Eu clinical trials register

US symposium features life, career of President Hồ Chí Minh Party, State leaders pay tribute to President Hồ Chí Minh Special stamp released to commemorate President Hồ Choosing the perfect place for Uncle Hồ’s statue Tree-planting campaigns launched to mark President Hồ Chí Minh’s birthday Volunteers for Việt Nam's second COVID-19 vaccine, COVIVAC, apply for human trial participation at Hà Nội Medical University on Friday. — VNA/VNS Photo Minh Quyết HÀ NỘI — Volunteers aged from 18-59 and living in Hà Nội, can register for human trials of Việt Nam’s second COVID-19 vaccine candidate COVIVAC from Friday morning. In the first phase,150 healthy volunteers will be injected with two 5ml doses over 28 days. They will be divided into five groups, including one group provided with placebo shots, and their health will be closely monitored within 24 hours after injections. Each volunteer will have their health checked up to eight times in 12 months. After 43 days since the first phase starts and shows good results, the second phase will be carried out at the medical centre of Thái Bình Province’s Vũ Thư District, with 300 volunteers. The homegrown vaccine has been developed by the Nha Trang-based Institute of Vaccines and Medical Biologicals (IVAC) and the Hà Nội Medical University since last May, using primary chicken embryo cell culture, a technique the institute used previously to successfully produce seasonal flu vaccines. COVIVAC has undergone pre-clinical trials in India, the US, and Việt Nam, said IVAC Director Dr. Dương Hữu Thái, adding that results showed that it satisfies all conditions to be tested on humans. The vaccine candidate demonstrated high immunogenicity during pre-clinical trials. It was created based on studies of new SARS-CoV-2 strains. This vaccine is expected to cost around VNĐ60,000 (US$2.59) per dose. Volunteers can register to participate in the trial at the Hà Nội Medical …

[Read more...] about Volunteers sought for second locally made COVID-19 vaccine trials

People, aged from 18-59 and residing in Hanoi , are encouraged to register for human trials of Vietnam’s second COVID-19 vaccine candidate COVIVAC (Photo: VNA) Hanoi (VNA) – People, aged from 18-59 and residing in Hanoi, can register for human t rials of Vietnam’s second COVID-19 vaccine candidate COVIVAC from March 5 morning. In the first phase of the trials, 150 healthy volunteers will be injected with two doses of 0.5ml with an interval of 28 days. They will be divided into five groups, including one group provided with placebo shots, and their health will be closely monitored within 24 hours after injections. Each volunteer will have their health checked-up eight times in 12 months. After 43 days since the first phase starts and shows good results, the second phase will be carried out at the medical centre of Thai Binh province’s Vu Thu district, with 300 volunteers. The homegrown vaccine has been developed by the Nha Trang-based Institute of Vaccines and Medical Biologicals (IVAC) and the Hanoi Medical University since last May, using primary chicken embryo cell culture, a technique the institute used previously to successfully produce seasonal flu vaccines. COVIVAC has undergone pre-clinical trials in India, the US, and Vietnam, said IVAC Director Dr. Duong Huu Thai, adding that results showed that it satisfies all conditions to be tested on humans. The vaccine candidate demonstrated high immunogenicity during pre-clinical trials. It was created based on studies of new SARS-CoV-2 strains. This vaccine is expected to have a price of around 60,000 VND (2.59 USD) per dose./. VNA …

[Read more...] about Volunteers sought for second homegrown COVID-19 vaccine trials

The Institute of Vaccines and Medical Biologicals (IVAC) on Friday started recruiting volunteers for the initial phase of clinical trials for the second Made-in-Vietnam Covid-19 vaccine known as Covivac. Illustrative photo by VNA According to IVAC, they will select 150 volunteers aged between 18 and 59 for the first phase of human trials, in which they will be injected with two 0.5 ml doses of the vaccine 28 days apart. Volunteers will remain at the clinical trial area for a period of 24 hours after receiving their shots in order to allow them to be under strict health observations by the research team. The aim of the first phase is to evaluate the safety of the doses, along with the patient’s immune response to the vaccine, thereby identifying the optimal level of the doses so trials can move on to the second phase. Through pre-clinical assessments carried out in India, the United States, and Vietnam, the locally-produced Covivac vaccine has recorded a strong immunological effect on laboratory animals and has so far proved to be safe. IVAC's director, Duong Huu Thai said the research project on the vaccine has been running since May, 2020, with the co-operation of scientists from universities, research institutes, and international organisations, adding that it has been produced from embryonic egg production technology, which is safe for animals. Thai emphasised that the Covivac vaccine was also proved to be effective against the new SARS-CoV strain detected in both the UK and South Africa. The vaccine is expected to be launched later this year after passing through three phases of human trials. Moving forward, the IVAC plans to offer the Covivac vaccine at a price of VND60,000 per dose. Furthermore, as the first domestically-produced Covid-19 vaccine, Nanocovax, which has been developed by Nanogen Pharmaceutical Biotechnology JSC, has now moved onto its second phase of human trials. …

[Read more...] about Vietnam recruits volunteers for human trials of second Covid-19 vaccine