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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Medical Research Council.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Information provided by:
Medical Research Council
ClinicalTrials.gov Identifier:
NCT00981695
First received: September 21, 2009
Last updated: June 15, 2011
Last verified: September 2009

September 21, 2009
June 15, 2011
November 2009
July 2011   (final data collection date for primary outcome measure)
For safety and reactogenicity: Actively and passively collected data on adverse events. [ Time Frame: Up to 28 weeks after vaccination ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00981695 on ClinicalTrials.gov Archive Site
  • For immunogenicity to KEPI vaccines: Antibody levels to specific vaccines as measured by ELISA. [ Time Frame: 1 week before and 1 week after vaccination ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1-infected Mothers
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
  • HIV-1
  • HIV Infections
Biological: MVA.HIVA
1 dose of 5 x 10^7 pfu of MVA.HIVA administered intramuscularly
  • Experimental: Vaccinees
    18 breast-fed and 18 formula-fed infants at the age of 20 weeks
    Intervention: Biological: MVA.HIVA
  • No Intervention: Controls
    18 breast-fed and 18 formula-fed infants at the age of 20 weeks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
October 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
up to 3 Days
No
Contact: Walter Jaoko, MB MTMed PhD +254-02-2717694 Wjaoko@kaviuon.org
Kenya
 
NCT00981695
PV002
Yes
Tomas Hanke, Medical Research Council, UK
Medical Research Council
European and Developing Countries Clinical Trials Partnership (EDCTP)
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
Medical Research Council
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP