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HIV-1 vaccine induced immune responses in newborns of HIV-1 infected mothers.

Author(s): McFarland EJ, Johnson DC, Muresan P, Fenton T, Tomaras GD, McNamara J, Read JS, Douglas SD, Deville J, Gurwith M, Gurunathan S, Lambert JS

Affiliation(s): Department of Pediatric Infectious Diseases, University of Colorado Health Sciences Center, Denver Colorado, USA. betsy.mcfarland@uchsc.edu

Publication date & source: 2006-07-13, AIDS., 20(11):1481-9.

Publication type: Clinical Trial, Phase I; Clinical Trial, Phase II; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't

OBJECTIVE: Breast milk transmission continues to account for a large proportion of cases of mother-to-child transmission of HIV-1 worldwide. An effective HIV-1 vaccine coupled with either passive immunization or short-term antiretroviral prophylaxis represents a potential strategy to prevent breast milk transmission. This study evaluated the safety and immunogenicity of ALVAC HIV-1 vaccine with and without a subunit envelope boost in infants born to HIV-1-infected women. DESIGN:: Placebo-controlled, double-blinded study. METHODS: Infants born to HIV-1-infected mothers in the US were immunized with a prime-boost regimen using a canarypox virus HIV-1 vaccine (vCP1452) and a recombinant glycoprotein subunit vaccine (rgp120). Infants (n = 30) were randomized to receive: vCP1452 alone, vCP1452 + rgp120, or corresponding placebos. RESULTS: Local reactions were mild or moderate and no significant systemic toxicities occurred. Subjects receiving both vaccines had gp120-specific binding serum antibodies that were distinguishable from maternal antibody. Repeated gp160-specific lymphoproliferative responses were observed in 75%. Neutralizing activity to HIV-1 homologous to the vaccine strain was observed in 50% of the vCP1452 + rgp120 subjects who had lost maternal antibody by week 24. In some infants HIV-1-specific proliferative and antibody responses persisted until week 104. HIV-1-specific cytotoxic T lymphocyte responses were detected in two subjects in each treatment group; the frequency of HIV-1 specific cytotoxic T lymphocyte responses did not differ between vaccine and placebo recipients. CONCLUSION: The demonstration of vaccine-induced immune responses in early infancy supports further study of HIV-1 vaccination as a strategy to reduce breast milk transmission.

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