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

HIV Infections Clinical Trial

— PedVacc001  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982579
• Other study ID #: PV001
• Status: Completed
• Phase: Phase 1
• First received: September 22, 2009
• Last updated: February 2, 2012
• Start date: November 2009
• Est. completion date: September 2011

Study information

• Verified date: September 2009
• Source: Medical Research Council
• Contact: n/a
• Is FDA regulated: No
• Health authority: Gambia: Department of State for Health and Social WelfareGambia: MRC Ethics CommitteeSweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• HIV-1

Intervention

Biological:
• MVA.HIVA
1 dose of 5 x 10^7 pfu of MVA.HIVA administered intramuscularly

Locations

Country	Name	City	State
Gambia	Medical Research Council Laboratories, The Gambia	Banjul	Fajara

Sponsors (2)

Lead Sponsor	Collaborator
Medical Research Council	European and Developing Countries Clinical Trials Partnership (EDCTP)

Country where clinical trial is conducted

Gambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	For safety and reactogenicity: Actively and passively collected data on adverse events		Up to 16 weeks after vaccination	Yes
Secondary	For immunity to EPI vaccines: Antibody levels to specific vaccines.		1 week before and 1 week after vaccination	No
Secondary	For immunogenicity: Frequency of IFN-? 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	No