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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: | NCT00981695 |
Purpose
Objectives:
Primary: Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Kenyan infants born to HIV-1-infected mothers.
Secondary:
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-1 HIV Infections |
Biological: MVA.HIVA |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety Study |
| Official Title: | An Open Randomized Phase I/II Study Evaluating Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA.HIVA, Administered to Healthy Infants Born to HIV-1-infected Mothers |
| Estimated Enrollment: | 72 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Vaccinees: Experimental
18 breast-fed and 18 formula-fed infants at the age of 20 weeks
|
Biological: MVA.HIVA
1 dose of 5 x 10^7 pfu of MVA.HIVA administered intramuscularly
|
|
Controls: No Intervention
18 breast-fed and 18 formula-fed infants at the age of 20 weeks
|
Eligibility| Ages Eligible for Study: | up to 3 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Infant Inclusion Criteria
Infant Exclusion Criteria
Contacts and Locations| Contact: Walter Jaoko, MB MTMed PhD | +254-02-2717694 | Wjaoko@kaviuon.org |
| Kenya | |
| Kenyatta National Hospital | |
| Nairobi, Kenya | |
| Study Director: | Tomas Hanke | Medical Research Council |
| Principal Investigator: | Walter Jaoko | University of Nairobi |
| Principal Investigator: | Grace John-Stewart | University of Washington |
| Principal Investigator: | Marie Reilly | Karolinska Institute |
More Information
| Responsible Party: | Medical Research Council, UK ( Tomas Hanke ) |
| Study ID Numbers: | PV002 |
| Study First Received: | September 21, 2009 |
| Last Updated: | October 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00981695 History of Changes |
| Health Authority: | Kenya: Ethical Review Committee; Kenya: Institutional Review Board; United States: Institutional Review Board; Sweden: Regional Ethical Review Board |
|
HIV Vaccine MVA |
PMTCT HIV preventive vaccine HIV seronegativity |
|
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 |