Safety and Effectiveness of PENNVAX-B Vaccine Alone, With Il-12, or IL-15 in Healthy Adults
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00528489 |
|
Recruitment Status :
Completed
First Posted : September 12, 2007
Last Update Posted : October 14, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Biological: PennVax B Biological: IL-12 Biological: IL-15 | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 |
| Study Start Date : | October 2007 |
| Actual Primary Completion Date : | January 2010 |
| Actual Study Completion Date : | January 2010 |
| Arm | Intervention/treatment |
|---|---|
|
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 |
- 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 ]
- 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 ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528489
| 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 | |
| NY Blood Ctr./Union Square CRS | |
| New York, New York, United States, 10003 | |
| HIV Prevention & Treatment CRS | |
| New York, New York, United States, 10032 | |
| United States, Pennsylvania | |
| 3535 Market Street CRS | |
| Philadelphia, Pennsylvania, United States | |
| United States, Tennessee | |
| Vanderbilt Vaccine CRS | |
| Nashville, Tennessee, United States | |
| Study Chair: | Scott Parker, MD | HVTN, FHCRC |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00528489 |
| Other Study ID Numbers: |
HVTN 070 10490 ( Registry Identifier: DAIDS ES Registry ID ) |
| First Posted: | September 12, 2007 Key Record Dates |
| Last Update Posted: | October 14, 2021 |
| Last Verified: | October 2021 |
|
HIV Seronegativity DNA Plasmid Vaccine HIV Preventive Vaccine |
|
HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections |
Retroviridae Infections RNA Virus Infections Virus Diseases Genital Diseases Urogenital Diseases Immunologic Deficiency Syndromes Immune System Diseases |