A Phase 1 interventional study of pGA2/JS7 DNA and Modified vaccinia Ankara/HIV62 in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 6 sites in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-08.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Prevention
The purpose of this study is to determine the safety of and immune response to a DNA HIV vaccine, pGA2/JS7, followed by a modified vaccinia (smallpox) HIV vaccine, MVA/HIV62, in HIV uninfected adults.
The worldwide HIV/AIDS epidemic may only be controlled through a safe and effective vaccine that will prevent HIV infection. DNA vaccines are inexpensive to construct, easily produced in large quantities, and stable for long periods of time. Recombinant modified vaccinia Ankara vaccines have been shown to be safe in humans, and immunogenicity after administration of both vaccines has been encouraging. When used together, a more robust immunologic response was associated with DNA HIV vaccine administration followed by modified vaccinia vaccine administration, compared to using either DNA or vaccinia vaccine alone. This study will evaluate the safety and immunogenicity of an experimental DNA HIV vaccine prime, pGA/JS7, followed by a similarly structured modified vaccinia boost, MVA/HIV62, in HIV uninfected adults. Participants in this study will be recruited only in the United States.
This study will be divided into 2 parts. Each participant will be involved with their part of study for 1 year. Participants in Part 1 will be randomly assigned to one of two different vaccination groups. Group 1A participants will be randomly assigned to receive either placebo or 2 lower doses of the DNA HIV vaccine (DNA) at study entry and Month 2, followed by 2 lower doses of the modified vaccinia vaccine (MVA) at Months 4 and 6. Group 1B will not enroll until safety and immunogenicity data from Group 1A have been evaluated. Group 1B participants will receive either placebo or two higher doses of DNA at study entry and Month 2, followed by two higher doses of MVA at Months 4 and 6.
Enrollment into Part 2 will begin only after safety data from Part 1 are reviewed. In Part 2, participants will be randomly assigned to one of two different vaccination groups. Within each group, participants will be randomly assigned to receive some series of vaccines or placebo. Group 2A participants will receive either placebo or the maximum tolerated dose (MTD) from Part 1 of DNA at study entry and MTD of MVA at Months 2 and 6. Group 2B participants will receive MTD of MVA at study entry and Months 2 and 6.
There will be 12 study visits over 12 months for Groups 1 and 2. There will be 11 study visits over 12 months for Groups 3 and 4. Medication history, a physical exam, an interview, HIV and pregnancy prevention counseling, and adverse events reporting will occur at all visits. Blood and urine collection and an electrocardiogram (ECG) will occur at selected visits.
4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 120 is above the median of 83 across 3,312 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,445 studies on the registry; 182 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 300 (75%) have results posted.
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Exclusion Criteria:
One 0.3 mg dose of DNA HIV vaccine or placebo administered at study entry and Month 2, followed by one dose of 1x10\^7 TCID50 MVA or placebo at Months 4 and 6
Biological: pGA2/JS7 DNA · Biological: Modified vaccinia Ankara/HIV62
One 3.0 mg dose of DNA HIV vaccine or placebo administered at study entry and Month 2, followed by one dose of 1x10\^8 TCID50MVA or placebo administered at Months 4 and 6
Biological: pGA2/JS7 DNA · Biological: Modified vaccinia Ankara/HIV62
One MTD (determined in Part 1) of DNA HIV vaccine or placebo administered at study entry. One dose of placebo or MTD of MVA at Months 2 and 6
Biological: pGA2/JS7 DNA · Biological: Modified vaccinia Ankara/HIV62
One dose of placebo or MTD of MVA administered at study entry and Months 2 and 6
Biological: Modified vaccinia Ankara/HIV62
DNA Vaccine
Recombinant Modified Ankara Vaccine
Also known as: MVA
Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse and serious experiences)
Time frame: Throughout study
Immunogenicity, as defined by the protocol
Time frame: Throughout study
Social impacts (negative experiences or problems reported by the participants)
Time frame: Throughout study
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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