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

This study has been completed.
Sponsor:
Collaborator:
HIV Vaccine Trials Network
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00528489
First received: September 10, 2007
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
HIV Infections
Biological: PennVax B
Biological: IL-12
Biological: IL-15
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Safety data including local and systemic reactogenicity sign and symptoms, laboratory measures of safety, and adverse and serious adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Safety data from Groups 1 and 4 [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • HIV-1 specific interferon gamma ELISpot and/or intracellular cytokine staining T cell response [ Time Frame: 2 weeks after 3rd and 4th vaccinations ] [ Designated as safety issue: No ]
  • HIV-1 specific neutralizing and binding antibody assays [ Time Frame: 2 weeks after 3rd and 4th vaccinations ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: October 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
PENNVAX-B with 0.8 mg IL-15 administered in both deltoids at Months 0, 1, 3, and 6
Biological: PennVax B
DNA vaccine containing the HIV genes Gag, Pol, and Env
Biological: IL-15
Cytokine injection
Experimental: 2
PENNVAX-B administered alone in both deltoids at Months 0, 1, 3, and 6
Biological: PennVax B
DNA vaccine containing the HIV genes Gag, Pol, and Env
Experimental: 3
PENNVAX-B administered alone in both deltoids at Months 0, 1, 3, and 6
Biological: PennVax B
DNA vaccine containing the HIV genes Gag, Pol, and Env
Biological: IL-12
Cytokine injection
Experimental: 4
PENNVAX-B with 2 mg IL-15 injected into both deltoids at Months 0, 1, 3, and 6
Biological: PennVax B
DNA vaccine containing the HIV genes Gag, Pol, and Env
Biological: IL-15
Cytokine injection

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528489

Locations
United States, Alabama
Alabama Vaccine CRS
Birmingham, Alabama, United States, 35294
United States, California
San Francisco Vaccine and Prevention CRS
San Francisco, California, United States
United States, Massachusetts
Brigham and Women's Hosp. CRS
Boston, Massachusetts, United States
United States, New York
NY Blood Ctr./Bronx CRS
Bronx, New York, United States, 10456
HIV Prevention & Treatment CRS
New York, New York, United States, 10032
NY Blood Ctr./Union Square CRS
New York, New York, United States, 10003
United States, Pennsylvania
3535 Market Street CRS
Philadelphia, Pennsylvania, United States
United States, Tennessee
Vanderbilt Vaccine CRS
Nashville, Tennessee, United States
Sponsors and Collaborators
HIV Vaccine Trials Network
Investigators
Study Chair: Scott Parker, MD HVTN, FHCRC
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00528489     History of Changes
Other Study ID Numbers: HVTN 070, 10490
Study First Received: September 10, 2007
Last Updated: August 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Seronegativity
DNA Plasmid Vaccine
HIV Preventive Vaccine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014