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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV-1 HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Vaccinees

Vaccinated at 20 weeks of age (n=24)

Group Type EXPERIMENTAL

MVA.HIVA

Intervention Type BIOLOGICAL

1 dose of 5 x 10\^7 pfu of MVA.HIVA administered intramuscularly

Controls

No experimental vaccine (n=24)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MVA.HIVA

1 dose of 5 x 10\^7 pfu of MVA.HIVA administered intramuscularly

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes