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Safety and Effectiveness of PENNVAX-B Vaccine Alone, With Il-12, or IL-15 in Healthy Adults

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PennVax B
IL-12
IL-15
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 HIV Seronegativity, DNA Plasmid Vaccine, HIV Preventive Vaccine

Eligibility Criteria

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

Inclusion Criteria:

  • HIV-1 and -2 uninfected
  • Willing to receive HIV test results
  • Good general health
  • Certain laboratory values within normal range or with site physician approval
  • Negative for Hepatitis B surface antigen
  • Negative Hepatitis C test
  • Willing to use acceptable methods of contraception

Exclusion Criteria:

  • HIV vaccines or placebos in prior HIV trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.
  • Immunosuppressive medications within 168 days prior to first study vaccination. Participants using corticosteroid nasal spray for allergies or topical corticosteroids for mild, uncomplicated dermatitis are not excluded.
  • Blood products within 120 days prior to first study vaccination
  • Receipt of immunoglobulin within 60 days prior to first vaccination
  • Live attenuated vaccines within 30 days prior to first study vaccination
  • Any vaccine that is not a live attenuated vaccine within 14 days prior to first study vaccination
  • Investigational research agents within 60 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. More information about this criterion can be found in the protocol.
  • Any medical, psychiatric, social, occupational, or other condition or responsibility that in the opinion of the investigator would interfere with the study. More information about this criterion can be found in the protocol.
  • Allergy to amide-type local anesthetics
  • Serious adverse reactions to vaccines
  • 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.
  • Asthma other than mild, well-controlled 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.
  • Thyroidectomy or thyroid disease 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 if episodes are considered serious or have required medication in the 2 years prior to study entry
  • Uncontrolled hypertension
  • Body Mass Index of 40 or greater OR of 35 or greater if certain other criteria apply. More information about these criteria can be found in the protocol
  • Bleeding disorder
  • Cancer. Participants with surgically removed cancer that is unlikely to recur are not excluded.
  • Seizure disorder
  • Absence of the spleen
  • Pregnancy or breastfeeding

Sites / Locations

  • Alabama Vaccine CRS
  • San Francisco Vaccine and Prevention CRS
  • Brigham and Women's Hosp. CRS
  • NY Blood Ctr./Bronx CRS
  • NY Blood Ctr./Union Square CRS
  • HIV Prevention & Treatment CRS
  • 3535 Market Street CRS
  • Vanderbilt Vaccine CRS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

PENNVAX-B with 0.8 mg IL-15 administered in both deltoids at Months 0, 1, 3, and 6

PENNVAX-B administered alone in both deltoids at Months 0, 1, 3, and 6

PENNVAX-B administered alone in both deltoids at Months 0, 1, 3, and 6

PENNVAX-B with 2 mg IL-15 injected into both deltoids at Months 0, 1, 3, and 6

Outcomes

Primary Outcome Measures

Safety data including local and systemic reactogenicity sign and symptoms, laboratory measures of safety, and adverse and serious adverse events
Safety data from Groups 1 and 4

Secondary Outcome Measures

HIV-1 specific interferon gamma ELISpot and/or intracellular cytokine staining T cell response
HIV-1 specific neutralizing and binding antibody assays

Full Information

First Posted
September 10, 2007
Last Updated
October 13, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
HIV Vaccine Trials Network
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1. Study Identification

Unique Protocol Identification Number
NCT00528489
Brief Title
Safety and Effectiveness of PENNVAX-B Vaccine Alone, With Il-12, or IL-15 in Healthy Adults
Official Title
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of PENNVAX-B (Gag, Pol, Env) Given Alone, With IL-12 DNA, or With a Dose Escalation of IL-15 DNA, in Healthy, HIV-1-uninfected Adults Participants
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
HIV Vaccine Trials Network

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine the safety, tolerability, and immune response to the DNA HIV vaccine, PENNVAX-B alone, in combination with IL-12, or with 2 different doses of IL-15.
Detailed Description
A vaccine that is effective against multiple strains of HIV remains the best option for preventing the spread of HIV. Plasmid DNA vaccines are inexpensive and easy to construct. When DNA vaccines are administered in combination with cytokines, such as IL-12 or IL-15, the immune response to the vaccine is increased. The purpose of this study is to determine the safety and tolerability of the DNA plasmid vaccine, PENNVAX-B when administered alone, or with IL-12 or IL-15 DNA adjuvants. The most effective and safe dose of IL-15 will also be determined during this study. This study will last approximately 12 months. Participants will be randomly assigned to one of four groups. Group 1 will receive an injection of PENNVAX-B combined with 0.8 mg IL-15 in each deltoid or placebo. Group 2 will receive an injection of PENNVAX-B alone or placebo. Group 3 will receive an injection of PENNVAX-B combined with IL-12 in each deltoid or placebo. Group 4 will receive PENNVAX-B combined with 2 mg IL-15 or placebo. Injections will occur at study entry, Months 1, 3, and 6. Additional study visits will occur on Days 14, 42, 98, 182, 273, and 364. At these visits a brief physical, blood collection, interview, and risk reduction counseling will occur. At some visits HIV testing, urine collection, and pregnancy tests will also occur. As of 05/30/08, participants will be enrolled into Groups 3 and 4 at a limited pace to allow for additional safety reviews for the first few participants in these groups. Additionally, safety data will be reviewed for Groups 1 and 2 to determine whether the remainder of participants in Groups 2, 3, and 4 will be enrolled.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
PENNVAX-B with 0.8 mg IL-15 administered in both deltoids at Months 0, 1, 3, and 6
Arm Title
2
Arm Type
Experimental
Arm Description
PENNVAX-B administered alone in both deltoids at Months 0, 1, 3, and 6
Arm Title
3
Arm Type
Experimental
Arm Description
PENNVAX-B administered alone in both deltoids at Months 0, 1, 3, and 6
Arm Title
4
Arm Type
Experimental
Arm Description
PENNVAX-B with 2 mg IL-15 injected into both deltoids at Months 0, 1, 3, and 6
Intervention Type
Biological
Intervention Name(s)
PennVax B
Intervention Description
DNA vaccine containing the HIV genes Gag, Pol, and Env
Intervention Type
Biological
Intervention Name(s)
IL-12
Intervention Description
Cytokine injection
Intervention Type
Biological
Intervention Name(s)
IL-15
Intervention Description
Cytokine injection
Primary Outcome Measure Information:
Title
Safety data including local and systemic reactogenicity sign and symptoms, laboratory measures of safety, and adverse and serious adverse events
Time Frame
Throughout study
Title
Safety data from Groups 1 and 4
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
HIV-1 specific interferon gamma ELISpot and/or intracellular cytokine staining T cell response
Time Frame
2 weeks after 3rd and 4th vaccinations
Title
HIV-1 specific neutralizing and binding antibody assays
Time Frame
2 weeks after 3rd and 4th vaccinations

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-1 and -2 uninfected Willing to receive HIV test results Good general health Certain laboratory values within normal range or with site physician approval Negative for Hepatitis B surface antigen Negative Hepatitis C test Willing to use acceptable methods of contraception Exclusion Criteria: HIV vaccines or placebos in prior HIV trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible. Immunosuppressive medications within 168 days prior to first study vaccination. Participants using corticosteroid nasal spray for allergies or topical corticosteroids for mild, uncomplicated dermatitis are not excluded. Blood products within 120 days prior to first study vaccination Receipt of immunoglobulin within 60 days prior to first vaccination Live attenuated vaccines within 30 days prior to first study vaccination Any vaccine that is not a live attenuated vaccine within 14 days prior to first study vaccination Investigational research agents within 60 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. More information about this criterion can be found in the protocol. Any medical, psychiatric, social, occupational, or other condition or responsibility that in the opinion of the investigator would interfere with the study. More information about this criterion can be found in the protocol. Allergy to amide-type local anesthetics Serious adverse reactions to vaccines 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. Asthma other than mild, well-controlled 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. Thyroidectomy or thyroid disease 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 if episodes are considered serious or have required medication in the 2 years prior to study entry Uncontrolled hypertension Body Mass Index of 40 or greater OR of 35 or greater if certain other criteria apply. More information about these criteria can be found in the protocol Bleeding disorder Cancer. Participants with surgically removed cancer that is unlikely to recur are not excluded. Seizure disorder Absence of the spleen Pregnancy or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Parker, MD
Organizational Affiliation
HVTN, FHCRC
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Vaccine CRS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
San Francisco Vaccine and Prevention CRS
City
San Francisco
State/Province
California
Country
United States
Facility Name
Brigham and Women's Hosp. CRS
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
NY Blood Ctr./Bronx CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10456
Country
United States
Facility Name
NY Blood Ctr./Union Square CRS
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
HIV Prevention & Treatment CRS
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
3535 Market Street CRS
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Vanderbilt Vaccine CRS
City
Nashville
State/Province
Tennessee
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17507706
Citation
Johnston MI, Fauci AS. An HIV vaccine--evolving concepts. N Engl J Med. 2007 May 17;356(20):2073-81. doi: 10.1056/NEJMra066267. No abstract available.
Results Reference
background
PubMed Identifier
1705391
Citation
Ogawa H, Ueno M, Uchibori H, Matsumoto I, Seno N. Direct carbohydrate analysis of glycoproteins electroblotted onto polyvinylidene difluoride membrane from sodium dodecyl sulfate-polyacrylamide gel. Anal Biochem. 1990 Nov 1;190(2):165-9. doi: 10.1016/0003-2697(90)90175-9.
Results Reference
background
PubMed Identifier
17627529
Citation
McBurney SP, Ross TM. Developing broadly reactive HIV-1/AIDS vaccines: a review of polyvalent and centralized HIV-1 vaccines. Curr Pharm Des. 2007;13(19):1957-64. doi: 10.2174/138161207781039841.
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
Links:
URL
http://www.hvtn.org
Description
Click here to learn more about the HIV Vaccine Trials Network

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Safety and Effectiveness of PENNVAX-B Vaccine Alone, With Il-12, or IL-15 in Healthy Adults

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