Pharmacy and Poisons Board: Applications

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Protocol No:

ECCT/22/10/04

Date of Protocol:

01-07-2022

Study Title:	A Phase IIb Multicenter, Observer-Blinded, Randomized, Placebo-Controlled Trial to Evaluate the Immunogenicity and Safety of the AdCLD-CoV19-1 in Healthy Adults aged 19 years old and above.
Study Objectives:	Primary Objectives i. To evaluate the safety of 2 doses of AdCLD-CoV19-1 at 2-month interval and 1 dose of AdCLDCoV19-1, in SARS-CoV-2 seronegative adults. ii. To evaluate and compare the immune responses as measured by wild-type virus neutralizing antibodies from baseline to 2 weeks post second dose injection, induced by 2 doses of AdCLDCoV19-1 at 2-month interval and by 1 dose of AdCLD-CoV19-1 followed by 1 dose of placebo at 2-month interval in SARS-CoV-2 seronegative adults. iii.To evaluate and compare the immune responses as measured by spike-binding IgG antibody from baseline to 2 weeks post second dose injection, induced by 2 doses of AdCLD-CoV19-1 at 2-month interval and by 1 dose of AdCLD-CoV19-1 followed by 1 dose of placebo at 2-month interval in SARS-CoV-2 seronegative adults. Secondary Objectives i. To evaluate the immune responses as measured by wild-type virus neutralizing antibodies from baseline to 1, 3 and 6 months post first dose injection, and 1, 3, 6 and 12 months post second dose injection, induced by 1 and 2 doses of AdCLD-CoV19-1 respectively in SARS-CoV-2 seronegative adults. ii. To evaluate the immune responses as measured by spike-binding IgG antibody from baseline to 2 weeks, and 1, 3 and 6 months post first dose injection, and 1, 3, 6 and 12 months post second dose injection induced by 1 and 2 doses of AdCLD-CoV19-1 respectively in SARS-CoV-2 seronegative adults. iii. To evaluate the Cell Mediated Immunity (CMI) as measured by Interferon-γ (IFN-γ) ELISpot from baseline to 2 weeks, 6 months post first dose injection and 2 weeks, 6 and 12 months post second dose injection induced by 1 and 2 doses of AdCLD-CoV19-1 respectively in SARS-CoV-2 seronegative adults.
Laymans Summary:	A cluster of pneumonia patients with pneumonia of unknown cause emerged in a seafood wholesale market in Wuhan, Hubei province, China, in December 2019 [4]. Soon after, the number of cases soared dramatically, spreading across China and worldwide. The etiologic agent was recognized as a previously unreported β-coronavirus. The World Health Organization (WHO) named the virus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the disease it causes coronavirus disease 2019 (COVID-19) ], declared the outbreak a Public Health Emergency of International Concern (PHEIC) on 30 January 2020, and announced pandemic on 11 March 2021 . Cough, fever, and dyspnea are symptoms of patients suffering from COVID-19. Severe acute respiratory distress, pneumonia, renal failure, and death are associated with severe forms of the infection. As of 6 November 2021, SARS-CoV-2 had infected more than 24,467,363 people worldwide contributing to more than 5,027,183 deaths. A lot of effort has been made to develop effective vaccines in a short timeframe. WHO has approved vaccines developed by Pfizer-BioNTech, Johnson & Johnson, Moderna, Sinopharm, Oxford-AstraZeneca, Serum Institute of India, and Sinovac for emergency use, for their emergency use. WHO has lately issued an emergency use listing (EUL) for eighth COVID-19 vaccine, Covaxin by Bharat Biotech . The purpose of developing AdCLD-CoV19-1 is to provide a wide coverage against COVID-19. AdCLDCoV19-1 contains a recombinant gene of SARS-CoV-2 Spike (S) protein inserted into a replication deficient adenovirus type 5/35 (Ad5/35) as a vector and can be stored at regular refrigerator temperatures (2-8 â„ƒ), increasing accessibility to the vaccine in those countries where the cold chain for very low temperature storage is challenging. The aim of this study Phase IIb Multicenter, Observer-Blinded, Randomized, Placebo-Controlled Trial in 200 healthy adults aged 19 years old and above is to assess the safety and immune responses to AdCLD-CoV19-1 for the prevention of COVID-19 and determine the dose regimen for the Phase III trial. A cluster of pneumonia patients with pneumonia of unknown cause emerged in a seafood wholesale market in Wuhan, Hubei province, China, in December 2019 [4]. Soon after, the number of cases soared dramatically, spreading across China and worldwide. The etiologic agent was recognized as a previously unreported β-coronavirus. The World Health Organization (WHO) named the virus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the disease it causes coronavirus disease 2019 (COVID-19) ], declared the outbreak a Public Health Emergency of International Concern (PHEIC) on 30 January 2020, and announced pandemic on 11 March 2021 . Cough, fever, and dyspnea are symptoms of patients suffering from COVID-19. Severe acute respiratory distress, pneumonia, renal failure, and death are associated with severe forms of the infection. As of 6 November 2021, SARS-CoV-2 had infected more than 24,467,363 people worldwide contributing to more than 5,027,183 deaths. A lot of effort has been made to develop effective vaccines in a short timeframe. WHO has approved vaccines developed by Pfizer-BioNTech, Johnson & Johnson, Moderna, Sinopharm, Oxford-AstraZeneca, Serum Institute of India, and Sinovac for emergency use, for their emergency use. WHO has lately issued an emergency use listing (EUL) for eighth COVID-19 vaccine, Covaxin by Bharat Biotech . The purpose of developing AdCLD-CoV19-1 is to provide a wide coverage against COVID-19. AdCLDCoV19-1 contains a recombinant gene of SARS-CoV-2 Spike (S) protein inserted into a replication deficient adenovirus type 5/35 (Ad5/35) as a vector and can be stored at regular refrigerator temperatures (2-8 â„ƒ), increasing accessibility to the vaccine in those countries where the cold chain for very low temperature storage is challenging. The aim of this study Phase IIb Multicenter, Observer-Blinded, Randomized, Placebo-Controlled Trial in 200 healthy adults aged 19 years old and above is to assess the safety and immune responses to AdCLD-CoV19-1 for the prevention of COVID-19 and determine the dose regimen for the Phase III trial.
Abstract of Study:	A cluster of patients with pneumonia of unknown cause emerged in a seafood wholesale market in Wuhan, Hubei province, China, in December 2019. Soon after, the number of cases soared dramatically, spreading across China and worldwide. The etiologic agent was recognized as a previously unreported β-coronavirus. The World Health Organization (WHO) named the virus severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and the disease it causes coronavirus disease 2019 (COVID-19), declared the outbreak a Public Health Emergency of International Concern (PHEIC) on 30 January 2020 and announced pandemic on 11 March 2021. Cough, fever, and dyspnea are some of the symptoms patients suffering from COVID-19 have. Severe acute respiratory distress, pneumonia, renal failure and death are associated with severe forms of the infection. As of 6 November 2021, SARS-CoV-2 has affected more than 24,467,363 people worldwide contributing to more than 5,027,183 deaths. A lot of effort has been made to develop effective vaccines in a short timeframe. WHO has approved vaccines developed by Pfizer-BioNTech, Johnson & Johnson, Moderna, Sinopharm, Oxford-AstraZeneca, Serum Institute of India and Sinovac for their emergency use. WHO has lately issued an emergency use listing (EUL) for the eighth COVID-19 vaccine; Covaxin by Bharat Biotech. As of 5 November 2021, 129 vaccines are in clinical development and 194 vaccines are in pre-clinical development. 35% of the vaccines in the clinical phase are protein subunits followed by 14% of viral vector (nonreplicating) vaccine, nucleic acid vaccines, inactivated vaccines, viral vector (replicating) vaccine, etc. Currently, the most widely used vaccines are Oxford-AstraZeneca vaccine (181 countries, viral vector vaccine), followed by Pfizer-BioNTech (146 countries, mRNA vaccine), Sinopharm (80 countries, Inactivated vaccine), Moderna (79 countries, mRNA vaccine), Johnson & Johnson (68 countries, viral vector vaccine (as of November 2021). With advances in biotechnology, vaccines based on new platform are being developed, including DNA vaccines, mRNA vaccines, and virus vector vaccines. DNA vaccines and mRNA vaccines have the advantage of being easy to manipulate and develop with speed, and based on these advantages, various DNA and mRNA-based vaccines have been developed as COVID-19 prevention vaccines and have entered clinical trials. The purpose of developing AdCLD-CoV19-1 is to provide a wide coverage against COVID-19. AdCLDCoV19-1 contains a recombinant gene of SARS-CoV-2 Spike (S) protein inserted into a replication deficient adenovirus type 5/35 (Ad5/35) as a vector, and can be stored at regular refrigerator temperatures (2-8 â„ƒ), increasing accessibility to the vaccine in those countries where the cold chain for very low temperature storage is challenging. This Phase IIb Multicenter, Observer-Blinded, Randomized, Placebo-Controlled Trial in 200 healthy adults aged 19 years old and above study is to assess the safety and immunogenicity of AdCLD-CoV19-1 for the prevention of COVID-19 and determine the dose regimen for the Phase III trial. The immunogenicity and safety profiles of AdCLD-CoV19-1 (5.0×10¹⁰ VP/dose) will be assessed for 1-dose or 2-dose regimen in SARS-CoV-2 seronegative healthy adults.