Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202201773975686 Date of Registration: 28/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Randomized, Double-Blinded, Placebo-Controlled, Phase III, Clinical Trial of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in Adults Aged 18 Years and Above
Official scientific title A Randomized, Double-Blinded, Placebo-Controlled, Phase III, Clinical Trial of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in Adults Aged 18 Years and Above
Brief summary describing the background and objectives of the trial The COVID-19 pandemic caused by the SARS-CoV-2 has spread to more than 210 countries and regions around the world. Currently, there is no specific treatment for COVID-19. The number of new cases and deaths is increasing every day, and rapid development of effective vaccine against SARS-CoV-2 is urgently needed. Up till now, the primary endpoints set in phase Ia/IIa clinical trials for the SARS-CoV-2 Vaccine, Inactivated (Vero Cell) of IMBCAMS are met. The preliminary analysis showed that the vaccine has good safety and immunogenicity. An individually randomized, double-blinded, placebo-controlled Phase III clinical trial is planned with an aim to further determine the efficacy and safety of the vaccine in adults aged 18 years and above. The main objective of the study is to evaluate the efficacy, safety and immunogenicity of SARS CoV 2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above after 2-dose schedule.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied COVID-19
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 28/02/2022
Actual trial start date
Anticipated date of last follow up 31/08/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 5000
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL https://clinicaltrials.gov/ct2/show/NCT04659239?term=20200404&draw=2&rank=1
Secondary Ids Issuing authority/Trial register
20200404 Sponsor: Institute of Medical Biology Chinese Academy of Medical Sciences
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo Inoculate one dose of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) or placebo on Day 0 and Day 14, respectively, and a total of 2 doses will be inoculated. Phosphate buffer solution containing aluminum hydroxide adjuvant and glycine without SARS-CoV-2 antigen 2500 Placebo
Experimental Group SARS CoV 2 Vaccine Inactivated Vero Cell Inoculate one dose of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) or placebo on Day 0 and Day 14, respectively, and a total of 2 doses will be inoculated. SARS-CoV-2 Vaccine, Inactivated (Vero Cell) that developed by Institute of Medical Biology Chinese Academy of Medical Sciences is used as the investigational vaccine. Specification: 0.5 mL/vial (syringe), each dose of 0.5 mL for per person per time use containing the amount of antigen (S protein) 150 U. 2500
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adults aged 18 years and above (including boundary values), both female and male; 2. Legal identification of the participants shall be provided; 3. Participants shall understand the content in the Informed Consent Form (ICF) and the vaccine for administration, sign the ICF voluntarily and are capable of using thermometers and rulers, and filling in diary cards and contact cards as per the requirements; 4. Participants shall be able to communicate well with investigators, understand and comply with the requirements of this study; 5. Participants with oral temperature ≤37.9℃. 6. Female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [i.e., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive OR consistently use any of the following methods of contraception: a) Condoms (male or female) b) Diaphragm with spermicide c) Cervical cap with spermicide d) Intrauterine device e) Oral or patch contraceptives f) Any country regulatory-approved contraceptive method that is designed to protect against pregnancy g) Abstinence, as a form of contraception, is acceptable if in line with the participant’s lifestyle (other approaches to abstinence are not acceptable) 1. Contraindications to commonly used vaccines 2. Known or suspected allergy history of vaccine or any of its components; 3. Received any vaccine within 1 month before enrollment, or received any SARS CoV-2 vaccine, SARS vaccine or Middle East respiratory syndrome (MERS) vaccine at any time before enrollment; 4. Serious diseases required to be excluded, including but not limited to pre-existing diseases in uncontrolled nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other systems, and a history of malignant tumors (uncontrolled disease refers to the change of treatment or hospitalization due to the deterioration of the disease in the past 3 months before enrollment); 5. Before enrollment, those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days; 6. Those who have a hereditary bleeding tendency or blood coagulation dysfunction, or a history of thrombosis or hemorrhagic disease; 7. Surgical removal of whole or part of spleen for any reason; 8. Those who have undergone surgery within 3 months before enrollment or those who are planning to undergo surgery throughout the study (including plastic surgery, dental and oral surgery); 9. Those who donated or lost blood (≥400 mL) or received blood transfusion or used of blood products, in the past 3 months before enrollment or who are planning to donate blood throughout the study; 10. Those who received other investigational or unregistered products (drugs, vaccines, biological product or devices) in the past 3 months before enrollment, or who are planning to participate in any other clinical trials throughout the study. 11. Those who received immunosuppressant therapy within 6 months before enrollment, such as long-term systemic glucocorticoid treatment (with systemic glucocorticoid therapy for more than 2 consecutive weeks within 6 months 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 27/01/2022 Dodowa Health Research Center
Ethics Committee Address
Street address City Postal code Country
Dodowa Health Research Centre, P.O. Box DD1, Dodowa Dodowa 00233 Ghana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 27/01/2022 Navrongo Health Research Center
Ethics Committee Address
Street address City Postal code Country
Navrongo Health Research Centre, P.O BOX 114, Navrongo U/E Region, Ghana Navrongo 00233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome - To evaluate the efficacy of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) against symptomatic and laboratory-confirmed (RT-PCR method) COVID-19 cases. - To evaluate the solicited adverse events (AE) within 7 days after each dose. 14 days
Secondary Outcome 1. To evaluate the efficacy of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) after at least one dose of immunization. 2.To evaluate the efficacy of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) against symptomatic and laboratory-confirmed (RT PCR method) severe COVID-19 cases. 3. To evaluate the efficacy of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) for symptomatic and laboratory-confirmed (RT-PCR method) COVID-19 cases caused by different SARS-CoV-2 variants. 4. To evaluate the levels of neutralizing antibody and IgG antibody against SARS-CoV-2 14 days after the whole-course immunization. 5.To demonstrate the consistency of 3 lots of investigational vaccine in terms of GMT on 14 days after the whole-course immunization. 6. To evaluate the immune persistence of the investigational vaccine.7. To evaluate AEs from the first dose to Day 28 after the whole-course immunization and SAEs from the first dose to at least 12 months after the whole-course immunization. 8. ADE/VED that may occur after vaccination. 14 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dodowa Health Research Centre Dodowa Health Research Centre, P.O. Box DD1, Dodowa Dodowa Ghana
Navrongo Health Research Center Navrongo Health Research Centre, P.O BOX 114, Navrongo U/E Region, Ghana Navrongo Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Institute of Medical Biology Chinese Academy of Medical Sciences 935 Jiaoling Road, Kunming, Yunnan Yunnan China
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Institute of Medical Biology Chinese Academy of Medical Sciences 935 Jiaoling Road, Kunming, Yunnan Yunnan China Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
PDC FZ LLC Dubai Science Park Laboratory Complex Office SD21272nd Floor PO Box 500767 Dubai United Arab Emirates Dubai United Arab Emirates
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alberta Amu alberta.amu@gmail.com +233244274807 Dodowa Health Research Centre, P.O. Box DD1, Dodowa
City Postal code Country Position/Affiliation
Dodowa Ghana Principal Investigator at Dodowa Health Research Centre
Role Name Email Phone Street address
Public Enquiries Alberta Amu alberta.amu@gmail.com +233244274807 Dodowa Health Research Centre, P.O. Box DD1, Dodowa
City Postal code Country Position/Affiliation
Dodowa Ghana Principal Investigator at Dodowa Health Research Centre
Role Name Email Phone Street address
Scientific Enquiries Alberta Amu alberta.amu@gmail.com +233244274807 Dodowa Health Research Centre, P.O. Box DD1, Dodowa
City Postal code Country Position/Affiliation
Dodowa Ghana Principal Investigator at Dodowa Health Research Centre
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All information relating to the identity of the participants shall be kept confidential and their names will not appear in any published materials or reports of this trial. The original raw materials obtained in this study are only used for publication in academic communication forms such as papers and conference reports related to the project. Clinical Study Report,Informed Consent Form,Study Protocol Kindly note as per the below link, IPD sharing statement is not provided yet. Study team, sponsor and all concerned regulatory authorities.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://clinicaltrials.gov/ct2/show/record/NCT04659239?term=20200404&draw=2&rank=1 No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information