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

United Kingdom Research and Innovation (UKRI)

Status and phase

Completed

Phase 1

Conditions

HIV-1

HIV Infections

Treatments

Biological: MVA.HIVA

Study type

Interventional

Funder types

Other

Identifiers

NCT00982579

PV001

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

Under 3 days old

Volunteers

Accepts Healthy Volunteers

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.