A Phase I Trial to Assess Safety and Immunogenicity of i.d. DNA Priming and i.m. MVA Boosting in Healthy Volunteers in Mozambique and to Develop Further HIV Vaccine Trial Capacity Building in Mozambique
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- Instituto Nacional de Saúde, Mozambique
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Adverse events (local and system reactogenicity)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
While antiretroviral drugs have shown great promise in reducing HIV replication and thus in reducing HIV/AIDS associated morbi-mortality and HIV transmission, the cost is substantial and side effects are a potentially limiting factor. Development of an effective safe-affordable vaccine is likely to be the best way to stop further virus spread. The study aims to determine safety and immunogenicity of the DNA-vaccine at a dose of 600µg and 1200µg delivered id in combination with MVA-CMDR boost im.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: 18 to 26 years
- •Willing to undergo HIV (Human Immunodeficiency Virus) counseling and testing
- •Have a negative antigen/antibody or antibody ELISA for HIV infection
- •Able to give informed consent
- •Satisfactory completion of an assessment of understanding prior to enrolment defined as 89% correct answers after three opportunities to take the test
- •Basic abilities to read and write
- •Resident in Maputo, and willing to remain so for the duration of the study
- •At low risk of HIV infection, defined as the absence of an identifiable risk factor/ behavior (their presence is therefore an exclusion criteria):
- •sexual partner with HIV
- •sexual partner with unknown HIV serostatus who is also unwilling to use protective condoms consistently in all sexual relations
Exclusion Criteria
- •At risk of HIV infection as mentioned above in the inclusion criteria
- •Active tuberculosis or other systemic infectious process elicited by review of systems, physical examination and laboratory detection
- •A history of immunodeficiency, chronic illness requiring continuous or frequent medical intervention
- •Autoimmune disease by history and physical examination
- •Hives or recurrent hives and severe eczema
- •A history of psychiatric, medical (including traditional medicine) and/or substance abuse problems during the past 6 months that the investigator believes would adversely affect the volunteer's ability to participate in the trial
- •History of epilepsy, or currently taking anti-epileptics
- •Received blood or blood products or immunoglobulins in the past 3 months
- •Receiving immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy
- •Use of experimental therapeutic agents within 30 days of study entry
Outcomes
Primary Outcomes
Adverse events (local and system reactogenicity)
Time Frame: 44 weeks
The safety of immunization will be assessed by clinical features and standard clinical chemistry and hematological tests. Safety endpoints: Adverse events will be assessed using a standard format for soliciting local and systemic reactogenicity to the vaccine and collection of unsolicited adverse events. Solicited reactogenicity will be evaluated for 7 days following each vaccination. All other AE will be collected from the time of first injection until the end of the study follow-up period.
Immunogenicity
Time Frame: 44 weeks
The primary immunogenicity endpoint will be determined by the interferon gamma (IFN-gama) enzyme linked immunospot (ELISPOT) assay. Secondary immunogenicity endpoints will include cellular immune responses determined by intracellular cytokine staining and T cell proliferation assays as well as binding antibody and neutralizing antibody responses.