NCT01799954

Evaluating the Safety and Priming Response of an HIV Vaccine Regimen in Healthy, HIV-Uninfected Adults

A Phase 1 Double Blind Placebo-controlled Clinical Trial to Evaluate the Safety and to Compare the Priming Ability of NYVAC Alone Versus NYVAC + AIDSVAX® B/E, and DNA Alone Versus DNA + AIDSVAX® B/E When Followed by NYVAC + AIDSVAX® B/E Boosts in Healthy, HIV-1-uninfected Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: HIV Vaccine Trials Network · Network
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety of and the body's immune response to experimental HIV vaccine regimens using different vaccine priming combination, and boosting with the vaccines NYVAC and AIDSVAX® B/E.

Detailed description

Although multiple candidate HIV vaccines are being studied, there is not yet an effective preventive HIV vaccine. This study will test 4 experimental HIV vaccine regimens, each boosting with the NYVAC + AIDSVAX® B/E vaccine combination. Priming will be done with NYVAC or DNA vaccines, alone or in combination with AIDSVAX® B/E. The study will enroll 96 healthy participants, ages 18 - 50 years. Participants will be randomly assigned to 1 of 4 groups. In each group, there will be 20 participants who receive the vaccine regimen and 4 receiving only placebo. Injections will take place at months 0, 1, 3, and 6. All groups will enroll simultaneously. Enrollment will be restricted to a maximum of 2 participants per day, with no more than (1) participant in group 1 or 2 and (1) participant in group 3 or 4 until 20 participants have been enrolled with 5 in each group (4 vaccine recipients and 1 placebo recipient in each group). The HVTN 096 PSRT will review the safety and immune response data for the first 168 hours postvaccination on each of these participants, and will determine whether it is safe to proceed with full enrollment. Total study duration will be 60 months: 18 months of clinic visits followed by annual health contacts to a total of 5 years after initial study injection. At the screening visit, participants will give a medical history and undergo a complete physical exam, cardiac symptom assessment (including ECG), urine collection, blood collection, interview, HIV test, and pregnancy test (for participants who were born female). On Days 0, 28, 84, and 168 participants will receive intramuscular (IM) vaccination (vaccine or placebo) into the right and left deltoids. On vaccination visits, participants will also undergo an abbreviated physical exam, cardiac symptom assessment, Social impact assessment, a pregnancy test (for participants who were born female), risk-reduction counseling, and blood collection. Immediately following vaccination, participants will remain in the clinic for observation for 30 minutes; participants will be given a post-vaccination symptom log and instructed on how to complete it. Follow-up visits will consist of a brief physical exam, blood collection, and interview; some follow-up visits may also consist of a urine collection, HIV test, or ECG. Optional mucosal secretion collection, if the participant agrees, will be done on days 0, 168, and 364. The last clinic visit will be at Day 545; after this visit, participants will be contacted for annual health follow-up consisting of confirming vital status, collecting safety information, and reporting a new HIV diagnosis or a pregnancy. A clinic visit will only be required if HIV confirmatory testing is necessary.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	DNA-HIV-PT123	4 mg of DNA encoding clade C ZM96 Gag and gp140, CN54 Pol-Nef, administered intramuscularly (IM)
BIOLOGICAL	NYVAC-HIV-PT1	(along with NYVAC-HIV-PT4); ≥ 5x106 PFU encoding clade C ZM96 gp140 and ZM96 Gag and CN54 Pol-Nef, administered IM
BIOLOGICAL	NYVAC-HIV-PT4	(along with NYVAC-HIV-PT1); ≥ 5x106 PFU encoding clade C ZM96 gp140 and ZM96 Gag and CN54 Pol-Nef, administered IM
BIOLOGICAL	AIDSVAX® B/E	300mcg of subtype B (MN) HIV gp120 glycoprotein and 300mcg of subtype E (A244) HIV gp120 glycoprotein absorbed onto 600mcg of aluminum hydroxide gel adjuvant, administered IM.
BIOLOGICAL	Placebo for DNA/NYVAC	Sodium Chloride for injection, 0.9% administered IM
BIOLOGICAL	Placebo for AIDSVAX(R) B/E	600 mcg of aluminum hydroxide adjuvant, administered IM

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-02-27
• Last updated: 2015-03-25

Locations

1 site across 1 country: Switzerland