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IAVI-006 was the first large randomised, double-blinded, placebo-controlled Phase I clinical trial to systematically investigate the prime-boost strategy for induction of HIV-1 specific CD8+ cytotoxic T-lymphocytes (CTL) in a factorial trial design using (i) priming with 0.5 mg or 2 mg of pTHr.HIVA DNA vaccine, followed by (ii) two booster vaccinations with 5 x 10(7) MVA.HIVA at weeks 8 and 12 (early boost) or weeks 20 and 24 (late boost). This study set the basis for later clinical trials and demonstrated the safety of these candidate HIV vaccines. The safety and immunogenicity results are presented and the lessons derived from this clinical trial are discussed.

Original publication

DOI

10.1016/j.vaccine.2008.09.016

Type

Journal article

Journal

Vaccine

Publication Date

02/12/2008

Volume

26

Pages

6671 - 6677

Keywords

AIDS Vaccines, Adolescent, Adult, CD8-Positive T-Lymphocytes, Double-Blind Method, Female, HIV Infections, HIV-1, Humans, Immunization, Secondary, Male, Middle Aged, Vaccines, DNA, Young Adult