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.: PACTR202107562417077 Date of Approval: 28/07/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Adults Aged 18 Years and Older
Official scientific title A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Adults Aged 18 Years and Older
Brief summary describing the background and objectives of the trial Primary Objectives: Efficacy: To evaluate the efficacy of the recombinant SARS-CoV-2 fusion protein vaccine (V-01) for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above severity) starting from at least 14 days (≥15 days) after full-course immunization (completing all vaccinations); Safety:  To evaluate the incidence of adverse events (AEs) of recombinant SARS-CoV-2 fusion protein vaccine (V-01) from the first vaccination to 28 days after full-course immunization; Secondary Objectives: Efficacy: 1. To evaluate the efficacy of the recombinant SARS-CoV-2 fusion protein vaccine (V-01) for the prevention of COVID-19 of severe or above severity starting from at least 14 days 15 days) after full-course immunization;  Definition of COVID-19 of severe or above severity (meeting any one of the following): 1) Tachypnea, respiratory rate ≥ 30 breaths/min; 2) Oxygen saturation [SpO2]≤93% at rest; 3) Arterial partial pressure of oxygen/fraction of inspired oxygen [PaO2/FiO2]≤300mmHg (in the areas with altitude over 1000 meters, PaO2/FiO2 should be corrected according to the following formula: PaO2/FiO2×[760/atmospheric pressure (mmHg)]); 4) Progressive worsening of clinical symptoms; chest imaging showing significant lesion progression > 50% within 24 to 48 hours (if any); 5) Respiratory failure and requiring mechanical ventilation; 6) Shock; 7) With other organ failure that requires intensive care unit (ICU) care. 2. To evaluate the efficacy of the recombinant SARS-CoV-2 fusion protein vaccine (V-01) for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above severity) starting from at least 14 days 15 days) after the first vaccination; 3. To evaluate the efficacy of the recombinant SARS-CoV-2 fusion protein vaccine (V-01) for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above severity) starting from at least 14 days 15 days) after full-course immunization in different age groups; 4. To evaluate the morbidity of suspected but not confirmed COVID-19 (negative or not detected); 5. To evaluate the mortality caused by COVID-19; 6. To evaluate the hospitalization rate caused by COVID-19; Safety: 1. To evaluate the incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) occurred from the first dose of recombinant SARS-CoV-2 fusion protein vaccine (V-01) to 12 months after full-course immunization; Immunogenicity (immunology subgroup only): 1. To evaluate the seroconversion rate of serum SARS-CoV-2 RBD protein-binding antibody, geometric mean titer (GMT) and geometric mean increase (GMI) at day 28, month 3, month 6, and month 12 after full-course immunization (enzyme-linked immunosorbent assay [ELISA]); 2. To evaluate the seroconversion rate of serum anti-SARS-CoV-2 neutralizing antibody, GMT and GMI at day 28, month 3, month 6, and month 12 after full-course immunization (live virus neutralization assay); Exploratory objectives: 1. To evaluate the severity of COVID-19 of participants in the vaccine group versus the control group, so as to evaluate the vaccine-mediated antibody-dependent enhancement (ADE); 2. To explore the correlation of immunogenicity and efficacy through evaluating the titer level of RBD protein-binding antibody in confirmed COVID-19 cases. 3. Genotypic analyses of SARS-CoV-2 nucleic acid sequence in symptomatic and RT-PCR-positive COVID-19 cases.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TG2101V01
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied severe acute respiratory syndrome coronavirus 2 SARS CoV 2
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/10/2021
Actual trial start date
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 22500
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Central randomisation by phone/fax Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo Suspension for Injection 05 mL vial Vaccination dosage:10 μg Approximately 20 months The sponsor can adjust sample size based on the blinded review of the number of COVID-19 cases during study period cumulative rate of events number and the proportion of participants with serological evidence of SARSCoV2 infection at baseline 22500 Placebo
Experimental Group Recombinant SARSCoV2 fusion protein vaccine V01 Suspension for Injection Suspension for Injection The recombinant SARSCoV2 fusion protein vaccine V01 contains V01 protein and other preparation ingredients including 05mgmL aluminum hydroxide adjuvant 066mgmL glacial acetic acid 122 mgmL sodium acetate equivalent to 20mM acetate buffer 44 2mgmL trehalose 02mgmL polysorbate 80 and 468mg mL sodium chloride with a pH of 46 Except for V01 protein the placebo contains the same components as the investigational vaccine 22500
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Voluntarily participate in this study and sign the informed consent form Adults aged 18 years and older, male or female According to the assessment of the investigator, the participant has a stable medical condition (which is defined as no significant changes in therapy or hospitalization caused by disease aggravation within 3 months before enrollment and are able to and willing to follow the requirements of the protocol Males of reproductive potential and females of child-bearing potential voluntarily agree to take effective and acceptable contraceptive methods from the signing of informed consent form to 12 months after full-course immunization; females of child-bearing potential have negative pregnancy test at screening and at the day of vaccination History of previous COVID19 infection Positive result for RTPCR test in screening period, or specific antibody IgG or IgM meet the following conditions If both IgG and IgM are negative the participant can be vaccinated without waiting for the RTPCR test results History of severe acute respiratory syndrome SARS middle east respiratory syndrome MERS and other human coronavirus infections or diseases History of severe allergy to any vaccine eg acute allergic reactions, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain etc or be allergic to any components of V01 Any confirmed or suspected immunosuppression or immunodeficiency condition known from medical history, including human immunodeficiency virus infection asplenia Serious or uncontrolled cardiovascular diseases, nervous system disorders eg Guillain-Barre syndrome blood and lymphatic system disorders, immune system disorders, hepatorenal disorders, respiratory system disorders e g active tuberculosis, pulmonary fibrosis metabolic and skeletal systems disorders or malignant tumors except for skin basal cell carcinoma or in situ carcinoma of uterine cervix that has been cured more than 5 years Hereditary hemorrhagic tendency or coagulation dysfunction, or a history of thrombosis or hemorrhagic disease, or requirement of continuous use of anticoagulants Prior use of any medications to prevent COVID19 e g use of antipyretics without pyrexia and any other symptoms History of vaccination against SARSCoV2 marketed or investigational Received attenuated live vaccine within 28 days before the first vaccination or any other vaccines licensed or investigational within 14 days before the first vaccination Injection of immunoglobulin and/or other blood products within 3 months before the administration of inves 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 27/07/2021 Kintampo Health Research Centre Institutional Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Kintampo Health Research Centre College of Health Street Kintampo 3821 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 23/07/2021 the Research Ethics Committee of the Makerere University School of Public Health MUSPH
Ethics Committee Address
Street address City Postal code Country
Plot 5159 Nakiwogo Road Entebbe Entebbe 76708 Uganda
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 23/07/2021 Rwanda National Ethics Committee RNEC
Ethics Committee Address
Street address City Postal code Country
Boulevard of Umuganda Kigali 20093 Rwanda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary Objectives Efficacy: To evaluate the efficacy of the recombinant SARS-CoV-2 fusion protein vaccine V-01 for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above severity) starting from at least 14 days (≥15 days) after full-course immunization (completing all vaccinations) Safety: To evaluate the incidence of adverse events (AEs) of recombinant SARS-CoV-2 fusion protein vaccine (V-01) from the first vaccination to 28 days after full-course immunization; Please refer to the above section
Secondary Outcome Secondary Objectives: Efficacy: 1. To evaluate the efficacy of the recombinant SARS-CoV-2 fusion protein vaccine (V-01) for the prevention of COVID-19 of severe or above severity starting from at least 14 days 15 days) after full-course immunization;  Definition of COVID-19 of severe or above severity (meeting any one of the following): 1) Tachypnea, respiratory rate ≥ 30 breaths/min; 2) Oxygen saturation [SpO2]≤93% at rest; 3) Arterial partial pressure of oxygen/fraction of inspired oxygen [PaO2/FiO2]≤300mmHg (in the areas with altitude over 1000 meters, PaO2/FiO2 should be corrected according to the following formula: PaO2/FiO2×[760/atmospheric pressure (mmHg)]); 4) Progressive worsening of clinical symptoms; chest imaging showing significant lesion progression > 50% within 24 to 48 hours (if any); 5) Respiratory failure and requiring mechanical ventilation; 6) Shock; 7) With other organ failure that requires intensive care unit (ICU) care. 2. To evaluate the efficacy of the recombinant SARS-CoV-2 fusion protein vaccine (V-01) for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above severity) starting from at least 14 days 15 days) after the first vaccination; 3. To evaluate the efficacy of the recombinant SARS-CoV-2 fusion protein vaccine (V-01) for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above severity) starting from at least 14 days 15 days) after full-course immunization in different age groups; 4. To evaluate the morbidity of suspected but not confirmed COVID-19 (negative or not detected); 5. To evaluate the mortality caused by COVID-19; 6. To evaluate the hospitalization rate caused by COVID-19; Safety: 1. To evaluate the incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) occurred from the first dose of recombinant SARS-CoV-2 fusion protein vaccine (V-01) to 12 months after full-course immunization; Please refer to the above section
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Navrongo Health Research Centre Ghana Health Service PO Box 114 Navrongo 3821 Ghana
Kintampo Health Research Center Kintampo Health Research Centre PO Box 200 Kintampo North Municipality Kintampo 3821 Ghana
Infectious Diseases Research Collaboration Nakasero Hill Road Mulago hospital Complex PO Box 7475 Kampala 759125 Uganda
Lira Regional Referral Hospital Plot 91 2141 Ngetta Road Police Rd Lira PO BOX 2 Lira 76708 Uganda
UVRI IAVI HIV Vaccine Program LTD CRS Plot 51 59 Nakiwogo Road P O Box 49 Entebbe 31301 Uganda
Makarere University Walter Reed Project MUWRP Plot 42 Nakasero Road PO Box 16524 Kampala 16524 Uganda
Center for Family Health Research KK 19 Av No 57 Kicukiro Kigali 20093 Rwanda
Rinda Ubuzima research centre KG 11 Avenue N47 PO Box 4560 KG 11 Avenue N47 PO Box 4560 20093 Rwanda
FUNDING SOURCES
Name of source Street address City Postal code Country
Livzon Mabpharm Inc No.38, Chuangye Road North, Jinwan, Zhuhai, Guangdong, China Zhuhai 519045 China
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Livzon Mabpharm Inc No.38, Chuangye Road North, Jinwan, Zhuhai, Guangdong, China Zhuhai 519045 China Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Hella Ghorbel hella.ghorbel@mct-cro.com 21628881436 4, Avenue de la livre Sterling, Les Berges du Lac 2
City Postal code Country Position/Affiliation
tunis 1053 Tunisia MCT CRO Regulatory Officer Africa
Role Name Email Phone Street address
Scientific Enquiries Najla Mathlouthi najla.mathlouthi@mct-cro.com 21628881436 4, Avenue de la livre Sterling, Les Berges du Lac 2
City Postal code Country Position/Affiliation
Tunis 1053 Tunisia MCT CRO Regulatory Officer Africa
Role Name Email Phone Street address
Principal Investigator Etienne Karita ekarita@rzhrg-mail.org 8004446107 KK 19 Av No 57
City Postal code Country Position/Affiliation
Kicukiro Rwanda Principal investigator
Role Name Email Phone Street address
Public Enquiries Vincent Mutabazi mutabazivincent@gmail.com 250788302073 KG 11 Avenue N47 PO Box 4560
City Postal code Country Position/Affiliation
Rinda Rwanda Principal investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request Informed Consent Form,Statistical Analysis Plan,Study Protocol upon request NA
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