Convidicea 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 vaccine 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,' said the company.
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 February 25, 2021, the company announced the interim analysis data of the phase III clinical trial of Convidecia™ shows that the vaccine candidate has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination and 68.83% at preventing all symptomatic COVID-19 disease 14 days after single-dose vaccination.
And, Ad5-nCoV has an efficacy of 90.07% at preventing severe disease 28 days after single-dose vaccination and 95.47% at preventing severe disease 14 days after single-dose vaccination. The data is based on interim results from Phase-3 clinical trials enrolling more than 4,000 participants in Pakistan, Mexico, Russia, Chile, and Argentina, according to CanSino.
CanSino Biologics Inc. Convidicea (Ad5-nCoV) Drugbank Accession Number: DB15655.
Convidicea Vaccine History
In early 2020, a joint team of the Institute of Biotechnology, the Academy of Military Medical Sciences, and CanSino Biologics began developing the AD5-nCOV vaccine candidate. According to China Daily, the team registered the experimental COVID-19 vaccine for the Phase I trial in China on March 23, 2020.
On April 15, 2020, China began the second phase of clinical trials for a COVID-19 vaccine with 500 volunteer participants recruited from Wuhan. It was the first Phase 2 human test for a COVID-19 vaccine, reported Xinhua News.
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.”
Tianjin 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 Vaccine Indication
Ad5-nCoV is indicated to prevent COVID-19 disease caused by SARS-CoV-2 coronavirus.
Convidicea Vaccine Dosage
The phase 3 clinical 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.
Convidecia™ can be stably stored and transported between 2°C and 8°C, making it more accessible, especially to underserved public health regions.
Convidicea Vaccine News
April 8, 2021 - CanSino Biologics Inc. announced that the Instituto de Salud Pública de Chile granted emergency use authorization for its Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) ("Ad5-nCoV", Convidecia™). This marks the first approval of Convidecia in South America and the first single-dose COVID-19 vaccine approved for emergency use in Chile.
March 22, 2021 - CanSinoBIO Biologics Inc. announced that the Hungarian National Institute of Pharmacy and Nutrition granted emergency use authorization for its Recombinant Novel Coronavirus Vaccine Convidecia™. The approval is based on the vaccine's interim results for Phase III clinical trial and marks the first approval of Convidecia™ in a European Union member state. Globally, Convidecia received authorization for emergency use by the Federal Commission for Protection against Sanitary Risks of Mexico and the Drug Regulatory Authority of Pakistan for adults aged 18 and above in February 2021.
March 22, 2021 - The National Medical Products Administration of China granted approval of CanSinoBIO's clinical trial application for an inhaled version of the COVID-19 vaccine. The safety and efficacy of the inhaled vaccine remain "subject to confirmation," the firm said.
February 28, 2021 - China's single-dose COVID-19 vaccine began its roll-out.
February 25, 2021 - CanSino Biologics Inc. announced that the National Medical Products Administration of China had granted conditional marketing authorization for its Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (“Ad5-nCoV”, trade name: Convidecia™), making it the first of its kind authorized in China.
February 24, 2021 - CanSino Biologics Inc. announced today that it had filed an application with National Medical Products Administration (NMPA) for conditional marketing authorization of the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (“Ad5-nCoV”, trade name: Convidecia™). The NMPA has accepted the application.
February 13, 2021 - Pakistan's Drug Regulatory Authority, on the recommendations of an experts committee, approved the emergency use of Convidicea (Ad5-nCoV). Pakistan is the second country after Mexico to approve the vaccine.
February 8, 2021 - Social Media reported CanSino Biologics Inc’s Convidicea COVID-19 vaccine candidate presented 65.7% efficacy in preventing symptomatic cases and a 90.98% success rate in stopping the severe disease in an interim analysis of global trials conducted in Pakistan.
February 4, 2021 - CanSino, the vaccine being tested in southern Chile, almost ready for international authorization. More than 3,500 volunteers have been inoculated with the experimental vaccine, waiting for volunteers' enrollment to conclude at the end of March. For analysis of the trials, the plan was to wait for 150 cases of Covid to be found in the world within a year, but the figure was reached earlier than previously thought. If the vaccine is approved in Chile, it will be the central laboratory in Canada that will finally decide whether it is marketable or not.
December 15, 2021 - CanSino, the Chinese vaccine that nobody talks about, begins its tests in southern Chile this Wednesday. In Chile, in addition to Sinovac, which has more than one hundred vaccinated volunteers in the country, CanSino Biologics began its tests in Santiago two weeks ago and began its tests this Wednesday in the south, in conjunction with the Universidad de la Frontera (UFRO), seeking to enroll people from Talcahuano, Valdivia, Osorno, Temuco, and Puerto Montt. The vaccine, developed by CanSino, the Beijing Institute of Biotechnology, and the Academy of Military Medical Sciences, is a viral vector vaccine similar to that of Gamaleya's AstraZeneca and Gam-COVID-Vac, the latter developed in Russia.
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 Vaccine Clinical Trials
Clinical Trial NCT04552366: A Phase 1 Clinical Trial of a Recombinant Adenovirus 5 Vectored COVID-19 Vaccine (Ad5-nCoV) With Two Doses in 168 Healthy Adults. The safety and immunogenicity of intramuscular vaccination and mucosal vaccination of two doses of Ad5-nCoV in different administration schedules will be evaluated.
Clinical Trial NCT04540419: Phase III Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Against COVID-19. 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. 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 NCT04566770: A Clinical Trial of A COVID-19 Vaccine Named Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector). This is a phase IIb clinical trial to evaluate the safety and immunogenicity of Ad5-nCoV developed by Cansino and Beijing Institute of Biotechnology in health people aged 6 years old and above. The study will be a double-blind, placebo-controlled trial with participants randomly allocated 2:1 to placebo and experimental vaccine. The immunization schedule is two doses of intramuscular injections (deltoid). Study Completion Date: October 20, 2022.
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 (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.
Clinical Trial NCT04568811: The Phase I Clinical Trial of Booster Vaccination of Adenovirus Type-5 Vectored COVID-19 Vaccine. This is a single-center, open-label phase I clinical trial of booster vaccination in 89 healthy 18 to 60 years of age, inclusive, who have been prime vaccinated with adenovirus type-5 vectored COVID-19 vaccine. This clinical trial is designed to assess the safety and immunogenicity of boosted vaccination of adenovirus type-5 vectored COVID-19 vaccine manufactured by Beijing Institute of Biotechnology and CanSino Biologics Inc.
Clinical Trial NCT04313127: 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).