Safety and immunogenicity of a candidate HIV-1 vaccine, MVA.HIVA, administered to healthy infants born to HIV-1/2-uninfected mothers.

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR2008120000904116
• Date of registration: 10/11/2008
• Primary sponsor: Medical Research Council UK
• Public title: Safety and immunogenicity of a candidate HIV-1 vaccine, MVA.HIVA, administered to healthy infants born to HIV-1/2-uninfected mothers.
• Scientific title: Evaluation of safety and immunogenicity of a candidate HIV-1 vaccine, MVA.HIVA, in healthy infants born to HIV-1/2 uninfected mothers
• Date of first enrolment: 2009-12-15
• Target sample size: 48
• Recruitment status: Closed to recruitment: follow up complete
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2008120000904116
• Study type: interventional
• Study design: Factorial: participants randomly allocated to either no,one,some or all interventions simultaneously,; Randomised,; randomised to one of the two study groups of 24 by picking the next envelope (block randomised) assigning them to one of the two treatment groups,; Sealed envelopes,

Countries of recruitment

South Africa

Contacts

• Name: Tomas Hanke
• Affiliation: MRC Tenure Scientist, Oxford University Research Lecturer, Jenner Institute Investigator

• Name: Tomas Hanke
• Affiliation: Head of HIV-1 vaccine group, Oxford University Research Lecturer, Jenner Institute Investigator

Key inclusion & exclusion criteria

Inclusion criteria: Healthy infants, 12 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-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 8 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.


Age minimum: 20 null
Age maximum: 20 null
Gender: Both

Health Condition(s) or Problem(s) studied

HIV/AIDS
null

Primary Outcome(s)

Safety and immunogenicity of MVA.HIVA vaccine in 3-month-old healthy Gambian infants born to HIV-1/2-uninfected mothers

Secondary Outcome(s)

Gross impact of MVA.HIVA on the immunogenicity of EPI vaccines (DTwPHib, Hep B and OPV) when administered simultaneously to infants who received BCG vaccine within the first two weeks of life. The trial will not be powered to detect small interference effects.

Source(s) of Monetary Support

EDCTP