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Safety of and Immune Response to an HIV-1 Vaccine (ALVAC-HIV vCP1521) in Infants Born to HIV Infected Mothers

NCT00098163 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-11-01

No results posted yet for this study

Summary

The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, ALVAC-HIV vCP1521, given to infants born to HIV-1 infected mothers in Uganda.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

ALVAC-HIV vCP1521

One 1-ml dose of HIV-1 vaccine administered after birth on or before Day 3 and at weeks 4, 8, and 12.

BIOLOGICAL

ALVAC HIV-1 vCP1521

One 1-ml dose of HIV-1 vaccine placebo administered after birth on or before Day 3 and at Weeks 4, 8, and 12.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Laura Guay, MD · Department of Pathology, Johns Hopkins University

  • Francis Mmiro, MBChB, FRCOG · Department of Obstetrics and Gynecology, Makerere University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Completion
2009-05-31

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00098163 on ClinicalTrials.gov