Study to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik-Light

COVID-19 Prevention Clinical Trial

— SPUTNIK-LIGHT  

Official title:

A Phase III, Randomized, Double-blind, Placebo-controlled International Multicenter Study to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik-Light Vector Vaccine in the Parallel Assignment of the Subjects in Prophylactic Treatment for SARS-СoV-2 Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04741061
• Other study ID #: 01 - Sputnik Light - 2021
• Status: Recruiting
• Phase: Phase 3
• Start date: February 19, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2021
• Source: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• Contact: Elena Merkulova
• Phone: +7 (495) 276 11 43
• Email: eam[@]ipharma.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study Global sponsor is planning several parallel studies of Sputnik-Light vector vaccine across the globe in United Arab Emirates, Russia and possibly in other countries in case of confirmation associated with the same medical product under similar protocols. The key objective of this study is to be conducted in several parallel studies of the same vaccine above the other countries. Using similar protocols on a portfolio basis of studies let us collect data for Efficacy, Immunogenicity, Safety and Tolerability confirmation of the Sputnik-Light vaccine.

Description:

This study is randomized, double-blind (blinded for the study subject and investigators), placebo-controlled international multicenter study in the parallel assignment of the subjects to assess efficacy, immunogenicity and safety of the Sputnik-Light vector vaccine in adults in the SARS-СoV-2 infection prophylactic treatment

The subjects will be randomized into two groups in the ratio of 1:3; a control group (1500 subjects receiving placebo) and a study group (4500 subjects receiving the Sputnik-Light vector vaccine against the SARS-СoV-2-induced COVID19 infection).

For the evaluation of immunogenicity an unbalanced design is adopted of the placebo and vaccinated group at a 1:3 ratio. Subsequently the number of subjects in Subgroup A tested will be 1076 subjects, distributed as follows: 269 in the placebo group and 807 in the vaccinated group, also randomized into two groups in the ratio of 1:3 who will attend for assessment of immunogenicity compared to baseline.

Each subjects will participate in the trial for approximately 6 months after the first dose of the study vaccine/placebo and will have at least tree 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: January 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 111 Years

Eligibility

Inclusion Criteria:

1. Agree to sign the study informed consent form (ICF) before performing any study specific procedure

2. Adults = 18 years old

3. Negative COVID-19 PCR test result at the screening visit and negative immunochromatographic SARS-CoV-2 antigen rapid-test result at the enrolment

4. Consent for using effective methods of contraception during the study

5. No evidence of 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 enrolment

Exclusion Criteria:

1. Any previous vaccination/immunization (within 30 days before the enrollment) and any planned vaccination within 30 days after enrollment

2. Any previous or planning COVID-19 vaccination with any other Regulatory approved vaccine

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 lactation

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 autoimmune disease and system collagenases in medical history

10. Organ transplantation and immunosuppressive therapy

11. Immunosuppressive therapy and corticosteroid system therapy within 3 months before the enrollment

12. Subjects with malignant neoplasms within 5 years before the enrollment

13. Splenectomy in the past medical history

14. Neutropenia (absolute neutrophil count <1,000 mm3 agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/L), immunodeficient disease in the medical history within 6 months before the enrollment

15. The 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 dysnutrition

18. Tattoos at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the vaccine/placebo

19. Alcohol or Drug abuse 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 investigator considers as a barrier to the trial completion as per the protocol

Related Conditions & MeSH terms

• COVID-19 Prevention

Intervention

Biological:
• Sputnik Light
Sputnik-Light vector vaccine: Active substance: recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) ? 1011 particles per dose.

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Russian Federation	Federal State Autonomous Educational Institution for Higher Education "Immanuel Kant Baltic Federal University"	Kaliningrad
Russian Federation	State Budgetary Healthcare Institution, Moscow, Consultation and Diagnosis Polyclinic No. 121, Moscow Healthcare Department	Moscow
Russian Federation	State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 210, Moscow Healthcare Department	Moscow
Russian Federation	State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 219, Moscow Healthcare Department	Moscow
Russian Federation	State budgetary institution of health care of the city of Moscow "diagnostic centre ? 5 associated with policlinic department of Moscow Healthcare Department"	Moscow
Russian Federation	State budgetary institution of health care of the city of Moscow "diagnostic clinical centre ? 1 Moscow Healthcare Department "	Moscow
Russian Federation	State budgetary institution of health care of the city of Moscow "Municipal Polyclinic ? 2 Moscow Healthcare Department"	Moscow
Russian Federation	State budgetary institution of health care of the city of Moscow "Municipal Polyclinic ? 36 Moscow Healthcare Department"	Moscow
Russian Federation	State budgetary institution of health care of the city of Moscow "Municipal Polyclinic ? 6 Moscow Healthcare Department"	Moscow
Russian Federation	State budgetary institution of health care of the city of Moscow "Municipal Polyclinic ? 62 Moscow Healthcare Department"	Moscow
Russian Federation	State budgetary institution of health care of the city of Moscow "Municipal Polyclinic ? 64 Moscow Healthcare Department"	Moscow
Russian Federation	St. Petersburg's state budgetary health care Institution "Municipal hospital ? 40 of Kurortniy area"	Saint Petersburg
Russian Federation	St. Petersburg's state budgetary health care Institution "Municipal hospital ?117"	Saint Petersburg
Russian Federation	Federal state budgetary educational Institution for Higher Education "Saratov State Medical University named after V.I. Razumovskiy" Ministry of Health of Russian Federation	Saratov
Russian Federation	LLC "Uromed"	Smolensk

Sponsors (4)

Lead Sponsor	Collaborator
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation	CRO: iPharma, Government of the city of Moscow, RDIF (Russian Direct Investment Fund)

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events in study subjects	Incidence and severity of AEs and SAEs during the subject's participation in the study	through the whole study, an average of 180 days
Primary	Percentage of study subjects with COVID-19 cases developed after vaccination	Percentage of study subjects with COVID-19 cases developed after vaccination with the Sputnik-Light vector vaccine as compared with placebo	through the whole study, an average of 180 days
Secondary	Humoral immunogenicity (Quantitative IgG antibodies to SARS-CoV-2 S Protein)	Geometric mean titer (GMT) levels of Quantitative IgG antibodies	at days 0, 42, 180
Secondary	Humoral immunogenicity (IgG SARS-CoV-2 N-antibodies)	Percentage of study subjects who have a post-treatment response as measures with Qualitative IgG SARS-CoV-2 N-antibodies	at days 0, 42, 180