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
  Purpose

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.

Condition Intervention Phase
HIV-1
HIV Infections
Biological: MVA.HIVA
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Medical Research Council:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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
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

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981695

Contacts
Contact: Walter Jaoko, MB MTMed PhD +254-02-2717694 Wjaoko@kaviuon.org

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

No publications provided

Responsible Party: Tomas Hanke, Medical Research Council, UK
ClinicalTrials.gov Identifier: NCT00981695     History of Changes
Other Study ID Numbers: PV002
Study First Received: September 21, 2009
Last Updated: June 15, 2011
Health Authority: Kenya: Ethical Review Committee
Kenya: Institutional Review Board
United States: Institutional Review Board
Sweden: Regional Ethical Review Board

Keywords provided by Medical Research Council:
HIV
Vaccine
MVA
PMTCT
HIV preventive vaccine
HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 20, 2014