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Virus Therapy
2 for Human Immunodeficiency Virus Infection
Phase 1
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HIV uninfected
Good general health as determined by medical history, physical examination, vital signs, and clinical laboratory measurements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study
Awards & highlights
Study Summary
This study will evaluate the safety of and immune response to a new HIV vaccine. The vaccine in this trial uses pieces of HIV DNA and HIV proteins. The vaccine itself cannot cause HIV infection or AIDS.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability
Secondary outcome measures
Cellular immunity
Cross-clade neutralizing antibody
Side effects data
From 2012 Phase 3 trial • 6104 Patients • NCT0134659227%
Injection site pain
25%
Pyrexia
14%
Upper respiratory tract infection
14%
Decreased appetite
14%
Diarrhea
10%
Injection site erythema
9%
Nasopharyngitis
9%
Irritability postvaccinal
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Hypersomnia
7%
Myalgia
7%
Injection site swelling
7%
Fatigue
6%
Crying
6%
Injection site hemorrhage
4%
Gastroenteritis
1%
Pneumonia
1%
Animal Bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATIV (6 to <72 Months)
TIV (6 to <72 Months)
Comparator TIV (6 to <72 Months)
Trial Design
5Treatment groups
Experimental Treatment
Group I: 5Experimental Treatment1 Intervention
Participants will receive the vaccine through either intradermal or intramuscular administration
Group II: 4Experimental Treatment1 Intervention
Participants will receive the vaccine through either intradermal or intramuscular administration
Group III: 3Experimental Treatment1 Intervention
Participants will receive different doses of the vaccine to determine the optimal dose
Group IV: 2Experimental Treatment1 Intervention
Participants will receive different doses of the vaccine to determine the optimal dose
Group V: 1Experimental Treatment1 Intervention
Participants will receive different doses of the vaccine to determine the optimal dose
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,261 Previous Clinical Trials
5,482,970 Total Patients Enrolled
Jeff Kennedy, MDStudy DirectorUniversity of Massachusetts, Worcester
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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