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.: PACTR202104601572565 Date of Approval: 16/04/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title SPUTNIK-LIGHT. COVID-19
Official scientific title A Phase III, Randomized, Double Blind, Placebo-Controlled International Multisite Clinical Trial in Parallel Assignment to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik Light Vector Vaccine in Adults in the SARS-CoV-2 Infection Prophylactic Treatment. COVID-19
Brief summary describing the background and objectives of the trial The study Global sponsor is planning several parallel studies of Sputnik-Light vector vaccine across the globe including a study in Russia and possibly in other countries yet to be confirmed with the same investigational product and under similar protocols. The ultimate goal of this trial is to conduct it in parallel with trials with the same investigational vaccine in other countries. Similar protocol designs across the portfolio will enable us to compile data from all to confirm efficacy, immunogenicity, safety and tolerability of Sputnik-Light. Data from this study will be submitted to the regulatory agencies in Russia, Ghana the UAE and possibly other jurisdictions as part of the Sponsor application to obtain Emergency Use Authorization to market the study vaccine in these countries, and subsequently Marketing Authorizations in Russia, UAE, Ghana and other jurisdictions.Primary Objectives: 1. Assess efficacy of the Sputnik-Light vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo 2. Assess tolerability and safety of the Sputnik-Light vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo Secondary Objectives: 1. Assess humoral immunogenicity of the Sputnik-Light vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo on Subset A which consists of 1076 participants. 2. Assess protective properties of the Sputnik-Light vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo for prevention of serologically confirmed SARS-CoV-2 infection 3. Assess efficacy of the Sputnik-Light vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo based on severity of COVID-19 disease
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SPUTNIK LIGHT
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied COVID 19 /SARS-CoV-2 Infection Prophylactic Treatment
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/05/2021
Actual trial start date
Anticipated date of last follow up 01/12/2021
Actual Last follow-up date 01/12/2021
Anticipated target sample size (number of participants) 2000
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 Dynamic (adaptive) random allocation such as minimization Allocation was determined by the holder of the sequence who is situated off site 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 Sputnik Light Vector Vaccine 0.5 ml per one dose on day 1 . Each subject will participate in the trial for approximately 6 months after the first dose of the study vaccine/placebo and will have in total five on-site visits, including a screening visit to the study clinical site during the study period and several observation Phone Call/ Tele-consultation visits during the study as follows: • V0: Screening visit o Day -7 to Day 0 • V1: Vaccination visit: o Day 1 • V2: Safety and Immunogenicity Visit o Day 42±4 days • V3: End of Study Visit o Day 180 ± 14 days • Per Schedule of Assessment Teleconsultations / Phone Calls will take place on the following days: o Day 2 o Day 4 o Day 7±1 days o Day 14±2 days o Day 21±2 days o Day 35±2 days o Day 42±4 days (except for Subgroup A and B, who need to attend in-person visit) o Day 56±7 days o Day 90±7 days o Day 120±14 days o Day 150±14 days o Day 180±14 days 1- Sputnik-Light vector vaccine Form: Solution for injection Dose: 0.5 ml per dose on day 1. Composition: Active substance: recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) х 1011 particles per dose. Excipients: Tris (hydroxymethyl) aminomethane - 1.21 mg, sodium chloride - 2.19 mg, sucrose - 25.0 mg, magnesium chloride hexahydrate - 102.0 µg, EDTA disodium salt dihydrate - 19.0 µg, polysorbate- 80 - 250 µg, ethanol 95% - 2.5 mcL, water for injection up to 0.5 ml. 1600
Control Group Placebo (0.5 ml per dose) once on day 1 Each subject will participate in the trial for approximately 6 months after the first dose of the study vaccine/placebo and will have in total five on-site visits, including a screening visit to the study clinical site during the study period and several observation Phone Call/ Tele-consultation visits during the study as follows: • V0: Screening visit o Day -7 to Day 0 • V1: Vaccination visit: o Day 1 • V2: Safety and Immunogenicity Visit o Day 42±4 days • V3: End of Study Visit o Day 180 ± 14 days • Per Schedule of Assessment Teleconsultations / Phone Calls will take place on the following days: o Day 2 o Day 4 o Day 7±1 days o Day 14±2 days o Day 21±2 days o Day 35±2 days o Day 42±4 days (except for Subgroup A and B, who need to attend in-person visit) o Day 56±7 days o Day 90±7 days o Day 120±14 days o Day 150±14 days o Day 180±14 days 1. Placebo Form: Solution for injection Dose: (0.5 ml per dose) on day 1 Composition: Tris (hydroxymethyl) aminomethane — 1.21 mg, sodium chloride — 2.19 mg, sucrose — 25.0 mg, magnesium chloride hexahydrate — 102.0 µg, EDTA disodium salt dihydrate — 19.0 µg, polysorbate — 80–250 µg, ethanol 95% — 2.5 mcL, water for injection up to 0.5 ml. 600 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Agree to sign the study informed consent form (ICF) before performing any study-specific procedure. 2. Adults ≥ 18 years old 3. Absence of COVID-19 that is confirmed with negative immunochromatographic SARS-CoV-2 antigen rapid test at randomization test use of point of care test system at the screening visit 4. Consent for using effective methods of contraception during the entire trial and 3 months after its completion 5. No evidence of pronounced vaccine-induced reactions or complications after receiving immunobiological products in medical history. 6. No acute infectious and/or respiratory diseases within at least 14 days before the enrollment. Inclusion criteria: 1. Agree to sign the study informed consent form (ICF) before performing any study-specific procedure. 2. Adults ≥ 18 years old 3. Absence of COVID-19 that is confirmed with negative immunochromatographic SARS-CoV-2 antigen rapid test at randomization test use of point of care test system at the screening visit 4. Consent for using effective methods of contraception during the entire trial and 3 months after its completion 5. No evidence of pronounced vaccine-induced reactions or complications after receiving immunobiological products in medical history. 6. No acute infectious and/or respiratory diseases within at least 14 days before the enrollment. Exclusion criteria: 1. Any previous vaccination/immunization (except for COVID-19 vaccination) within 30 days before the enrollment and any planned vaccination within 30 days after enrollment. 2. Any previous COVID-19 vaccination or planned vaccination against COVID-19 with another vaccine approved by the regulatory authority 3. Positive SARS-CoV-2 screening result obtained by PCR at screening 4. Administration of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment. 5. Pregnancy or breast-feeding 6. Acute coronary syndrome or stroke suffered less than one year before study enrollment 7. Tuberculosis, chronic systemic infections associated with immunocompromised subjects in medical history 8. History of severe allergic reaction to drug or vaccine (anaphylactic shock, Quincke's edema, and other life-threatening allergic reactions), acute exacerbation of allergic diseases on screening and vaccination day.\ 9. Chronic immune disease or systemic collagenosis in medical history 10. Subjects who received transplantation and on immunosuppressive therapy 11. Other immunosuppressive therapy that completed less than three months prior to randomization into the study 12. Splenectomy in the past medical history 13. Subjects with oncological disease within 5 years prior to inclusion into the study 14. Neutropenia (absolute neutrophil count less than <1000/mm2), agranulocytosis, significant loss of blood, severe anemia (hemoglobin < 80 g/l) Immunodeficiency in the medical history within 6 months before the enrollment 15. Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B, or C 16. Acute Kidney injury or dialysis 17. Anorexia or Malnutrition 18. Tattoos or scars at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the study vaccine/placebo administration 19. Alcohol or Drug addiction in medical history 20. Participation in other interventional clinical trial within the previous 90 days prior to vaccination and over duration of the trial 21. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol. 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 26/04/2021 Ghana Health Service Ethical Review Committee Research and Development Division
Ethics Committee Address
Street address City Postal code Country
P. O. Box MB 190 Accra. Ghana Health Service Ethical Review Committee Accra Ghana Accra MB 190 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Secondary Endpoints: 1. Humoral immunogenicity induced by the vaccine resulting in increase in the Quantitative IgG antibodies to SARS-CoV-2 S Protein in trial subjects (Subset A, 1 076 Subjects) a. Geometric mean titer (GMT) levels of Quantitative IgG antibodies to S Protein from baseline levels at Visit 1 (vaccination day, prior to injecting the first dose of the study vaccine/placebo) to Visit 2 (Day 42) and Visit 3 (Day 180) after injection with vaccine/placebo b. Percentage of trial subjects with four-fold or more increase in the titers of Quantitative IgG antibodies to S Protein from baseline levels at Visit 1 (vaccination day, prior to injecting the first dose of the study vaccine/placebo) to Visit 2 (Day 42) and Visit 3 (Day 180) after injection with vaccine/placebo c. Percentage of trial subjects with seroconversion to SARS-CoV-2 S Protein from baseline levels at Visit 1 (vaccination day, prior to injecting the first dose of the study vaccine/placebo) to Visit 2 (Day 42) and Visit 3 (Day 180) after injection with vaccine/placebo d. Immunogenicity of the Sputnik-Light vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo for the levels of virus-neutralizing antibodies compared at baseline (Visit 1), to Visit 2 (Day 42) and Visit 3 (Day 180) after injection with vaccine/placebo 2. Percentage of trial subjects who have a post-treatment response as measures with Qualitative IgG and IgM SARS-CoV-2 N-antibodies at to Visit 2 (Day 42) and Visit 3 (Day 180) after injection with vaccine/placebo 3. Percentage of trial subjects with severe and extremely severe COVID-19 disease that developed after vaccination with Sputnik Light compared to placebo Visit Two equivalent to Day forty two and Visit three equivalent to Day One hundred and eighty after injection with vaccine/placebo
Primary Outcome Primary Endpoints: 1. Proportion of study subjects with active COVID-19 disease developed 21±2 days after vaccination with the Sputnik-Light vector vaccine as compared with placebo 2. Incidence and severity of adverse events in trial subjects: a. Incidence of local and systemic reactions to the vaccine in 7 days after injection with vaccine/placebo b. Incidence and severity of AEs and SAEs over the course of subject’s participation in the study Twenty One days after vaccination with the Sputnik-Light vector vaccine as compared with placebo
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Novrongo Heatlh Research center Post Office Box 114 Navrongo 00000 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Limited Liability Company Human Vaccine part of the group of the entities of JointStock Company Management Company of Russian Direct Investment Fund Capital City South Tower 7th 8th floor 8 bld 1 Presnenskaya nab Moscow Russia 123112 Moscow Russian Federation
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Limited Liability Company Human Vaccine part of the group of the entities of JointStock Company Management Company of Russian Direct Investment Fund Capital City South Tower 7th 8th floor 8 bld 1 Presnenskaya nab Moscow Russia 123112 Moscow Russian Federation Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nana Akosua Ansah ansah.nanaakosua@gmail.com 00233246729726 Post Office Box 114
City Postal code Country Position/Affiliation
Novrongo Ghana Clinical Researcher
Role Name Email Phone Street address
Principal Investigator Alberta Amu alberta.amu@gmail.com +233244274807 Dodowa Health Research Centre. Box DD1, Dodowa, Ghana
City Postal code Country Position/Affiliation
Dodowa Ghana Clinical Epidemiologist
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mostafa Mohamed.Mostafa@pdc-cro.com +971555389246 No. 101N, Floor 1, Building HQ Complex, P.O BOX 500767 Dubai, United Arab Emirates.
City Postal code Country Position/Affiliation
Dubai United Arab Emirates CEO at PDC CRO
Role Name Email Phone Street address
Public Enquiries Alberta Amu alberta.amu@gmail.com +233244274807 Dodowa Health Research Centre. Box DD1, Dodowa, Ghana
City Postal code Country Position/Affiliation
Dodowa Ghana Clinical Epidemiologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1. Date of posting of results summaries 2. Date of the first journal publication of results Results Reporting and IPD 3 3. URL hyperlink(s) related to results and publications 4. Baseline Characteristics: Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age and sex, and study-specific measures. 5. Participant flow: Information to document the progress and numbers of research participants through each stage of a study in a flow diagram or tabular format. 6. Adverse events: An unfavourable change in the health of a participant, including abnormal laboratory findings, and all serious adverse events and deaths that happen during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. 7. Outcome measures: A table of data for each primary and secondary outcome measure and their respective measurement of precision (e.g. a 95% confidence interval) by arm (that is, initial assignment of participants to arms or groups) or comparison group (that is, analysis groups), including the result(s) of scientifically appropriate statistical analyses that were performed on the outcome measure data, if any. 8. URL link to protocol file(s) with version and date. This will apply when the protocol has wither been published in a journal or on an institutional website. 9. Brief summary Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol within 12 months of the study completion date Controlled
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