Trial record 8 of 56 for:    " September 09, 2009":" October 09, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

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 16 weeks after vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: November 2009
Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccinees
Vaccinated at 20 weeks of age (n=24)
Biological: MVA.HIVA
1 dose of 5 x 10^7 pfu of MVA.HIVA administered intramuscularly
No Intervention: Controls
No experimental vaccine (n=24)

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00982579

Locations
Gambia
Medical Research Council Laboratories, The Gambia
Banjul, Fajara, Gambia
Sponsors and Collaborators
Medical Research Council
European and Developing Countries Clinical Trials Partnership (EDCTP)
Investigators
Study Director: Tomas Hanke Medical Research Council
Principal Investigator: Katie Flanagan Medical Research Council, The Gambia
Principal Investigator: Marie Reilly Karolinska Institutet
  More Information

No publications provided by Medical Research Council

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Tomas Hanke, Medical Research Council, UK
ClinicalTrials.gov Identifier: NCT00982579     History of Changes
Other Study ID Numbers: PV001
Study First Received: September 22, 2009
Last Updated: February 2, 2012
Health Authority: Gambia: Department of State for Health and Social Welfare
Gambia: MRC Ethics Committee
Sweden: Regional Ethical Review Board

Keywords provided by Medical Research Council:
HIV preventive vaccine

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 April 16, 2014