Phase 1 and 2 trials for a warm vaccine developed by scientists of Indian Institute of Science (IISc.) and Bengaluru-based biotech company Mynvax Laboratories will be initiated by March-April 2023.
This warm, or heat tolerant vaccine, can be stored at 37 degree Celsius for a month and at 100 degree Celsius for up to 90 minutes. It is expected to come handy in countries which have poor cold-chain, refrigeration and transportation facilities.
The warm vaccine has already proven effective against all current SARS-CoV-2 variants of concern — Alpha, Beta, Gamma, Delta and Omicron.
What will be tested during each phase of the trial of warm vaccine
Covaxin and Covishield can be stored at 2 to 8 degree Celsius, Pfizer requires minus 70 degree Celsius, Moderna minus 20 degree Celsius and Sputnik V needs to be stored at 2 to 8 degree Celsius.
“We expect to initiate Phase 1 and 2 trials by March-April 2023 with about 120 human volunteers,” said Dr. Gautham Nadig, Executive Director, Mynvax.
During Phase 1 of the trial, the safety of the vaccine would be evaluated. During Phase 2, the focus would be on preliminary immunogenicity of the vaccine.
“We will be evaluating the immunogenicity of the vaccine to see if there is sufficient neutralising anti-bodies that are elicited by the vaccine in people who already have had Covid-19. We want to check if this vaccine will act as a booster dose,” Dr. Nadig said.
Time frame for trials
When asked about the time frame for completing the different phases of trials, he said, ”It all depends on the data we derive from Phase 2. But Phase 1 and 2 trials should not take more than 6-8 months. Further for Phase 3, we can’t do the trials with the old strains. Now, the Omicron derivatives have come, and we will have to change the strain for Phase 3, which should be completed in another year.”
Dr. Nadig added that Mynvax Laboratories has received funding from Biotechnology Industry Research Assistance Council in March 2022 to enable production for animal safety toxicity studies, Good Manufacturing Practice (GMP) production for clinical trials and Phase 1 and 2 clinical trials.
