Journal article
Immunogenicity of ALVAC-HIV vCP1521 in Infants of HIV-1 Infected Women in Uganda (HPTN 027): the first pediatric HIV vaccine trial in Africa
Journal of acquired immune deficiency syndromes (1999), Vol.65(3), pp.268-277
03/01/2014
DOI: 10.1097/01.qai.0000435600.65845.31
PMCID: PMC4171956
PMID: 24091694
Abstract
Objective: Maternal-to-child-transmission of HIV-1 infection remains a significant cause of HIV-1 infection despite successful prevention strategies. Testing protective HIV-1 vaccines remains a critical priority. The immunogenicity of ALVAC-HIV vCP1521 (ALVAC) in infants born to HIV-1-infected women in Uganda was evaluated in the first pediatric HIV-1 vaccine study in Africa.
Design: HIV Prevention Trials Network 027 was a randomized, double-blind, placebo-controlled phase I trial to evaluate the safety and immunogenicity of ALVAC in 60 infants born to HIV-1-infected mothers with CD4 counts of >500 cells per microliter, which were randomized to the ALVAC vaccine or placebo. ALVAC-HIV vCP1521 is an attenuated recombinant canarypox virus expressing HIV-1 clade E env, clade B gag, and protease gene products.
Methods: Infants were vaccinated at birth and 4, 8, and 12 weeks of age with ALVAC or placebo. Cellular and humoral immune responses were evaluated using interferon-γ enzyme-linked immunosorbent spot, carboxyfluorescein diacetate succinimidyl ester proliferation, intracellular cytokine staining, and binding and neutralizing antibody assays. Fisher exact test was used to compare positive responses between the study arms.
Results: Low levels of antigen-specific CD4 and CD8 T-cell responses (intracellular cytokine assay) were detected at 24 months (CD4-6/36 vaccine vs. 1/9 placebo; CD8-5/36 vaccine vs. 0/9 placebo) of age. There was a nonsignificant trend toward higher cellular immune response rates in vaccine recipients compared with placebo. There were minimal binding antibody responses and no neutralizing antibodies detected.
Conclusions: HIV-1-exposed infants are capable of generating low levels of cellular immune responses to ALVAC vaccine, similar to responses seen in adults.
Details
- Title: Subtitle
- Immunogenicity of ALVAC-HIV vCP1521 in Infants of HIV-1 Infected Women in Uganda (HPTN 027): the first pediatric HIV vaccine trial in Africa
- Creators
- Pontiano Kaleebu - Medical Research Council/Uganda Virus Research Institute, Nakiwogo Road, PO Box 49 Entebbe, UgandaHarr Freeya Njai - Medical Research Council/Uganda Virus Research Institute, Nakiwogo Road, PO Box 49 Entebbe, UgandaLei Wang - SCHARP, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, LE-400, PO Box 19024, Seattle, WA, USA 98109Norman Jones - Viral and Rickettsial Disease Laboratory, 850 Marina Bay Parkway, Richmond, CA, USA 94804Isaac Ssewanyana - Joint Clinical Research Center, Plot 101, Upper Lubowa Estates, PO Box 10005, Kampala, UgandaPaul Richardson - Johns Hopkins University School of Medicine, 600 North Wolfe Street, Pathology 313, Baltimore, MD, USA 21287Kenneth Kintu - Makerere University-Johns Hopkins University Research Collaboration, PO Box 7072, Kampala, UgandaLynda Emel - SCHARP, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, LE-400, PO Box 19024, Seattle, WA, USA 98109Philippa Musoke - Makerere University-Johns Hopkins University Research Collaboration, PO Box 7072, Kampala, UgandaMary Glenn Fowler - Johns Hopkins University School of Medicine, 600 North Wolfe Street, Pathology 313, Baltimore, MD, USA 21287San-San Ou - SCHARP, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, LE-400, PO Box 19024, Seattle, WA, USA 98109J Brooks Jackson - University of Iowa, PathologyLaura Guay - George Washington University School of Public Health and Health Services, 2100 W. Pennsylvania Avenue N.W., 8th Floor, Washington DC, USA 20037Philip Andrew - FHI 360, 2224 East NC Hwy 54, Durham, NC, USA 27713Lynn Baglyos - Sanofi Pasteur, Discovery Drive, Swiftwater, PA, USA 18370Huyen CaoHPTN 027 protocol team
- Resource Type
- Journal article
- Publication Details
- Journal of acquired immune deficiency syndromes (1999), Vol.65(3), pp.268-277
- DOI
- 10.1097/01.qai.0000435600.65845.31
- PMID
- 24091694
- PMCID
- PMC4171956
- NLM abbreviation
- J Acquir Immune Defic Syndr
- ISSN
- 1525-4135
- eISSN
- 1944-7884
- Publisher
- Ovid Technologies (Wolters Kluwer Health)
- Language
- English
- Date published
- 03/01/2014
- Academic Unit
- Pathology; VPMA - Administration
- Record Identifier
- 9984046816702771
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