HIV Infections Clinical Trial
Official title:
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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