We are excited to announce that the HVTN 124 clinical trial results, published in The Lancet HIV, was selected as the paper of the month August 2024 by the International Society for Vaccine (ISV).
The HVTN 124 clinical trial is wrapping up while the stability of the used vaccines is confirmed.
HVTN 124 is a phase 1 clinical trial conducted by NIH-funded HIV Vaccine Trials Network, testing the safety and immunogenicity of PDPHV-201401, WHV’s preventive HIV vaccine candidate. The trial has now been formally concluded with the lock of the database. Volunteers and researchers will be unblinded to the treatment group assignment in the near future. The preliminary data from the peak immunogenicity analyses are very encouraging and support the advancement of this vaccine candidate to further clinical testing. The data will be presented at the HVTN’s annual 2021 Full Group Meeting on May 5-7, 2021.
Working with Waisman Biomanufacturing, WHV also formally completed the studies initiated by Dr. Shan Lu’s laboratory at UMass as part of the IPCAVD program to test the stability of all vaccine components used in the HVTN 124 trial. The results of these studies indicate that DNA vaccine, gp120 Env recombinant protein vaccine, and the GLA-SE adjuvant are all stable after 4-5 years and can be used in the planned WHV 138 clinical trial. To support the use of these vaccines in the WHV 138 trial, WHV extended the stability studies for all components.
Safety and immunogenicity results from the HVTN 124 study will be presented by WHV at the Full Group meeting of HVTN.
HVTN 124 is a phase 1 clinical trial conducted by NIH-funded HIV Vaccine Trials Network, testing the safety and immunogenicity of PDPHV-201401, WHV’s preventive HIV vaccine candidate. The trial recently completed and immunogenicity is being assessed by both HVTN and WHV. The preliminary data from these analyses supports the advancement of this vaccine candidate to further clinical testing.
HVTN leadership invited WHV to present the results of the trial at its annual 2021 Full Group Meeting. The meeting will be held virtually on May 5-7, 2021 and will cover the progress in immune-mediated HIV prevention approaches including vaccines and passive immunizations.
HVTN approved WHV proposal to conduct an exploratory study to better characterize the immune responses observed in volunteers in the HVTN 124 clinical study testing WHV’s PDPHV vaccine candidate.
HIV Vaccine Trials Network is conducting immunogenicity assays to assess the peak immune responses observed two weeks after the last immunization in the HVTN 124 trial. At the same time, WHV plans to supplement HVTN’s work by conducting its own investigation into the dynamics of immune responses, as well as conducting additional assay to better assess the breadth and potency of antibodies elicited by the PDPHV vaccine candidate. WHV formally applied to HVTN to request the samples from volunteers needed for the study and the request has been approved.
This work will be conducted in collaboration with Dr. Shan Lu’s Laboratory of Nucleic Acid Vaccines (LNAV) at the UMMS in Worcester, MA. Dr. Lu is the co-inventor of the PDPHV vaccine candidate and his laboratory has extensive expertise in assessing immune responses to the DNA/protein vaccines. Another co-inventor, Dr. Shixia Wang, will lead the studies. The results from both the HVTN study and the exploratory study by WHV will be available later this year.
WHV scientists will conduct a study to better characterize the immune responses observed in volunteers in the HVTN 124 clinical study testing its PDPHV vaccine candidate.
With the completion of immunizations in all volunteers in the ongoing HVTN 124 Phase I clinical study, HIV Vaccine Trials Network recently advanced to assessing the peak immune responses observed two weeks after the last immunization. At the same time, WHV plans to supplement HVTN’s work by conducting its own investigation into the dynamics of immune responses, as well as conducting additional assay to better assess the breadth and potency of antibodies elicited by the PDPHV vaccine candidate. This proposal has been met positively by HVTN, who agreed to share the necessary samples from the HVTN124 study volunteers.
This work will be conducted in collaboration with Dr. Sha Lu’s Laboratory of Nucleic Acid Vaccines (LNAV) at the UMMS in Worcester, MA. Dr. Lu is the co-inventor of the PDPHV vaccine candidate and his laboratory has extensive expertise in assessing immune responses to the DNA/protein vaccines. Another co-inventor, Dr. Shixia Wang, will lead the studies.
In preparation for this work, LNAV recently obtained an approval for this project from UMMS’ Institutional Review Board (IRB) and is currently working with HVTN to identify and transfer the required samples for the study. The results from the study will be available later this year.
WHV’s vaccine candidate PDPHV is currently being tested in the HVTN 124 clinical trial. The trial sites recently completed all scheduled vaccinations and collected samples to assess the peak immune responses elicited by the vaccine. On November 20, 2019, WHV convened with HVTN to discuss the priorities and the timelines of conducting laboratory assays. The immediate focus was placed on the magnitude and quality of the antibody responses, including binding to Env proteins from a wide diversity of viral variants, as well as neutralization of viruses and ADCC functionality of antibodies. The results are expected in 3 months. Later this year, the volunteers will return to provide samples at 6 months after the last vaccination, which will be used to assess the durability of the responses.
WHV is preparing to file a new IND for PDPHV, its investigational DNA-prime/protein-boost vaccine. PDPHV is comprised of five DNA plasmids and four gp120 recombinant proteins and is being tested in a Phase I clinical trial (HVTN 124) as a prime-boost regimen or co-administered in repeated doses, in healthy adult volunteers. Results of the HVTN 124 trial are expected in early/mid 2020. If the vaccine is proven safe and immunogenic, the IND will allow WHV to rapidly advance PDPHV through to Phase IIa clinical testing.
The National Institutes of Allergy and Infectious Diseases (NIAID) holds the current IND for the vaccine candidate and NIAID-supported HVTN is running the Phase I HVTN 124 trial. WHV will work with NIAID, the U.S. FDA, and other regulatory partners to clarify the regulatory pathway for PDPHV.
For more information on the HVTN124 trial, please visit HVTN 124 Trial.
The HVTN 124 team completed enrollment of all 60 volunteers scheduled for the trial. Vaccinations will continue through October of 2019.
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The HVTN 124 Protocol Safety Review Team has reviewed the cumulative safety data for the first 10 participants in Part B and concluded that enrollment can re-open for the remaining participants.
Learn more about the HVTN 124 trial
The HVTN 124 clinical trial testing WHV’s polyvalent DNA-prime/protein-boost vaccine opened for recruitment on March 16, 2018. The first volunteer was enrolled into the trial on April 19, 2018.
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Learn more about the HVTN 124 trial
