GPO to start clinical trial phase 1/2 of a COVID-19 vaccine
The Government Pharmaceutical Organization (GPO) is planning to initiate early-stage clinical evaluation of a NDV-HXP-S COVID-19 vaccine candidate at Faculty of Tropical Medicine, Mahidol University. The trial will recruit 460 volunteers both males and females at aged between 18 to 75 years old.
Dr. Withoon Danwiboon, managing director says that this vaccine candidate was developed in the United States by Drs. Peter Palese, Adolfo Garcia-Sastre, and Florian Krammer at the Icahn School of Medicine at Mount Sinai in New York. The candidate also includes a key component called HexaPro by Dr. Jason McLellan, an associate professor and Welch Chair at the University of Texas at Austin, and his team.
The innovative design works by using another virus, inactivated Newcastle disease virus (NDV), to induce the body to defend against COVID-19. The seed virus developed by Mount Sinai was produced by genetically modified NDV to express Hexapro, a stabilized spike protein of the coronavirus on the surface. The genetically engineered virus is inactivated (or killed) so that it does not cause COVID-19. It can be cultivated in embryonated eggs as well as influenza virus. The production process of the COVID-19 vaccine is also similar to what is being used to produce influenza vaccine. Therefore, the COVID-19 vaccine can be produced at the GPO industrial-scale plant.
Via license agreements with Mount Sinai and the University of Texas at Austin, the global organization PATH is helping to provide GPO and other manufacturers around the world access to the vaccine. In an effort to advance the supply of affordable and accessible vaccines, PATH has also played a limited technical advisory support role over the course of the vaccine’s development.
The preliminary pre-clinical toxicity study results in India and challenge study results in the United States showed that the vaccine candidate was safe, protective against COVID-19 infection and able to stimulate the immune system against spike protein of SARS-CoV-2. Currently, it is in the process of document submission to Thai FDA for clinical trial application approval.
Managing Director adds that GPO works with Faculty of Tropical Medicine, Mahidol University to conduct the clinical trial phase 1/2. The trial have already started recruiting 460 volunteers both males and females aged between 18 to 75 years old on 20 March 2021. This trial is divided into 2 phases; phase 1 to conduct in 210 volunteers at 18-59 years old and phase 2 to conduct in 250 volunteers at 18-75 years old. Volunteers who participate in this trial must not be infected with SARS-CoV-2 (nCoV-2019) which will be screened at the recruitment. The first immunization of NDV-HXP-S COVID-19 vaccine began on 22nd March 2021. Treatments include five formulas of the vaccine containing different spike contents with or without adjuvant and placebo. The objective of the trial is to study the safety profile and to select the suitable vaccine formulas for clinical trial phase 2. If both clinical studies showed promising results, the clinical trial phase 3 will be conducted.
“If successful, GPO would submit this information to Thai FDA for vaccine product registration. At present, GPO Vaccine Manufacturing Plant is capable of producing the COVID-19 vaccine at 25-30 million doses per year. This is to build vaccine security and self-reliance in Thailand.” said managing director.