Maria C Rodriguez-Barradas1, Jose A Serpa2, Iona Munjal3, Daniel Mendoza1, Adriana M Rueda4, Mahwish Mushtaq4, Liise-Anne Pirofski5. 1. Medical Care Line, Infectious Disease Section Center for Translational Research on Inflammatory Diseases, Michael E. DeBakey Veterans Affairs Medical Center Department of Medicine, Baylor College of Medicine. 2. Department of Medicine, Baylor College of Medicine Thomas Street Clinic, Harris Health System, Houston, Texas. 3. Department of Pediatrics. 4. Medical Care Line, Infectious Disease Section Department of Medicine, Baylor College of Medicine. 5. Department of Medicine, Division of Infectious Diseases, Montefiore Medical Center and the Albert Einstein College of Medicine, Bronx, New York.
Abstract
BACKGROUND:Pneumococcal vaccination is recommended for human immunodeficiency virus-infected (HIV+) persons; the best timing for immunization with respect to initiation of antiretroviral therapy (ART) is unknown. METHODS: Double-blind, placebo-controlled trial in HIV+ with CD4(+) T cells/µL (CD4) ≥ 200 randomized to receive the 23-valent pneumococcal polysaccharide vaccine (PPV23) or placebo at enrollment, followed by placebo or PPV23, respectively, 9-12 months later (after ≥6 months of ART). Capsular polysaccharide-specific immunoglobin (Ig) G and IgM levels to serotypes 1, 3, 4, 6B, and 23F, and opsonophagocytic killing activity (OPA) to serotypes 6B and 23F were evaluated 1 month postvaccination. RESULTS:One hundred seven subjects were enrolled, 72 (67.3%) were evaluable (36/group). Both groups had significant increases in pre- to 1-month postvaccination IgG levels, but negligible to IgM, and significant increases in OPA titers to serotype 6B but not to 23F. There were no significant differences between groups in serotype-specific IgM or IgG levels or OPA titers. For the combined groups, there was a significant correlation between serotype-specific IgG and OPA titers to 23F but not to 6B. There was no correlation between CD4, viral load and IgG responses. CONCLUSIONS: In HIV+ with CD4 ≥ 200, delaying PPV23 until ≥6 months of ART does not improve responses and may lead to missed opportunities for immunization. Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.
RCT Entities:
BACKGROUND:Pneumococcal vaccination is recommended for human immunodeficiency virus-infected (HIV+) persons; the best timing for immunization with respect to initiation of antiretroviral therapy (ART) is unknown. METHODS: Double-blind, placebo-controlled trial in HIV+ with CD4(+) T cells/µL (CD4) ≥ 200 randomized to receive the 23-valent pneumococcalpolysaccharide vaccine (PPV23) or placebo at enrollment, followed by placebo or PPV23, respectively, 9-12 months later (after ≥6 months of ART). Capsular polysaccharide-specific immunoglobin (Ig) G and IgM levels to serotypes 1, 3, 4, 6B, and 23F, and opsonophagocytic killing activity (OPA) to serotypes 6B and 23F were evaluated 1 month postvaccination. RESULTS: One hundred seven subjects were enrolled, 72 (67.3%) were evaluable (36/group). Both groups had significant increases in pre- to 1-month postvaccination IgG levels, but negligible to IgM, and significant increases in OPA titers to serotype 6B but not to 23F. There were no significant differences between groups in serotype-specific IgM or IgG levels or OPA titers. For the combined groups, there was a significant correlation between serotype-specific IgG and OPA titers to 23F but not to 6B. There was no correlation between CD4, viral load and IgG responses. CONCLUSIONS: In HIV+ with CD4 ≥ 200, delaying PPV23 until ≥6 months of ART does not improve responses and may lead to missed opportunities for immunization. Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.
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