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.: PACTR202103845381761 Date of Approval: 04/03/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A global Phase III clinical trial of recombinant COVID-19 vaccine (Sf9 cells) in adults aged 18 years and older
Official scientific title A global multicenter, randomised, double-blind, placebo-controlled, phase III clinical trial to evaluate the efficacy, safety, and immunogenicity of recombinant COVID-19 vaccine (Sf9 cells), for the prevention of COVID-19 in adults aged 18 years and older.
Brief summary describing the background and objectives of the trial The Coronavirus Disease 2019 (COVID-19) is caused by the infection of the 2019 novel coronavirus (SARS-CoV-2) started in January 2020. World Health Organization (WHO) declared COVID-19 a worldwide pandemic on March 12, 2020. As of Oct.20, 2020, there are over 42 million cases worldwide and over 1 million deaths in 185 countries/regions . As of July 27, 2020, there are over 16,114,449 cases worldwide and over 646,641 deaths in 185 countries/regions. The COVID-19 pandemic has brought heavy economic pressure, medical burden, and severe harm to people's lives and health. This Phase III study is a global multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety, and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in 40,000 participants aged 18 years and older who do not have known history of SARS-CoV-2 infection but whose locations or circumstances put them at appreciable risk of acquiring COVID-19 or SARS-CoV-2 infection. All participants will receive three doses of either study vaccine or placebo on Day 0, Day 21, Day 42 in a ratio of 1:1.
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 Coronavirus disease COVID-19
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/04/2021
Actual trial start date
Anticipated date of last follow up 31/08/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 40000
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Parallel: different groups receive different interventions at same time 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
Experimental Group Recombinant COVID19 Vaccine Sf9 cells 0.5mL after every 21 days 42 days Recombinant COVID-19 Vaccine (Sf9 cells) 20000
Control Group Placebo for Recombinant COVID19 vaccine Sf9 cells 0.5mL after every 21 days 42 days Placebo for Recombinant COVID-19 vaccine (Sf9 cells) 20000 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Aged 18 years and older. 2. Able and willing (in the investigator’s opinion) to comply with all study requirements. 3. Willing to allow the investigators to discuss the volunteer’s medical history with their general practitioner/personal doctor and access all medical records which are relevant to study procedures. 4. Healthy adults, or stable-healthy adults who may have a pre-existing medical condition that does not meet any exclusion criteria. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment. 5. For females of childbearing potential only, willingness to practice continuous effective contraception (see glossary) for 90 days after completion of 3 doses vaccination during the study, and have a negative pregnancy tests before each dose vaccination. Note:nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to Screening without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm postmenopausal status. 6. Males participating in this study who are involved in heterosexual sexual activity must agree to practice adequate contraception (see glossary) and refrain from donating sperm for 90 days after receiving the study vaccination. 7. Agreement to refrain from blood donation during the study. 8. Provide written informed consent form (ICF). 1. Participation in any other COVID-19 prophylactic drug trials during the duration of the study. Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalization due to COVID-19. The study team should be informed as soon as possible. 2. Positive HIV antibody testing results. 3. Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus during the duration of the study. Note: Disclosure of serostatus post enrolment may accidentally unblind participants to group allocation. Participation in this trial can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys 4. Planned receipt of any licensed or investigational vaccine, other than the study intervention, within 14 days before and after study vaccination 5. Prior receipt of an investigational or licensed COVID-19 vaccine. 6. Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the investigational products (IPs). 7. Any confirmed or suspected immunosuppressive or immunodeficient state; positive HIV status; asplenia; recurrent severe infections and chronic use (more than 14 days) of immunosuppressant medication within the past 6 months. Topical steroids or short-term (course lasting ≤14 days) oral steroids are not an exclusion criteria. 8. History of allergic disease or reactions likely to be exacerbated by any component of Recombinant COVID-19 vaccine (Sf9 cells) 9. Any history of angioedema 10. Pregnancy, lactation or willingness/intention to become pregnant within 90 days after receiving study vaccine 11. Current diagnosis or treatment of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) 12. History of serious psychiatric condition likely to affect participation in the study 13. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 08/03/2021 Kenyatta National Hospital University of Nairobi
Ethics Committee Address
Street address City Postal code Country
KNH, Ngong Road Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Efficacy of recombinant COVID-19 vaccine (Sf9 cells) in preventing virologically confirmed (PCR positive) symptomatic COVID-19 Weekly for 20 months
Primary Outcome Safety of recombinant COVID-19 vaccine (Sf9 cells) in terms of SAE, MAAE and AESI in all participants from Day 0 through 6 months after completion of 3 doses vaccination Weekly for 20 months
Secondary Outcome Efficacy of recombinant COVID-19 vaccine (Sf9 cells) in preventing virologically confirmed (PCR positive) symptomatic COVID-19 cases first occurring ﹥14 days after completion of 3 doses vaccination, regardless of severity. 14 days after the third dose
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KAVI Institute of Clinical Research University of Nairobi Ngong Road Nairobi Kenya
KEMRI Wellcome Trust Hospital Road Kilifi Kenya
AMPATH Moi University Teaching and Referral Hospital Eldoret Nandi Road Eldoret Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Chengdu WestVac Biopharm Co Ltd and West China Hospital of Sichuan University No. 17, Section 3, Renmin South Road, Chengdu, China 610041 Chengdu 610041 China
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Chengdu WestVac Biopharm Co Ltd Chengdu Tianfu International Biological City 618 Phoenix Road, Shuangliu District China 610219 Chengdu 610219 China Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Kenya AIDS Vaccine Initiative KAVI Ngong Road Nairobi Kenya
KEMRI Wellcome Trust Hospital Road Kilifi 80108 Kenya
Moi University Teaching and Referral Hospital and AMPATH Nandi Road Eldoret Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Walter Jaoko wjaoko@kaviuon.org +254727555254 Ngong Road
City Postal code Country Position/Affiliation
Nairobi Kenya Director KAVI Institute of Clinical Research University of Nairobi
Role Name Email Phone Street address
Public Enquiries Gilbert Kokwaro gkokwaro@strathmore.edu +254722323651 Ole Sangale Road Madaraka,
City Postal code Country Position/Affiliation
Nairobi Kenya Director Institute of Healthcare Management Strathmore University
Role Name Email Phone Street address
Scientific Enquiries Walter Jaoko wjaoko@kaviuon.org +254727555254 Ngong Road
City Postal code Country Position/Affiliation
Nairobi Kenya Director KAVI Institute of Clinical Research University of Nairobi
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data collected from this study, including de-identified individual participant data, will be made available upon publication to members of the scientific and medical community for non-commercial use only, upon email request to the corresponding author. Clinical Study Report,Study Protocol Within 12 months of study completion COVID 19 Vaccine
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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