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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)

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: NCT00982579
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : February 3, 2012
European and Developing Countries Clinical Trials Partnership (EDCTP)
Information provided by:
Medical Research Council

Brief Summary:


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : November 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. For safety and reactogenicity: Actively and passively collected data on adverse events [ Time Frame: Up to 16 weeks after vaccination ]

Secondary Outcome Measures :
  1. For immunity to EPI vaccines: Antibody levels to specific vaccines. [ Time Frame: 1 week before and 1 week after vaccination ]
  2. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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): NCT00982579

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Medical Research Council Laboratories, The Gambia
Banjul, Fajara, Gambia
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: Katie Flanagan Medical Research Council, The Gambia
Principal Investigator: Marie Reilly Karolinska Institutet
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Tomas Hanke, Medical Research Council, UK Identifier: NCT00982579    
Other Study ID Numbers: PV001
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: September 2009
Keywords provided by Medical Research Council:
HIV preventive vaccine
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