Study of an HIV Preventive Vaccine Given With or Without an Adjuvant in HIV Uninfected Adults
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Gag DNA Vaccine With or Without IL-12 DNA Adjuvant, Boosted With Homologous Plasmids in Healthy, HIV-1 Uninfected Adult Participants
2 other identifiers
interventional
144
2 countries
4
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of an experimental HIV vaccine. The vaccine will be given with or without IL-12 DNA adjuvant (at three escalating doses of 100, 500, and 1,500 mcg respectively), a substance that helps the body respond to a vaccine. This study will also determine the safety and tolerability of an experimental HIV vaccine boosted with two adjuvants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2005
CompletedFirst Posted
Study publicly available on registry
May 24, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedOctober 14, 2021
October 1, 2021
May 23, 2005
October 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety, as judged by local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious experiences
Throughout the study
Secondary Outcomes (1)
Immunogenicity, as judged by HIV-specific cellular responses assessed by interferon-gamma ELISpot assays and by intracellular cytokine staining (ICS)
Throughout the study
Study Arms (7)
1
EXPERIMENTALHIV gag DNA vaccine or placebo on Days 0, 28, and 84
2
EXPERIMENTALHIV gag DNA vaccine plus 100 mcg of IL-12 or placebo on Days 0, 28, and 84
3
EXPERIMENTALHIV gag DNA vaccine plus 500 mcg of IL-12 or placebo on Days 0, 28, and 84
4
EXPERIMENTALHIV gag DNA vaccine plus 1,500 mcg of IL-12 or placebo on Days 0, 28, and 84
5
EXPERIMENTALHIV gag DNA vaccine or placebo on Days 0, 28, 84, 168, and 273
6
EXPERIMENTALHIV gag DNA vaccine plus IL-12 or placebo on Days 0, 28, and 84 plus CTL MEP/RC529-SE/GM-SCF booster vaccine on Days 168 and 273
7
EXPERIMENTALHIV gag DNA vaccine plus IL-12 DNA adjuvant or placebo on Days 0 and 84
Interventions
A 0.75 mL intramuscular injection of HIV gag DNA vaccine into the deltoid
Injection IL-12 DNA adjuvant intramuscularly into the deltoid
All placebo groups will receive an intramuscular injection of sodium chloride (0.9%) in the deltoid. Group 1 will receive a 0.75 mL injection on Days 0, 28, and 84. Group 2 will receive a 0.8 mL injection on Days 0, 28, and 84. Group 3 will receive a 1.0 mL injection on Days 0, 28, and 84. Group 4 will receive a 1.5 mL injection on Days 0, 28, and 84. Group 5 will receive a 0.75 mL injection on Days 0, 28, 84, 168, and 273. Group 6 will receive a 1.5 mL injection on Days 0, 28, 84, 168, and 273. Group 7 will receive a 1.5 mL injection on Days 0, 28, and 84 and a 1 mL injection into the deltoid on Days 168 and 273.
Eligibility Criteria
You may qualify if:
- HIV uninfected
- Access to a participating HIV Vaccine Trials Unit (HVTU)
- Willing to receive HIV test results
- Willing and able to comply with all study requirements
- In good general health
- Willing to use acceptable methods of contraception for at least 21 days prior to study entry and until the last study visit. More information about this criterion can be found in the protocol.
- Hepatitis B surface antigen negative
- Anti-hepatitis C virus (anti-HCV) antibody negative or negative HCV PCR if anti-HCV antibody is positive
- Weighs of or greater than 110 pounds (50 kg)
You may not qualify if:
- HIV infection
- HIV vaccines or placebos in prior HIV trial
- Immunosuppressive medications within 168 days prior to first study vaccination
- Blood products within 120 days prior to first study vaccination
- Live attenuated vaccines within 30 days prior to first study vaccination
- Medically indicated subunit or killed vaccines within 14 days prior to first study vaccination
- Pneumococcal vaccine within 14 days prior to first study vaccination
- Allergy treatment with antigen injections within 30 days prior to first study vaccination
- Current anti-tuberculosis (TB) preventive therapy or treatment
- Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health
- Any medical, psychiatric, or social condition that would interfere with the study. More information about this criterion can be found in the protocol.
- Any job-related responsibility that would interfere with the study
- Allergies to local amide-type anesthetics
- Serious adverse reactions to vaccines, including hypersensitivity and related symptoms. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
- Autoimmune disease or immunodeficiency
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Alabama Vaccine CRS
Birmingham, Alabama, 35294-2041, United States
Project Brave HIV Vaccine CRS
Baltimore, Maryland, 21201, United States
Vanderbilt Vaccine CRS
Nashville, Tennessee, 37232, United States
Chiang Mai Univ. HVTN CRS
Chiang Mai, Thailand
Related Publications (5)
Bolesta E, Gzyl J, Wierzbicki A, Kmieciak D, Kowalczyk A, Kaneko Y, Srinivasan A, Kozbor D. Clustered epitopes within the Gag-Pol fusion protein DNA vaccine enhance immune responses and protection against challenge with recombinant vaccinia viruses expressing HIV-1 Gag and Pol antigens. Virology. 2005 Feb 20;332(2):467-79. doi: 10.1016/j.virol.2004.09.043.
PMID: 15680412BACKGROUNDLetvin NL. Progress toward an HIV vaccine. Annu Rev Med. 2005;56:213-23. doi: 10.1146/annurev.med.54.101601.152349.
PMID: 15660510BACKGROUNDSha BE, Onorato M, Bartlett JA, Bosch RJ, Aga E, Nokta M, Adams EM, Li XD, Eldridge J, Pollard RB. Safety and immunogenicity of a polyvalent peptide C4-V3 HIV vaccine in conjunction with IL-12. AIDS. 2004 May 21;18(8):1203-6. doi: 10.1097/00002030-200405210-00015.
PMID: 15166537BACKGROUNDJin X, Morgan C, Yu X, DeRosa S, Tomaras GD, Montefiori DC, Kublin J, Corey L, Keefer MC; NIAID HIV Vaccine Trials Network. Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials. Vaccine. 2015 May 11;33(20):2347-53. doi: 10.1016/j.vaccine.2015.03.036. Epub 2015 Mar 25.
PMID: 25820067DERIVEDKalams SA, Parker S, Jin X, Elizaga M, Metch B, Wang M, Hural J, Lubeck M, Eldridge J, Cardinali M, Blattner WA, Sobieszczyk M, Suriyanon V, Kalichman A, Weiner DB, Baden LR; NIAID HIV Vaccine Trials Network. Safety and immunogenicity of an HIV-1 gag DNA vaccine with or without IL-12 and/or IL-15 plasmid cytokine adjuvant in healthy, HIV-1 uninfected adults. PLoS One. 2012;7(1):e29231. doi: 10.1371/journal.pone.0029231. Epub 2012 Jan 5.
PMID: 22242162DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Spyros Kalams, MD
Vanderbilt University
- STUDY CHAIR
Scott Parker, MD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2005
First Posted
May 24, 2005
Study Completion
May 1, 2008
Last Updated
October 14, 2021
Record last verified: 2021-10