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Safety of and Immune Response to a Combination HIV Vaccine Regimen in HIV Uninfected Adults

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Clade B gag DNA/PLG and env DNA/PLG Microparticles
Clade B Recombinant, Oligomeric gp140/MF59 Adjuvant
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Note: As of 07/01/05, Group 5 will begin enrollment after enrollment into Groups 1, 2, 3, and 4 is completed. Inclusion Criteria Understanding of vaccination procedure Willing to receive HIV test results and provide informed consent Good general health HIV negative Hepatitis B surface antigen negative Anti-hepatitis C virus (HCV) antibody negative, or negative for HCV PCR if the anti-HCV is positive Not pregnant and agrees to use acceptable forms of contraception Exclusion Criteria Received HIV vaccines or placebo in a prior HIV vaccine trial Immunosuppressive medications within 168 days prior to study Blood products within 120 days prior to study Immunoglobulin within 60 days prior to study Live attenuated vaccines within 30 days prior to study Investigational research agents within 30 days prior to study Medically indicated subunit or killed vaccines within 14 days prior to study Current anti-tuberculosis prophylaxis or therapy Anaphylaxis or other serious adverse reactions to vaccines; a person who had an adverse reaction to pertussis vaccine as a child is not excluded Autoimmune disease or immunodeficiency Active syphilis infection Unstable asthma (e.g., use of oral, orally inhaled, or intravenous corticosteroids, emergent care, urgent care, hospitalization or intubation during the past 2 years) Diabetes mellitus; a participant with past gestational diabetes is not excluded Thyroid disease, including removal of thyroid and diagnoses requiring medication Serious angioedema Uncontrolled hypertension Diagnosis of bleeding disorder Malignancy, except those with a surgical excision and subsequent observation period that in the investigator's estimate has a reasonable assurance of sustained cure and/or is unlikely to recur during the period of the study Seizure disorder requiring medication within the last 3 years Absence of the spleen Mental illness that would interfere with compliance with the protocol Breastfeeding Unprotected rectal or vaginal sex with a partner known to be HIV infected within 6 months of enrollment

Sites / Locations

  • Saint Louis Univ. School of Medicine, HVTU
  • Miriam Hospital's HVTU
  • Vanderbilt Vaccine CRS
  • FHCRC/UW Vaccine CRS

Outcomes

Primary Outcome Measures

Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse and serious experiences)
immunogenicity (presence of HIV-specific immune response as measured by the interferon-gamma ELISpot, FACS Intracellular Cytokine Staining [ICS], neutralizing antibody, or HIV antigen-binding ELISA assays)
social impacts (negative experiences or problems reported by the participants)

Secondary Outcome Measures

Full Information

First Posted
November 18, 2003
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
NCT00073216
Brief Title
Safety of and Immune Response to a Combination HIV Vaccine Regimen in HIV Uninfected Adults
Official Title
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Clade B Gag DNA/PLG and Env DNA/PLG Microparticles Vaccine and a Clade B Recombinant, Oligomeric gp140/MF59 Adjuvant Vaccine 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
September 2007 (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
To prevent HIV infection, a vaccine that produces strong HIV-specific humoral (B-cell) and cellular (T-cell) immune system responses is desirable. The purpose of this study is to test the safety of and immune response to a novel combination HIV vaccine in HIV uninfected adults. This study will also test the safety of and immune response to a protein vaccine given alone.
Detailed Description
The development of a vaccine eliciting HIV-specific humoral and cellular immune responses is desirable for the prevention of HIV infection. This study will investigate a combination vaccine regimen consisting of priming with DNA followed by boosting with a recombinant envelope glycoprotein adjuvanted in MF59. All participants will be followed for 15 months. Participants enrolled in Groups 1, 2, 3, and 4 will receive either the vaccine or placebo. Study visits will be completed at initial entry; five visits every 14 days for the first 2.5 months; and visits at Months 4, 4.5, 6, 6.5, 9, 9.5, 12, and 15. All participants will undergo physical exams, urine collection, and blood tests to assess safety, HIV infection, and immune responses to injections. Risk reduction/pregnancy prevention counseling will be given at every study visit. Participants will also be asked to complete questionnaires about outside testing and beliefs at certain visits. There are two parts to this study. In Part A, participants will be sequentially assigned to one of three groups. Each group will receive injections of different amounts of either DNA vaccine or placebo at entry, Month 1, and Month 2. This is followed by identical injections of glycoprotein/adjuvant or placebo at Months 6 and 9. Group 1 will receive 250 mcg each of the gag and env DNA plasmid with microparticle vaccine; Group 2 will receive 500 mcg of each vaccine; Group 3 will receive 1000 mcg of each vaccine. Participants will be enrolled sequentially from low to high dose beginning with Group 1. In Part B, Group 4 will begin the second part of the study simultaneously after safety review of all participants in Part A. Group 4 participants will receive identical injections of either DNA vaccine or placebo at entry and at Months 1, 2, 6, and 9. Group 5 will begin enrollment after enrollment is completed for Groups 1, 2, 3, and 4. Group 5 participants will receive identical injections of either glycoprotein/adjuvant or placebo at study entry and at Months 3 and 9. There will be 11 study visits for Group 5 participants; they will occur at screening, study entry, and Months 0.5, 2, 3, 3.5, 6, 9, 9.5, 12, and 15. A physical exam and risk reduction/pregnancy prevention counseling will occur at all visits; participants will be asked at every visit about any adverse events they may have experienced. Blood and urine collection will occur at selected visits. Participants will be also asked to complete questionnaires about outside testing and beliefs at certain visits.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Clade B gag DNA/PLG and env DNA/PLG Microparticles
Intervention Type
Biological
Intervention Name(s)
Clade B Recombinant, Oligomeric gp140/MF59 Adjuvant
Primary Outcome Measure Information:
Title
Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse and serious experiences)
Title
immunogenicity (presence of HIV-specific immune response as measured by the interferon-gamma ELISpot, FACS Intracellular Cytokine Staining [ICS], neutralizing antibody, or HIV antigen-binding ELISA assays)
Title
social impacts (negative experiences or problems reported by the participants)

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
Note: As of 07/01/05, Group 5 will begin enrollment after enrollment into Groups 1, 2, 3, and 4 is completed. Inclusion Criteria Understanding of vaccination procedure Willing to receive HIV test results and provide informed consent Good general health HIV negative Hepatitis B surface antigen negative Anti-hepatitis C virus (HCV) antibody negative, or negative for HCV PCR if the anti-HCV is positive Not pregnant and agrees to use acceptable forms of contraception Exclusion Criteria Received HIV vaccines or placebo in a prior HIV vaccine trial Immunosuppressive medications within 168 days prior to study Blood products within 120 days prior to study Immunoglobulin within 60 days prior to study Live attenuated vaccines within 30 days prior to study Investigational research agents within 30 days prior to study Medically indicated subunit or killed vaccines within 14 days prior to study Current anti-tuberculosis prophylaxis or therapy Anaphylaxis or other serious adverse reactions to vaccines; a person who had an adverse reaction to pertussis vaccine as a child is not excluded Autoimmune disease or immunodeficiency Active syphilis infection Unstable asthma (e.g., use of oral, orally inhaled, or intravenous corticosteroids, emergent care, urgent care, hospitalization or intubation during the past 2 years) Diabetes mellitus; a participant with past gestational diabetes is not excluded Thyroid disease, including removal of thyroid and diagnoses requiring medication Serious angioedema Uncontrolled hypertension Diagnosis of bleeding disorder Malignancy, except those with a surgical excision and subsequent observation period that in the investigator's estimate has a reasonable assurance of sustained cure and/or is unlikely to recur during the period of the study Seizure disorder requiring medication within the last 3 years Absence of the spleen Mental illness that would interfere with compliance with the protocol Breastfeeding Unprotected rectal or vaginal sex with a partner known to be HIV infected within 6 months of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Spearman
Organizational Affiliation
Vanderbilt University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michelle Lally
Organizational Affiliation
Brown University
Official's Role
Study Chair
Facility Information:
Facility Name
Saint Louis Univ. School of Medicine, HVTU
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Miriam Hospital's HVTU
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Vanderbilt Vaccine CRS
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
FHCRC/UW Vaccine CRS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15285710
Citation
Malkevitch NV, Robert-Guroff M. A call for replicating vector prime-protein boost strategies in HIV vaccine design. Expert Rev Vaccines. 2004 Aug;3(4 Suppl):S105-17. doi: 10.1586/14760584.3.4.s105.
Results Reference
background
PubMed Identifier
11533167
Citation
O'Hagan D, Singh M, Ugozzoli M, Wild C, Barnett S, Chen M, Schaefer M, Doe B, Otten GR, Ulmer JB. Induction of potent immune responses by cationic microparticles with adsorbed human immunodeficiency virus DNA vaccines. J Virol. 2001 Oct;75(19):9037-43. doi: 10.1128/JVI.75.19.9037-9043.2001.
Results Reference
background
PubMed Identifier
10699327
Citation
O'Hagan DT, Ugozzoli M, Barackman J, Singh M, Kazzaz J, Higgins K, Vancott TC, Ott G. Microparticles in MF59, a potent adjuvant combination for a recombinant protein vaccine against HIV-1. Vaccine. 2000 Mar 6;18(17):1793-801. doi: 10.1016/s0264-410x(99)00522-8.
Results Reference
background
PubMed Identifier
16026246
Citation
Slobod KS, Bonsignori M, Brown SA, Zhan X, Stambas J, Hurwitz JL. HIV vaccines: brief review and discussion of future directions. Expert Rev Vaccines. 2005 Jun;4(3):305-13. doi: 10.1586/14760584.4.3.305.
Results Reference
background
PubMed Identifier
14738219
Citation
Stratov I, DeRose R, Purcell DF, Kent SJ. Vaccines and vaccine strategies against HIV. Curr Drug Targets. 2004 Jan;5(1):71-88. doi: 10.2174/1389450043490686.
Results Reference
background
PubMed Identifier
21451004
Citation
Spearman P, Lally MA, Elizaga M, Montefiori D, Tomaras GD, McElrath MJ, Hural J, De Rosa SC, Sato A, Huang Y, Frey SE, Sato P, Donnelly J, Barnett S, Corey LJ; HIV Vaccine Trials Network of NIAID. A trimeric, V2-deleted HIV-1 envelope glycoprotein vaccine elicits potent neutralizing antibodies but limited breadth of neutralization in human volunteers. J Infect Dis. 2011 Apr 15;203(8):1165-73. doi: 10.1093/infdis/jiq175.
Results Reference
derived

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Safety of and Immune Response to a Combination HIV Vaccine Regimen in HIV Uninfected Adults

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