Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1-infected Mothers (PedVacc002)
June 15, 2011 updated by: Medical Research Council
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
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
72
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nairobi, Kenya
- Recruiting
- Kenyatta National Hospital
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Principal Investigator:
- Walter Jaoko
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 3 days (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Infant Inclusion Criteria
- Healthy infants
- < 3 days of age (day of birth = Day 0) at enrolment
- Birth weight > 2500 grams
- Born to an eligible woman
- Written informed consent by parent
Infant Exclusion Criteria
- HIV infection, as determined by a filter paper and/or RNA test prior to vaccination.
- Participation in any other HIV-1 vaccine or drug trial.
- Failure to receive all standard KEPI immunizations according to national immunization programme.
- Weight for age z-scores outside of 2 standard deviations of normal at the time of vaccination.
- Acute disease at the time of vaccination (acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory tract infection with or without low-grade febrile illness, i.e., temperature of <37.5 °C).
- Axillary temperature of ≥ 37.5 °C at the time of vaccination.
- Any clinically significant abnormal finding on screening from biochemistry or haematology by the time of vaccination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g., egg products.
- Presence of any underlying disease that compromises the diagnosis and evaluation of response to the vaccine.
- Any other on-going chronic illness requiring hospital specialist supervision.
- Administration of immunoglobulins and/or any blood products within one month preceding the planned administration of the vaccine candidate.
- Any history of anaphylaxis in reaction to vaccination.
- Research Physician's assessment of lack of willingness by parents to participate and comply with all requirements of the protocol, or identification of any factor felt to significantly increase the infant's risk of suffering an adverse outcome.
- Likelihood of travel away from the study area.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Vaccinees
18 breast-fed and 18 formula-fed infants at the age of 20 weeks
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1 dose of 5 x 10^7 pfu of MVA.HIVA administered intramuscularly
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No Intervention: Controls
18 breast-fed and 18 formula-fed infants at the age of 20 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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For safety and reactogenicity: Actively and passively collected data on adverse events.
Time Frame: Up to 28 weeks after vaccination
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Up to 28 weeks after vaccination
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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For immunogenicity to KEPI vaccines: Antibody levels to specific vaccines as measured by ELISA.
Time Frame: 1 week before and 1 week after vaccination
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1 week before and 1 week after vaccination
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For immunogenicity to MVA.HIVA: Frequency of IFN-γ-producing cells determined in an ELISPOT assay after overnight stimulation with a pool of HIVA-derived peptides.
Time Frame: Up to 24 weeks after vaccination
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Up to 24 weeks after vaccination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Tomas Hanke, Medical Research Council
- Principal Investigator: Marie Reilly, Karolinska Institutet
- Principal Investigator: Walter Jaoko, University of Nairobi
- Principal Investigator: Grace John-Stewart, University of Washington
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Anticipated)
July 1, 2011
Study Completion (Anticipated)
October 1, 2011
Study Registration Dates
First Submitted
September 21, 2009
First Submitted That Met QC Criteria
September 21, 2009
First Posted (Estimate)
September 22, 2009
Study Record Updates
Last Update Posted (Estimate)
June 16, 2011
Last Update Submitted That Met QC Criteria
June 15, 2011
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PV002
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