Local Nanocovax vaccine's phase 3 trial to begin next week
Next week, Vietnam will start the phase 3 trial of the Vietnamese-made Nanocovax vaccine on about 13,000 volunteers.
The Committee for Ethics of the Ministry of Health has approved the phase 3 clinical research for the Nanocovax vaccine.
The vaccine will be tested on about 13,000 volunteers at the Military Medical Academy in Hanoi, Hung Yen Province in the north, the Pasteur Institute in Ho Chi Minh City, and Long An province in the south.
The phase 3 trial will be divided into several periods, firstly on 800 registered volunteers. More volunteers will be chosen for the later periods.
The optimal dose chosen for phase 3 is 25mcg. Research shows that all three doses of 25mcg, 50mcg and 75mcg produced equivalent immunity, so the Ethics Committee chose the lowest dose to save raw materials.
A woman is one of the first three volunteers vaccinated with the Nanocovax vaccine. Photo: Thuy Hanh
The phase 2 trial of Nancocovax vaccine was completed on April 8, but the follow-up will last for one year. It is currently in mid-term evaluation phase but the research results are very positive. The vaccine is effective in both British and South African variants. The effect on the Indian variant will be studied in phase 3.
It is expected that phase 3 trial will be completed by the end of September, and then Vietnam can produce the first Covid-19 vaccine.
According to studies around the world, the immune response of volunteers has been good, producing antibodies four times higher than normal, and in some cases 20 times more.
With Nanocovax, 35 days after the first injection, antibodies from some volunteers increased to more than 60 times, and after 3 months to 34 times.
The vaccine is produced by the Nanogen company based on recombinant protein technology. Phase 1 trial started on December 17, 2020 and on April 8 the phase 2 ended on 554 volunteers, including 108 elderly people.
In phase 2, the volunteers were divided into four groups, with three injected with doses of 25mcg, 50mcg, 75mcg, and the other a placebo.
Phase 2 results show that all three doses are safe, and 100% of the volunteers generated immunity at different levels.
In particular, the virus neutralizing antibody index (the ability to kill SARS-CoV-2 virus) after two weeks of injection of the 2nd dose in the group of volunteers given the 25mcg dose gave the highest results, with over 90%.
The results were insignificantly less for the two groups of volunteers who were injected with 50mcg and 75mcg doses.
Nanocovax is Vietnam's first Covid-19 vaccine now still in clinical trials. The second locally-made vaccine is Covivac of IVAC company, which has completed its phase 1 trial.
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