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

September 10, 2007
August 6, 2013
October 2007
January 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Safety data including local and systemic reactogenicity sign and symptoms, laboratory measures of safety, and adverse and serious adverse events [ Time Frame: Throughout study ]
  • Safety data from Groups 1 and 4 [ Time Frame: Throughout study ]
Complete list of historical versions of study NCT00528489 on ClinicalTrials.gov Archive Site
  • 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 ]
  • HIV-1 specific interferon gamma ELISpot and/or intracellular cytokine staining T cell response [ Time Frame: 2 weeks after 3rd and 4th vaccinations ]
  • HIV-1 specific neutralizing and binding antibody assays [ Time Frame: 2 weeks after 3rd and 4th vaccinations ]
Not Provided
Not Provided
 
Safety and Effectiveness of PENNVAX-B Vaccine Alone, With Il-12, or IL-15 in Healthy Adults
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
HIV Infections
  • Biological: PennVax B
    DNA vaccine containing the HIV genes Gag, Pol, and Env
  • Biological: IL-12
    Cytokine injection
  • Biological: IL-15
    Cytokine injection
  • Experimental: 1
    PENNVAX-B with 0.8 mg IL-15 administered in both deltoids at Months 0, 1, 3, and 6
    Interventions:
    • Biological: PennVax B
    • Biological: IL-15
  • Experimental: 2
    PENNVAX-B administered alone in both deltoids at Months 0, 1, 3, and 6
    Intervention: Biological: PennVax B
  • Experimental: 3
    PENNVAX-B administered alone in both deltoids at Months 0, 1, 3, and 6
    Interventions:
    • Biological: PennVax B
    • Biological: IL-12
  • Experimental: 4
    PENNVAX-B with 2 mg IL-15 injected into both deltoids at Months 0, 1, 3, and 6
    Interventions:
    • Biological: PennVax B
    • Biological: IL-15

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00528489
HVTN 070, 10490
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Vaccine Trials Network
Study Chair: Scott Parker, MD HVTN, FHCRC
National Institute of Allergy and Infectious Diseases (NIAID)
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP