Finding a vaccine or a treatment against the new coronavirus is a race against time, but thankfully a lot of promising projects are already very advanced. This week, the first volunteer participated in a clinical trial of the vaccine candidate VPM1002 in Hanover, Germany.
In the first trial, 1200 hospital professionals will be participating, followed by a second trial two weeks later, targeting approximately 2100 elderly people.
“The idea that this candidate could be used as a vaccine against respiratory diseases is quite old”, says Dr. Leander Grode from Vakzine Projekt Management GmbH on a video call from his office in Hanover. “But sometimes you need an extreme situation like this to get fast approval.” Grode is coordinating the clinical trials and has been working on VPM1002 since 2000; at the beginning as a scientist at the Max-Planck-Institute for Infection Biology in Berlin and later since 2004 in cooperation with the group of Prof. Dr. Stefan H.E. Kaufmann from the Max Planck Institute for Infection Biology in Berlin"
Originally, VPM1002 was only developed as a vaccine against tuberculosis (TB) and is being developed in a setting with a high burden of TB (Africa). In 2012 the German team started their collaboration with Serum Institute of India Pvt. Ltd. (SIIPL), one of the biggest vaccine manufacturers in the world, with plans to make the promising TB vaccine available to all newborn infants who are at risk of infection, mostly in poorer countries in South East Asia and Africa.
Getting funding for research concerning illnesses that barely affect Western countries, like TB, is often a long and complex process. But finally, Grode was getting closer to setting the Phase III trial for VPM1002 in motion. But at this fateful moment, the coronavirus pandemic hit, and all eyes were now on a new vaccine.
From the start there were a few indicators that suggested that VPM1002 could be a good candidate in the fight against COVID-19. BCG, the original immunization against TB, is the most used vaccine in the world and also the predecessor of the VPM1002 candidate. This old TB vaccine has not changed much in the past 100 years, but is known to cause several side effects. VPM1002 was developed as a safer alternative to BCG with significantly less adverse reactions.
BCG has been shown to help against viral respiratory infections in general, like influenza. When Grode learned that BCG was being tested for use against COVID-19 in the Netherlands, he jumped on the opportunity to initiate clinical development for VPM1002 in this context as well.
The goal was to conduct two Phase III clinical trials, one with healthcare professionals and one with elderly people. If these studies obtain positive results, VPM1002 would be allowed to proceed into market authorization right away. By the beginning of May, the German authorities gave their approval after an extremely fast but thorough review process.
There is an important distinction between BCG or VPM1002 and other potential vaccines that are currently under development: VPM1002 and BCG are immune stimuli, which means that they do not prevent the infection as such, but minimize the impact of respiratory disease like COVID-19. “We hope it strengthens the immune system, so the severity and the duration of the disease are reduced”, Grode explains. If proven successful, VPM1002 will be a significant weapon in the fight against COVID-19, not only because it boost the immune system, but because it could be used much sooner and more broadly than a COVID-19 specific vaccine, bridging the gap for the people who desperately need it until an effective vaccine is found and manufactured.
One of the main concerns towards the use of BCG against the new coronavirus is that it will take away critical supplies from newborn infants in developing countries, leaving them vulnerable to TB. BCG with its traditional manufacturing methods cannot be produced on a large scale that fast. However, the manufacturing process for VPM1002 is significantly more efficient and scalable. The SIIPL, is able to get five million doses of VPM out of a 30-liter vessel, which also can be scaled up to vessels of 500 or even 1000 liters. “You will have more doses than you can imagine. If it’s successful, they will really bring the vaccine to everyone”, Grode says. “Not just the rich countries.”
A week prior to the trial start in Germany, SIIPL started a similar trial in India. “We will share and compare our data as soon as we have it”, Grode says. A realistic expectation is March 2021, that’s when the first – and final – results will be in, he says. “Being patient will make the results a lot more valid”, says Grode. “Quality needs time.”
May 29, 2020 by kENUP Foundation