Innovative DNA/MVA Vaccine Study
Learn about the promising results of the HVTN 094 trial involving a groundbreaking combination DNA and MVA vaccine developed by GeoVax. This study supported by NIAID showcased the potential of Virus-Like Particles in HIV prevention, building on successful applications in Hepatitis B and HPV vaccines. Discover the safety and efficacy of these vaccines in human studies, alongside new additions like the adjuvant GM-CSF. Explore the study's novel approaches and key findings, shedding light on advancements in HIV vaccine research.
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The Results of HVTN 094: A combination DNA and MVA vaccine trial Susan Buchbinder, MD On behalf of the HVTN 094 Team October 2, 2017 This work was supported by the National Institute of Allergy and Infectious Diseases (NIAID) U.S. Public Health Service Grants UM1 AI068614 [LOC: HIV Vaccine Trials Network], UM1 AI068635 [SDMC: HIV Vaccine Trials Network], UM1 AI068618 [LC: HIV Vaccine Trials Network], U01 AI069452 [Birmingham], UM1 AI069412 [Boston], UM1 AI069511 [Rochester], and UM1 AI069496 [San Francisco]. Support for product was received through Integrated Preclinical/Clinical AIDS Vaccine Development award to GeoVax Labs, Inc., U19 AI074073. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIAID or National Institutes of Health (NIH).
What is promising and new about the GeoVax DNA/MVA vaccines? VLPs expressed by DNA VLPs expressed by MVA Two vaccines are given in combination: A DNA Vaccine An MVA Vaccine (related to the smallpox vaccine) They produce Virus Virus- -Like Particles (VLPs) Like Particles (VLPs) that may generate a more effective response as they look more like a real virus These vaccines have protected monkeys from an HIV-like virus
Virus-Like Particles in Other Vaccines This approach has been used successfully in creating vaccines that prevent: Hepatitis B HPV -- 3
What did we already know about these vaccines in human studies? Two earlier studies of these vaccines showed: They were safe and didn t cause serious side effects When 2 doses of each vaccine were given (DDMM), there was a strong response by T cells When 3 doses of the MVA were given (MMM), there was a strong antibody antibody response T cells 4
What was new about the HVTN 094 study? 1. The vaccine An adjuvant (booster) called GM-CSF was added to the DNA vaccine to try to increase the immune response 2. To get the best T cell and antibody immune response, this study tested: 2 DNAs with MVAs (DDMM) against 2 DNAs with 3 MVAs Whether a 4-month delay before the last vaccination was better than a 2-month delay 5
Who participated in the study? Study participants Study participants Women Men Race/Ethnicity White Black/African-American Latino Asian/Pacific Islander Multi-racial Average age Total number = 48 Total number = 48 63% 37% 63% 10% 13% 8% 6% 25 years 7
What did we learn? The vaccines generate a strong immune response Good antibodies were high (IgG, IgG3) and lasted longer than what was seen in the Thai vaccine study, RV144 Bad antibodies were low (IgA) The cellular immune response was strong and balanced between helper and killer T cells 3 doses of MVA was better than 2 4-month wait before the last dose was better than a 2-month wait GM-CSF adjuvant did not boost the immune response as hoped 9
What comes next? New trials will not use the GM-CSF We will be testing these vaccines along with a protein vaccine, as that may lead to an even stronger antibody response and more protection If results from the new studies are favorable, these vaccines could be tested in the future to see if they protect against HIV infection 10
Thank You to: The study participants! The staff and study investigators at the sites The laboratory and statistical centers The vaccine manufacturer, GeoVax NIH for funding the research 11
