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Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1-infected Mothers (PedVacc002)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00981695
Recruitment Status : Unknown
Verified September 2009 by Medical Research Council.
Recruitment status was:  Recruiting
First Posted : September 22, 2009
Last Update Posted : June 16, 2011
European and Developing Countries Clinical Trials Partnership (EDCTP)
Information provided by:
Medical Research Council

Brief Summary:


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


  • 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.

Condition or disease Intervention/treatment Phase
HIV-1 HIV Infections Biological: MVA.HIVA Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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
Study Start Date : November 2009
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Vaccinees
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

No Intervention: Controls
18 breast-fed and 18 formula-fed infants at the age of 20 weeks

Primary Outcome Measures :
  1. For safety and reactogenicity: Actively and passively collected data on adverse events. [ Time Frame: Up to 28 weeks after vaccination ]

Secondary Outcome Measures :
  1. For immunogenicity to KEPI vaccines: Antibody levels to specific vaccines as measured by ELISA. [ Time Frame: 1 week before and 1 week after vaccination ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00981695

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Contact: Walter Jaoko, MB MTMed PhD +254-02-2717694

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Kenyatta National Hospital Recruiting
Nairobi, Kenya
Principal Investigator: Walter Jaoko         
Sponsors and Collaborators
Medical Research Council
European and Developing Countries Clinical Trials Partnership (EDCTP)
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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 Institutet

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Tomas Hanke, Medical Research Council, UK Identifier: NCT00981695     History of Changes
Other Study ID Numbers: PV002
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: June 16, 2011
Last Verified: September 2009

Keywords provided by Medical Research Council:
HIV preventive vaccine
HIV seronegativity

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs