Surrogates of Protection in Repeated Low-Dose Challenge Experiments

Details

• Alternative Title:
  Stat Med
• Personal Author:
  Long, Dustin M. ; Hudgens, Michael G. ; Wu, Chih-Da
• Description:
  A critical step toward developing a successful vaccine to control the human immunodeficiency virus pandemic entails evaluation of vaccine candidates in non-human primates (NHPs). Historically, these studies have usually entailed challenges (i.e., exposures) with very high doses of a simian version of human immunodeficiency virus, resulting in infection of all NHPs in the experiment after a single challenge. More recently, researchers have begun to conduct repeated low-dose challenge (RLC) studies in NHPs that are believed to more closely mimic typical exposure in natural human transmission settings. One objective of RLC studies is to assess whether measured immune responses to vaccination can serve as surrogate endpoints for the primary endpoint of interest, namely infection. In this paper, different designs of RLC studies for assessing a binary surrogate of protection are considered.
• Subjects:
  AIDS Vaccines Animals Article Binomial Distribution Causal Inference Computer Simulation Cross-Over Studies Disease Models, Animal Drug Evaluation, Preclinical HIV HIV Infections Humans Immunogenicity Infectious Diseases Likelihood Functions Primates Simian Acquired Immunodeficiency Syndrome Simian Immunodeficiency Virus Transmission Probability Vaccine

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• Source:
  Stat Med. 2014; 34(10):1747-1760.
• Pubmed ID:
  25628249
• Pubmed Central ID:
  PMC4390486
• Document Type:
  Journal Article
• Funding:
  P30 AI050410/AI/NIAID NIH HHS/United States ; P30-AI50410/AI/NIAID NIH HHS/United States ; R37 AI054165/AI/NIAID NIH HHS/United States ; R37-AI054165/AI/NIAID NIH HHS/United States ; U48-DP-001921/DP/NCCDPHP CDC HHS/United States ; U54 GM104942/GM/NIGMS NIH HHS/United States ; U54-GM104942/GM/NIGMS NIH HHS/United States
• Volume:
  34
• Issue:
  10
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:6cad433a68526c6500ddb95e8d29d41925e8df08a5594b6de03820ad1038071c
• Download URL:
  https://stacks.cdc.gov/view/cdc/31382/cdc_31382_DS1.pdf
• File Type:
  [PDF - 293.88 KB ]