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Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1/2-uninfected Mothers

NCT00982579 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-02-03

No results posted yet for this study

Summary

Objectives:

Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Gambian infants born to HIV-1/2-uninfected mothers.

Gross impact of MVA.HIVA on the immunogenicity of EPI vaccines (DTwPHib, HepB, PCV-7 and OPV) when administered at 20 weeks (4 weeks after the last EPI vaccines), who have had BCG vaccine within the first 4 weeks of life.

Conditions

Interventions

BIOLOGICAL

MVA.HIVA

1 dose of 5 x 10\^7 pfu of MVA.HIVA administered intramuscularly

Sponsors & Collaborators

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • Medical Research Council

    lead OTHER_GOV

Principal Investigators

  • Tomas Hanke · Medical Research Council

  • Katie Flanagan · Medical Research Council, The Gambia

  • Marie Reilly · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
3 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-06-30
Completion
2011-09-30

Countries

  • The Gambia

Study Locations

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Entities

Diseases
Companies

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 NCT00982579 on ClinicalTrials.gov