An Ad5-vectored HIV-1 vaccine elicits cell-mediated immunity but does not affect disease progression in HIV-1–infected male subjects: Results from a randomized …
DW Fitzgerald, H Janes, M Robertson… - Journal of Infectious …, 2011 - academic.oup.com
DW Fitzgerald, H Janes, M Robertson, R Coombs, I Frank, P Gilbert, M Loufty, D Mehrotra…
Journal of Infectious Diseases, 2011•academic.oup.comAbstract (See the editorial commentary by Altfeld and Goulder, on pages 753–5.)
Background. The Step study was a randomized trial to determine whether an adenovirus
type 5 (Ad5) vector vaccine, which elicits T cell immunity, can lead to control of human
immunodeficiency virus (HIV) replication in participants who became HIV-infected after
vaccination. Methods. We evaluated the effect of the vaccine on trends in HIV viral load,
CD4+ T cell counts, time to initiation of antiretroviral therapy (ART), and AIDS-free survival in …
Background. The Step study was a randomized trial to determine whether an adenovirus
type 5 (Ad5) vector vaccine, which elicits T cell immunity, can lead to control of human
immunodeficiency virus (HIV) replication in participants who became HIV-infected after
vaccination. Methods. We evaluated the effect of the vaccine on trends in HIV viral load,
CD4+ T cell counts, time to initiation of antiretroviral therapy (ART), and AIDS-free survival in …
Abstract
(See the editorial commentary by Altfeld and Goulder, on pages 753–5.)
Background . The Step study was a randomized trial to determine whether an adenovirus type 5 (Ad5) vector vaccine, which elicits T cell immunity, can lead to control of human immunodeficiency virus (HIV) replication in participants who became HIV-infected after vaccination.
Methods . We evaluated the effect of the vaccine on trends in HIV viral load, CD4+ T cell counts, time to initiation of antiretroviral therapy (ART), and AIDS-free survival in 87 male participants who became infected with HIV during the Step study and who had a median of 24 months of post-infection follow-up.
Results . There was no overall effect of vaccine on mean log10 viral load (estimated difference between groups, -0.11; P = .47). In a subset of subjects with protective HLA types (B27, B57, B58), mean HIV-1 RNA level over time was lower among vaccine recipients. There was no significant difference in CD4+ T cell counts, time to ART initiation, or in AIDS-free survival between HIV-1–infected subjects who received vaccine versus those who received placebo.
Conclusions . HIV RNA levels, CD4+ T cell counts, time to initiation of ART, and AIDS-free survival were similar in vaccine and placebo recipients. There may have been a favorable effect of vaccine on HIV-1 RNA levels in participants with HLA types associated with better control of HIV-1.
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