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| Sponsor: | Medical Research Council |
|---|---|
| Collaborator: |
European and Developing Countries Clinical Trials Partnership (EDCTP) |
| Information provided by: | Medical Research Council |
| ClinicalTrials.gov Identifier: | NCT00982579 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-1 HIV Infections |
Biological: MVA.HIVA |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety Study |
| Official Title: | An Open Randomized Phase I Study Evaluating Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA.HIVA, Administered to Healthy Infants Born to HIV-1/2-uninfected Mothers |
| Estimated Enrollment: | 48 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Vaccinees: Experimental
Vaccinated at 20 weeks of age (n=24)
|
Biological: MVA.HIVA
1 dose of 5 x 10^7 pfu of MVA.HIVA administered intramuscularly
|
|
Controls: No Intervention
No experimental vaccine (n=24)
|
Eligibility| Ages Eligible for Study: | up to 3 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Katie Flanagan | +220 4496647 | kflanagan@mrc.gm |
| Gambia, Fajara | |
| Medical Research Council Laboratories, The Gambia | |
| Banjul, Fajara, Gambia | |
| Study Director: | Tomas Hanke | Medical Research Council |
| Principal Investigator: | Katie Flanagan | Medical Research Council, The Gambia |
| Principal Investigator: | Marie Reilly | Karolinska Institute |
More Information
| Responsible Party: | Medical Research Council, UK ( Dr. Tomas Hanke ) |
| Study ID Numbers: | PV001 |
| Study First Received: | September 22, 2009 |
| Last Updated: | October 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00982579 History of Changes |
| Health Authority: | Gambia: Department of State for Health and Social Welfare; Gambia: MRC Ethics Committee; Sweden: Regional Ethical Review Board |
|
HIV preventive vaccine |
|
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |