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
Brief 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.

Detailed 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

Unknown status
COVID-19 Prevention

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) х 1011 particles per dose.

Other: Placebo

Placebo

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 111 Years
Countries
Russian Federation
Locations

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, Russian Federation

Contacts

Elena Merkulova
+7 (495) 276 11 43 - 495
eam@ipharma.ru

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
NCT Number
Keywords
Covid-19
Vaccine
vector vaccine
adenovirus vector
SARS-CoV-2
MeSH Terms
COVID-19