Safety and Immune Response to a Clade C DNA HIV Vaccine — HVTN111  

HIV Infections Clinical Trial

Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV Clade C DNA and of MF59-adjuvanted Clade C Env Protein, in Healthy, HIV-uninfected Adult Participants

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• HIV Infections

• NCT number: NCT02997969
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Completed
• Phase: Phase 1
• Start date: June 21, 2016
• Completion date: July 11, 2018