CanSino Biologics, technically in the lead of the vaccine race, was able to publish results of their Phase I clinical trial in The Lancet. A large group of government, academics, and industry reported that the overall results of the assessment of the safety, tolerability, and immunogenicity of the company’s recombinant adenovirus type-5 (Ad5) vectored COVID-19 vaccine expressing the spike glycoprotein SARS-CoV-2 was tolerable and immunogenic at 28 days post-vaccination. Their findings warrant further investigation into the Ad5 vectored COVID-19 vaccine.
The study’s financing originated from the industry sponsor, CanSino Biologics, as well as the National Key R&D Program of China and the National Science and Technology Major Project.
CanSino Biologics and investigational team targeted 108 healthy volunteers in this Chinese single-center, open-label, dose-escalating Phase I study. With participants ranging from 18 to 60 years old, the study team sought to assess the safety, reactogenicity, and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 vector) manufactured by Beijing Institute of Biotechnology and CanSino Biologics. The participants were enrolled into one of three cohorts and received an intramuscular (IM) injection of experimental vaccine or placebo on Days 1 in the deltoid muscle.
The Research Center & Collaborators of Study
The study commenced at the Hubei Provincial Center for Disease Control and Prevention in Wuhan Hubei, China, as well as Tongji Hospital. In addition to commercial sponsor CanSino Biologics, partners in this effort include the Peoples Liberation Army of China (Institute of Biotechnology, Academy of Military Medical Sciences) as well as the Jiangsu Province Centers for Disease Control and Tongji Hospital.
As disclosed in The Lancet, the study team screened 195 individuals for eligibility between March 16 and March 27, 2020. Out of that total, 108 participants (51% male, 49% female) were selected, representing a mean age of 36.3 years old. Out of the three cohorts, 36 participants received the low dose, 36 participants the middle dose, and 36 participants the high dose of the vaccine. The study team incorporated all of the participant data for the end of the study analysis.
One adverse reaction within the first seven days after the vaccination was 30 participants in the low dose group, 30 participants in the middle dose group, and 27 participants in the high dose group. Most commonly, participants felt some pain at the injection site—reported in 58 (54%) vaccine recipients, and the most commonly reported systematic adverse reactions were fever (46%); fatigue (44%); headache (39%) and muscle pain (17%).
Much of the adverse reactions were identified in all dose groups and were mild or moderate in severity. The team reported no serious adverse event within the 28 days post-vaccination. ELISA antibodies and neutralizing antibodies spiked at day 14 and peaked 28 days after the vaccination. The authors reported that at day 14 and beyond, specific T cell responses peaked.
The study teams suggest that humoral responses against SARS-CoV-2 peaked at day 28 post-vaccination in healthy adults. Moreover, the vaccine is tolerable and immunogenic at day 28 post-vaccine. Moreover, specific T-cell responses were observed from day 14 post-vaccination. Their recommendations based on the findings: continue to pursue the investigation.
TrialSite News reported that CanSino Biologics was proceeding to a Phase II clinical trial “soon.” The public-private partnership includes at the core CanSino Biologics and the State-backed Academy of Military Medical Sciences’ Institute of Biotechnology.
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Phase I Clinical Investigator
Wang Wei, MD Tongji Hospital
Zhu Fengcai, Jiang, MD, Jiangsu Province Centers for Disease Control and Prevention
Guan Xuhua, MD, Hubei Provincial Center for Disease Control and Prevention
Call to Action: TrialSite News recently reported that CanSino Biologics inked a deal with the Canadian government (to provide vaccine) and announced a partnership with Vancouver-based Precision NanoSystems to develop another line of vaccine product based on mRNA. We suggested perhaps CanSino Biologics was hedging their bets with a more modern and efficient, not to mention more scalable, underlying technology.