Preclinical research showed that it elicits neutralizing antibodies in non-human primates against COVID-19 variants of concern, including the SARS-CoV-2 Alpha variant, Beta variant, Delta variant, and Gamma variant. In Singapore On 3 August,<unk> urus Therapeutics confirmed that the company had received approval for a clinical trial of<unk>  and another vaccine called<unk> -165 in Singapore. The Phase I-II clinical trial will evaluate the vaccines as a primary vaccination series and a booster following first dose with Pfizer–BioNTech COVID-19 vaccine. The study is being partially funded by a grant from the Singapore Government. In Vietnam The clinical trials of the vaccine in Vietnam are completely sponsored and funded by Vinbiocare, a Vingroup subsidiary. On 2 August, Vinbiocare received regulatory approval to start a clinical trial of its COVID-19 vaccine candidate in Vietnam. The company will coordinate with the Ministry of Health to carry out Phase I-III clinical trials of VBC-COV19-154 vaccine on 21,000 adults in three phases in August 2021. The clinical trial Phase 1 will recruit 100 volunteers to evaluate the safety, tolerability, and initial assessment of immunogenicity of the vaccine. The clinical trial Phase 2 enrolled 300 volunteers at designated medical facilities in multiple provinces, while the third phase of human trials is expected to involve 20,600 volunteers, including phase 3a (600 volunteers) and 3b (20,000 volunteers). Those receiving placebo will receive active vaccine after 6 months, while all participants will be followed up for 1 year. In December 2021, the company plans to complete and submit procedures to the Ministry of Health, applying for an emergency authorization in Vietnam. Phase I The clinical trial Phase I began on 15-16 August at Hanoi Medical University. Phase I was conducted on 100 healthy volunteers randomly assigned in a ratio of 3:1, i.e. 75% of them received the<unk>  vaccine and 25% received a placebo. The primary objective of the phase one trial was to assess safety and immunogenicity of the vaccine. Volunteers will receive 2 doses of<unk>  vaccine or placebo, 28 days apart. Data of the volunteers from the first dose (day 1) to 7 days after the second dose (day 36), will be evaluated by the research team. Phase I report on the safety of the<unk>  vaccine was approved by the Ethics Committee on September 20, 2021. Preliminary results show that the<unk>  vaccine is safe in healthy volunteers. Phase II and III Phase II and IIIa trials of the vaccine were carried out at the same time in Bắc Ninh, Hanoi and Long An with a total of 1,000 volunteers. The trial work in the northern localities is carried out by Hanoi Medical University and Pasteur Institute in Ho Chi Minh City in the south. In Bắc Ninh, from 20 to 23 September, the research team started recruiting volunteers and selected 338 people aged 18-65, who received the first dose from 27 to 29 September. In Long An and Hanoi, the Ministry of Health also implemented the first dose for volunteers. The phase IIIa trial is expected to end on November 24, and the research team will report the results of the trial to the Ministry of Health on December 30.
ARCT-154
TPA-023
BGR-34
BIM-1
COVAX-19
ALG1-CDG
VIR-576
STS-135 