HIV/AIDS
Conditions
Sponsors
Swedish Institute for Infectious Disease Control
Muhimbili University of Health and Allied Sciences
Eligibility
Sex/Gender
All
Inclusion 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 11. Be willing to practice safe sex for the duration of the study to avoid sexually transmitted infections including HIV. 12. Good health as determined by medical history, physical examination, clinical judgment and by key laboratory parameters as judged by the study physician.
Exclusion criteria
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. 11. Reception of any live, attenuated vaccine within 60 days of study entry. {NOTE: Medically indicated subunit or killed vaccines (e.g., Hepatitis A or Hepatitis B) are not exclusionary but should be given at least 2 weeks before or after HIV immunization to avoid potential confusion of adverse reactions}. 12. Abnormality in ECG that could indicate risk or make interpretation of vaccine effects difficult according to the study operating procedures. 13. Previously received an HIV candidate vaccine. 14. History of severe local or general reaction to vaccination in the past 15. Lactating mother 16. Study site employees who are involved in the protocol 17. Ulikeliness of protocol compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Immunogenicity by IFN-gamma ELISPOT | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity by intracellular cytokine staining (ICS);Immunogenicity by Lymphoproliferation Assay (LPA) | — |
Countries
United Republic of Tanzania
Contacts
Public ContactMuhammad Bakari
Senior Lecturer at MUHAS
Outcome results
None listed