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Improving the immunogenicity of pneumococcal conjugate vaccine in HIV-infected adults with a toll-like receptor 9 agonist adjuvant: a randomized, controlled trial

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BACKGROUND: Persons infected with human immunodeficiency virus (HIV) are often hyporesponsive to immunization, including pneumococcal vaccines. We hypothesized that adding CPG 7909, a toll-like receptor 9 (TLR9) agonist and vaccine adjuvant, to 7-valent pneumococcal conjugate vaccine (7vPnC) would increase its immunogenicity in HIV-infected adults.

METHODS: We performed a double-blind, placebo-controlled, phase 1b/2a trial randomizing HIV-positive patients to receive double doses of 7vPnC (Prevnar) at 0 and 3 months and 1 dose of 23-valent pneumococcal polysaccharide vaccine (PPV-23; Pneumo Novum) at 9 months, with experimental patients receiving 1 mg of CPG 7909 added to each of their 3 vaccine doses; control patients had phosphate-buffered saline added instead. Immunogenicity and safety were evaluated for up to 10 months. The primary end point was the proportion of vaccine high responders at 9 months, defined as a 2-fold increase in IgG levels to > or = 1 microg/mL for at least 5 of 7 of the 7vPnC serotypes.

RESULTS: Ninety-seven participants were included in the study. The proportion of vaccine high responders was higher in the experimental group (n = 48) than among controls (n = 49; 48.8% vs 25.0%; P = .02) at 9 months. Greater proportions of high responders were also observed at 3 (51.1% vs 39.6%; P = .26), 4 (77.3% vs 56.3%; P = .03), and 10 months (87.8% vs 51.1%; P < .001). Mild systemic and injection site reactions to 7vPnC were more common in the experimental group than the control group (100% vs 81.3%; P = .002). CPG 7909 did not increase non-7vPnC IgG levels after PPV-23 immunization. No adverse effects on CD4(+) cell count or organ functions occurred in either group.

CONCLUSIONS: The addition of a TLR9 agonist to 7vPnC significantly enhanced the proportion of vaccine high responders.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00562939 .

Original languageEnglish
JournalClinical infectious diseases : an official publication of the Infectious Diseases Society of America
Volume51
Issue number1
Pages (from-to)42-50
Number of pages9
ISSN1058-4838
DOIs
Publication statusPublished - 1 Jul 2010
Externally publishedYes

    Research areas

  • AIDS-Related Opportunistic Infections/prevention & control, Adjuvants, Immunologic/pharmacology, Adult, Antiretroviral Therapy, Highly Active, CD4 Lymphocyte Count, Double-Blind Method, Female, HIV Infections/drug therapy, Humans, Immunoglobulin G/blood, Intention to Treat Analysis, Male, Middle Aged, Pneumococcal Vaccines/adverse effects, Pneumonia, Pneumococcal/prevention & control, RNA, Viral, Toll-Like Receptor 9/agonists, Vaccines, Conjugate

ID: 54966419