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Appendix C: CDC Anthrax Vaccine Safety and Efficacy Research Plan
Pages 113-136

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From page 113...
... Appendix C Anthrax Vaccine Safety & Efficacy Research Plan Centers for Disease Control and Prevention (CDC) Department of Health and Human Services February 21, 2002 113
From page 114...
... The DoD role is to focus on the clinical management and follow-up of service personnel with vaccine associated adverse events and the CDC role is to evaluate the VHC network's impact, assess interventions and conduct vaccine safety-related research through these centers. This CDCAnthrax Vaccine Safety & Efficacy Research Plan proposes in greater detail several AVA research studies and activities that address the U.S.
From page 115...
... Summary of Objectives for E~cacy 10 Human clinical trials: 10 Non-human primate studies: 10 2. SAFETY 1 0 Rationale.
From page 116...
... In addition to evaluating the efficacy and short and long-term safety of AVA, CDC and its partners will use a variety of approaches to improve the acceptance of AVA amongst military personnel. The implementation of the CDCAnthrax Vaccine Safety & Efficacy Research Plan will provide scientific benefits for researchers in several disciplines e.g., the identification of measurable markers of protective immunity to anthrax infection will facilitate ongoing efforts by DoD, NTEl, and others to design and validate a new generation of technologically advanced vaccines that will be more effective, less reactogenic, and easier to administer than AVA.
From page 117...
... . ~ addition, four different AVA efficacy studies conducted in nonhuman primates indicated that the vaccine provides protection against challenge with aerosolized anthrax spores.7 ~ 9 it Animal studies suggest that AVA's efficacy is based on a protective immune response to a protein called Protective Antigen SPAN.
From page 118...
... ldcluded in the list are the studies' prioritization and an explanation for the basis of their pnoritization. An integrated timeline of all CDC's AVA research studies is included in Section 2 of the binder and a table that outlines the critical AVA safety and efficacy research questions that are addressed by each study is included in Section 3 of the binder.
From page 119...
... Priority: Level ~ Basis: The human clinical trial is expected to serve as the pnncipal scientific basis for decisions regarding changes in route of vaccine administration and reduction in number of doses in the vaccination series. In combination with the other studies, this trial will provide new understanding about anthrax pathogenesis and immunologic correlates for protection against inhalational anthrax in humans.
From page 120...
... Priority: Level ~ Basis: This is the only nationally representative survey to obtain data on the knowledge and awareness of VAERS, and the attitudes and practices of both military and civilian healthcare providers regarding the reporting of adverse events following AVA immunization. A contract has been established with RTt and a draft protocol is being developed.
From page 121...
... 6, 2001. Study S. Enhanced Signal Detection and Hypothesis Testing for Adverse Events Following Anthrax Vaccination & MOU Between AVSA/N~ and AMSA/DoD (See Section 13 in the binder for study summary)
From page 122...
... Efficacy Rationale: Because AVA's efficacy in providing protection against inhalational anthrax cannot be ethically evaluated in human subjects, the efficacy studies will involve concurrent teals in humans and non-human Inmates. The animal studies will include a dose-ranging study whose aim is to induce a graded series of humoral and cell-mediated immune responses in animals vaccinated with different dilutions of AVA, using 3 priming shots of each dilution in each trial group.
From page 123...
... The program has elicited some opposition among service personnel and allegations have been made regarding the health effects associated with the vaccine including high rates of local adverse events, and possible linkage with Gulf War Illness, Chronic Fatigue Syndrome, and reproductive toxicity. These concerns led the U.S.
From page 124...
... Safety studies conducted as part of the human clinical trials will help deter~nine whether intramuscular administration and a reduction in the number of priming shots decreases the incidence of local AEs, and other short-term AVA-associated AEs. These studies will also help identify potential risk factors for AEs (e.g., gender differences)
From page 125...
... , using the SF-36 Health Survey Other safety studies: D Identify rare or long-term AVA-associated adverse events, through: Active, VHC-based surveillance for AVA-associated AEs [Study 73.
From page 126...
... Conducting clinical evaluations and retrospective studies of individuals with rare AVA associated AEs. Identification methods for these individuals will occur through VHC Network and/or VAERS reports (including as a result of enhanced signal detection methods)
From page 127...
... The implementation ofthe CDCAnthrax Vaccine Safety & Efficacy Research Plan will have significant future benefits beyond the immediate ones of evaluating the safety, efficacy, and acceptability of AVA. For example, the identification of the immune correlates of protection against anthrax infection, as well as the standardization of relevant immunologic assays will speed the development, laboratory evaluation, and clinical testing of the next generation of anthrax vaccines.
From page 128...
... Department of Defense: CDC will continue to partner with DoD and expand the VHC network, which will serve as a platform from which to conduct AVA safety and acceptability research among military personnel. DoD centers and divisions involved in the partnership thus far include: Walter Reed Army Medical Center (WRAMC)
From page 129...
... Universities and medical centers: The human clinical trial is being performed in collaboration with scientists and physicians at Emory University School of Medicine, Baylor College of Medicine, Mayo Clinic and Foundation, Walter Reed Army Institute of Research and TIniversitv cuff A] ahama at Birmingham · "d "d · .
From page 130...
... The Laboratory Issues Panel, which met in September, 2001, to review the laboratory assays in Studies ~ through 3, and which will meet on a semi-annual basis to confirm that the assays are adequate for identifying and measuring immunologic markers of immune protection in animals and humans. The Statistics Panel, which met in October, 2001, and which will meet on a semi-annual basis to consider how to perform multiple imputations of the clinical trial data set to properly account for missing data from non-compliance or loss to follow-up, and to consider how the correlates of protection data (Study 3)
From page 131...
... The Ad hoc Pane] for Review of the National Immunization Program's KAB Survey Protocol, which met in December, 2001, to review the research protocol for the national survey of knowledge, attitudes and beliefs regarding the anthrax vaccine among military personnel and to offer recommendations on improvements and/or enhancements to the research protocol.
From page 132...
... Expert Consultation Panels Data Safely Monitoring Board Date: Sept 2S, 2001 Charge: To review all aspects of human clinical trial design, including Studies ~ through 3. Panel Members: Stanley Plotkin, M.D.
From page 133...
... Date: October I-2, 2001 Charge: to consider how to perform multiple imputations of the clinical trial data set to properly account for missing data from non-compliance or loss to follow-up, and to consider how the correlates of protection data (Study 3) might be pooled and analyzed to make inferences about how long protection lasts, when it is achieved and whether a reduced number of priming doses will provide adequate protection in humans.
From page 134...
... University of Minnesota The Ad hoc Pane! for Review of the National Immunization Program's Research Agenda for Investigating the Safely of AVA Date: October 19, 2001 Charge: To offer comments on the overall focus and design of NIP's AVA-related research agenda, and to offer recommendations on improvements andJor enhancements to the current research agenda.
From page 135...
... Senior Scientist, USAMRUD The CDC Internal Pane! to Review the Draft Protocol for a Long-term Follow up Study of Civilian Recipients of AVA Date: October 4, 2001 Charge: To review the draft research protocol for evaluating the mortality experience and current functional status of persons who were vaccinated with AVA more than 10 years ago.
From page 136...
... regarding the anthrax vaccine among military personnel and to offer recommendations on improvements and/or enhancements. In particular recommendations concerning the soundness of study design, and strategies to ensure the methods proposed answer the aims of the KAB survey in each of the following areas: Does the study design appear feasible?


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