Variability of CD4+ Cell Counts in HIV-1–Uninfected Volunteers Who Are Eligible for a Phase I HIV Vaccine Study

Objective: Vaccines and biologics containing CD4 molecules or HIV-1 gp120 might induce antibodies targeting CD4. We evaluated temporal variability of CD4 levels in healthy volunteers to quantify declines that could indicate true adverse events. Design: Prospective observational cohort study of 100 healthy adults without HIV-1 infection from the Baltimore region. Methods: Participants enrolled and consented to blood draws for immunologic laboratory panels performed once every 8 weeks for 48 weeks. The primary CD4+ measurements were CD4+ absolute count (cells/mm3) and CD4 percentage (CD4%, total CD4 cells/total lymphocyte cells). CD4 changes over time were modeled using fold changes for CD4+ absolute counts and differences for CD4 percentages. Results: Variation of average CD4+ cell counts and percentages were highly participant-specific (P
Source: JAIDS Journal of Acquired Immune Deficiency Syndromes - Category: Infectious Diseases Tags: Prevention Research Source Type: research