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: www.pactr.org
Trial no.: PACTR202203469339247 Date of Approval: 25/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A randomized study, assessing the safety and immunogenicity of a COVID-19 vaccine in healthy adults
Official scientific title A Randomized, Observer-Blind, Dose-Escalation, Placebo-Controlled Phase 1 Clinical Trial of COVAC-1 in Generally Healthy Adults
Brief summary describing the background and objectives of the trial VIDO has developed a vaccine called COVAC-1. The study vaccine contains a portion of the SARS-CoV-2 spike protein, called S1. Spike proteins are typically club-shaped in shape and project from the surface of the virus. The spike protein is the part of the virus that attaches to the surface of host cells, which are normal cells in your body which have certain molecules or chemicals that promote attachment. COVAC-1 contains an adjuvant [ad-joo-van-t] called TriAdj. An adjuvant is a compound that is added to a vaccine to help the vaccine produce a better immune response. These three components working together improve the body’s response to the S1 protein. The vaccine is expected to stimulate the body to make antibodies (which are proteins that circulate in the blood and recognize foreign substances like viruses and neutralize them) against the S1 protein. The antibodies will recognize the viral spike protein if the body is exposed to the virus and prevent or reduce the severity of COVID-19 illness. In animal studies, the immune response generated by the COVAC-1 vaccine was able to protect the vaccinated animals against a severe SARS-CoV-2 infection. This research study is being done to assess the safety and ability of the investigational COVAC 1 vaccine to generate an immune response against SARS-CoV-2.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied COVID -19,Infections and Infestations,Respiratory
Sub-Disease(s) or condition(s) being studied COVID -19
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 04/04/2022
Actual trial start date 14/04/2022
Anticipated date of last follow up 22/03/2023
Actual Last follow-up date 15/08/2023
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Kenya Pharmacy and Poisons Board
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group PLACEBO 0.9% sodium chloride for injection 2 doses (750 µL) – 2nd dose after 4 weeks from first dose after 4 weeks from first dose Placebo: non-active comparator 16 Placebo
Experimental Group COVAC 25 µg or 50 µg S1 Immunogen in TriAdj adjuvant/PBS solution 2 doses (750 µL) – 2nd dose after 4 weeks from first dose 2 doses (750 µL) – 2nd dose after 4 weeks from first dose Experimental vaccine 32
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Generally healthy male and female adults aged 18 years of age or older at the time of signing the informed consent form (i.e., 18 to 54 for Arm 1a and ≥55 for Arm 1b); 2. Good general health as determined by screening evaluation no greater than 30 days before injection of first dose; Note: Participants who are overtly healthy as determined by medical evaluation or are considered medically stable according to the judgment of the Investigator. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to enrolment, and/or hospitalization within the entire study period is not anticipated. Also, the participant appears likely to be able to remain in follow-up through the end of protocol-specified period. Mild to moderate well-controlled comorbidities are allowed. 3. If female of child-bearing potential and heterosexually active, practice of adequate contraception for 30 days prior to injection, negative pregnancy test on the day of injection, and agreement to continue adequate contraception until 180 days after the second injection 4.Written informed consent, after review of the consent form and having adequate opportunity to discuss the study with an Investigator or a qualified designee 1. Presence of any febrile illness or any known or suspected acute illness on the day of any immunization; 2. Any immunodeficiency (congenital or acquired) disease, disorder, or finding that may significantly increase the risk of study participant or, in the Investigator’s judgment, make the participant inappropriate for the study; 3. Clinically significant bleeding disorder (e.g., clotting factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture; 4. Receiving systemic immunosuppressive therapy or history of receiving chemotherapy in last 5 years other than topical agents; 5. Receipt of systemic glucocorticoids (a dose ≥ 20 mg/day prednisone or equivalent for 14 days) within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months prior to injection of first dose; 6. Cancer diagnosis in the last 5 years, excluding basal cell and squamous cell carcinoma of the skin, which are allowed; 7. Presence of autoimmune disease; 8. Receipt of any investigational drug within 6 months; 9. Receipt of any non-COVID-19 authorized vaccines within 2 weeks of receiving study dose injection; 10. Receipt of any authorized COVID-19 vaccine prior to study enrollment; 11. Receipt of any other experimental SARS-CoV-2/COVID-19 or other experimental coronavirus vaccine(s) at any time prior to or during the study; 12. Receipt of blood products or immunoglobulin (IVIg or IMIg) within 3 months of study entry/baseline serologic evaluation; Adult: 19 Year-44 Year 18 Year(s) 54 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 04/04/2022 Kenyatta National Hospital University of Nairobi Ethics Research Committee
Ethics Committee Address
Street address City Postal code Country
Kenyatta National Hospital Road Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Occurrence of adverse events (AEs) from the first injection to Day 28, in all participants, in all groups: o The occurrence of each solicited local and general AE, during each 7-day follow-up period after injection (e.g., the day of injection and 6 subsequent days). o The occurrence of any unsolicited AEs for the entire study period. o The occurrence of any hematological (hemoglobin level, WBC, lymphocyte, neutrophil, eosinophil, and platelet count) and biochemical (ALT, AST, BUN, and Cr) clinically significant laboratory abnormality through to Day 28 and; o The occurrence of any serious AEs (SAEs) medically attended events (MAE), or adverse event of special interest (AESI) through to Day 365. • Occurrence of AEs from the second injection to Day 56 (28 days post injection), in all participants, in all groups: o The occurrence of solicited local and general AE, during each 7-day follow-up period after the second injection (e.g., the day of 2nd injection and 6 subsequent days); o The occurrence of any unsolicited AEs for the entire study period and; o The occurrence of any hematological (hemoglobin level, WBC, lymphocyte, neutrophil, eosinophil, and platelet count) and biochemical (ALT, AST, BUN, and Cr) clinically significant laboratory abnormality through to Day 42 first injection to Day 28
Secondary Outcome The immune response to the study vaccine, as measured by antibody (e.g., IgG and other isotypes) directed to Wuhan spike antigen or neutralizing antibodies preinjection (Day 0) and post-injection(s) (Days 14, 28, 35, 42, 56, 90, 120, and 365); • The immune response to the study vaccine, as measured by cell immune response markers in PBMCs collected pre-injection (Day 0) and post-injection (Days 14, 28, 35, 42, 120 and 365). pre-injection and post-injection
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenya AIDS Vaccine Initiative Institute of Clinical Research university of Nairobi Road Nairobi 00202 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Vaccine and Infectious Disease Organization 120 Veterinary Road Saskatoon 120 Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Saskatchewan Vaccine and Infectious Disease Organization Veterinary Road Saskatoon 120 Canada University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omu Anzala OAnzala@kaviuon.org +254727555279 University of Nairobi Road
City Postal code Country Position/Affiliation
Nairobi 0020 Kenya Kenya AIDS Vaccine Initiative Institute of Clinical Research
Role Name Email Phone Street address
Public Enquiries Valerie Awuondo vawuondo@kaviuon.org +254701671991 University of Nairobi Road
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Kenya AIDS Vaccine Initiative Institute of Clinical Research
Role Name Email Phone Street address
Scientific Enquiries Michael Mutua mmutua@kaviuon.org +254724653138 University of Nairobi Road
City Postal code Country Position/Affiliation
Nairobi Kenya Kenya AIDS Vaccine Initiative Institute of Clinical Research
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Your study records will be identified by a unique study number. This number will not include any personal information that could identify you (i.e. it will not include your name, Personal Health Number, Social Insurance Number, or initials, etc.). The number will be used on any research-related information and samples that go outside the study site. The list that matches your name to the unique study number that is used on research-related information is kept at the study site securely and will not be removed and/or released without your consent, unless required by law. Your study records, including confidential information collected during the study, will be kept in a secure location for at least 15 years. Study information, your study code, and samples collected as part of this study will be included in secure electronic trial systems. These systems may be managed and monitored by companies who work with VIDO. No information that discloses your identity will be released or published without your specific consent. Rarely, your study documents may be obtained by courts of law. Unless required by law, your name will not be disclosed outside the research clinic. Your name will be available only to the following people or agencies: the study doctor and staff; and authorized representatives of the study doctor; the Kenyatta National Hospital – University of Nairobi Ethics and Research Committee (KNH/UoN ERC), the Pharmacy and Poisons Board (PPB), VIDO-authorized representatives; and authorized Clinical Research Organization representatives. The above-mentioned individuals as well as some authorities will use the personal information collected as part of this study, which may include your medical records so as to check that the study is conducted correctly and to ensure your study and medical record information is correct. These people are all obligated to maintain confidentiality by the nature of their work, or are bound by confidentiality agreements. Your study Clinical Study Report,Informed Consent Form,Study Protocol Your study records, including confidential information collected during the study, will be kept in a secure location for at least 15 years No information that discloses your identity will be released or published without your specific consent. Unless required by law, your name will not be disclosed outside the research clinic If you decide to withdraw from this study, your study and medical records will be made available to these agencies. However, they will only look at your records up to the date of your withdrawal, except where the reporting of side effects associated with the vaccine is required
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