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NCT00428337 Clinical Trial

Safety of and Immune Response to a DNA Vaccine and a Recombinant HIV-1-MVA Vaccine, Separately and in Combination, in Healthy Adults

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00428337
Other study ID # HVTN 067
Secondary ID 10394
Status Completed
Phase Phase 1
First received
Last updated
Start date April 2007
Est. completion date August 2008

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date August 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• EP-1233
DNA-HIV-recombinant vaccine
• MVA-mBN32
HIV-recombinant viral vaccine

Locations
Country Name City State
United States Vanderbilt Vaccine CRS Nashville Tennessee
United States Univ. of Rochester HVTN CRS Rochester New York
United States San Francisco Vaccine and Prevention CRS San Francisco California

Sponsors (4)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Bavarian Nordic, HIV Vaccine Trials Network, Pharmexa-Epimmune

Country where clinical trial is conducted

United States, 

References & Publications (3)

Dale CJ, Thomson S, De Rose R, Ranasinghe C, Medveczky CJ, Pamungkas J, Boyle DB, Ramshaw IA, Kent SJ. Prime-boost strategies in DNA vaccines. Methods Mol Med. 2006;127:171-97. Review. — View Citation

Ostrowski MA, Yu Q, Yue FY, Liu J, Jones B, Gu XX, Loutfy M, Kovacs CM, Halpenny R. Why can't the immune system control HIV-1? Defining HIV-1-specific CD4+ T cell immunity in order to develop strategies to enhance viral immunity. Immunol Res. 2006;35(1-2):89-102. Review. — View Citation

Rodriguez-Chavez IR, Allen M, Hill EL, Sheets RL, Pensiero M, Bradac JA, D'Souza MP. Current advances and challenges in HIV-1 vaccines. Curr HIV/AIDS Rep. 2006 Feb;3(1):39-47. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Throughout study
Secondary HIV-specific intracellular cytokine staining (ICS) assay and/or interferon-gamma ELISA responses At 2 weeks following the third and fourth injection
Secondary Vaccinia-specific neutralizing binding assays performed on serum samples from participants receiving the MVA vaccine At 2 weeks following the final vaccination
Secondary Self reports on social impact of participation in study Throughout study
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