The first groups of volunteers participating in the international phase of clinical trials of the Ad5-nCov vaccine candidate against the SARS-CoV-2 virus, developed by CanSino Biologics Inc., have already been successfully vaccinated. The volunteers are feeling well and none of them has had serious adverse events.
CanSino has received permission from the Russian Ministry of Health to participate in a comprehensive international, multicenter, placebo-controlled phase III trial to evaluate the effectiveness and immunogenicity of the vaccine. The international trial is carried out in partnership with Petrovax company.
The clinical trial, involving over 40,000 volunteers, is aimed at evaluating the safety and effectiveness of a recombinant coronavirus vaccine in people with the minimum age of 18. The study will aim to attract a total of 8,000 Russian volunteers. The vaccination results will be analyzed by an international team of scientists.
The vaccine uses human adenoviral vector platform carrying the S-protein of the coronavirus. This vector acts as a "delivery vehicle", and the S-protein is an antigen to which an immune response is generated. The phase III of the international trials is one of the key stages of a comprehensive global research program for developing the Ad5-nCov vaccine candidate and evaluating its safety and effectiveness against the SARS-CoV-2 virus.
The main objective of the trials is to confirm the effectiveness of the Ad5-nCoV vaccine in the prevention of all severity levels of COVID-19 within 12 months after vaccination. The incidence of COVID-19 in the Ad5-nCoV vaccine group will be compared with that in the control group.
It is critically important to assess the incidence of serious adverse events (SAE) within 12 months after vaccination in all study participants.
The clinical trial is being carried out in compliance with the Declaration of Helsinki and appropriate clinical practices.
After registering the vaccine in the Russian Federation, Petrovax is ready to launch its production at its plant in the Moscow region, certified by both Russian and international GMP standards.
Earlier in August, Russia launched first stage of a local phase III clinical trial of the Ad5-nCov vaccine candidate, and in September the vaccination of the first volunteers started in medical centers. Petrovax has completed vaccination of all volunteers from the declared number of participants. The vaccine has demonstrated a high safety profile. Interim research data will be available before the end of this year.
The phase I trial held in March by the CanSino Biologics in China involved 108 volunteers. The phase II trial took place in Wuhan with 508 people participating. The results of the two phases were published in the peer-reviewed medical journal The Lancet. According to the report, the vector COVID-19 vaccine studied by Ad5 is safe and induces a significant humoral and cellular immune response in the majority of vaccinated after a single dose of vaccine.
About CanSino Biologics Inc.
CanSinoBIO (SHSE: 688185, HKEX: 06185), founded in 2009, is dedicated to the research, production and commercialization of innovative vaccines for China and global public health security. The company possesses four integrated platform technologies, including adenovirus-based vectors, conjugation, protein engineering, and recombination and formulation. As of today, it has established a robust pipeline of 16 vaccines covering 13 diseases, including a globally innovative Ebola virus vaccine approved in 2017 as well as the investigational Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector).
Additional information can be found online at www.cansinotech.com