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Study of an HIV Preventive Vaccine Given With or Without an Adjuvant in HIV Uninfected Adults

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
HIV-1 gag DNA
HIV-1 gag DNA plus IL-12 DNA adjuvant
CTL MEP/RC529-SE/GM-CSF (CTL MEP vaccine)
Sodium chloride injection (0.9%)
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring AIDS Vaccines, HIV Vaccines, HIV Preventive Vaccine, HIV Seronegativity

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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 Active syphilis infection. Participants who have been fully treated for syphilis over 6 months prior to study entry are not excluded. Moderate to severe asthma. More information on this criterion can be found in the protocol. Type 1 or type 2 diabetes mellitus. Participants with histories of isolated gestational diabetes are not excluded. Thyroid disease or surgical removal of the thyroid requiring medication during the 12 months prior to study entry Accumulation of fluid in the blood vessels (angioedema) within 3 years prior to study entry, with episodes requiring medication in the 2 years prior to study entry Hypertension that is not well controlled by medication OR blood pressure of 150/100 or higher at study entry Body mass index (BMI) of 40 or greater OR BMI of 35 or greater, if certain criteria are met. More information about these criteria can be found in the protocol. Bleeding disorder Cancer. Participants with surgically removed cancer that, in the opinion of the investigator, is unlikely to recur are not excluded. Absence of the spleen Plans to become pregnant during the study Pregnancy or breastfeeding Exclusion Criterion for Participants in Part B: Allergies to yeast-derived products

Sites / Locations

  • Alabama Vaccine CRS
  • Project Brave HIV Vaccine CRS
  • Vanderbilt Vaccine CRS
  • Chiang Mai Univ. HVTN CRS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

5

6

7

Arm Description

HIV gag DNA vaccine or placebo on Days 0, 28, and 84

HIV gag DNA vaccine plus 100 mcg of IL-12 or placebo on Days 0, 28, and 84

HIV gag DNA vaccine plus 500 mcg of IL-12 or placebo on Days 0, 28, and 84

HIV gag DNA vaccine plus 1,500 mcg of IL-12 or placebo on Days 0, 28, and 84

HIV gag DNA vaccine or placebo on Days 0, 28, 84, 168, and 273

HIV 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

HIV gag DNA vaccine plus IL-12 DNA adjuvant or placebo on Days 0 and 84

Outcomes

Primary Outcome Measures

Safety, as judged by local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious experiences

Secondary Outcome Measures

Immunogenicity, as judged by HIV-specific cellular responses assessed by interferon-gamma ELISpot assays and by intracellular cytokine staining (ICS)

Full Information

First Posted
May 23, 2005
Last Updated
October 13, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00111605
Brief Title
Study of an HIV Preventive Vaccine Given With or Without an Adjuvant in HIV Uninfected Adults
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
Detailed Description
The HIV epidemic is a major global health challenge, causing tremendous human suffering and economic loss throughout the world. The need for a safe, effective, and affordable HIV preventive vaccine is critical. This study will determine the safety and immunogenicity of an experimental HIV vaccine, HIV-1 gag DNA, given with or without an IL-12 adjuvant and boosted HIV-1 gag DNA with or without IL-12 DNA adjuvant. This study will comprise two parts (Parts A and B). Part A will last 9 months and Part B, 15 months. Part A will consist of 48 participants enrolled in 4 groups. Group 1 participants will be randomly assigned to receive the gag DNA vaccine or placebo. Participants in Groups 2, 3, and 4 will be randomly assigned to receive the gag DNA vaccine and either 100 mcg, 500 mcg, or 1,500 mcg IL-12 DNA or placebo. Vaccinations for Groups 1 through 4 will be given intramuscularly and will occur at study entry and at Months 1 and 3. Part B will consist of 96 participants, enrolled in 3 groups. Participants in Part B will receive their first vaccination 2 weeks after Part A participants receive their second vaccination. Group 5 participants will receive either the HIV-1 gag DNA vaccine or placebo. Group 6 participants will receive either the HIV-1 gag DNA vaccine plus IL-12 DNA or placebo. Vaccinations for Groups 5 and 6 will occur at study entry and at Months 1, 3, 6, and 9. Group 7 participants will receive either the gag DNA vaccine plus IL-12 DNA or placebo at study entry and at Months 1 and 3. Throughout the study, blood and urine collections will occur, physical exams will be conducted, HIV testing and counseling will be offered, and interviews and questionnaires will be completed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
AIDS Vaccines, HIV Vaccines, HIV Preventive Vaccine, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
HIV gag DNA vaccine or placebo on Days 0, 28, and 84
Arm Title
2
Arm Type
Experimental
Arm Description
HIV gag DNA vaccine plus 100 mcg of IL-12 or placebo on Days 0, 28, and 84
Arm Title
3
Arm Type
Experimental
Arm Description
HIV gag DNA vaccine plus 500 mcg of IL-12 or placebo on Days 0, 28, and 84
Arm Title
4
Arm Type
Experimental
Arm Description
HIV gag DNA vaccine plus 1,500 mcg of IL-12 or placebo on Days 0, 28, and 84
Arm Title
5
Arm Type
Experimental
Arm Description
HIV gag DNA vaccine or placebo on Days 0, 28, 84, 168, and 273
Arm Title
6
Arm Type
Experimental
Arm Description
HIV 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
Arm Title
7
Arm Type
Experimental
Arm Description
HIV gag DNA vaccine plus IL-12 DNA adjuvant or placebo on Days 0 and 84
Intervention Type
Biological
Intervention Name(s)
HIV-1 gag DNA
Intervention Description
A 0.75 mL intramuscular injection of HIV gag DNA vaccine into the deltoid
Intervention Type
Biological
Intervention Name(s)
HIV-1 gag DNA plus IL-12 DNA adjuvant
Intervention Description
Injection IL-12 DNA adjuvant intramuscularly into the deltoid
Intervention Type
Biological
Intervention Name(s)
CTL MEP/RC529-SE/GM-CSF (CTL MEP vaccine)
Intervention Description
A 1 mL intramuscular injection in the deltoid
Intervention Type
Biological
Intervention Name(s)
Sodium chloride injection (0.9%)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety, as judged by local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious experiences
Time Frame
Throughout the study
Secondary Outcome Measure Information:
Title
Immunogenicity, as judged by HIV-specific cellular responses assessed by interferon-gamma ELISpot assays and by intracellular cytokine staining (ICS)
Time Frame
Throughout the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 Active syphilis infection. Participants who have been fully treated for syphilis over 6 months prior to study entry are not excluded. Moderate to severe asthma. More information on this criterion can be found in the protocol. Type 1 or type 2 diabetes mellitus. Participants with histories of isolated gestational diabetes are not excluded. Thyroid disease or surgical removal of the thyroid requiring medication during the 12 months prior to study entry Accumulation of fluid in the blood vessels (angioedema) within 3 years prior to study entry, with episodes requiring medication in the 2 years prior to study entry Hypertension that is not well controlled by medication OR blood pressure of 150/100 or higher at study entry Body mass index (BMI) of 40 or greater OR BMI of 35 or greater, if certain criteria are met. More information about these criteria can be found in the protocol. Bleeding disorder Cancer. Participants with surgically removed cancer that, in the opinion of the investigator, is unlikely to recur are not excluded. Absence of the spleen Plans to become pregnant during the study Pregnancy or breastfeeding Exclusion Criterion for Participants in Part B: Allergies to yeast-derived products
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Spyros Kalams, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Scott Parker, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Vaccine CRS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-2041
Country
United States
Facility Name
Project Brave HIV Vaccine CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Vanderbilt Vaccine CRS
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Chiang Mai Univ. HVTN CRS
City
Chiang Mai
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
15680412
Citation
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. Erratum In: Virology. 2005 May 10;335(2):291.
Results Reference
background
PubMed Identifier
15660510
Citation
Letvin NL. Progress toward an HIV vaccine. Annu Rev Med. 2005;56:213-23. doi: 10.1146/annurev.med.54.101601.152349.
Results Reference
background
PubMed Identifier
15166537
Citation
Sha 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.
Results Reference
background
PubMed Identifier
25820067
Citation
Jin 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.
Results Reference
derived
PubMed Identifier
22242162
Citation
Kalams 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.
Results Reference
derived

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Study of an HIV Preventive Vaccine Given With or Without an Adjuvant in HIV Uninfected Adults

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