Among the three doses that were put into injection, the dose of 25 mcg had the highest protective effect, the research team has announced, adding that all volunteers participating in the second phase of the trials are safe, with no serious reactions following their injection.
Nano Covax, researched and developed by Nanogen Company, is the first made-in-Vietnam vaccine that has entered phase 2 of its clinical trials on 560 people divided into four groups, injecting three doses of 25mcg, 50mcg and 75mcg, along with another group receiving placebo injections.
In the second stage, 560 were given the first dose, but four had withdrawn for objective reason in the second dose, leaving 556 injected.
The results showed that all three doses ensured safety, with 100% of volunteers given the three doses above were immunised at different levels, of which the 25 mcg dose has been rated to be most effective, at over 90% at 14 days after the second injection (i.e. 42 days after the first injection). The other two doses were almost approximate to the 25 mcg dose, but the difference was not statistically significant.
In phase 2, the injection has expanded to the elderly with underlying medical condition. Currently, 108 elderly people have been injected, of which the eldest is 76 years old.
After injecting the second dose, some volunteers had reactions such as low-grade fever, injection site pain that went away on its own, muscle pain, joint pain and fatigue but they quickly disappeared, without requiring medical intervention.
It is expected that on April 27, the research team will report to the Biomedical Ethics Council of the Ministry of Health and propose a plan to implement phase 3 that is expected to begin from May 5.
A lager group of volunteers, from 10,000-15,000 people, both in Vietnam and abroad are projected to join the next phase, with only the most effective dose of 25 mcg to be used. Each person will be injected with two doses 28 days apart.
All these proposals will be submitted to the panel for review.
The home-grown Nano Covax started human trials on December 17, 2020. It now has completed phase 2 and is preparing to move to phase 3, which is the final stage of testing before the vaccine is released on the market.
After phase 1, 100% of the injected were safe and producing antibodies in high concentrations and had good protective effects against COVID-19 variables, including the new variant of the SARS-CoV-2 virus as found in the UK.
Based on the results of phase 1 and phase 2, experts are optimistic that if progress moves favourably, the phase 3 trial of Nano Covax will be completed by the end of the third quarter of 2021, a further three months reduction compared to the previous plan.
