Convidicea (Ad5-nCoV) Vaccine Description
Convidicea (Ad5-nCoV) is the first novel coronavirus vaccine for COVID-19 in China's clinical trial. The vaccine candidate is built upon CanSinoBIO’s adenovirus-based viral vector vaccine technology platform.
The CanSino Biologics Convidicea (Ad5-nCoV) candidate is a genetically-engineered vaccine candidate with the replication-defective adenovirus type 5 as the vector to express SARS-CoV-2 spike protein. Convidicea is a viral vector vaccine similar to AstraZeneca's AZD1222 vaccine.
'We have used protein structure design technology to design pneumococcal protein antigens. We have also developed novel recombinant strains to produce a new generation pertussis vaccine. We also developed a proprietary cell line to be used for viral vector production,' says the company.
'This technology enabled us to translate our globally innovative Ebola virus vaccine from a concept to an approved product in only three years. Our adenovirus-based vector technology is also applied to our TB Booster and other vaccine candidates.'
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.
On May 16, 2020, Health Canada approved human clinical trials for a possible coronavirus vaccine.
On May 22, 2020, the Ad5 vectored COVID-19 vaccine was reported in a study to be tolerable and immunogenic at 28 days post-vaccination. Humoral responses against SARS-CoV-2 peaked at day 28 post-vaccination in healthy adults, and rapid, specific T-cell responses were noted from day 14 post-vaccination. Our findings suggest that the Ad5 vectored COVID-19 vaccine warrants further investigation.
On June 29, 2020, media sources reported China's military had received the 'green-light' to use a COVID-19 vaccine candidate developed by its research unit, and CanSino Biologics after clinical trials proved it was safe and somewhat efficient.'
On July 20, 2020, a study published in The Lancet reported the Ad5-vectored COVID-19 vaccine at 5 × 1010 viral particles are safe and induced significant immune responses in the majority of recipients after a single immunization during a phase 2 study.
The primary endpoints for immunogenicity were the geometric mean titers of specific ELISA antibody responses to the receptor-binding domain and neutralizing antibody responses at day 28. The primary endpoint for safety evaluation was the incidence of adverse reactions within 14 days. All recruited participants who received at least one dose were included in the primary and safety analyses.
On August 11, 2020, China granted its first COVID-19 vaccine patent, according to the National Intellectual Property Administration. The patent was submitted for application on March 18, 2020.
SCMP reported on September 2, 2020, “The company is currently driving the international multi-center phase three clinical trial for Ad5-nCoV and plans to conduct the clinical trial for Ad5-nCoV in several countries,” it said in the statement. It plans to recruit 40,000 volunteers in countries, including Russia, Saudi Arabia, Pakistan, and Mexico.
On September 21, 2020, Petrovax announced it would produce more than 4 million doses of the vaccine per month in 2020 at its Moscow Region facilities. Vaccine production can be increased to 10 million doses per month in 2021 due to the planned production capacity expansion. As a Russian vaccine manufacturer, Petrovax will have exclusive rights to supply it in Russia and the CIS countries.
Dr. Xuefeng Yu, Chairman, and CEO of CanSinoBIO stated in a press release issued on November 7, 2020: “Launching the clinical study of Ad5-nCoV in Mexico, represents another milestone of CanSinoBIO. We are delighted to collaborate with EPIC and the authorities that make this initial clinical study conducted in Mexico possible. Hopefully, we could see the outcome of the study very soon and contributes to the pandemic fight in Mexico.”
China-based CanSino Biologics Inc. is an innovative biopharmaceutical company dedicated to exploring the best solutions to preventing 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 several vaccines, including 13 for infectious diseases.
Convidicea (Ad5-nCoV) Vaccine Indication
Ad5-nCoV is indicated to prevent COVID-19 disease caused by SARS-CoV-2 coronavirus.
Convidicea (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 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 (Convidicea) Vaccine News
December 6, 2020 - The Health Ministry has allowed Russia's participation in the massive international multi-center randomized placebo-controlled third phase of clinical trials of the candidate coronavirus vaccine's efficacy and immunogenicity Ad5-nCov made by CanSino Biologics. The international trials are conducted in partnership with Petrovax," the company said.
November 7, 2020 - CanSinoBIO announced it had initiated the Phase III clinical trial for a recombinant COVID-19 vaccine (Ad5-nCoV) developed in Mexico. The Mexican authority approved the study in October. The trial aims to recruit a total number of 15,000 subjects to demonstrate the candidate's efficacy further. Previously, CanSinoBIO signed an advance purchase agreement with Mexico’s government to supply 35 million doses of the COVID-19 vaccine candidate. Dr. Xuefeng Yu, CEO of CanSinoBIO, stated, “Launching the clinical study of Ad5-nCoV in Mexico, represents another milestone of CanSinoBIO. We are delighted to collaborate with EPIC and the authorities that make this initial clinical study conducted in Mexico possible. Hopefully, we could see the outcome of the study very soon and contributes to the pandemic fight in Mexico.”
October 15, 2020 - CanSino Biologics Inc. announced that it had signed an advance purchase agreement with the Mexican government, aims to provide Mexico with 35 million doses of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) ("Ad5-nCoV"). According to the agreement, CanSinoBIO will supply 35 million doses of the COVID-19 vaccine to Mexico from 2020 to 2021.
October 2, 2020 - SOLBIO has signed a deal with China-based CanSino Biologics to distribute the Ad5-nCoV vaccine candidate targeting COVID-19 in Malaysia.
September 21, 2020 - The Petrovax company, CanSino Biologics Inc. The contract research organization OCT Clinical has launched its first volunteers at Moscow medical centers. According to clinical regulations, study participants will be under direct supervision for the first 28 days after vaccination. They will have to undergo four interim face-to-face examinations at treatment centers.
September 10, 2020 - China media reported CanSino's Chief Scientific Officer Zhu Tao stressed the safety of a recombinant adenovirus vector vaccine the company has developed after a trial on another vaccine using a similar mechanism was suspended by AstraZeneca and Oxford University after a volunteer became ill during the trial. One difference is that Ad5-nCoV uses an adenovirus that exists in human bodies, while the AstraZeneca vaccine candidate uses chimpanzee adenovirus. No severe adverse effects from Ad5-nCoV have been discovered so far, Zhu noted.
September 2, 2020 - CanSino Biologics announced it had initiated phase 3 clinical trials for its Ad5-nCoV vaccine candidate in Russia after receiving Moscow's health ministry approval.
August 27, 2020 - The National Research Council of Canada announced a COVID-19 vaccine-development partnership between China’s CanSino Biologics and Dalhousie University in Nova Scotia had been abandoned.
August 17, 2020 - Russia’s Petrovax has started a late-stage clinical trial of a COVID-19 candidate vaccine from CanSino Biologics. Inc.
August 9, 2020 - Saudi Arabia announced that it would begin a Phase 3 clinical trial on around 5,000 people.
July 20, 2020 - The Lancet published 'Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomized, double-blind, placebo-controlled, phase 2 trial. The Ad5-vectored COVID-19 vaccine at 5 × 1010 viral particles is safe and induced significant immune responses in the majority of recipients after a single immunization.
July 11, 2020 - Chinese vaccine developer CanSino Biologics announced it is in talks with Russia, Brazil, Chile, and Saudi Arabia to launch a Phase III trial of its experimental COVID-19 vaccine.
June 29, 2020 - China's military has received permission to use a COVID-19 vaccine candidate, Ad5-nCoV, which was developed by its research unit and CanSino Biologics after clinical trials proved it was safe and somewhat efficient.
June 25, 2020 - China’s Central Military Commission approved the use of the vaccine by the military for a period of 1-year.
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.
On May 16, 2020, Health Canada approved human clinical trials for a possible coronavirus vaccine. Prime Minister Justin Trudeau says the first Canadian clinical trials will be conducted out of the Canadian Centre for Vaccinology at Dalhousie University.
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. “Thanks to our collaborators and our diligent team, who worked almost around the clock since late January to develop this vaccine candidate with sound scientific data to support IND filing,” said Xuefeng Yu, Chairman and CEO of CanSinoBIO, “Having committed to providing unconditional support to fight against the global pandemic, CanSinoBIO is determined to launch our vaccine product candidate as soon as possible with no compromise on quality and safety.”
Convidicea (Ad5-nCoV) Vaccine Clinical Trials
Clinical Trial NCT04540419: Phase III Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Against COVID-19 Last Updated: November 13, 2020
This study is a phase III clinical trial to evaluate the efficacy, reactogenicity, and safety of the vaccine Ad5-nCoV compared with placebo in volunteers at the age from 18 to 85 years，with the randomized, double-blind design.
A total of 500 healthy adult volunteers from 18 to 85 years will be randomized into two treatment (vaccination) groups in ratio 3:1 by double-blind design.
Estimated Study Completion Date: July 31, 2021.
Clinical Trial NCT04526990: Phase III Trial of A COVID-19 Vaccine of Adenovirus Vector in Adults 18 Years Old and Above - Last Update Posted: December 4, 2020.
This is a global phase III clinical trial to evaluate the efficacy, safety, immunogenicity of Ad5-nCoV manufactured by Cansino and Beijing Institute of Biotechnology in healthy adults aged 18 years old and above. The study will be a double-blind, placebo-controlled trial with participants randomly allocated 1:1 to placebo and experimental vaccine cohorts. The immunization schedule is one dose of intramuscular injections (deltoid).
Estimated Study Completion Date: January 30, 2022.
Clinical Trial NCT04341389: A Phase II Clinical Trial to Evaluate the Recombinant Vaccine for COVID-19 (Adenovirus Vector) (CTII-nCoV) - Last updated on May 18, 2020.
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 (ChiCTR2000031781) involves the Institute of Biotechnology's co-sponsor, the 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.
603 volunteers were recruited and screened for eligibility between April 11 and 16, 2020. 508 eligible participants (50% male; mean age 39·7 years, SD 12·5) consented to participate in the trial and were randomly assigned to receive the vaccine (1 × 1011 viral particles n=253; 5 × 1010 viral particles n=129) or placebo (n=126). In the 1 × 1011 and 5 × 1010 viral particles dose groups, the RBD-specific ELISA antibodies peaked at 656·5 (95% CI 575·2–749·2) and 571·0 (467·6–697·3), with seroconversion rates at 96% (95% CI 93–98) and 97% (92–99), respectively, at day 28.
Both doses of the vaccine-induced significant neutralizing antibody responses to live SARS-CoV-2, with GMTs of 19·5 (95% CI 16·8–22·7) and 18·3 (14·4–23·3) in participants receiving 1 × 1011 and 5 × 1010 viral particles, respectively. Specific interferon γ enzyme-linked immunospot assay responses post-vaccination were observed in 227 (90%, 95% CI 85–93) of 253 and 113 (88%, 81–92) of 129 participants in the 1 × 1011 and 5 × 1010 viral particles dose groups, respectively. Solicited adverse reactions were reported by 183 (72%) of 253 and 96 (74%) of 129 participants in the 1 × 1011 and 5 × 1010 viral particles dose groups.
Severe adverse reactions were reported by 24 (9%) participants in the 1 × 1011 viral particles dose group and one (1%) participant in the 5 × 1010 viral particles dose group. No serious adverse reactions were documented.
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 18 and 60 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 that 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 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.