PACTR201211000435126
Recruiting
N/A
A Phase II trial to assess the safety and immunogenicity of DNA priming
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Swedish Institute for Infectious Disease Control
- Enrollment
- 198
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: 18 to 40 years
- •Willing to undergo counselling and HIV testing
- •Have a negative antigen/antibody ELISA for HIV infection
- •Able to give informed consent
- •Basic abilities to read and write.
- •Satisfactory completion of an assessment of understanding prior to enrolment defined
- •as 90% correct answers after three opportunities to take test.
- •Resident in Dar es Salaam, Mbeya or Maputo catchment areas, 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/
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 (for example detection of Hepatitis B
- •surface antigen or active syphilis).
- •A history of immunodeficiency, ongoing medical and/or psychiatric condition and/or
- •chronic illness requiring continuous or frequent medical intervention
- •Autoimmune disease by history and physical examination.
- •Hives or recurrent hives and severe eczema
- •Substance abuse problems (including traditional medicine) during the past 12 months
- •that in the opinion of the investigator would preclude participation
Outcomes
Primary Outcomes
Not specified
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