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Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1/2-uninfected Mothers (PedVacc001)

This study has been completed.
Sponsor:
Collaborator:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Information provided by:
Medical Research Council
ClinicalTrials.gov Identifier:
NCT00982579
First received: September 22, 2009
Last updated: February 2, 2012
Last verified: September 2009

September 22, 2009
February 2, 2012
November 2009
June 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 16 weeks after vaccination ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00982579 on ClinicalTrials.gov Archive Site
  • For immunity to EPI vaccines: Antibody levels to specific vaccines. [ Time Frame: 1 week before and 1 week after vaccination ] [ Designated as safety issue: No ]
  • For immunogenicity: Frequency of IFN-γ producing cells determined in ex-vivo (effector) and 10-day cultured (memory) ELISPOT assays after overnight stimulation with pools of HIVA-derived peptides [ Time Frame: Up to 16 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-1/2-uninfected Mothers
An Open Randomized Phase I Study Evaluating Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA.HIVA, Administered to Healthy Infants Born to HIV-1/2-uninfected Mothers

Objectives:

Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Gambian infants born to HIV-1/2-uninfected mothers.

Gross impact of MVA.HIVA on the immunogenicity of EPI vaccines (DTwPHib, HepB, PCV-7 and OPV) when administered at 20 weeks (4 weeks after the last EPI vaccines), who have had BCG vaccine within the first 4 weeks of life.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • HIV-1
  • HIV Infections
Biological: MVA.HIVA
1 dose of 5 x 10^7 pfu of MVA.HIVA administered intramuscularly
  • Experimental: Vaccinees
    Vaccinated at 20 weeks of age (n=24)
    Intervention: Biological: MVA.HIVA
  • No Intervention: Controls
    No experimental vaccine (n=24)
Afolabi MO, Ndure J, Drammeh A, Darboe F, Mehedi SR, Rowland-Jones SL, Borthwick N, Black A, Ambler G, John-Stewart GC, Reilly M, Hanke T, Flanagan KL. A phase I randomized clinical trial of candidate human immunodeficiency virus type 1 vaccine MVA.HIVA administered to Gambian infants. PLoS One. 2013 Oct 24;8(10):e78289. doi: 10.1371/journal.pone.0078289. eCollection 2013.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
September 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy infants, 19 weeks of age, with weight for age z-scores within 2 standard deviations of normal.
  • Have received all standard EPI immunizations according to national immunization programme.
  • Written informed consent by parent.
  • Mother HIV-1/2-uninfected.

Exclusion Criteria:

  • 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. axillary 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 at 19 weeks.
  • 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.
  • Invasive bacterial infections (pneumonia, meningitis).
  • 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.
  • Untreated malaria infection.
  • Any other clinical evidence of infection.
Both
up to 3 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Gambia
 
NCT00982579
PV001
Yes
Dr. 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: Katie Flanagan Medical Research Council, The Gambia
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