MedTrace Logo

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

NCT00981695 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2011-06-16

No results posted yet for this study

Summary

Objectives:

Primary: Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Kenyan infants born to HIV-1-infected mothers.

Secondary:

* HIV-1 immunogenicity comparison between MVA.HIVA and age-matched unvaccinated control arms in each cohort (breastfeeding or formula feeding)
* HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants receiving MVA.HIVA
* HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants in the age-matched unvaccinated control group
* Comparison of responses to certain Kenyan Extended Programme on Immunization (KEPI) vaccines (OPV, DTP, HBV, and HiB) between MVA.HIVA versus age-matched unvaccinated controls in each cohort, between breast versus formula feeding infants in the age-matched unvaccinated control group, and between breast versus formula infants receiving MVA.HIVA
* Comparison of immune activation and phenotypic profile of lymphocytes between breast and formula feeding infants in each cohort (MVA.HIVA and age-matched unvaccinated control)
* Build capacity for Infant HIV-1 Vaccine Clinical Trials Centre in Nairobi, Kenya.

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

  • Walter Jaoko · University of Nairobi

  • Grace John-Stewart · University of Washington

  • Marie Reilly · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-07-31
Completion
2011-10-31

Countries

  • Kenya

Study Locations

More Related Trials

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 NCT00981695 on ClinicalTrials.gov