PENNVAX-GP: normal flight
Inovio announced the high effectiveness of the new HIV vaccine
Ivan Shangin, Life4me+
The American pharmaceutical company Inovio Pharmaceuticals, Inc. reported that the PENNVAX-GP HIV vaccine undergoing clinical trials has shown extremely high efficacy and safety results. According to the developer's press service, the vaccine maintained a long and stable immune response for 12 months, six months after the last administration of the drug as part of a phase 1 clinical trial.
Earlier, Inovio reported that PENNVAX-GP, consisting of a combination of four HIV antigens that generate antibodies to a number of virus strains, demonstrates the highest rates of immune response (cellular and humoral) that have ever been observed in an HIV vaccine study.
Data on the successful passage of the phase 2 CI vaccine were announced on May 14 in Washington (USA, DC) at the plenary meeting of the full HVTN 2018 group.
The HVTN 098 study is the first PENNVAX-GP clinical trial. A randomized placebo-controlled multicenter study involved 94 subjects (85 vaccines and 9 placebos). The goal is to optimize the scheme of four doses of PENNVAX–GP DNA vaccine administered intradermally (ID) or intramuscularly (IM) in combination with a DNA-encoded immune activator, IL-12 (INO-9012).
Advanced immune analysis showed that PENNVAX-GP (plus IL-12) generates specific antibodies and demonstrates a response rate close to 100%.
For example, 96% (26 out of 27) of participants who received PENNVAX-GP and IL-12 via the IM route demonstrated an immune response. The same percentage (96% or 27 out of 28) of participants "responded to HIV" by receiving the vaccine through the ID pathway. And this is despite the fact that those vaccinated with intradermal administration received only 20% of the dose of those vaccinated intramuscularly.
New data, a year after the start of the study, showed that immune responses were maintained in the majority of participants for 12 months (six months after the last administration of the drug). It is noteworthy that the percentage of patients who had immune responses immediately after the last dose, the response itself remained the same or even slightly increased during the 6-month follow-up period.
All the results of the study were supported by the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
"Almost all immunogenicity tests for HVTN 098 have been completed, and their results clearly demonstrate that almost all participants had stable immune responses [...] Not only high response rates were noted, but [also that they] were maintained for a 12-month period or a full six months after the last dose" Dr. De Rosa, associate professor of Laboratory Medicine at the University of Washington and the Fred Hutchinson Cancer Research Center, said.
Inovio President and CEO Dr. J. Joseph Kim (Dr. J. Joseph Kim), in turn, stressed:
"We are really pleased to see these encouraging immune response data, which are among the best we have seen in HIV vaccines, and [especially] in terms of demonstrating an almost 100% response to the virus and a very favorable safety profile.
In addition, [the vaccine variant] for intradermal administration has shown that we can get a very high immune response to a much lower dose.
We look forward to further advancing PENNVAX-GP to a later stage of clinical development."
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