The heterologous HIV vaccine candidate PDPHV – currently tested in phase 1b WHV138 – recently completed the stability program for both its main components, the 5-plasmid DNA vaccine and the 4-valent recombinant gp120 Protein vaccine. The DNA vaccine was manufactured in 2015 and has proven to remain stable for 8 years. The 4 separate Protein lots from HIV-1 clades A, B, C, and AE, which are mixed at bedside into a single 4-valent vaccine, recently successfully completed the final stability testing after 6.5 years since the beginning of the stability program in 2016. Both of these products were previously used for the phase 1a HVTN124 trial. The remarkable stability profile of PDPHV is the best evidence showing WHV’s high quality GMP manufacturing and QC/QA programs. WHV would like to thank their contracted manufacturing partner Waisman Biomanufacturing (WB) for such high quality vaccine products.
For the soon to be conducted phase 2a study, new lots of each of the components of PDPHV have already been produced at WB. A further optimized protein vaccine vialing method was successfully implemented to allow for a simplified vaccine dispensing of the four gp120 Protein vaccine components as a single pre-mixed Drug Product (DP). It is no longer needed to mix the 4-valent protein vaccine at bedside. For the DNA vaccine component, a new lot was produced with substantial improvements in yield and purity as compared to the previously produced product. The formulations of both the DNA and the Protein vaccines did not change and after thorough consultation, the FDA provided positive feedback regarding WHV’s plans to use the newly manufactured DPs for PDPHV’s advancing product development program. The stability program of both DPs is off to a great start: The new DNA product has recently passed its third year of stability testing and the recombinant 4-valent pre-mix Protein vaccine recently passed its second year of stability testing. Both products will continue the stability program until the upcoming phase 2a in-human trial is completed.
