Ad5-nCoV Vaccine Description
Ad5-nCoV is the first novel coronavirus vaccine for COVID-19 in a clinical trial in China. The vaccine candidate is built upon CanSinoBIO’s adenovirus-based viral vector vaccine technology platform.
The Ad5-nCoV vaccine candidate is a genetically engineered vaccine candidate with the replication-defective adenovirus type 5 as the vector to express SARS-CoV-2 spike protein.
Results from preclinical animal studies of Ad5-nCoV show that the vaccine candidate can induce a strong immune response in animal models. Preclinical animal safety studies also demonstrated a good safety profile.
The new Ad5 vectored COVID-19 vaccine evaluated in the phase 1 trial is the first to be tested in humans. It uses a weakened common cold virus (adenovirus, which infects human cells readily but is incapable of causing disease) to deliver genetic material that codes for the SARS-CoV-2 spike protein to the cells. These cells then produce the spike protein and travel to the lymph nodes where the immune system creates antibodies that will recognize that spike protein and fight off the coronavirus
CanSino Biologics Inc. is an innovative biopharmaceutical company dedicated to exploring the best solutions to the prevention of diseases through cutting edge research & development, advanced manufacturing, and commercialization of innovative vaccine products for human use worldwide.
CanSino Biologics was established in Tianjin, China in 2009. Inclusive of the COVID-19 vaccine, they are developing a number of vaccines including 13 for infectious diseases.
Ad5-nCoV Vaccine Indication
Ad5-nCoV is indicated to prevent COVID-19 disease, which is caused by SARS-CoV-2 coronavirus.
Ad5-nCoV Vaccine Dosage
Recombinant novel coronavirus vaccine (Adenovirus type 5 vector): This study did a dose-escalation, single-center, open-label, non-randomized, phase 1 trial of an Ad5 vectored COVID-19 vaccine in Wuhan, China. Healthy adults aged between 18 and 60 years were sequentially enrolled and allocated to one of three dose groups (5 × 1010, 1 × 1011, and 1·5 × 1011 viral particles) to receive an intramuscular injection of vaccine.
Ad5-nCoV Vaccine News
- May 22, 2020 - The first human trial of a COVID-19 vaccine finds it is safe and induces a rapid immune response. "These results represent an important milestone. The trial demonstrates that a single dose of the new adenovirus type 5 vectored COVID-19 (Ad5-nCoV) vaccine produces virus-specific antibodies and T cells in 14 days, making it a potential candidate for further investigation", says Professor Wei Chen from the Beijing Institute of Biotechnology in Beijing, China.
- May 12, 2020 - The National Research Council of Canada announced a collaboration with CanSino Biologics Inc. to advance bioprocessing and clinical development in Canada of a candidate vaccine against COVID-19 disease, which is caused by SARS-CoV-2 coronavirus.
- April 9, 2020 - CanSino Biologics Inc. Chairman Xuefeng YU filed a public statement which says 'Based on the preliminary safety data of phase I clinical trial for the Recombinant Novel Coronavirus Disease Vaccine (Adenovirus Type 5 Vector) (the “Ad5-nCoV”), the Company and the Institute of Biotechnology, Academy of Military Medical Sciences plan to initiate phase II clinical trial for Ad5-nCoV in China.
- March 17, 2020 - CanSinoBIO’s Investigational Vaccine Against COVID-19 Approved for Phase 1 Clinical Trial in China.
Ad5-nCoV Vaccine Clinical Trial
Clinical Trial NCT04341389: A Phase II Clinical Trial to Evaluate the Recombinant Vaccine for COVID-19 (Adenovirus Vector) (CTII-nCoV)
- A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Recombinant Novel Coronavirus Vaccine (Adenovirus Vector) in Healthy Adults Aged Above 18 Years.
- This Phase 2 clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2. Start date of April 12, 2020.
- This major Chinese study involves the co-sponsor of the Institute of Biotechnology, Academy of Military Medical Science. Research sites include the Hubei Provincial CDC in Wuhan, Hubei Province, China. Other participants include the Jiangsu Province CDC, the Hubei Provincial CDC, and the Zhongnan Hospital.
Chinese Clinical Trial Registration: ChiCTR2000030906: Phase I clinical trial of recombinant new coronavirus (2019-COV) vaccine (adenovirus vector)
- A single-center, open, and dose-increasing phase I clinical trial of recombinant coronavirus vaccine (adenoviral vector) in healthy adults between 18 and 60 years of age
- The trial assessed the safety and ability to generate an immune response of different dosages of the new Ad5-nCoV vaccine in 108 healthy adults between the ages of 18 and 60 years who did not have SARS-CoV-2 infection. Volunteers were enrolled from one site in Wuhan, China, and assigned to receive either a single intramuscular injection of the new Ad5 vaccine at a low dose (5 × 1010 viral particles/0·5ml, 36 adults), middle dose (1×1011 viral particles/1.0ml, 36 adults), or high dose (1.5 x 1011 viral particles/1.5ml, 36 adults).
- The researchers tested the volunteers' blood at regular intervals following vaccination to see whether the vaccine stimulated both arms of the immune system: the body's 'humoral response' (the part of the immune system that produces neutralizing antibodies which can fight infection and could offer a level of immunity), and the body's cell-mediated arm (which depends on a group of T cells, rather than antibodies, to fight the virus). The ideal vaccine might generate both antibody and T cell responses to defend against SARS-CoV-2.
- The vaccine candidate was well tolerated at all doses with no serious adverse events reported within 28 days of vaccination. Most adverse events were mild or moderate, with 83% (30/36) of those receiving low and middle doses of the vaccine and 75% (27/36) in the high dose group reporting at least one adverse reaction within 7 days of vaccination.