PACTR2009040001075080
Other
Phase 2
A phase I/II trial to assess safety & immunogenicity of a plasmid DNA-MVA prime boost HIV-1 vaccine candidate among volunteers in DaresSalaam, Tanzani
Swedish Institute for Infectious Disease Control (SMI)0 sites0 target enrollmentNovember 26, 2008
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Swedish Institute for Infectious Disease Control (SMI)
- Status
- Other
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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