Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-05 @ 6:38 PM
Study NCT ID:
NCT02997969
Status:
COMPLETED
Last Update Posted:
2019-06-21
First Post:
2016-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immune Response to a Clade C DNA HIV Vaccine
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
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
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HVTN111
Brief 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: