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Ad5 nCOV - Tianjin CanSino Biotechnology

Drug Profile

Ad5 nCOV - Tianjin CanSino Biotechnology

Alternative Names: 5E10 vp; Ad5-nCOV - Tianjin CanSino Biotechnology; Ad5-nCoV-IH; Adenovirus type-5 vectored COVID-19 vaccine; Convidecia; COVID-19 vaccine - Tianjin CanSino Biotechnology; Low dose adenovirus type-5 vectored COVID-19 vaccine; Recombinant Coronavirus Vaccine - Tianjin CanSino Biotechnology; Recombinant novel coronavirus vaccine (adenovirus type 5 vector) - Tianjin CanSino Biotechnology; Recomboinant novel coronavirus vaccine - Tianjin CanSino Biotechnology

Latest Information Update: 28 Oct 2023

At a glance

  • Originator Tianjin CanSino Biotechnology
  • Developer Beijing Institute of Biotechnology; Tianjin CanSino Biotechnology
  • Class COVID-19 vaccines; Synthetic vaccines; Viral vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Registered COVID 2019 infections

Most Recent Events

  • 28 Oct 2023 No recent reports of development identified for phase-I development in COVID-2019-infections(Prevention) in China (Transmucosal, Injection)
  • 18 Jun 2023 CanSino Biologics in collaboration with Beijing Institute of Biotechnology withdraws a planned phase III SeiHOPE trial for COVID-2019 infections (Prevention) in China (Inhalation) (NCT05124561)
  • 10 Feb 2023 Tianjin CanSino Biotechnology completes a phase III trial in COVID-2019-infections in China (NCT04916886)

Development Overview

Introduction

Ad5 nCoV is a recombinant adenovirus type 5 vector coronavirus vaccine, being developed by Tianjin CanSino Biotechnology, in collaboration with Beijing Institute of Biotechnology, for the prevention of COVID-19 infections. The vaccine is a replication defective Ad5 vectored vaccine expressing the full-length spike glycoprotein of SARS-CoV-2. CanSinoBIO’s adenovirus-based viral vector vaccine technology platform has been applied to develop the vaccine similar to Ebola virus infection. The company is developing inhaled formulation of vaccine Ad5 nCoV. The vaccine is approved under emergency use authorisation in Chile, Hungary, Mexico, Indonesia and Pakistan. The vaccine is also approved in Argentina, Malaysia, Ecuador, Kyrgyzstan, United Arab Emirates and China. Clinical development for varied formulations is underway in Russia, Chile and China.

As at October 2023, no recent reports of development had been identified for phase-I development in COVID-2019-infections (Prevention) in China (Transmucosal, Injection).

Company Agreements

In December 2021, CanSinoBIO announced a development and commercial supply partnership agreement with Aerogen for the inhaled delivery of CanSinoBIO’s vaccine Convidecia™ utilizing Aerogen’s proprietary vibrating mesh aerosol drug delivery technology. Commercial terms of the partnership have not been disclosed. [1]

In May 2020, in continuation with the previous collaboration, The National Research Council (NRC) of Canada and Tianjin CanSino Biotechnology again announced the collaboration to advance bioprocessing and clinical development of Ad5-nCoV, a vaccine against COVID 2019 infections in Canada. According to the collaboration, NRC to advance a scale-up production process for Ad5-nCoV, using its proprietary HEK293 cell line that were designed and developed at the NRC. Both companies will utilize their respective technologies and expertise together to develop the vaccine. As a preparatory step, the Government of Canada had announced $44 million in funding to support upgrades to the NRC's facilities in Montréal to enable compliance with Good Manufacturing Practice (GMP) standards, to ensure readiness for Canadian bioprocessing of potential vaccine candidates as they become available.

Tianjin CanSino Biotechnology is utilising HEK 293 cells and the process developed by National Research Council Canada for the manufacturing of Ad5 adenovirus vector monovalent Ebola virus vaccine. [2] [3]

In August 2020, CanSinoBIO entered into a supply agreement with Shanghai Pharmaceuticals to expand production capacity, storage and supply chain management of Ad5-nCoV vaccine.

In March 2021, CanSinoBIO signed a purchase agreement with Government of Mexico to supply 35 million doses of Ad5 nCoV vaccine for prevention of COVID-2019 infections.

Key Development Milestones

As of May 2022, CanSinoBIO's Convidecia™ received approvals in Ecuador, Kyrgyzstan, United Arab Emirates [4] .

In March 2022, CanSino Biologics reported that Ad5 nCoV has been approved by the Ministry of Health Malaysia (MOH Malaysia) and the Indonesian National Agency of Drug and Food Control (BPOM) as a heterologous booster. The MOH Malaysia recommended using Convidecia™ as a heterologous booster for individuals, aged 18 and above, who have been administered two doses of inactivated COVID-19 vaccine at least three months prior. The approval was made as the Malaysian authorities continued to achieve high booster vaccination rates. The BPOM recommended that adults, who have received inactivated COVID-19 vaccines, opt for either Convidecia™ or an mRNA vaccine as a booster. Earlier, in September 2021, Convidecia™ received emergency use authorization from the BPOM in Indonesia [5] .

Convidecia™ has been approved for use as a heterologous booster in China in national vaccination programs, in February 2022. It is also the first and only adenovirus-vectored vaccine to be included in the heterologous vaccination program in China [5] .

Convidecia™ has been approved for use as a heterologous booster in Argentina, in national vaccination programs, November 2021 [5] .

In April 2021, CanSino Biologics Inc announced that the Instituto de Salud Pública de Chile ("ISP") granted emergency use authorisation for single dose Adenovirus type 5 vector (Ad5-nCoV, Convidecia™) vaccine in Chile [6] .

In March 2021, the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI) granted emergency use authorisation for Adenovirus type 5 vector (Ad5-nCoV) for the prevention of COVID-2019 infections. The approval of Ad5-nCoV was based on the interim results from a phase III trial [see below] [7] .

In March 2021, Ad5-nCoV vaccine was approved by the National Medical Products Administration of China [7] . Earlier, in February 2021, CanSino Biologics filed an application with National Medical Products Administration (NMPA) for Ad5-nCoV. The NMPA accepted the application and granted conditional marketing authorization for Ad5-nCoV for prevention of COVID-2019 infections [8] .

In February 2021, Adenovirus type 5 vector vaccine received emergency use authorisation from the Federal Commission for Protection against Sanitary Risks of Mexico [7] .

In February 2021, the Drug Regulatory Authority of Pakistan also granted emergency use authorization for Ad5-nCoV vaccine for prevention of COVID-2019 infections in adults aged 18 and above [7] .

In June 2020, Ad5-nCoV received Military Specially-needed Drug Approval in China issued by the Health Bureau of the Logistics Support Department of the Central Military Commission [8] .

In May 2022, CanSino Biologics announced that the World Health Organization (WHO) granted Emergency Use Listing for Convidecia™. Convidecia™ can be stably transported and stored between 2°C and 8°C [4] .

In July 2022, CanSino Biologics completed a phase III trial of Ad5 nCoV in population 6-59 years old. Earlier in June 2021, CanSino Biologics and Jiangsu Province Centers for Disease Control and Prevention initiated a clinical trial to evaluate immunogenicity bridging between different manufacture scales and between different lots of Ad5 nCoV in population 6-59 years old (NCT04916886; JSVCT118). The single-centre, randomised and double-blinded trial intends to enrol 2016 participants in China [9] .

In October 2022, CanSino Biologics completed a phase III trial which was designed to assess the efficacy, safety and immunogenicity of Ad5-nCoV in healthy adults 18 years old and above (CS-CTP-AD5NCOV-Ⅲ; NCT04526990). The randomised, double-blind trial was initiated in September 2020 and enrolled 44247 patients in Argentina, Chile, Mexico, Pakistan and Russia. In February 2021, interim analysis data of the phase III clinical trial of Ad5-nCoV was released by CanSino Biologics [8] . In December 2021, results from the trial was released by CanSino Biologics [10] [11] .

In January 2023, CanSino Biologics and Beijing Institute of Biotechnology terminated a phase III trial due to difficulty in recruitment of subjects, that evaluated the safety and immunogenicity of intramuscular and inhaled Ad5 nCOV in children aged 6-12 years and adolescents aged 13-17 years who have been immunised with two doses of CoronaVac (NCT05169008; CS-CTP-AD5NCOV-PDⅢ). The open-label, randomised trial, initiated in February 2022, enrolled 91 individuals in Chile [12] .

In June 2023, CanSino Biologics in collaboration with Beijing Institute of Biotechnology had withdrawn a phase III SeiHOPE before enrollment because the trial protocol was not approved by the regulatory authorities (NCT05124561; CS-CTP-AD5NCOV-IH-III). The trial was supposed to evaluate the efficacy, safety, and immunogenicity of recombinant COVID-19 vaccine for inhalation (Ad5-nCoV-IH) in adults aged 18 years and above who have received one dose of intramuscular Ad5-nCoV. The randomized, double-blind, trial was planned to initiate in December 2021 [13] .

In September 2020, CanSino Biologics initiated a phase III trial to assess the efficacy, safety and reactogenicity of Ad5-nCoV in healthy volunteers of age 18 years old and above (Prometheus_Rus; NCT04540419). The randomised, double-blind trial intends to enrol approximately 500 volunteers in Russia. As of September 2020, first group of volunteers were vaccinated in a phase III trial [14] [15] .

In October 2021, Dalhousie University in collaboration with CanSino Biologics initiated a phase IIb trial to evaluate the immunogenicity and safety of Ad5-nCov for the prevention of COVID-2019 infections, in participants previously received one dose of Sputnik V (FH63CS-nCoV-SeqAD26; NCT05293223). The open-label trial intends to enroll approximately 450 subjects in Argentina [16] .

In June 2021, CanSino Biologics in collaboration with Canadian Center for Vaccinology initiated a phase II trial to evaluate the efficacy, safety and immunogenicity of AD5 nCOV in adults 18 years of age and older, living with HIV, on stable treatment, and virologically suppressed for at least 6 months (FH-58; NCT05005156). The randomized, double-blind, placebo-controlled trial intends to enrol approximately 876 patients in Argentina [17] .

In January 2022, CanSino Biologics completed a phase II trial that assessed the efficacy, safety and immunogenicity of Ad5-nCoV in healthy adults and children of 6 years old and above (NCT04566770; JSVCT093). The randomised, double-blind trial initiated in September 2020 enrolled 480 volunteers in China [18]

In December 2020, CanSino Biologics completed a phase II trial that evaluated the immunogenicity and safety of Ad5-nCoV in healthy adults aged above 18 years (NCT04341389; JSVCT089). The double blind trial was initiated in April 2020, enrolled 508 participants in China [19] .

In September 2020, Jiangsu Provincial Center for Disease Control and Prevention initiated a phase I trial to evaluate the safety of a booster vaccination of adenovirus type-5 vectored COVID-19 vaccine in healthy adults aged 18-60 years (JSVCT100; NCT04568811). The open label trial intends to enrol 89 volunteers in China.

In April 2021, Institute of Biotechnology and Zhongnan Hospital completed a phase I trial that assessed the safety and immunogenicity of a recombinant adenovirus 5 vectored COVID-19 vaccine (Ad5-nCoV) with two doses and with different adminstration routes in healthy adults aged 18 years and older (AMMS85-2004; NCT04552366). The open-label trial, initiated in September 2020, enrolled 149 participants in China [20] .

In March 2020, Jiangsu Provincial Center for Disease Control and Prevention initiated a phase I trial to assess the safety and tolerability of Ad5 nCoV in healthy volunteers aged 18 to 60 years (ChiCTR2000030906). The open-label trial intends to enrol approximately 108 participants in China.

In February 2021, Tianjin CanSino Biotechnology (CanSino Biologics) completed the phase I CTCOVID-19 trial that assessed the safety, reactogenicity and immunogenicity of Ad5 nCoV in healthy adults (NCT04313127; JSVCT088). The non-randomised, open-label trial was initiated in March 2020, and enrolled 108 volunteers in China [21] .

In March 2020, National medical products administration (NMPA) approved IND (Investigational new drug) application for phase I study of Ad5 nCoV in healthy volunteers in China. The data from preclinical study was used to submit the IND application [22] .

As of March 2020, Preclinical studies were conducted in animal models by Tianjin CanSino Biotechnology and demonstrated strong immune response with good safety profile [22] .

Inhalation formulation

In September 2021, Jiangsu Province Centers for Disease Control and Prevention initiated a phase I/II trial to evaluate the immunogenicity and safety of aerosolised Ad5 nCoV after two-dose priming with an inactivated SARS-CoV-2 vaccine (JSVCT127; NCT05043259). The randomised, open-label, parallel-controlled trial intends to enroll approximately 420 volunteers in China [23] .

In August 2022, CanSino Biologics completed a phase I/II trial of Ad5-nCoV for the treatment of COVID-19. Earlier in March 2021, CanSino Biologics initiated a phase I/II trial to evaluate the safety and immunogenicity of Ad5-nCoV for inhalation in healthy volunteers (NCT04840992; JSVCT092). The randomised, placebo-controlled trial intends to enrol approximately 840 participants in China [24] [25] .

In March 2021, the NMPA granted approval to CanSino Biologics.s clinical trial application for inhaled formulation of Ad5-nCoV COVID-19 vaccine in China [6] .

Drug Properties & Chemical Synopsis

  • Route of administration IM, Inhalation, Parenteral, Transmucosal
  • Formulation Injection, Liquid, unspecified
  • Class COVID-19 vaccines, Synthetic vaccines, Viral vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7E9 (All other viral vaccines)

Biomarkers Sourced From Trials

Indication Biomarker Function Biomarker Name Number of Trials

cOVID 2019 infections

Detailed Description

vitronectin

Tumor necrosis factor alpha (TNF-alpha)

T-cell surface antigen CD4

T-Cell differentiation antigen CD8

Interleukin-5 (IL-5)

Interleukin-4 (IL-4)

Interleukin-13 (IL-13)

Interferon Gamma (IFNg)

1

1

1

1

1

1

1

1

cOVID 2019 infections

Eligibility Criteria

T-cell surface antigen CD4

DNA (cytosine-5-)-methyltransferase 3 beta

1

1

cOVID 2019 infections

Outcome Measure

vitronectin

Tumor necrosis factor alpha (TNF-alpha)

T-cell surface antigen CD4

T-Cell differentiation antigen CD8

Interleukin-5 (IL-5)

Interleukin-4 (IL-4)

Interleukin-2 (IL-2)

Interleukin-13 (IL-13)

Interferon Gamma (IFNg)

Interferon alpha (IFN-alpha)

Creatinine

ALT

9

3

4

4

2

2

3

3

6

1

1

1

COVID-19 respiratory infection

Outcome Measure

vitronectin

Fibrinogen

C-reactive protein (CRP)

1

1

1

respiratory tract infections

OutcomeMeasure

vitronectin

1

Biomarker

Drug Name Biomarker Name Biomarker Function
Ad5 nCOV - Tianjin CanSino Biotechnology C-reactive protein (CRP) Outcome Measure
DNA (cytosine-5-)-methyltransferase 3 beta Eligibility Criteria
Fibrinogen Outcome Measure
Interferon alpha (IFN-alpha) Outcome Measure
Interferon Gamma (IFNg) Detailed Description, Outcome Measure
Interleukin-13 (IL-13) Detailed Description, Outcome Measure
Interleukin-2 (IL-2) Outcome Measure
Interleukin-4 (IL-4) Detailed Description, Outcome Measure
Interleukin-5 (IL-5) Detailed Description, Outcome Measure
T-Cell differentiation antigen CD8 Detailed Description, Outcome Measure
T-cell surface antigen CD4 Detailed Description, Eligibility Criteria, Outcome Measure
Tumor necrosis factor alpha (TNF-alpha) Detailed Description, Outcome Measure
vitronectin Detailed Description, Outcome Measure
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - Prevention Registered Ecuador, Kyrgyzstan, United Arab Emirates Parenteral / unspecified Tianjin CanSino Biotechnology 19 May 2022
COVID 2019 infections emergency use authorisation In adults, In the elderly, Prevention Registered Indonesia, Malaysia IM / Injection Tianjin CanSino Biotechnology 22 Mar 2022
COVID 2019 infections emergency use authorisation In adults, Prevention Registered Pakistan IM / Injection Tianjin CanSino Biotechnology 28 Feb 2021
COVID 2019 infections under emergency use authorisation emergency use authorisation Prevention Registered Argentina, Chile, China, Hungary, Mexico IM / Injection Tianjin CanSino Biotechnology 01 Nov 2021
COVID 2019 infections - In adolescents, In children, Prevention Phase III Chile Inhalation / Liquid Beijing Institute of Biotechnology 25 Feb 2022
COVID 2019 infections - In adolescents, In children, Prevention Phase III Chile IM / Injection Beijing Institute of Biotechnology 25 Feb 2022
COVID 2019 infections - Prevention Phase III Russia IM / Injection Tianjin CanSino Biotechnology 11 Sep 2020
COVID 2019 infections - In adolescents, In adults, In children, Prevention Phase II China IM / Injection Beijing Institute of Biotechnology, Tianjin CanSino Biotechnology 24 Sep 2020
COVID 2019 infections - Prevention Phase I/II China Inhalation / unspecified Tianjin CanSino Biotechnology 31 Mar 2021
COVID 2019 infections - Prevention No development reported (I) China Transmucosal / Injection Beijing Institute of Biotechnology 28 Oct 2023

Commercial Information

Involved Organisations

Organisation Involvement Countries
Tianjin CanSino Biotechnology Originator China
Tianjin CanSino Biotechnology Owner China
Aerogen Technology Provider USA
Beijing Institute of Biotechnology Collaborator
Jiangsu Provincial Center for Disease Control and Prevention Collaborator China
Canadian Center for Vaccinology Collaborator Canada
Aerogen Collaborator USA
National Research Council Canada Collaborator Canada

Brand Names

Brand Name Organisations Indications Countries
Convidecia Tianjin CanSino Biotechnology COVID 2019 infections China, Mexico, Ecuador, Pakistan, Chile, Indonesia, Kyrgyzstan, Malaysia, United Arab Emirates, Hungary

Scientific Summary

Immunogenicity

Summary

Phase III

Updated results from a phase III trial met all of the primary efficacy endpoints and indicated an overall efficacy rate of 63.7% (95% CI 52.9-72.1) and an efficacy rate of 96.0% (95% CI 70.5-99.5) against severe disease 14 days after receiving a single dose of Convidecia. The overall efficacy rate 28 days post-vaccination was 57.5% (95% CI 39.7-70.0), with an efficacy rate of 91.7% (95% CI 36.1- 99.0) against severe disease. Interim analysis data of the phase III clinical trial of Ad5-nCoV showed an 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. Ad5-nCoV demonstrated 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 [10] [8] [11] .

Future Events

Expected Date Event Type Description Updated
15 Dec 2021 Trial Update CanSino Biologics in collaboration with Beijing Institute of Biotechnology plans phase III SeiHOPE trial for COVID-2019 infections (Prevention) in China (Inhalation) in December 2021 (NCT05124561) 30 Jun 2023
20 Apr 2021 Trial Update CanSino Biologics plans a phase I/II trial for COVID-2019 infection (Prevention, In adults, In the elderly) in China (Inhalation) in April 2021 (NCT04840992) 27 May 2021
31 May 2020 Trial Update CanSino Biotechnology plans a phase I/II trial in Healthy volunteers (In adults, In elderly) in Canada (IM) (NCT04398147) (700322291) 21 Sep 2020
14 May 2020 Regulatory Status Tianjin CanSino Biotechnology plans to file CTA to Health Canada for COVID-2019 infections [3] 14 May 2020

Development History

Event Date Update Type Comment
28 Oct 2023 Phase Change - No development reported No recent reports of development identified for phase-I development in COVID-2019-infections(Prevention) in China (Transmucosal, Injection) Updated 28 Oct 2023
18 Jun 2023 Trial Update CanSino Biologics in collaboration with Beijing Institute of Biotechnology withdraws a planned phase III SeiHOPE trial for COVID-2019 infections (Prevention) in China (Inhalation) (NCT05124561) Updated 30 Jun 2023
10 Feb 2023 Trial Update Tianjin CanSino Biotechnology completes a phase III trial in COVID-2019-infections in China (NCT04916886) Updated 16 Feb 2023
08 Feb 2023 Trial Update Tianjin CanSino Biotechnology completes a phase I/II trial in COVID-2019 infections in China (NCT04840992) Updated 16 Feb 2023
13 Jan 2023 Trial Update CanSino Biologics and Beijing Institute of Biotechnology terminates a phase-III trial in COVID-2019 infections (Prevention, In adolescents, In children) in Chile (IM, Inhalation) (NCT05169008) Updated 26 Jun 2023
21 Oct 2022 Trial Update CanSino Biologics completes a phase III trial in COVID-2019 infections (Prevention) in Argentina, Chile, Mexico, Pakistan, Russia (IM) (NCT04526990) Updated 27 Jun 2023
19 May 2022 Phase Change - Registered Registered for COVID-2019 infections (Prevention) in Ecuador, United Arab Emirates, Kyrgyzstan (IM) as of May 2022 [4] Updated 23 May 2022
18 May 2022 Phase Change - Preregistration Preregistration for COVID-2019 infections (Prevention) in Ecuador, Kyrgyzstan, United Arab Emirates (Parenteral) as of May 2022 [4] Updated 23 May 2022
15 Apr 2022 Trial Update Seventh Medical Center of PLA General Hospital plans a phase II trial for COVID-19 infections in April 2022 (NCT05330871) Updated 19 Apr 2022
22 Mar 2022 Phase Change - Preregistration Preregistration for COVID-2019 infections (Prevention, In adults, In the elderly) in Malaysia, Indonesia (IM), prior to March 2022 [5] Updated 25 Mar 2022
22 Mar 2022 Phase Change - Registered Registered for COVID-2019 infections (Prevention, In adults, In the elderly) in Malaysia (IM), prior to March 2022 [5] Updated 25 Mar 2022
22 Mar 2022 Regulatory Status The Indonesian National Agency of Drug and Food Control approves Ad5 nCOV as a heterologous booster in Indonesia (IM) [5] Updated 25 Mar 2022
22 Mar 2022 Regulatory Status The Ministry of Health Malaysia approves Ad5 nCOV as a heterologous booster in Malaysia (IM) [5] Updated 25 Mar 2022
25 Feb 2022 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Prevention, In adolescents, In children) in Chile (IM) (NCT05169008) Updated 12 Sep 2022
25 Feb 2022 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Prevention, In adolescents, In children) in Chile (Inhalation) (NCT05169008) Updated 12 Sep 2022
01 Feb 2022 Regulatory Status The regulatory body approves Ad5 nCOV as a heterologous booster in China [5] Updated 25 Mar 2022
19 Jan 2022 Trial Update CanSino Biologics completed a phase-II clinical trials in COVID-2019 infections (In children, In adults, In adolescents, Prevention) in China (IM) (NCT04566770) Updated 11 Nov 2022
24 Dec 2021 Scientific Update Immunogenicity data from a phase III trial in Covid-2019 infections released by CanSino Biologics [10] Updated 29 Dec 2021
23 Dec 2021 Trial Update CanSino Biologics and Beijing Institute of Biotechnology plans a phase III trial in COVID-2019 infections (In children, In adolescents) in Mexico, Chile in December 2021 (IM) (Inhalation) (NCT05169008) Updated 30 Dec 2021
09 Dec 2021 Regulatory Status Tianjin CanSino Biotechnology enters into a development and commercial supply agreement with Aerogen for Ad5 nCOV [1] Updated 14 Dec 2021
18 Nov 2021 Trial Update CanSino Biologics in collaboration with Beijing Institute of Biotechnology plans phase III SeiHOPE trial for COVID-2019 infections (Prevention) in China (Inhalation) in December 2021 (NCT05124561) Updated 30 Jun 2023
01 Nov 2021 Phase Change - Preregistration Preregistration for COVID-2019 infections (Prevention) in Argentina (IM), prior to November 2021 [5] Updated 25 Mar 2022
01 Nov 2021 Phase Change - Registered Registered for COVID-2019 infections (Prevention) in Argentina (IM) [5] Updated 25 Mar 2022
01 Nov 2021 Regulatory Status The regulatory body approves Ad5 nCOV as a heterologous booster in Argentina [5] Updated 25 Mar 2022
01 Oct 2021 Trial Update Dalhousie University in collaboration with CanSino Biologics initiates a phase IIb trial of Ad5-nCov in COVID-2019 infections (Prevention), in Argentina (IM) (NCT05293223) Updated 29 Mar 2022
16 Sep 2021 Trial Update Jiangsu Province Centers for Disease Control and Prevention initiates a phase I/II trial of Ad5 nCoV in COVID-2019 infection (Prevention), in China (Inhalation)(NCT05043259) Updated 17 Sep 2021
14 Sep 2021 Biomarker Update Biomarkers information updated Updated 31 Oct 2021
01 Sep 2021 Phase Change - Registered Registered for COVID-2019 infections (Prevention, In adults, In the elderly) in Indonesia (IM) - emergency use authorization [5] Updated 25 Mar 2022
24 Jun 2021 Phase Change - II Phase-II clinical trials in COVID-2019 infections (In adults, In the elderly, Prevention) in Argentina (IM)(NCT05005156) Updated 19 Aug 2021
03 Jun 2021 Trial Update Tianjin CanSino Biotechnology and Jiangsu Provincial Center for Disease Control and Prevention initiates a clinical trial in COVID-2019 infections (In children, In adults, In adolescents, Prevention) in China (IM) (NCT04916886) Updated 15 Jun 2021
30 Apr 2021 Trial Update Institute of Biotechnology in collaboration with Zhongnan Hospital completes a phase I trial in COVID-19 infections(Prevention) in China (IM, Injection) (NCT04552366) Updated 30 May 2023
14 Apr 2021 Trial Update CanSino Biologics plans a phase I/II trial for COVID-2019 infection (Prevention, In adults, In the elderly) in China (Inhalation) in April 2021 (NCT04840992) Updated 27 May 2021
08 Apr 2021 Phase Change - Registered Registered for COVID-2019 infections (Prevention) in Chile (IM) [6] Updated 12 Apr 2021
08 Apr 2021 Trial Update CanSinoBIO plans a clinical trial of Ad5 nCoV (Prevention) in China (Inhalation) [6] Updated 12 Apr 2021
31 Mar 2021 Phase Change - I/II Phase-I/II clinical trials in COVID-2019 infections (Prevention) in China (Inhalation) [24] (NCT04840992) Updated 27 May 2021
22 Mar 2021 Phase Change - Registered Registered for COVID-2019 infections (Prevention) in China (IM) Updated 12 Apr 2021
22 Mar 2021 Regulatory Status NMPA approves clinical trial application of COVID-2019 infections (Prevention) in China (Inhalation) [6] Updated 12 Apr 2021
22 Mar 2021 Phase Change - Registered Registered for COVID-2019 infections (Prevention) in Hungary (IM) [7] Updated 30 Mar 2021
28 Feb 2021 Phase Change - Registered Registered for COVID-2019 infections (Prevention, In adults) in Pakistan (IM) [7] Updated 30 Mar 2021
28 Feb 2021 Phase Change - Registered Registered for COVID-2019 infections in Mexico (Prevention) (IM) [7] Updated 30 Mar 2021
24 Feb 2021 Phase Change - Preregistration Preregistration for COVID-2019 infections (Prevention) in China (IM) [8] Updated 26 Feb 2021
24 Feb 2021 Regulatory Status Ad5-nCoV receives Military Specially-needed Drug Approval by the Health Bureau of the Logistics Support Department of the Central Military Commission in China before February 2021 [8] Updated 26 Feb 2021
24 Feb 2021 Scientific Update Interim immunogenicity data from a phase III trial in COVID-2019 infections released by CanSino Biologics [8] Updated 26 Feb 2021
20 Feb 2021 Trial Update Tianjin CanSino Biotechnology completes the phase I CTCOVID-19 trial in COVID-2019 infections (Prevention) in China (IM) (NCT04313127) Updated 09 Aug 2021
31 Dec 2020 Trial Update CanSino Biologics completes a phase II trial in COVID-2019 infections (Prevention) in China (IM, Injection) (NCT04341389) Updated 29 May 2023
26 Sep 2020 Trial Update Jiangsu Provincial Center for Disease Control and Prevention initiates enrolment in a phase I trial for COVID-2019 infections (Prevention) in China (NCT04568811) Updated 01 Oct 2020
24 Sep 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections (In children, In adults, In adolescents, Prevention) in China (IM) (NCT04566770) Updated 01 Oct 2020
20 Sep 2020 Phase Change - I Phase-I clinical trials in COVID-2019 infections (Prevention) in China (Transmucosal) (NCT04552366) Updated 04 Nov 2020
20 Sep 2020 Trial Update Institute of Biotechnology initiates enrolment in a phase I trial for COVID-2019 infections (Prevention) in China (NCT04552366) Updated 22 Sep 2020
15 Sep 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Prevention) in Pakistan (IM) (NCT04526990) Updated 21 Sep 2020
11 Sep 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Prevention) in Russia (IM) (NCT04540419) Updated 21 Sep 2020
07 Sep 2020 Trial Update NPO Petrovax and CanSino Biologics plans a phase III trial for COVID-2019 infections (Prevention) in Russia (IM) in September 2020 (NCT04540419) Updated 11 Sep 2020
30 Aug 2020 Trial Update CanSino Biologics plans a phase III trial in COVID-2019 infections in Pakistan (IM) (NCT04526990) Updated 01 Sep 2020
28 May 2020 Trial Update CanSino Biotechnology plans a phase I/II trial in Healthy volunteers (In adults, In elderly) in Canada (IM) (NCT04398147) Updated 21 Sep 2020
14 May 2020 Licensing Status The National Research Council (NRC) of Canada and Tianjin CanSino Biotechnology continue collaboration for clinical development of Ad5 nCOV for COVID-2019 infections in Canada [3] Updated 14 May 2020
12 May 2020 Regulatory Status Tianjin CanSino Biotechnology plans to file CTA to Health Canada for COVID-2019 infections [3] Updated 14 May 2020
12 Apr 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections (Prevention) in China (IM) (NCT04341389) Updated 21 Apr 2020
12 Apr 2020 Trial Update Tianjin CanSino Biotechnology plans the phase II CTII-nCoV trial for COVID-2019 infections (In Volunteers, Prevention) in China (IM, Injection) (NCT04341389) Updated 14 Apr 2020
17 Mar 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in China (IM), before March 2020 [22] Updated 20 Mar 2020
17 Mar 2020 Regulatory Status National medical products administration approves IND application for phase I trial for Ad5 nCOV in COVID-19 infections (Prevention) [22] Updated 20 Mar 2020
17 Mar 2020 Trial Update Tianjin CanSino Biotechnology plans a phase I trial for COVID-19 infections (In Volunteers, Prevention) in China (NCT04313127) [22] Updated 20 Mar 2020
16 Mar 2020 Trial Update Jiangsu Provincial Center for Disease Control and Prevention initiates a phase I trial for COVID-2019 infections (Prevention) in China (IM) (ChiCTR2000030906) Updated 23 Jun 2020
16 Mar 2020 Phase Change - I Phase-I clinical trials in COVID-2019 infections (Prevention) in China (IM) (NCT04313127) Updated 27 Mar 2020

References

  1. Aerogen(R) and CanSinoBIO agree on landmark development and commercial supply partnership for worlds first inhaled Covid-19 vaccine delivery.

    Media Release
  2. National Research Council contribution plays key role in newly approved Ebola vaccine.

    Media Release
  3. The National Research Council of Canada and CanSino Biologics Inc. announce collaboration to advance vaccine against COVID-19.

    Media Release
  4. CanSinoBIO's COVID-19 Vaccine Convidecia(TM) Receives WHO Emergency Use Listing.

    Media Release
  5. CanSinoBIO's Convidecia(Tm) Approved as Heterologous Booster in Malaysia and Indonesia.

    Media Release
  6. CanSinoBIO Announces Approval for its Single-Dose COVID-19 Vaccine Convidecia(TM) in Chile.

    Media Release
  7. CanSinoBIO Announces Approval for its Single-Dose COVID-19 Vaccine Convidecia(Tm) in Hungary.

    Media Release
  8. NMPA Accepts the Application for Conditional Marketing Authorization of CanSinoBIO's COVID-19 Vaccine ConvideciaTM .

    Media Release
  9. To Evaluate the Immunogenicity Bridging Between Different Manufacture Scales and Between Different Lots of Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV) in Population 6-59 Years of Age.

    ctiprofile
  10. Convidecia(TM) Phase III Results Published in The Lancet.

    Media Release
  11. A Global Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Designed Phase III Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of Ad5-nCoV in Adults 18 Years of Age and Older

    ctiprofile
  12. A Multicenter, Randomized, and Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of Intramuscular and Inhaled COVID-19 Vaccine in Children Aged 6-12 Years and Adolescents Aged 13-17 Years Who Have Been Immunized With Two Doses of CoronaVac

    ctiprofile
  13. A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial on the Efficacy, Safety, and Immunogenicity of Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation (Ad5-nCoV-IH) in Adults Aged 18 Years and Above Who Have Received One Dose of Intramuscular Ad5-nCoV

    ctiprofile
  14. THE FIRST GROUP OF VOLUNTEERS ARE VACCINATED WITH AD5-NCOV CANDIDATE VACCINE IN RUSSIA.

    Media Release
  15. Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group Study Evaluating Efficacy, Reactogenicity and Safety of Recombinant Vaccine Ad5-nCoV Against Novel Coronavirus Infection in Adult Volunteers

    ctiprofile
  16. An Open-label Clinical Trial Phase IIB to Evaluate the Immunogenicity and Safety of Recombinant Novel Coronavirus Vaccine in Participants Aged 18 Years and Above That Previously Received One Dose of Sputnik V

    ctiprofile
  17. Phase IIb Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV) in Adults 18 Years of Age and Older, Living With HIV, on Stable Treatment, and Virologically Suppressed for at Least 6 Months

    ctiprofile
  18. A Randomized, Double-blind, Placebo -Controlled Phase IIb Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-nCoV in Person 6 Years of Age and Older and Those Who Have Previously Been Vaccinated With Ad5-EBOV

    ctiprofile
  19. 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

    ctiprofile
  20. A Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Adenovirus 5 Vectored COVID-19 Vaccine (Ad5-nCoV) With Two Doses in Healthy Adults Aged 18 Years and Older

    ctiprofile
  21. A Single-center,Open-label Dose-escalating Phase I Clinical Trial to Evaluate Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Healthy Adults Aged 18-60 Years Old

    ctiprofile
  22. CanSinoBIO's Investigational Vaccine Against COVID-19 Approved for Phase 1 Clinical Trial in China.

    Media Release
  23. Immunogenicity and Safety of the Heterologous Prime-boost Immunization With an Aerosolised Adenovirus Type-5 Vector-based COVID-19 Vaccine (Ad5-nCoV) After Two-dose Priming With an Inactivated SARS-CoV-2 Vaccine in Adults at 18 Years of Age or Above: a Randomised, Open-label, Parallel-controlled Clinical Trial

    ctiprofile
  24. CanSinoBIO Receives European GMP Certification for its COVID-19 Vaccine Convidecia(Tm).

    Media Release
  25. A Randomized, Double-blind, Placebo-Controlled Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-nCoV for Inhalation in Adults 18 Years of Age and Older

    ctiprofile
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