Worcester HIV Vaccine

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NIAID stops vaccinations in the HVTN 702 trial

WHV commends the many researchers, donors, partners and more than 5,000 participants of the HVTN 702 trial in South Africa, which was stopped early due to lack of efficacy.

Science is incremental and with each efficacy trial the field learns what works and what does not.  It’s clear that much work needs to be done to better understand  the results of HVTN 702.    

In 2009, the RV144 trial of an HIV-1 vaccine in Thailand showed 31% efficacy in preventing HIV infections in general population. Detailed follow-up studies identified correlates of risk, suggesting which immune responses may be likely to provide protection against the virus.

Building on this success, the Pox Protein Public-Private Partnership (P5) consisting of a diverse group of stakeholders in the field, designed a similar vaccine to target subtype C HIV-1 prevalent in sub-Saharan Africa and launched the efficacy HVTN 702 trial in South Africa. Early stage clinical trials of this vaccine showed responses similar to or better than those observed in RV144.

So while the field was hopeful that the HVTN 702 trial would show some efficacy, the results are disappointing, but once again highlight the extraordinary challenge of HIV-1 vaccine development.  Now more than ever, there is a clear need to explore diverse and innovative approaches. 

Worcester HIV Vaccine remains committed to rapidly advancing its unique vaccine candidate PDPHV to further clinical testing, including an efficacy study. We will work tirelessly to make sure that a safe and effective vaccine is available to prevent HIV-1 infections around the world.

WHV Poised to Move Novel HIV Vaccine Through Clinical Development

Collaboration with UMMS Allows for Faster, More Effective Path to Advancing Clinical Trials

[DECEMBER 1, 2019]  ̶  This World AIDS Day researchers at Worcester HIV Vaccine (WHV), a biotechnology organization next to the University of Massachusetts Medical School (UMMS) announced plans to take their innovative HIV vaccine candidate through to Phase IIa clinical testing.  If proven immunogenic, this would be the first and only vaccine candidate that targets all four major HIV subtypes to advance to safety and efficacy trials in humans.

“A safe and effective HIV vaccine has the potential to shape the future course of this epidemic,” said Shan Lu, M.D., Ph.D., professor of Medicine at UMMS and the creator of WHV’s HIV vaccine. “Despite significant progress on the potential of new biomedical strategies in the global HIV response, we are still seeing more than 37 million people living with HIV around the world, and another 1.7 million newly infected each year. We know an effective vaccine to prevent HIV would be one of the biggest advances in global health.”

WHV’s investigational HIV vaccine candidate, PDPHV is in formative stages of development.  It is comprised of five DNA plasmids and four gp120 recombinant proteins and is being tested in healthy adult volunteers in a Phase I clinical trial (HVTN 124) run by the National Institute of Allergy and Infectious Diseases’ (NIAID) HIV Vaccine Trials Network (HVTN).  Immunogenicity results from the HVTN 124 trial are expected in early 2020 having just concluded all vaccinations in October.

“We are making excellent progress in preparing for the Phase IIa clinical trial of PDPHV – something that could happen as early as mid-2020, should the Phase I results show positive immunogenicity,” said Yegor Voronin, Ph.D., chief operating officer of WHV.  “We’ve done the hard work of advancing GMP manufacturing, optimizing the clinical trial design, and clarifying the regulatory pathway, all in an effort to move Phase IIa study as quickly as possible should we see a positive signal.”

Earlier this year, WHV researchers showed that they can improve the manufacturing of the DNA component of PDPHV and confirmed that its proteins continue to demonstrate an excellent stability profile, which will allow a faster and more effective path to Phase II clinical trials. 

Shan Lu and his group at UMMS have been working for more than two decades to advance a preventive HIV vaccine.  The PDPHV vaccine combines HIV DNA, which is used to prime the immune system to receive a boost of HIV protein, which signals the body to produce antibodies against HIV. This prime-boost approach activates both antibody and cell-mediated immune responses, and induces functional antibodies with better qualities and longevity than using either type of vaccine alone as shown by an earlier version of this vaccine in a single-site clinical trial conducted at UMMS.

Much of WHV’s progress in early research and development has been the result of collaborations with UMMS. In the last decade, Dr. Lu’s group at UMass Medical School received more than $30 million to oversee the development and manufacturing of PDPHV, which allowed WHV to license PDPHV from UMMS in early 2018 for its further development.  WHV has worked with Waisman Biomanufacturing (WB), a third party contracted manufacturing organization, to use  DH5a E. coli strain with WB’s proprietary technology, to manufacture DNA plasmids with purer quality and higher yields than previous cell lines. WHV is also establishing broad collaboration with academic and industry partners including the UMMS Mass Spectrometry Facility, led by Scott Shaffer, Ph.D., to develop new analytical assays to use during vaccine manufacturing.     This world AIDS Day as the global HIV community reflects upon its accomplishments, and takes stock of the challenges that lie ahead, WHV renews its commitment to rapidly and efficiently advancing a novel HIV vaccine through clinical development.  There’s no doubt that a safe and effective HIV vaccine is an essential component to ending the HIV epidemic once and for all.

HVTN to assess peak immune responses in HVTN 124

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 Researchers Poised to Advance HIV Vaccine Candidate – Previously Tested Proteins Prove Promising

Researchers at WHV tested proteins previously manufactured for the ongoing HVTN 124 Phase I trial of PDPHV, its investigational DNA-prime/protein-boost vaccine, to determine their utility for future use.  They confirmed that these proteins continue to demonstrate an excellent stability profile, which indicates they will be effective for use in WHV’s next Phase IIa clinical trial of PDPHV.

PDPHV is the first and only HIV vaccine candidate to use four recombinant HIV Env proteins. This multivalent approach is important because it is designed to protect against the diverse HIV strains around the world. It is hoped that PDPHV will enter a Phase IIa clinical trial in 2020.

The validation of PDPHV proteins shows that the timeline and cost to advance to the Phase IIa trial will be significantly reduced. Typically, the manufacturing of proteins for HIV vaccines is quite cumbersome and expensive given relatively low yields of recombinant HIV Env and the complexities of the process to purify the proteins for the vaccine.

For more information on WHV’s vaccine approach, please visit Our Approach.

WHV Researchers Advance Production of Investigational HIV Vaccine

WHV researchers showed that they can improve the manufacturing of the DNA component of their candidate HIV vaccine PDPHV to allow a faster and more effective path to Phase II clinical trials.  These biomanufacturing advances have the potential to inform the way HIV vaccine candidates are manufactured in the future.

WHV researchers together with Waisman Biomanufacturing, a non-profit biomanufacturing partner, confirmed that by using DH5a, E. coli strain, with a proprietary technology, they can manufacture DNA plasmids that are purer and result in higher yields than previously thought.  This development shows a  more robust and effective approach to making the essential components of the PDPHV vaccine and could accelerate manufacturing of the candidate vaccine for future clinical trials and eventual manufacturing of the vaccine after its approval.

PDPHV is WHV’s investigational DNA-prime/protein-boost vaccine, which is comprised of five DNA plasmids and four gp120 recombinant proteins and is being tested as a prime-boost regimen or co-administered in repeated doses, in healthy adult volunteers.

Specifically, researchers completed manufacturing of five plasmid constructs for the DNA vaccine, which included the creation of new cell banks for all five plasmids. Plasmid constructs are essential because they make up the DNA prime component of the vaccine. This is an important step toward the planned Phase IIa trial of PDPHV and demonstrates a new level of advancement in biomanufacturing.

Historically, protein HIV vaccines have been poorly immunogenic because of a number of immune escape mechanisms deployed by the viral Env protein. Using a DNA delivery of HIV Env to prime the immune response ensures high magnitude and high quality of antibodies elicited by boosting with recombinant HIV Env proteins.

PDPHV is the first and only HIV vaccine candidate to use a multivalent approach with HIV Env proteins from the four major clades or strains of HIV.  The PDPHV vaccine is currently being tested by the HIV Vaccine Trials Network (HVTN) in a Phase I clinical trial HVTN 124.

For more information, visit Our Approach.

WHV Prepares to File Investigational New Drug (IND) Application to the U.S. FDA to Test its Candidate HIV Vaccine in a Phase IIa Clinical Trial

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.