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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
HIV-1, HIV Infections

Intervention / Treatment
-----------------
* Biological: MVA.HIVA


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Maximum Age: 3 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccinees<br>Vaccinated at 20 weeks of age (n=24) | Biological: MVA.HIVA<br>* 1 dose of 5 x 10^7 pfu of MVA.HIVA administered intramuscularly<br>|
| No Intervention: Controls<br>No experimental vaccine (n=24) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For safety and reactogenicity: Actively and passively collected data on adverse events |  | Up to 16 weeks after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For immunity to EPI vaccines: Antibody levels to specific vaccines. |  | 1 week before and 1 week after vaccination | 
| 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 |  | Up to 16 weeks after vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV preventive vaccine