Safety and Effectiveness of PENNVAX-B Vaccine Alone, With Il-12, or IL-15 in Healthy Adults
NCT ID: NCT00528489
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
120 participants
INTERVENTIONAL
2007-10-31
2010-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
PENNVAX-B with 0.8 mg IL-15 administered in both deltoids at Months 0, 1, 3, and 6
PennVax B
DNA vaccine containing the HIV genes Gag, Pol, and Env
IL-15
Cytokine injection
2
PENNVAX-B administered alone in both deltoids at Months 0, 1, 3, and 6
PennVax B
DNA vaccine containing the HIV genes Gag, Pol, and Env
3
PENNVAX-B administered alone in both deltoids at Months 0, 1, 3, and 6
PennVax B
DNA vaccine containing the HIV genes Gag, Pol, and Env
IL-12
Cytokine injection
4
PENNVAX-B with 2 mg IL-15 injected into both deltoids at Months 0, 1, 3, and 6
PennVax B
DNA vaccine containing the HIV genes Gag, Pol, and Env
IL-15
Cytokine injection
Interventions
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PennVax B
DNA vaccine containing the HIV genes Gag, Pol, and Env
IL-12
Cytokine injection
IL-15
Cytokine injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
Yes
Sponsors
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HIV Vaccine Trials Network
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Scott Parker, MD
Role: STUDY_CHAIR
HVTN, FHCRC
Locations
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Alabama Vaccine CRS
Birmingham, Alabama, United States
San Francisco Vaccine and Prevention CRS
San Francisco, California, United States
Brigham and Women's Hosp. CRS
Boston, Massachusetts, United States
NY Blood Ctr./Union Square CRS
New York, New York, United States
HIV Prevention & Treatment CRS
New York, New York, United States
NY Blood Ctr./Bronx CRS
The Bronx, New York, United States
3535 Market Street CRS
Philadelphia, Pennsylvania, United States
Vanderbilt Vaccine CRS
Nashville, Tennessee, United States
Countries
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References
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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.
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.
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.
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.
Related Links
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Click here to learn more about the HIV Vaccine Trials Network
Other Identifiers
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10490
Identifier Type: REGISTRY
Identifier Source: secondary_id
HVTN 070
Identifier Type: -
Identifier Source: org_study_id