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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528489
• Other study ID #: HVTN 070
• Secondary ID: 10490
• Status: Completed
• Phase: Phase 1
• Start date: October 2007
• Est. completion date: January 2010

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• PennVax B
DNA vaccine containing the HIV genes Gag, Pol, and Env
• IL-12
Cytokine injection
• IL-15
Cytokine injection

Locations

Country	Name	City	State
United States	Alabama Vaccine CRS	Birmingham	Alabama
United States	Brigham and Women's Hosp. CRS	Boston	Massachusetts
United States	NY Blood Ctr./Bronx CRS	Bronx	New York
United States	Vanderbilt Vaccine CRS	Nashville	Tennessee
United States	HIV Prevention & Treatment CRS	New York	New York
United States	NY Blood Ctr./Union Square CRS	New York	New York
United States	3535 Market Street CRS	Philadelphia	Pennsylvania
United States	San Francisco Vaccine and Prevention CRS	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	HIV Vaccine Trials Network

Country where clinical trial is conducted

United States, 

References & Publications (3)

Johnston MI, Fauci AS. An HIV vaccine--evolving concepts. N Engl J Med. 2007 May 17;356(20):2073-81. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety data including local and systemic reactogenicity sign and symptoms, laboratory measures of safety, and adverse and serious adverse events		Throughout study
Primary	Safety data from Groups 1 and 4		Throughout study
Secondary	HIV-1 specific interferon gamma ELISpot and/or intracellular cytokine staining T cell response		2 weeks after 3rd and 4th vaccinations
Secondary	HIV-1 specific neutralizing and binding antibody assays		2 weeks after 3rd and 4th vaccinations

External Links

•   Click here to learn more about HIV Preventive Vaccines
•   Click here to learn more about the HIV Vaccine Trials Network
•   Haga clic aquí para ver información sobre este ensayo clínico en español