Vietnam’s first COVID-19 vaccine in phase 3 trial on humans

This is Vietnam’s first COVID-19 vaccine to be put into human clinical trials, researched by Nanogen Pharmaceutical Biotechnology Joint Stock Company, and officially deployed from mid-December 2020.
On June 11, in Hanoi, the Military Medical Academy (Ministry of National Defense) launched a trial injection of the COVID-19 Nano Covax vaccine phase 3 for the first 240 volunteers.

According to Lieutenant Colonel, Associate Professor, Assoc. Prof. Dr. Chu Van Men, Director of the Center for Clinical Trials and Bioequivalence, Military Medical Academy, phase 3 injected the Nano Covax vaccine to 13,000 people and administered only a single dose group injection. at least 25 mcg and the placebo injection group. Specifically, according to the protocol approved by the Ministry of Health, the first 1,000 trial injectors of the first phase of phase 3, the volunteers are injected with the ratio of “6 people vaccinated, 1 person injected placebo”. The remaining 12,000 people injected according to the ratio “2 people vaccinated, 1 person injected placebo”. It is expected that the first phase of phase 3 will be conducted by the Military Medical Academy and the Pasteur Institute in Ho Chi Minh City with 1,000 volunteers, each with 500 people. Vietnam’s first COVID-19 vaccine tested in phase 3 on humans. Regarding the reason for choosing the dose group of 25 mcg, Assoc. Prof. Dr. Chu Van Men said that testing at 3 dose levels of 25-50-75 mcg showed that the vaccine was safe on volunteers, capable of generating immunity in 3 doses. There was no difference in dose groups. Therefore, the National Ethical Council in Biomedical Research, Ministry of Health decided to only inject 1 optimal dose of 25 mcg at this stage. Phase 3 is implemented in many centers in the country: The North is deployed by the Military Medical Academy as the focal point at Military Medical Hospital 103, in collaboration with the Preventive Medicine Center of Hung Yen province to deploy locally; In the South, the Ho Chi Minh City Pasteur Institute is the focal point to deploy, in collaboration with the Preventive Medicine Centers of Long An and Tien Giang provinces to deploy locally. After the phase 1 and phase 2 trials, the Nano Covax vaccine is judged to be quite safe, so the criteria for recruiting volunteers will be relaxed more than the previous two phases. 13,000 volunteers participating in phase 3, aged 18-75 years old, only need to check their blood count and check for antibodies to the SARS-CoV-2 virus. People who have been exposed to the SARS-CoV-2 virus or already have antibodies will be excluded from the test population. As of June 11, more than 6,500 volunteers have registered to test the Nano Covax vaccine against COVID-19 phase 3. Senior Colonel, Assoc. Prof. Dr. Ho Anh Son, Deputy Director of the Military Medical and Pharmaceutical Research Institute, Military Medical Academy added: “It is expected that by mid-September 2021, after about 42 days of the second injection. In two of the first 1,000 experimental injections, we will summarize the results of the quality assessment to report. If it is favorable, we will submit the dossier and propose the Government, the Ministry of Health, and the National Ethical Council in the study. In parallel with that process, the unit will continue to test the Nano Covax vaccine on 12,000 volunteers to continue to control the experimental injection and evaluate the effectiveness. protective power of vaccines”. During the testing process and after the antibody sample is available, the Military Medical Academy will coordinate with the Nanogen Pharmaceutical Biotechnology Joint Stock Company, the testing units to conduct the assessment of the ability to neutralize the SARS-CoV virus. -2 in the laboratory for existing virus strains to determine the development direction of vaccine research in the coming period. Through discussions with the expert group of Nanogen Pharmaceutical Biotechnology Joint Stock Company, in addition to recombinant protein technology, there are other technologies for research and production of vaccines. Nanogen as well as many Vietnamese scientists are very interested in mRNA technology – which has been of great interest to the world in recent years. This technology has the advantage of reacting very quickly to the disease, quickly getting a vaccine. According to available information, vaccines produced by this technology are very safe for human use. More information about the phase 3 trial, Lieutenant General, Prof. Dr. Do Quyet, Director of the Military Medical Academy, said that this trial phase is designed according to the adaptive design method, continuing to inject the experimental vaccine. trial and placebo group; health assessment at the time of the first injection, the second dose (done on the 28th day), the 35th day and the 42nd day after injection. The Director of the Military Medical Academy expressed confidence in the safety of the Nano Covax vaccine with the results achieved through the previous two testing phases. Specifically, the concentration of SARS-CoV-2 virus antibodies after the phase 2 trial injection showed that the antibody titre increased very high, from tens to hundreds of times. After the second injection, the volunteers had a physical examination (blood test, blood pressure measurement…) once a week to assess the amount of antibodies appearing in the body; then continue to be monitored for 6 months to get information, assess health as well as immunity ability. Up to now, 100% of volunteers who have been vaccinated with Nano Covax vaccine have produced antibodies in the blood. – Phase I (December 2020), the COVID-19 vaccine Nano Covax was administered to 60 volunteers. – Phase II (February 2021) injected over 554 people. From phase 2, the trial was conducted both at the Military Medical Academy and the Medical Center of Ben Luc district – Long An province (by the Pasteur Institute in Ho Chi Minh City).