Gilbert PB, Chiu YL, Allen M, Lawrence DN, Chapdu C, Israel H et al.Long-term safety analysis of preventive HIV-1 vaccines evaluated in AIDS vaccine evaluation group NIAID-sponsored Phase I and II clinical trials. Vaccine 21:2933-2947

University of Rochester, Rochester, New York, United States
Vaccine (Impact Factor: 3.62). 07/2003; 21(21-22):2933-47. DOI: 10.1016/S0264-410X(03)00158-0
Source: PubMed


This report evaluates long-term safety data from 3189 human immunodeficiency virus type 1 (HIV-1) uninfected, healthy volunteers who were enrolled into 51 National Institute of Allergy and Infectious Diseases (NIAID)-sponsored Phase I and II multicentred, randomized, double-blind trials of recombinant HIV-1 subunit vaccines (23 studies), synthetic peptide vaccines (7 studies), live vaccinia-vector recombinant envelope vaccines (7 studies), canarypox vector recombinant vaccines (13 studies), a DNA vaccine (1 study), and a Salmonella-vector vaccine (1 study). During the 12,340 person-years of follow-up, participants were monitored for adverse events including immune dysfunction/autoimmunity, anaphylaxis, cancer, death, and vaccine allergy. The analysis provides evidence that a preparation of a C4-V3 polypeptide vaccine emulsified in incomplete Freund's caused serious toxicity, but otherwise no safety problems considered serious were identified for any of the vaccines and adjuvants studied. These data serve to solidify the growing safety base of current vaccine technologies utilized in candidate vaccines for HIV-1 infection.

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    • "In addition, PCPP has been safely tested in Phase I clinical trials as an adjuvant with an influenza vaccine on young and elderly human adults with enhanced immune responses in sera and no side effects [45]. PCPP also been used in clinical trials on a HIV vaccine [46]. Clinical studies of PCEP have yet to be reported. "
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    • "HVTN clinical staff code adverse events into MedDRA lower level terms, which are then linked to MedDRA body system and preferred terms for reporting. A comprehensive summary of safety events in NIAID-sponsored Phase I and II HIV-1 vaccine trials can be found in Ref. [16] "
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    • "These papers are not consistent with each other, and the more frequently cited study, by Oh et al., has serious design flaws that may cast doubt on the gp120 concentrations it promulgates. The much lower gp120 concentrations recorded by Gilbert et al. (2003) are likely to be closer to true levels. And the presence of plasma anti-gp120 Abs that block receptor binding should inform the design of in vitro experiments (see Box 1). "
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