Safety of and Immune Response to an Adenoviral HIV Vaccine (VRC-HIVADV014-00-VP) With or Without a Plasmid HIV Vaccine (VRC-HIVDNA016-00-VP) in HIV Uninfected Adults
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00124007
First received: July 22, 2005
Last updated: February 10, 2012
Last verified: February 2012
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Purpose
The purpose of this study is to determine the safety of and immune response to an investigational HIV vaccine, VRC-HIVADV014-00-VP, with or without a second investigational HIV vaccine, VRC-HIVDNA016-00-VP, in HIV uninfected adults.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Biological: VRC-HIVADV014-00-VP Biological: VRC-HIVDNA016-00-VP |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Diagnostic |
| Official Title: | A Phase I, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine Followed by Recombinant, Multiclade HIV-1 Adenoviral Vector Vaccine or the Multiclade HIV-1 Adenoviral Vector Vaccine Alone in Healthy Adult Volunteers Not Infected With HIV |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Primary Outcome Measures:
- Local reactogenicity signs and symptoms
- systemic reactogenicity signs and symptoms
- laboratory measures of safety
- adverse and serious adverse experiences
Secondary Outcome Measures:
- Proportion of volunteers who have HIV-1 specific T-cell responses quantified by intracellular cytokine staining (ICS; both CD4+ and CD8+) and ELISPOT and magnitude of the responses
- proportion of volunteers with HIV-1 specific antibodies and magnitude of the response
- proportion of volunteers with increase in antibodies to rAd5
- impact of pre-existing immunity to rAd5 on immunogenicity
- proportion of volunteers who test "false positive" on standard HIV testing algorithm.
| Enrollment: | 114 |
| Study Completion Date: | April 2007 |
The worldwide HIV/AIDS epidemic may only be controlled through development of a safe and effective vaccine that will prevent HIV infection. This study will evaluate the safety and immunogenicity of an experimental adenovirus-vectored multiclade HIV vaccine, VRC-HIVADV014-00-VP, followed with either a similarly structured DNA plasmid HIV vaccine, VRC-HIVDNA016-00-VP, or a placebo. The DNA plasmids in both vaccines code for proteins from HIV subtypes A, B, and C, which together represent 90% of new HIV infections in the world. HIV uninfected volunteers will be recruited in Kenya and Rwanda.
Volunteers will participate in this study for 1 year. Participants will be randomly assigned to one of four groups:
- Group A participants will receive a low dose of the adenovirus-vectored vaccine or placebo at study entry.
- Group B participants will receive a higher dose of the adenovirus-vectored vaccine or placebo at study entry.
- Group C participants will receive the DNA plasmid vaccine or placebo at study entry and Months 1 and 2. They will receive either a low dose of the adenovirus-vectored vaccine or placebo at Month 6.
- Group D participants will receive the DNA plasmid vaccine or placebo at study entry and Months 1 and 2. They will receive either a higher dose of the adenovirus-vectored vaccine or placebo at Month 6.
All participants will undergo vital signs measurements before and after receiving each vaccination.
Participants in Groups A and B will have 9 study visits over 12 months. A physical exam, adverse events reporting, and medical and medication history will occur at each visit. HIV testing and counseling and blood and urine collection will occur at selected visits.
Participants in Groups C and D will have 17 study visits over 12 months. A physical exam, adverse events reporting, and medical and medication history will occur at each visit. HIV testing and counseling and blood and urine collection will occur at selected visits.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Willing to follow all the requirements of the study and available for follow-up for the duration of the study
- Have understanding of the study and provide written informed consent
- Willing to undergo HIV testing and counseling and willing to receive HIV test results
- Willing to use acceptable forms of contraception
Exclusion Criteria:
- HIV infected
- Hepatitis B virus infected
- Hepatitis C virus infected
- Active or untreated syphilis
- Participated in high-risk behavior for HIV infection within 6 months prior to study entry. More information on this criterion can be found in the protocol.
- Any clinically significant abnormality in history or upon examination (e.g., immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the investigator) within 6 months prior to study entry
- Any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would make the volunteer unsuitable for the study
- Live attenuated vaccines within 30 days prior to study entry OR plan to receive a live attenuated vaccine within 60 days after vaccination in this study
- Subunit or killed vaccines within 14 days prior to study entry OR plan to receive a subunit or killed vaccine within 14 days after vaccination in this study
- Blood transfusion or blood products within 120 days prior to study entry
- Immunoglobulin within 60 days prior to study entry
- Participation in another investigational product clinical trial in the 3 months prior to study entry OR expected to participate in another investigational trial during this study
- Any other investigational HIV vaccine at any time
- History of severe local or systemic reactogenicity to vaccines or history of severe allergic reactions
- Major psychiatric illness, including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, or suicide attempt or suicidal thoughts within the 3 years prior to study entry
- Uncontrolled hypertension
- Pregnant, breastfeeding, or plan to become pregnant
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124007
Locations
| Kenya | |
| KEMRI, Ctr. for Geographic Medicine Research Coast at Kilifi | |
| Kilifi, Kenya | |
| KAVI, KNH at Kangemi | |
| Nairobi, Kenya | |
| Rwanda | |
| Projet San Francisco | |
| Kigali, Rwanda | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Job Bwayo, MD, PhD | Kenya AIDS Vaccine Initiative, University of Nairobi |
| Principal Investigator: | Etienne Karita, MD | Project San Francisco |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00124007 History of Changes |
| Other Study ID Numbers: | IAVI V001, 10380 |
| Study First Received: | July 22, 2005 |
| Last Updated: | February 10, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
HIV Seronegativity HIV Preventive Vaccine |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on March 14, 2013
