HIVIS03
- Conditions
- HIV/AIDS
- Registration Number
- PACTR2009040001075080
- Lead Sponsor
- Swedish Institute for Infectious Disease Control (SMI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- All
- Target Recruitment
- 0
18-40 years
Willing to be counseled & HIV tested
Negative HIV Ag/Ab ELISA
Informed consent
Minimum 7 years of 1° Education.
Resident in Dar es Salaam
At low risk of HIV, (absence of: sexual partner with HIV, partner with unknown HIV serostatus and unwilling to use protection in sexual relations, partner known to be at high risk for HIV, >1 sexual partner in last 6 months, alcoholic (>35 units/week), STI in past 6 months).
Assurances for birth control measures till 4 months after last vaccination
Negative UPT
Willingness for safe sex practice
Good health by clinical & lab parameters: (FBG <7.8 mmol/l, Hb >10.5g/dl, WBC count >1,300/mm3, Granulocytes >6.4/ mm3, Lymphocytes >1.0/ mm3, Platelets >120,000/ mm3, CD4 >400cells/mm3, RBG 2.5-7.0 mmol/L; if elevated, then a FBG <7.8 mmol/l, Bilirubin <1.25 x uln, ALT <1.25 x uln, Creatinine <1.25 x uln, -ve/trace urine dipstick for protein and blood)
Active TB/other systemic infection
Positive HBsAg
Active syphilis
Immunodeficiency/chronic illness
Autoimmune disease
Severe eczema
Psychiatric/substance abuse problem in past 6 months
Grand-mal epilepsy, or current use of anti-epileptics
Blood/Blood products/immunoglobulins use in past 3 months
Immunosuppressive therapy.
Experimental therapeutic agents within 30 days of study entry
Any live, attenuated vaccination within 60 days of study entry
Receipt of an HIV candidate vaccine.
Severe local or general reaction to vaccination
Lactating mothers
Study site employees
Protocol non-compliance
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method