A phase 1/2 study of a multiclade HIV-1 DNA plasmid prime and recombinant adenovirus serotype 5 boost vaccine in HIV-uninfected east africans (RV 172)

Hannah Kibuuka, Robert Kimutai, Leonard Maboko, Fred Sawe, Mirjam S. Schunk, Arne Kroidl, Douglas Shaffer, Leigh Anne Eller, Rukia Kibaya, Michael A. Eller, Karin B. Schindler, Alexandra Schuetz, Monica Millard, Jason Kroll, Len Dally, Michael Hoelscher, Robert Bailer, Josephine H. Cox, Mary Marovich, Deborah L. BirxBarney S. Graham, Nelson L. Michael, Mark S. De Souza, Merlin L. Robb

Research output: Contribution to journalArticlepeer-review

98 Scopus citations

Abstract

Background. Human immunodeficiency virus (HIV) vaccine development remains a global priority. We describe the safety and immunogenicity of a multiclade DNA vaccine prime with a replication-defective recombinant adenovirus serotype 5 (rAd5) boost. Methods. The vaccine is a 6-plasmid mixture encoding HIV envelope (env) subtypes A, B, and C and subtype B gag, pol, and nef, and an rAd5 expressing identical genes, with the exception of nef. Three hundred and twentyfour participants were randomized to receive placebo (n = 138), a single dose of rAd5 at 10 10 (n = 24) or 10 11 particle units (n = 24), or DNA at 0, 1, and 2 months, followed by rAd5 at either 10 10 (n = 114) or 10 11 particle units (n = 24) boosting at 6 months. Participants were followed up for 24 weeks after the final vaccination. Results. The vaccine was safe and well tolerated. HIV-specific T cell responses were detected in 63% of vaccinees. Titers of preexisting Ad5 neutralizing antibody did not affect the frequency and magnitude of T cell responses in prime-boost recipients but did affect the response rates in participants that received rAd5 alone (P = .037). Conclusion. The DNA/rAd5 vaccination regimen was safe and induced HIV type 1 multi-clade T cell responses, which were not significantly affected by titers of preexisting rAd5 neutralizing antibody.

Original languageEnglish
Pages (from-to)600-607
Number of pages8
JournalJournal of Infectious Diseases
Volume201
Issue number4
DOIs
StatePublished - 15 Feb 2010
Externally publishedYes

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