Skip to main content

An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program (2003) / Chapter Skim
Currently Skimming:

7 Summary Assessment of the CDC Anthrax Vaccine Research Plan
Pages 91-100

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 91...
... determining immunological correlates of protection and documenting vaccine efficacy; and (3) optimizing the vaccination schedule and routes of administration to assure efficacy while minimizing the number of doses required and the occurrence of adverse events." Over the course of the committee's five open meetings, CDC provided written information and oral presentations about its developing anthrax vaccine research program.
Read the entire page →
From page 92...
... While CDC designated all of the proposed studies as of high priority; the committee concluded that two efforts should be considered of the highest priority. One is the clinical trial and its related studies, which are aimed at identifying correlates of protection and establishing the optimal vaccination schedule and route of vaccine administration in terms of achieving a satisfactory immune response and minimizing the occurrence of adverse events.
Read the entire page →
From page 93...
... 53) VHC-based study of the effect of womeh's hormonal phase on the occurrence of adverse events following immunization with AVA (Chapter 5, p.
Read the entire page →
From page 94...
... Network could, with a study population comparable in size to that of the clinical trial, provide useful postmarketing-type data to confirm the rates observed in the human clinical trial of common adverse events that occur soon after vaccination. With the plans to seek approval from the Food and Drug Administration for a change from SQ to IM administration of AVA, the study must be initiated promptly to include the planned comparisons of rates of adverse events with SQ and IM administration.
Read the entire page →
From page 95...
... Hypothesis testing with DMSS should be one of CDC's highest priorities, but the research plan does not reflect that. Finally, the committee believes the proposed study of the possible role of aluminum hydroxide in adverse events would be difficult to conduct and is not of sufficient priority to pursue as part of the CDC anthrax vaccine research program.
Read the entire page →
From page 96...
... This research is also needed to establish the appropriate duration for antibiotic prophylaxis after vaccine administration (IOM, 2002~. Finding: Additional studies in laboratory animals of the efficacy of AVA in combination with antibiotics following inhalational exposure to anthrax spores are needed to establish an appropriate duration for antibiotic prophylaxis after vaccine administration (see TOM, 2002~.
Read the entire page →
From page 97...
... A NEED FOR A SINGLE PROGRAM LEADER From its review, the committee sees evidence of a need for strong overall leadership of the CDC anthrax vaccine research plan to provide management and oversight. Although the research Sian responds well to the specific elements of the congressional mandate, it currently includes studies that the committee concluded should have a low priority or should not be conducted, and it omits studies that the committee considers important.
Read the entire page →
From page 98...
... The committee is persuaded that effective coordination of a research program distributed across two separate organizational units of CDC requires management by a single senior CDC biomedical scientist with responsibility for the overall program. In addition to monitoring timelines and providing prioritization and strategic planning for the research program, a clearly defined leader can facilitate appropriate responses to changing circumstances and new opportunities that may arise.
Read the entire page →
From page 99...
... Recommendation: CDC should establish clearly defined senior leadership for the anthrax vaccine research program to articulate precise objectives for the research plan and to provide authority and accountability in the management of a coherent research plan. A single senior biomedical scientist should be given management authority for the entire program.
Read the entire page →

Key Terms

  • adverse events
  • research plan
  • clinical trial
  • vaccine research
  • congressional mandate

  • anthrax spores
  • cdc anthrax
  • human clinical
  • cdc research
  • defense medical

  • individual studies
  • military personnel
  • medical surveillance
  • efficacy research
  • vaccine following

  • vaccine safety
  • passive protection
  • chronic illnesses
  • testing hypotheses
  • vaccination schedule

  • immunological correlates
  • critical research
  • hypothesis generation
  • vulnerable populations
  • protection studies

  • vaccine administration
  • hormonal phase
  • changing circumstances
  • low priority
  • screen data


    • This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
    More information on Chapter Skim is available.