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Study to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik-Light (SPUTNIK-LIGHT)

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ClinicalTrials.gov Identifier: NCT04741061
Recruitment Status : Recruiting
First Posted : February 5, 2021
Last Update Posted : February 21, 2021
Sponsor:
Collaborators:
Russian Direct Investment Fund
CRO: iPharma
Government of the city of Moscow
Information provided by (Responsible Party):
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

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.

Condition or disease Intervention/treatment Phase
COVID-19 Prevention Biological: Sputnik Light Other: Placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, double-blind (blinded for the study subject and investigators), placebo-controlled
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : February 19, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : January 31, 2022

Arm Intervention/treatment
Active Comparator: Sputnik Light Vaccine
study group (4500 receiving the Sputnik-Light vector vaccine) against the SARS-СoV-2-induced coronavirus infection.
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.


Placebo Comparator: Placebo Group
control group (1500 subjects receiving placebo)
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Incidence and severity of adverse events in study subjects [ Time Frame: through the whole study, an average of 180 days ]
    Incidence and severity of AEs and SAEs during the subject's participation in the study

  2. Percentage of study subjects with COVID-19 cases developed after vaccination [ Time Frame: through the whole study, an average of 180 days ]
    Percentage of study subjects with COVID-19 cases developed after vaccination with the Sputnik-Light vector vaccine as compared with placebo


Secondary Outcome Measures :
  1. Humoral immunogenicity (Quantitative IgG antibodies to SARS-CoV-2 S Protein) [ Time Frame: at days 0, 42, 180 ]
    Geometric mean titer (GMT) levels of Quantitative IgG antibodies

  2. Humoral immunogenicity (IgG SARS-CoV-2 N-antibodies) [ Time Frame: at days 0, 42, 180 ]
    Percentage of study subjects who have a post-treatment response as measures with Qualitative IgG SARS-CoV-2 N-antibodies



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 111 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04741061


Contacts
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Contact: Elena Merkulova +7 (495) 276 11 43 ext 495 eam@ipharma.ru

Locations
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Russian Federation
Federal State Autonomous Educational Institution for Higher Education "Immanuel Kant Baltic Federal University" Not yet recruiting
Kaliningrad, Russian Federation
Contact: Vladimir Rafalskiy         
Principal Investigator: Vladimir Rafalskiy         
State Budgetary Healthcare Institution, Moscow, Consultation and Diagnosis Polyclinic No. 121, Moscow Healthcare Department Recruiting
Moscow, Russian Federation
Contact: Elena Klimova, MD         
State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 210, Moscow Healthcare Department Recruiting
Moscow, Russian Federation
Contact: Anna Gratzianskaya         
State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 219, Moscow Healthcare Department Recruiting
Moscow, Russian Federation
Contact: Natalia Nenasheva, MD         
State budgetary institution of health care of the city of Moscow "diagnostic centre № 5 associated with policlinic department of Moscow Healthcare Department" Not yet recruiting
Moscow, Russian Federation
Contact: Tamara Vilegzhanina         
Principal Investigator: Tamara Vilegzhanina         
State budgetary institution of health care of the city of Moscow "diagnostic clinical centre № 1 Moscow Healthcare Department " Recruiting
Moscow, Russian Federation
Contact: Natalia Shartanova         
Principal Investigator: Natalia Shartanova         
State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 2 Moscow Healthcare Department" Recruiting
Moscow, Russian Federation
Contact: Sergey Fitilev, MD         
Principal Investigator: Sergey Fitilev         
State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 36 Moscow Healthcare Department" Recruiting
Moscow, Russian Federation
Contact: Irina Isakova         
Principal Investigator: Irina Isakova         
State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 6 Moscow Healthcare Department" Not yet recruiting
Moscow, Russian Federation
Contact: Marina Ivzhits         
Principal Investigator: Marina Ivzhits         
State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 62 Moscow Healthcare Department" Recruiting
Moscow, Russian Federation
Contact: Marina Rusanova, MD, PhD         
Principal Investigator: Marina Rusanova         
State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 64 Moscow Healthcare Department" Recruiting
Moscow, Russian Federation
Contact: Svetlana Rachina         
Principal Investigator: Svetlana Rachina         
St. Petersburg's state budgetary health care Institution "Municipal hospital № 40 of Kurortniy area" Not yet recruiting
Saint Petersburg, Russian Federation
Contact: Alina Agafina, MD         
Principal Investigator: Alina Agafina         
St. Petersburg's state budgetary health care Institution "Municipal hospital №117" Not yet recruiting
Saint Petersburg, Russian Federation
Contact: Diana Alpenidze         
Principal Investigator: Diana Alpenidze         
Federal state budgetary educational Institution for Higher Education "Saratov State Medical University named after V.I. Razumovskiy" Ministry of Health of Russian Federation Not yet recruiting
Saratov, Russian Federation
Contact: Yury Shvarts         
Principal Investigator: Yury Shvarts         
LLC "Uromed" Not yet recruiting
Smolensk, Russian Federation
Contact: Alla Andreeva         
Principal Investigator: Alla Andreeva         
Sponsors and Collaborators
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Russian Direct Investment Fund
CRO: iPharma
Government of the city of Moscow
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Responsible Party: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
ClinicalTrials.gov Identifier: NCT04741061    
Other Study ID Numbers: 01 - Sputnik Light - 2021
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation:
COVID-19
vaccine
vector vaccine
adenovirus vector
SARS-CoV-2