated, and many were unacceptably virulent in animal models. One clonal virus (ACAM1000) was selected and produced at clinical grade in MRC-5 human diploid cells. ACAM1000 was comparable to Dryvax1 in immunogenicity and protective activity but was less neurovirulent for mice and nonhuman primates. To meet requirements for large quantities of vaccine after the events of September 11th 2001, the ACAM1000 master virus seed was used to prepare vaccine (designated ACAM2000) at large scale in Vero cells under serum-free conditions. -
Vaccinia Virus
APPENDIX 2 Vaccinia Virus • Accidental infection following transfer from the vac- cination site to another site (autoinoculation) or to Disease Agent: another person following intimate contact Likelihood of Secondary Transmission: • Vaccinia virus • Significant following direct contact Disease Agent Characteristics: At-Risk Populations: • Family: Poxviridae; Subfamily: Chordopoxvirinae; • Individuals receiving smallpox (vaccinia) vaccination Genus: Orthopoxvirus • Individuals who come in direct contact with vacci- • Virion morphology and size: Enveloped, biconcave nated persons core with two lateral bodies, brick-shaped to pleo- • Those at risk for more severe complications of infec- morphic virions, ~360 ¥ 270 ¥ 250 nm in size tion include the following: • Nucleic acid: Nonsegmented, linear, covalently ᭺ Immune-compromised persons including preg- closed, double-stranded DNA, 18.9-20.0 kb in length nant women • Physicochemical properties: Virus is inactivated at ᭺ Patients with atopy, especially those with eczema 60°C for 8 minutes, but antigen can withstand 100°C; ᭺ Patients with extensive exfoliative skin disease lyophilized virus maintains potency for 18 months at 4-6°C; virus may be stable when dried onto inanimate Vector and Reservoir Involved: surfaces; susceptible to 1% sodium hypochlorite, • No natural host 2% glutaraldehyde, and formaldehyde; disinfection of hands and environmental contamination with soap Blood Phase: and water are effective • Vaccinia DNA was detected by PCR in the blood in 6.5% of 77 military members from 1 to 3 weeks after Disease Name: smallpox (vaccinia) vaccination that resulted in a major skin reaction. • Progressive vaccinia (vaccinia necrosum or vaccinia • In the absence of complications after immunization, gangrenosum) recently published PCR and culture data suggest that • Generalized vaccinia viremia with current vaccines must be rare 3 weeks • Eczema vaccinatum after vaccination. -
Study Protocol
Clinical Trial Protocol FY12-19, HP-12-19, POX-MVA-006 A randomized, open-label Phase III non-inferiority trial to compare indicators of efficacy for MVA-BN smallpox vaccine to ACAM2000 in 18-42 year old® healthy vaccinia naïve ®subjects Clinical Trial Protocol Edition 8 29 September 2016 NCT 01913353 Bavarian Nordic Page 1 of 1 Clinical Trial Protocol Doc. No. 92000007 FY12-19, HP-12-19, POX-MVA-006 Edition 8 FY12-19, HP-12-19, POX-MVA-006 A randomized, open-label Phase III non-inferiority trial to compare indicators of efficacy for MVA-BN smallpox vaccine to ACAM2000 in 18-42 year old® healthy vaccinia naïve ®subjects Clinical Trial Protocol Edition 8 29 September 2016 Bavarian Nordic Restricted Business Proprietary Page 1 of 208 Clinical Trial Protocol Doc. No. 92000007 FYI2-19, HP-12-19, POX-MVA-006 Edition 8 29-Sep-20 16 1 General Information 1.1 Principal Investigator Signature Page Herewith I agree that I have read and fully understand this protocol: A randomized, open-label Phase Ill non-inferiority trial to compare indicators of efficacy for MVA BN® smallpox vaccine to ACAM2000® in 18-42 year old healthy vaccinia-naiVe subjects This protocol describes all the information necessary to conduct the trial. I agree that I will conduct the trial according to the instructions given within this protocol. FUithermore, T agree that I will conduct this trial according to rnternational Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP), the 2013 version ofthe Declaration ofHelsinki, the Belmont Report, as well as applicable local legal and regulatory requirements in the respective countries. -
IMVANEX, Common Name – Modified Vaccinia Ankara Virus
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT IMVANEX suspension for injection Smallpox vaccine (Live Modified Vaccinia Virus Ankara) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml) contains: Modified Vaccinia Ankara – Bavarian Nordic Live virus1 no less than 5 x 107 Inf.U * *infectious units 1 Produced in chick embryo cells This vaccine contains trace residues of chicken protein, benzonase, gentamicin and ciprofloxacin (see section 4.3). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Light yellow to pale white, milky suspension. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Active immunisation against smallpox in adults (see sections 4.4 and 5.1). The use of this vaccine should be in accordance with official recommendations. 4.2 Posology and method of administration Posology Primary vaccination (individuals previously not vaccinated against smallpox): A first dose of 0.5 ml should be administered on an elected date. A second dose of 0.5 ml should be administered no less than 28 days after the first dose. See sections 4.4 and 5.1. Booster vaccination (individuals previously vaccinated against smallpox): There are inadequate data to determine the appropriate timing of booster doses. If a booster dose is considered necessary then a single dose of 0.5 ml should be administered. See sections 4.4 and 5.1. -
IMVAMUNE® and ACAM2000® Provide Different Protection Against
Article IMVAMUNE® and ACAM2000® Provide Different Protection against Disease When Administered Postexposure in an Intranasal Monkeypox Challenge Prairie Dog Model M. Shannon Keckler 1,2 , Johanna S Salzer 1,3, Nishi Patel 1,4, Michael B Townsend 1, Yoshinori J Nakazawa 1, Jeffrey B Doty 1, Nadia F Gallardo-Romero 1, Panayampalli S Satheshkumar 1, Darin S Carroll 1,5, Kevin L Karem 1,6 and Inger K Damon 1,* 1 Poxvirus and Rabies Branch, Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Atlanta, GA 30333, USA; [email protected] (M.S.K.); [email protected] (J.S.S.); [email protected] (N.P.); [email protected] (M.B.T.); [email protected] (Y.J.N.); [email protected] (J.B.D.); [email protected] (N.F.G.-R.); [email protected] (P.S.S.); [email protected] (D.S.C.); [email protected] (K.L.K.) 2 Clinical and Environmental Microbiology Branch, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Atlanta, GA 30333, USA 3 Bacterial Special Pathogens Branch, Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Atlanta, GA 30333, USA 4 Respiratory Diseases Branch, Division of Bacterial Diseases, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Atlanta, GA 30333, USA 5 Office of the Director, National Center for Emerging and Zoonotic Diseases, Centers for Disease Control and Prevention, U.S. -
(ACIP) General Best Guidance for Immunization
Appendix 1: Glossary Adverse event. An undesirable medical condition that occurs following vaccination which might be truly caused by a vaccine, or it might be pure coincidence. Adverse reaction. An undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect. Adjuvant. A vaccine component distinct from the antigen that enhances the immune response to the antigen. Antitoxin. A solution of antibodies against a toxin. Antitoxin can be derived from either human (e.g., tetanus immune globulin) or animal (usually equine) sources (e.g., diphtheria and botulism antitoxin). Antitoxins are used to confer passive immunity and for treatment. Hyperimmune globulin (specific). Special preparations obtained from blood plasma from donor pools preselected for a high antibody content against a specific antigen (e.g., hepatitis B immune globulin, varicella-zoster immune globulin, rabies immune globulin, tetanus immune globulin, vaccinia immune globulin, cytomegalovirus immune globulin, botulism immune globulin). Immune globulin. A sterile solution containing antibodies, which are usually obtained from human blood. It is obtained by cold ethanol fractionation of large pools of blood plasma and contains 15%-18% protein. Intended for intramuscular administration, immune globulin is primarily indicated for routine maintenance of immunity among certain immunodeficient persons and for passive protection against measles and hepatitis A. General Best Practice Guidelines for Immunization: Appendix 1: Glossary 189 Immunobiologic. Antigenic substances (e.g., vaccines and toxoids) or antibody- containing preparations (e.g., globulins and antitoxins) from human or animal donors. -
Guidelines for Vaccination of Adult Solid Organ Transplant Candidates and Recipients
Stanford Healthcare Vaccination Subcommittee Issue Date: 7/2018 Guidelines for Vaccination of Adult Solid Organ Transplant Candidates and Recipients A. General considerations regarding vaccination 1. Adult solid organ transplant (SOT) candidates and recipients should receive all vaccines indicated based on their ages, medical conditions, and other factors that apply to non- SOT candidates or recipients (see http://www.cdc.gov/vaccines/schedules/hcp/adult.html, Appendix A, and Appendix B) except for the below-listed exceptions or additions. • All SOT candidates and recipients should be vaccinated against pneumococcus with PCV13 and PPSV23. • All SOT candidates and recipients should receive a HepB vaccine series with post-vaccination titers unless they have a documented anti-HBs titer of ≥ 10 mIU/mL after a properly-timed HepB series or unless they have known hepatitis B virus infection. • All SOT candidates and recipients should receive a HepA vaccine series unless previously administered or unless they have a positive hepatitis A virus immunoglobulin G assay. • Live-attenuated vaccines1 should not be administered to SOT recipients, SOT candidates on immunosuppression, or SOT candidates who may undergo SOT within 4 weeks. The timing of inactivated, subunit, or toxoid vaccines is discussed below. Vaccine Notes Influenza Can be given pre- and/or post-SOT (see Appendix C) Tdap or Td Can be given pre- and/or post-SOT Live-attenuated vaccine to be given pre-SOT only; generally those born MMR before 1957 (among others) are considered immune -
The Study of Thimerosal and Autism
The Study of Thimerosal and Autism Documentation and Codebook for the Child Vaccination Histories File: Cambridge, MA Lexington, MA Hadley, MA Bethesda, MD September 3, 2010 Chicago, IL Prepared for Frank DeStefano National Immunization Program Centers for Disease Control and Prevention Atlanta, GA 30329 Prepared by Cristofer Price Yeqin He Abt Associates Inc. Suite 800 North 4550 Montgomery Avenue Bethesda, MD 20814-3343 This documentation was prepared by Cristofer Price and Yeqin He of Abt Associates Inc. for the Immunization Safety Office (ISO) of the Centers for Disease Control and Prevention (CDC) Atlanta, GA 30333. Questions about the documentation, substantive questions, or technical issues regarding the data file should be directed to the CDC ISO, MS D26, 1600 Clifton Road, Atlanta, Georgia 30333 (404-639-8256). Suggested Citation for Study of Thimerosal and Autism Public Use Data Set: Price, C.S., He, Y. (2010) The Study of Thimerosal and Autism: Data Set Documentation. Bethesda MD: Abt Associates, Inc; Prepared for the National Immunization Program Centers for Disease Control and Prevention Atlanta, GA Abt Associates Inc. 1 Documentation and Codebook for the Child Vaccination Histories File 1. Introduction to the Child Vaccination Histories File............................................... 2 2. File Formats and Variable Descriptions................................................................... 4 1. Introduction to the Child Vaccination Histories File The Child Vaccination Histories File contains the data that were used to construct the measures of early childhood (postnatal) exposure to ethylmercury from thimerosal- containing vaccines and immune globulin preparations received by the study children during the age range spanning birth to 20 months. The Child Vaccination Histories File is provided with the public use data in order to make the calculation of exposure amounts transparent, and so that analysts have the potential to calculate alternative measures of exposure1. -
Investigator's Brochure: Vaccinia Immune Globulin
Use of Vaccinia Immune Globulin (VIG) For Treatment of vaccinia vaccine complications and for prophylaxis of unvaccinated individuals exposed to Orthopoxviruses responsive to VIG Investigational New Drug (IND) Proposal TABLE OF CONTENTS: 1. Introduction............................................................Page 2 2. Effects in Humans..................................................Pages 3 - 4 3. Nonclinical Studies.................................................Pages 5- 6 4. Rationale and Objectives.........................................Page 7 5. Study Design... .......................................................Page 8 6. Additional Information - Selected References..........Pages 9 - 15 Page -1- INVESTIGATOR’S BROCHURE INTRODUCTION This Investigational New Drug Application is being filed in order to make existing stocks of Vaccinia Immune Globulin available for treatment of complications of vaccinia vaccination or exposure to vaccinia or related pox viruses. Vaccinia Immune Globulin (VIG) (Human) is an isotonic sterile solution of the immunoglobulin fraction of plasma from persons vaccinated with vaccinia vaccine. The current lot, 0448A101A, was released as a licensed product by Baxter Healthcare Corporation in 1995. In 1998 a slight discoloration was noted in this product and the FDA placed a hold on its release. Consequently, VIG can no longer be entered into interstate commerce under terms of the approved license and must therefore revert to IND (investigational new drug) status. CDC follows the June 22, 2001 Recommendations of the Immunization Practices Advisory Committee (ACIP) for Vaccinia (Smallpox) Vaccine. Since 1983 CDC has provided vaccinia vaccine for laboratory workers directly involved with smallpox or closely related orthopox viruses (e.g., monkeypox and vaccinia). Due to clinical trials involving recombinant vaccinia virus vaccines, health-care workers (e.g., physicians and nurses) may now be exposed to vaccinia and recombinant vaccinia viruses and may be considered for vaccinia vaccination. -
(GRADE) for Use of Smallpox Vaccine in Laboratory and Health
Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) for Use of Smallpox Vaccine in Laboratory and Health-Care Personnel at Risk for Occupational Exposure to Orthopoxviruses: Recommendations of the Advisory Committee on Immunization Practices, 2015. Background ACAM2000, a live vaccinia virus vaccine, is the only smallpox vaccine currently licensed and available in the United States (U.S.) for vaccination of persons at risk for orthopoxviral disease. ACAM2000 is produced in Vero cells and derived from a clonal isolate of Dryvax, the New York City Board of Health strain widely used during the smallpox eradication campaign [1-5]. Like Dryvax, ACAM2000 is administered percutaneously using a bifurcated needle, and comes with potential risks of serious adverse events [6-7]. Recommendations of the U.S. Advisory Committee on Immunization Practices (ACIP) regarding smallpox (vaccinia) vaccination, most recently revised in 2003, specify Dryvax as the designated smallpox vaccine in routine non-emergency vaccination programs, which primarily involve laboratory and health-care personnel, as well as select military personnel [8-9]. However, as the license for Dryvax was withdrawn in 2008, and remaining vaccine supplies were subsequently destroyed, the need to develop new ACIP recommendations based on ACAM2000 is paramount [10]. Thus, the ACIP Smallpox Vaccine Work Group has applied the GRADE framework to the available evidence evaluating the administration of ACAM2000 in laboratory and health-care personnel at risk for orthopoxviral -
Nebraska State Immunization Information System – Flat File Specification Version 10.1.0 (Revised 7/09/2021)
Nebraska State Immunization Information System – Flat File Specification Version 10.1.0 (Revised 7/09/2021) Immunization data is passed to the central registry using three flat files containing client, immunization, and comment information (optional) respectively. The files will be linked via a 24-character Record Identifier supplied by the provider of the file. This identifier will uniquely identify each client and will appear in each immunization and comment (optional) record to link the immunization and comment (optional) to the client. Character fields need to be left justified and blank-filled, number fields right justified and blank- filled, and date fields in format MMDDYYYY with leading zeroes. If a site is unable to supply any information for a specified field, the entire field needs be filled with spaces. Below are the fields to include in each of the files. Files need to be generated using the ASCII character set. Records will be fixed length and need to be terminated with a carriage return/line feed. If you have questions on concerning flat files, contact the Help Desk at [email protected]. Client Data Column Data type Required Default Notes Record Identifier Char(24) Y Supplied by sender, used to link a Client to Immunization records. Client Status Char(1) A Use the NESIIS code set for Client Status. First Name Char(25) Y If client does not have a first name, NO FIRST NAME must be entered in this field. Middle Name Char(25) Last Name Char(35) Y Name Suffix Char(10) JR, III, etc. Birth Date Date(8) Y MMDDYYYY Death Date Date(8) MMDDYYYY Mothers First Name Char(25) These are mandatory fields in NESIIS.