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NCT01386489
Immune Responses to Two Experimental HIV Vaccines in Healthy Adults
Phase 1 trial testing VRC-HIVDNA016-00-VP in HIV Negative in 36 participants. Completed in 19 March 2014.
9 March 2014
Quick facts
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 36 |
| Start date | 17 June 2011 |
| Primary completion | 9 March 2014 |
| Estimated completion | 19 March 2014 |
| Sites | 1 location across United States |
Drugs / interventions tested
- VRC-HIVDNA016-00-VP — full drug profile →
- VRC-HIVADV014-00-VP — full drug profile →
Conditions studied
- HIV Negative — all drugs for HIV Negative →
- Adaptive Immunity — all drugs for Adaptive Immunity →
- Innate Immunity — all drugs for Innate Immunity →
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
Adults 18 to 50, any sex, with HIV Negative or Adaptive Immunity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: The primary focus of the Vaccine Research Center (VRC) at the NIH is to develop vaccines for HIV/AIDS. The main purpose of this study is to look in detail at the body s immune response to two experimental HIV vaccines currently in development at the VRC. One is known as the rAd5 vaccine and the other is known as the DNA vaccine. These vaccines are made with pieces of manufactured DNA. They do not contain live or killed HIV. It is impossible for study vaccines to give you HIV and they cannot cause you to give HIV to someone else. Both of these experimental vaccines have been given to people before in other research studies. They have not been approved for treating or preventing HIV infection. Purpose: The main purpose of this study is to look in detail at the body s immune responses after the experimental HIV vaccines are given and to assess safety of the study vaccines. Eligibility: Healthy volunteers between the ages of 18 and 50 who are not infected with HIV and who meet the eligibility requirements. Design: Participants will be screened with a medical history (including questions about sexual history and drug use), physical exam, and blood tests. The study will have two groups: \<TAB\>One group will receive one injection of the rAd5 vaccine, and have 8 clinic visits over 3 months. \<TAB\>The second group will have three injections of the DNA vaccine, one injection of the rAd5 vaccine, and have 12 clinic visits over 6 months. All participants will be asked to provide blood and body fluid samples for testing during the study. Payment for participation will be provided....
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01386489
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Related trials
Other trials of VRC-HIVDNA016-00-VP
Trials testing the same drug.
- NCT00270465 — Safety and Immune Response to a Prime-Boost Vaccination Schedule in HIV-infected Patients · Phase 1 · completed
- NCT00109629 — "Prime-Boost" Vaccine Schedule for Prevention of HIV Infection · Phase 1 · completed
- NCT00089531 — Candidate HIV Vaccine · Phase 1 · completed
- NCT00498056 — Safety and Effectiveness of an HIV DNA Vaccine Followed by an HIV Adenoviral Vector Vaccine for Prevention of HIV Infect · Phase 2 · withdrawn
- NCT00415649 — Safety of and Immune Response to an HIV DNA Plasmid Vaccine Followed by HIV Adenoviral Vector Vaccine in Healthy African · Phase 2 · withdrawn
Other National Institute of Allergy and Infectious Diseases (NIAID) trials
Trials by the same sponsor.
- NCT07216794 — Small Trial of Alendronate Impact on the Reservoir of HIV · Phase 2 · not yet recruiting
- NCT07215858 — BPL-1357 Against H1N1 Influenza Virus Challenge · Phase 2 · recruiting
- NCT06987318 — A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) · Phase 1 · not yet recruiting
- NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of · Phase 1, PHASE2 · not yet recruiting
- NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01386489 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
- Last refreshed: 16 December 2019
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