Feasibility and safety of ALVAC-HIV vCP1521 vaccine in HIV-exposed infants in Uganda: results from the first HIV vaccine trial in infants in Africa

Kenneth Kintu; Philip Andrew; Philippa Musoke; Paul Richardson; Brenda Asiimwe-Kateera; Teopista Nakyanzi; Lei Wang; Mary Glenn Fowler; Lynda Emel; San-San Ou; Lynn Baglyos; Sanjay Gurunathan; Sheryl Zwerski; Jay Brooks Jackson; Laura Guay

doi:10.1097/QAI.0b013e31827f1c2d

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Feasibility and safety of ALVAC-HIV vCP1521 vaccine in HIV-exposed infants in Uganda: results from the first HIV vaccine trial in infants in Africa

Journal article

Open access

Peer reviewed

Feasibility and safety of ALVAC-HIV vCP1521 vaccine in HIV-exposed infants in Uganda: results from the first HIV vaccine trial in infants in Africa

Kenneth Kintu, Philip Andrew, Philippa Musoke, Paul Richardson, Brenda Asiimwe-Kateera, Teopista Nakyanzi, Lei Wang, Mary Glenn Fowler, Lynda Emel, San-San Ou, …

Journal of acquired immune deficiency syndromes (1999), Vol.63(1), pp.1-8

05/01/2013

DOI: 10.1097/QAI.0b013e31827f1c2d

PMCID: PMC3625520

PMID: 23221981

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Abstract

The development of a safe and effective vaccine against HIV type 1 for the prevention of mother-to-child transmission of HIV would significantly advance the goal of eliminating HIV infection in children. Safety and feasibility results from phase 1, randomized, double-blind, placebo-controlled trial of ALVAC-HIV vCP1521 in infants born to HIV type 1-infected women in Uganda are reported. HIV-exposed infants were enrolled at birth and randomized (4:1) to receive vaccine or saline placebo intramuscular injections at birth, 4, 8, and 12 weeks of age. Vaccine reactogenicity was assessed at vaccination and days 1 and 2 postvaccination. Infants were followed until 24 months of age. HIV infection status was determined by HIV DNA polymerase chain reaction. From October 2006 to May 2007, 60 infants (48 vaccine and 12 placebo) were enrolled with 98% retention at 24 months. One infant was withdrawn, but there were no missed visits or vaccinations among the 59 infants retained. Immune responses elicited by diphtheria, polio, hepatitis B, haemophilus influenzae type B, and measles vaccination were similar in the 2 arms. The vaccine was well tolerated with no severe or life-threatening reactogenicity events. Adverse events were equally distributed across both study arms. Four infants were diagnosed as HIV infected [3 at birth (2 vaccine and 1 placebo) and 1 in vaccine arm at 2 weeks of age]. The ALVAC-HIV vCP1521 vaccination was feasible and safe in infants born to HIV-infected women in Uganda. The conduct of high-quality infant HIV vaccine trials is achievable in Africa.

HIV-1

HIV Infections - prevention & control

Double-Blind Method

HIV Envelope Protein gp120 - adverse effects

HIV Infections - virology

Humans

Vaccination

Breast Feeding

Child, Preschool

Infant

Treatment Outcome

HIV Envelope Protein gp120 - administration & dosage

AIDS Vaccines - adverse effects

Young Adult

HIV Infections - diagnosis

Adolescent

Adult

Female

HIV Infections - transmission

Uganda

AIDS Vaccines - administration & dosage

Infectious Disease Transmission, Vertical - prevention & control

Infant, Newborn

Milk, Human

Details

Title: Subtitle: Feasibility and safety of ALVAC-HIV vCP1521 vaccine in HIV-exposed infants in Uganda: results from the first HIV vaccine trial in infants in Africa
Creators: Kenneth Kintu - Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda. kkintu@mujhu.org
Philip Andrew
Philippa Musoke
Paul Richardson
Brenda Asiimwe-Kateera
Teopista Nakyanzi
Lei Wang
Mary Glenn Fowler
Lynda Emel
San-San Ou
Lynn Baglyos
Sanjay Gurunathan
Sheryl Zwerski
Jay Brooks Jackson
Laura Guay
Resource Type: Journal article
Publication Details: Journal of acquired immune deficiency syndromes (1999), Vol.63(1), pp.1-8
DOI: 10.1097/QAI.0b013e31827f1c2d
PMID: 23221981
PMCID: PMC3625520
NLM abbreviation: J Acquir Immune Defic Syndr
ISSN: 1525-4135
eISSN: 1944-7884
Publisher: United States
Grant note: U01 AI48054 / NIAID NIH HHS U01AI068632 / NIAID NIH HHS U01 AI048054 / NIAID NIH HHS U01 AI046749 / NIAID NIH HHS U01AI46749 / NIAID NIH HHS U01 AI068632 / NIAID NIH HHS UM1 AI068632 / NIAID NIH HHS U01 AI069530 / NIAID NIH HHS
Language: English
Date published: 05/01/2013
Academic Unit: Pathology; VPMA - Administration
Record Identifier: 9984047977102771

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