On March 15, 2021, at the Hanoi Medical University, the research program on clinical trial phase 1 of COVIVAC vaccine COVID-19 was researched by the Institute of Vaccines and Medical Biology (IVAC) under the Ministry of Health. Research and production has officially deployed vaccines for volunteers to participate.
Implementation of Decision No. 1407 / QD-BYT of the Ministry of Health approving the research protocol on clinical trial phase 1 - 2 COVIVAC vaccine COVID-19 prevention, the morning of March 15, 2021, doses of COVIVAC vaccine Firstly, it was given to 06 healthy volunteers at the Clinical Trial Area, Hanoi Medical University.
With a very positive response from the people of the country, the coordination and preparation of a team of experienced researchers from the National Institute of Hygiene and Epidemiology, Hanoi Medical University, Institute of Vaccines and Biology Health products (Ministry of Health), PATH Foundation, the research team has recruited 120 volunteers out of more than 1000 volunteers registered to participate.
Prof. Dr. Tran Van Thuan - Deputy Minister of Health emphasized: The clinical trial of COVID-19 COVIVAC vaccine is an important milestone of the COVID-19 vaccine research and production process “made in Vietnam "
Speaking at the event, Prof. Dr. Tran Van Thuan - Deputy Minister of Health shared: I am delighted to witness an important milestone in the COVID-19 vaccine research and production process " made in Vietnam ”is implemented by an affiliated unit of the Ministry of Health.
"I suggest the implementing units strictly follow the procedures and techniques for implementing vaccine clinical trials and closely monitor volunteers after injection. The Ministry of Health will direct and organize. The mission supervised the entire research implementation process and reviewed the results of the mid-term phase 1 trial to approve the implementation of phase 2 to ensure the safety of the volunteers participating
”- Deputy Minister Tran Van Thuan emphasized.Volunteer prequalification process"
At the event, Prof. Dr. Ta Thanh Van - Chairman of the Council of Hanoi Medical University said that, after the initial preliminary examination, from the afternoon of March 10, 2021 to the afternoon of March 12, 2021, 230 volunteers from 18-59 years old were invited to consult, provide information about the research, sign consent form to participate in research, check health and take blood samples for screening tests at Hanoi Medical University. Of these, 06 people were unable to participate in the study due to time reasons.
On March 13, all 224 people who agreed to participate had full health examination and testing results. Based on the results of clinical examination and testing, the key researchers of the research team carefully evaluated the subjects and selected 120 qualified healthy volunteers, divided equally by age groups and sexes. count in turn to taking the first scheduled dose injection of the study.
Deploy phase 1 clinical trial injection
According to the study design, 120 volunteers in phase 1 clinical trial were divided into 5 groups to inject with different doses: 03 groups of vaccines without adjuvants with doses: 1mcg of S antigens; 3mcg S antigens; 10mcg S antigens; 01 group of vaccines with the dose of 1mcg of S antigens with additional additives; 01 group of 20 people injected placebo (sterile saline used for injection) to compare with those vaccinated groups above.
During the injection on the morning of March 15, 2021, six volunteers received the first shot (vaccine or placebo). After the first injection, volunteers were kept in the clinical trial area for 24 hours so that doctors could continue to monitor, detect, promptly manage and record adverse events if possible. happening.
With the first dose, the remaining 114 people will be injected in turn, 8 days apart, until April 20, 2021. According to the research schedule, each round will organize injections from 12-18 people / day.
The second shot is given 28 days after the first. After any 8-day injection, volunteers are invited to have a physical examination, record the adverse events that have occurred in the past 8 days and take blood to test blood counts, liver enzymes and kidney function.
During the study, volunteers will be monitored by phone calls and invited to visit the remaining 7 times according to the study schedule (the last time was 365 +28 days after dose 1) to fight. the safety and immunogenicity of the vaccine.
The report is expected to complete the phase 1 midterm report in July 2021.
"Prof. Dr. Ta Thanh Van - Chairman of the Management Board of Hanoi Medical University speaking at the event Ensure test injection safety"
The whole field part of the first phase of COVIVAC vaccine clinical trial took place at the Clinical Trial Area - Hanoi Medical University, the facility was certified by the Department of Science, Technology and Training, and the Ministry of Health. Good clinical practice only for Phase I vaccine clinical trials.
Currently, this area is dedicated to the COVIVAC vaccine trial, with reception desks, survival index room, pregnancy test, health check, examination and grant of study codes, sampling. , dispensing and vaccination, post-vaccination monitoring, emergency room, 24-hour storage and monitoring rooms, well-prepared dining and entertainment rooms, fully equipped and always with a team of doctors, nurses, researcher on duty.
The deployment unit is ready both in terms of facilities and manpower to welcome volunteers to test the first COVIVAC vaccine.
Information at the trial said that after the midterm and late phase 1 results were reported, if the vaccine showed that the safety standards were met and the immunization was developed, With the approval of the Ministry of Health, the team will continue to implement phase 2 with a larger sample size at the Medical Center of Vu Thu district, Thai Binh province - a medical facility that has been approved by the Trung Institute of Hygiene and Epidemiology. nurseries select and organize the implementation of clinical trials of many vaccines in the past.
The Mission of the Ministry of Health will supervise the entire clinical trial injection process of COVIVAC vaccine and coordinate with relevant agencies to ensure that the trial research process is safe and effective.
COVIVAC vaccine is the COVID-19 vaccine. Pure, inactivated, liquid all-particle vaccine with or without adjuvants, preservative-free. COVIVAC is a product of IVAC cooperation with Icahn Medical College in Mount Sinai, New York, University of Texas at Austin, PATH Foundation (USA) and other domestic and foreign partners.
The organization receiving the test is the Central Institute of Hygiene and Epidemiology, the coordinating organization for the implementation is Hanoi Medical University. The study is independently monitored by Vietstar Biomedical Research and data is managed and analyzed by BIOPHICS Center (Mahidol University, Thailand) ./. Vietnam Visa Services
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