Last updated on February 2018

Safety and Immune Response to a Clade C DNA HIV Vaccine

Brief description of study

The purpose of this study is to evaluate the safety and immune response to an HIV clade C DNA vaccine and to an MF59-adjuvanted clade C Env protein in healthy, HIV-uninfected adults.

Detailed Study Description

This study will evaluate the safety, tolerability, and immunogenicity to DNA-HIV-PT123 (an HIV clade C DNA vaccine) and to Bivalent Subtype C gp120/MF59 in healthy, HIV-uninfected adults.

The study will enroll healthy, HIV-uninfected participants aged 18 to 40 years. Participants will be randomly assigned to one of 6 groups. Each group will receive experimental vaccine and protein and/or placebo at 4 study visits. Participants in Groups 1-3 will receive all injections via needle and syringe. Participants in Groups 4-6 will receive the DNA vaccine via Biojector, and protein and/or placebo via needle and syringe.

Participants in Groups 1 and 4 will receive the DNA vaccine at months 0, 1, 3, and 6 and the protein at months 3 and 6. Participants in Groups 2 and 5 will receive the DNA vaccine and the protein at months 0, 1, and 6 and placebo at month 3. Participants in Groups 3 and 6 will receive placebo at months 0, 1, 3, and 6.

Study visits will include a physical examination, an interview and/or questionnaire, HIV testing and HIV risk-reduction counseling, and urine and blood collection. Participants may optionally choose to provide rectal fluid, cervical fluid, or semen samples.

Clinical Study Identifier: NCT02997969

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Isipingo CRS

Westville, South Africa
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Recruitment Status: Open

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