Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
Safety profile of phase I and II preventive HIV type 1 envelope vaccination: experience of the NIAID AIDS Vaccine Evaluation Group.
AIDS Res Hum Retroviruses. 1997 Sep 20;13(14):1163-77. Unique Identifier : AIDSLINE /MED97454208 Keefer MC; Wolff M; Gorse GJ; Graham BS; Corey L; Clements-Mann ML; Verani-Ketter N; Erb S; Smith CM; Belshe RB; Wagner LJ; McElrath MJ; Schwartz DH; Fast P; University of Rochester School of Medicine and Dentistry, New York; 14642, USA.
Abstract:
The NIAID-sponsored AIDS Vaccine Evaluation Group was established in 1988 to perform phase I/II clinical trials with candidate preventive HIV-1 vaccines. This report includes safety data from 1398 HIV-negative, healthy volunteers who were enrolled into 25 phase I and 1 phase H multicentered, randomized, double-blind studies evaluating seven recombinant HIV-1 envelope vaccines, two V3 loop synthetic peptide vaccines, and two live poxvirus-vectored recombinant envelope vaccines. All studies but three were placebo controlled; the placebo was either the adjuvant alone or, in studies of recombinant poxvirus vaccines, it was the vector with no gene insert or a non-HIV gene insert. All candidate vaccines were generally well tolerated. The only adverse effects that were clearly related to vaccination were occasional acute local and systemic reactions that were associated with the adjuvants. Three adjuvants in particular were associated with moderate to severe local reactions: alum plus deoxycholate (ImmunoAg), MTP-PE (Biocine Corp.), and QS21 Genentech, Inc.). MTP-PE was also associated with self-limited severe systemic reactions. There were no serious adverse laboratory toxicities and no evidence of significant immunosuppressive events after receipt of the candidate vaccines. A few volunteers experienced symptoms that might relate to an underlying immunopathologic mechanism (rash, hemolytic anemia, arthralgia), but their presentations were mild and their incidence was low. Eleven volunteers were diagnosed with malignancies during or after their participation, which was within the 95% confidence interval of the number of cases predicted by the National Cancer Institute SEER (Program for cancer surveillance, epidemiology, and end result reporting) database. In conclusion, the envelope-based recombinant or synthetic candidate HIV-1 vaccines appear to be safe and this work has prepared the way for the testing of increasingly complex candidate HIV-1 vaccines.
Keywords: *AIDS Vaccines/ADMINISTRATION & DOSAGE *Gene Products, env/IMMUNOLOGY *HIV-1/IMMUNOLOGY 980130
M9811038
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Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
