PACTR2010050002122368
Completed
N/A
A Phase I/II trial to assess safety and immunogenicity of i.d. DNA priming, i.m. MVA and i.m. rgp140/GLA-AF boosting in healthy volunteers in Tanzania and to develop further HIV vaccine trial capacity building in Tanzania
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Swedish Institute for Infectious Disease Control
- Enrollment
- 120
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age: 18 to 40 years
- •2\. Willing to undergo counseling and HIV testing
- •3\. Have a negative antigen/antibody ELISA for HIV infection
- •4\. Able to give informed consent
- •5\. Satisfactory completion of an assessment of understanding prior to enrolment defined as 90% correct answers after three opportunities to take test.
- •6\. Basic abilities to read and write.
- •7\. Resident in Dar es Salaam or Mbeya, 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
- •9\. Verbal assurances that adequate birth control measures are used not to conceive/father a child during the study and up to 3 months after the last vaccine injection
- •10\. Women shall have a negative urinary pregnancy test
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 (for example detection of Hepatitis B surface antigen, or active syphilis).
- •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 grand\-mal 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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