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.: PACTR202210848418417 Date of Registration: 24/10/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Safety and Immunogenicity of COVID-19 Vaccine, AdCLD-CoV19-1
Official scientific 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
Brief summary describing the background and objectives of the trial This is a Phase IIb, multicenter, randomized, observer-blinded, placebo-controlled trial in healthy adults aged 19 years and above. In this study, a dose regimen of AdCLD-CoV19-1 will be selected between 1 or 2 doses based on safety and immunogenicity. A total of 200 participants will be enrolled for dose selection. The participants will be randomly allocated to 3 groups. Group l, 2 doses AdCLD-CoV19-1 at 2-months interval (N=80), group 2) AdCLD-CoV19-1 as a first dose and placebo as a second dose at 2-months interval (N=80), group 3) Placebo as a first dose and AdCLD-CoV19-1 as a second dose at 2-months interval (N=40). Each participant will be part of the study for approximately 14 months.
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 COVID19
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 21/11/2022
Actual trial start date 21/11/2022
Anticipated date of last follow up 21/03/2024
Actual Last follow-up date 21/03/2024
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
NCT05520970 Clinicaltrials.gov
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 Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group AdCLD.CoV19.1 0.5mL / each vaccination. Total 2 times Investigational Product vaccination at 2 month interval. IM administration in the deltoid muscle 80
Control Group AdCLD.CoV19.1 and Normal Saline 0.5mL / each vaccination 1 time for Investigational product vaccination and 1 time for placebo at 2 month interval. IM administration in the deltoid region 120 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Healthy individual aged 19 years and above at consentconsent. 2. Individual willing to provide written informed consent to participate study voluntarily. 3. Individuals who can be followed up during the study period and can comply with the study requirements. 4. Individual who agrees not to donate blood during the study participation 5. Females of childbearing potential with negative serum or urinary pregnancy test on the day of screening. 6. Females of childbearing potential who are using an effective birth control method* for at least 4 weeks before the screening and during the study participation. 1.Prior SARS-CoV-2 infection confirmed by a rapid antibody kit at screening. 2. History of receiving any vaccine (licensed or investigational) for SARS-CoV-2. 3. History of SARS-CoV-1 or MERS vaccination and treatment. 4.Individual determined to be clinically significantly abnormal by the screening outcome based on medical history, physical examination, laboratory evaluations (negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, and Human Immunodeficiency Virus (HIV) antibody), electrocardiogram (ECG) and Chest X-ray, and the clinical judgment of the investigator. 5. Individual who has received other vaccines from 4 weeks prior to the first dose of test vaccination or planned to receive any vaccine within 4 weeks of the last dose of the study vaccine. 6. Febrile illness (tympanic temperature ≥ 38°C) or acute illness with any clinically significant,, respiratory symptoms (e.g., sore throat, cough, sputum) within 3 days prior to the study vaccination. 7. Known history or allergy to study vaccine components and/or excipients or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial (e.g., Guillain-Barre Syndrome). 8. Individual with major congenital abnormalities, which in the opinion of investigator may affect the participant’s participation in the study. 9. Chronic use of systemic steroids (>10 mg/day prednisone equivalent for periods exceeding 14 days), cytotoxic or other immunosuppressive drugs within the past 6 weeks. 10. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental to the safety of the participant and interfere with the assessment of the study objectives. 11. Individual with hereditary or idiopathic angioneurotic edema 12. Individual concomitantly enrolled or scheduled to be enrolled in another trial. 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) 99 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
Yes 06/10/2022 Kenya Medical Research Institute
Ethics Committee Address
Street address City Postal code Country
00200 Off Raila Odinga Way. Kenya. Nairobi 230-80108 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/07/2022 Ifakara Health Institute
Ethics Committee Address
Street address City Postal code Country
Kiko Avanue, Plot 463 Mikocheni Dar es Salaam 78373 Tanzania
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 02/09/2022 Mbeya Medical Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Hospital Hill Road Mbeya 2410 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome • Proportion of participants achieving seroresponse (SR defined as at least 4-fold increase from baseline) of wild-type virus neutralizing antibody titer 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 • GMT of SARS-CoV-2 Spike-binding ELISA 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 • GMFR of SARS-CoV-2 Spike-binding ELISA 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 Immunogenicity time points: Day 0, 14, 28, 70, Months 3, 5, 6, 8, 14
Primary Outcome For safety • • Proportion of immediate adverse events (AE) within 30 minutes (2 hours for ≥75 years old) post each dose injection • Proportion of solicited local and systemic adverse events within 7 days post each dose injection • Proportion of unsolicited adverse events within 28 days post each dose injection • Proportion of any SAE/AESI/MAAEs from the vaccination throughout the entire study • Proportion of clinically significant changes in clinical safety laboratory parameters at 1, 2 and 4 weeks post each dose injection For Immunogenicity •Geometric Mean Titer (GMT) of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assay 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. • Geometric Mean Fold Rise (GMFR) of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assay 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 For Safety: Day 0,7,14, 28, 56,63,70, Months 3,5,6,8,14 For Immunogenicity: Day 0,14, 28, 70
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ifakara Health Institute Kiko Avanue, Plot 463 Mikocheni, Dar es Salaam 78 373 Tanzania
NIMR MBEYA MEDICAL RESEARCH CENTER Hospital Hill RD Mbeya 2410 Tanzania
Kenya Medical Research Institute Walter Reed Project Kericho Hospital Road Kericho 1357-2020 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Korea Drug Development Fund 9F, 137 Mapo-daero, Mapo-gu, Seoul, Korea Seoul 04143 Korea, Republic of
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cellid 1, Gwanak-ro, Gwanak-gu,, Seoul 08826 Korea, Republic of Commercial Sector/Industry
Secondary Sponsor International Vaccine Institute 1, Gwanak-ro, Bwanak-Gu Seoul 08826 Korea, Republic of International Organization
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fredrick Sawe fredrick.sawe@usamru-k.org +25452203600010 Hospital Road
City Postal code Country Position/Affiliation
Kericho 1357-2020 Kenya Doctor
Role Name Email Phone Street address
Public Enquiries Katerina Rok Song katerina.song@ivi.int +82028811228 1, Gwanak-rp, Gwanak-gu
City Postal code Country Position/Affiliation
Seoul 08826 Korea, Republic of Study Project Lead
Role Name Email Phone Street address
Scientific Enquiries Rita Baiden rita.baiden@ivi.int +233246905292 3 Spindle Avenue
City Postal code Country Position/Affiliation
Tema n/a Ghana Study Medical Monitor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will not be available. At the end of the study, the study result summary or its publication will be available within 12 months of the study completion date. Study Protocol 18 months Not applicable as IPD will not be available. The study results will be publicly available.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
NA 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