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

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	HIV Vaccine Trials Network
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00528489

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 I

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Interleukin-12

U.S. FDA Resources

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 ]

Estimated 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

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

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
San Francisco Department of Public Health
San Francisco, California, United States, 94102
Mt. Zion Hopsital
San Francisco, California, United States, 94102
United States, New York
New York Blood Center - Bronx
Bronx, New York, United States, 10456
New York Blood Center - Union Square
New York, New York, United States, 10003
Columbia University
New York, New York, United States, 10032

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

HIV Vaccine Trials Network

Investigators

Study Chair:

Scott Parker, MD

HVTN, FHCRC

More Information

Additional Information:

Click here to learn more about the HIV Vaccine Trials Network This link exits the ClinicalTrials.gov site

Click here to learn more about HIV Preventive Vaccines This link exits the ClinicalTrials.gov site

Haga clic aquí para ver información sobre este ensayo clínico en español This link exits the ClinicalTrials.gov site

Publications:

Johnston MI, Fauci AS. An HIV vaccine--evolving concepts. N Engl J Med. 2007 May 17;356(20):2073-81. Review. No abstract available.

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.

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. Review.

Responsible Party:	Rona Siskind, DAIDS
ClinicalTrials.gov Identifier:	NCT00528489 History of Changes
Other Study ID Numbers:	HVTN 070
Study First Received:	September 10, 2007
Last Updated:	May 12, 2010
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:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on February 12, 2012