Safety of and Immune Response to a DNA Vaccine and a Recombinant HIV-1-MVA Vaccine, Separately and in Combination, in Healthy Adults
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
![](https://webarchive.library.unt.edu/web/20130315212243im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
The purpose of this study is to determine the safety of and immune response to two experimental vaccines, designed for use in combination, for the prevention of HIV infection in healthy adults.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Biological: EP-1233 Biological: MVA-mBN32 |
Phase 1 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
Official Title: | A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of DNA Vaccine EP-1233 and Recombinant MVA-HIV Polytope Vaccine MVA-mBN32, Separately and in a Combined Prime-boost Regimen, When Given to Healthy, Vaccinia-naive, HIV-1-uninfected Adults |
- Safety of vaccination, as measured by number of adverse events, local and systemic reactogenicity signs and symptoms, changes in electrocardiogram (ECG), cardiac troponin I levels, and differences in other safety laboratory measures [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- HIV-specific intracellular cytokine staining (ICS) assay and/or interferon-gamma ELISA responses [ Time Frame: At 2 weeks following the third and fourth injection ] [ Designated as safety issue: No ]
- Vaccinia-specific neutralizing binding assays performed on serum samples from participants receiving the MVA vaccine [ Time Frame: At 2 weeks following the final vaccination ] [ Designated as safety issue: No ]
- Self reports on social impact of participation in study [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Enrollment: | 36 |
Study Start Date: | April 2007 |
Study Completion Date: | August 2008 |
Arms | Assigned Interventions |
---|---|
Experimental: 1
Participants will receive one injection of DNA vaccine EP-1233 or placebo in each shoulder on Days 0 and 28 and one injection of MVA-mBN32 or placebo in each arm on Days 84 and 168
|
Biological: EP-1233
DNA-HIV-recombinant vaccine
Biological: MVA-mBN32
HIV-recombinant viral vaccine
|
Experimental: 2
Participants will receive one injection of DNA vaccine EP-1233 or placebo in each shoulder on Days 0, 28, 84, and 168
|
Biological: EP-1233
DNA-HIV-recombinant vaccine
|
Experimental: 3
Participants will receive one injection of MVA-mBN32 or placebo in each arm on Days 0, 28, 84, and 168
|
Biological: MVA-mBN32
HIV-recombinant viral vaccine
|
Detailed Description:
The worldwide HIV/AIDS epidemic may only be controlled through the development of a safe and effective vaccine that will prevent HIV infection. DNA-based vaccines alone promote a weak immune response but when used as priming immunogens, followed by a recombinant viral vaccine that is a very attenuated vaccinia (smallpox) vaccine presenting the same immunogens as a booster, immunization with such a combination regimen seems to induce much stronger responses. EP-1233 is a DNA-HIV-recombinant vaccine designed to interact with CD4 (helper-inducer) and CD8 (cytotoxic) T lymphocytes (T cells) to prime CD4 and CD8 cells to respond to HIV components. MVA-mBN32 is a HIV-recombinant viral (MVA) vaccine that through other ways of interacting with CD4 and CD8 cells to immunize (boost) with similar HIV immunogens, may result in a stronger immune response.
The purpose of this study is to determine the safety of and immune response to two experimental vaccines for the prevention of HIV infection, individually and in combination, in healthy adults who have not been previously vaccinated against smallpox. Participants will be randomly assigned to one of three groups. All participants will receive injections at Days 0, 28, 84, and 168 of the study. Participants assigned to Group 1 will receive, on Day 0, one injection in each arm of EP-1233 or placebo and the same study product (EP-1233 or the DNA placebo) on Day 28. Thereafter, each Group 1 participant will receive one injection of MVA-mBN32 or placebo on Days 84 and 168. Groups 2 and 3 will not begin enrollment until safety and immunogenicity data from Group 1 have been evaluated. Participants assigned to Group 2 will receive only the DNA vaccine EP-1233 (or placebo) in each arm on all injection days. Participants in Group 3 will not begin enrollment until safety and immunogenicity data from Group 1 have been evaluated. Participants assigned to Group 3 will receive a consistent regimen of MVA-mBN32 (or placebo) on all injection days. Participants will be required to keep a symptom log for 3 days after each injection and attend clinical visits on Day 0, 14, 28, 42, 84, 98, 168, 182, 273, and 364 of the study. At each of the 10 visits, a physical exam, cardiac assessment, and HIV risk reduction and prevention counseling will occur. Blood collection will occur on Days 0, 14, 42, 98, 182, 273, and 364. Urine collection will occur on Days 14, 42, 98, and 182.
![](https://webarchive.library.unt.edu/web/20130315212243im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Good general health
Exclusion Criteria:
- Previous receipt of smallpox vaccination
- HIV-infected
- Hepatitis B surface antigen positive
- Participation in prior HIV vaccination trial
- Immunosuppressive medications within 168 days prior to study entry
- Receipt of blood products within 120 days of study entry
- Receipt of live attenuated, medically indicated subunit, or killed (inactivated) vaccines within 30 days of study entry
- Certain abnormal lab values
- Pregnant or breastfeeding
![](https://webarchive.library.unt.edu/web/20130315212243im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
United States, California | |
San Francisco Vaccine and Prevention CRS | |
San Francisco, California, United States, 94102 | |
United States, New York | |
Univ. of Rochester HVTN CRS | |
Rochester, New York, United States, 14642 | |
United States, Tennessee | |
Vanderbilt Vaccine CRS | |
Nashville, Tennessee, United States, 37232 |
Study Chair: | Geoffrey Gorse | Saint Louis University School of Medicine |
Study Chair: | Christine Mhorag Hay | University of Rochester |
![](https://webarchive.library.unt.edu/web/20130315212243im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
Publications:
Additional 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: | NCT00428337 History of Changes |
Other Study ID Numbers: | HVTN 067, 10394 |
Study First Received: | January 29, 2007 |
Last Updated: | November 7, 2012 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Seronegativity EP1233 MVA-mBN32 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 March 14, 2013