PACTR201106000304583
Recruiting
N/A
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
ConditionsHIV/AIDS
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- HIV/AIDS
- Sponsor
- Swedish Institute for Infectious Disease Control
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age: 18 to 26 years
- •2\. Willing to undergo HIV counseling and testing
- •3\. Have a negative antigen/antibody or antibody ELISA for HIV infection
- •4\. Able to give informed consent
- •5\. Satisfactory completion of an assessment of understanding prior to enrolment defined as 89% correct answers after three opportunities to take the test
- •6\. Basic abilities to read and write
- •7\. Resident in Maputo, and willing to remain so for the duration of the study
- •8\. 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
- •1\. At risk of HIV infection as mentioned above in the inclusion criteria
- •2\. Active tuberculosis or other systemic infectious process elicited by review of systems, physical examination and laboratory detection
- •3\. A history of immunodeficiency, chronic illness requiring continuous or frequent medical intervention
- •4\. Autoimmune disease by history and physical examination
- •5\. Hives or recurrent hives and severe eczema
- •6\. 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
- •7\. History of epilepsy, or currently taking anti\-epileptics
- •8\. Received blood or blood products or immunoglobulins in the past 3 months
- •9\. Receiving immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy
- •10\. Use of experimental therapeutic agents within 30 days of study entry
Outcomes
Primary Outcomes
Not specified
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