Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19

NCT ID: NCT04530396

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 33758 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-07
• Study Completion Date: 2021-05-01

Brief Summary

Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.

Detailed Description

Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.

The trial will include 40,000 volunteers aged 18+. After screening, they will be randomized (3:1) into two groups - a reference group of 10,000 volunteers receiving placebo and a study group of 30,000 volunteers receiving the Gam-COVID-Vac combined vector vaccine against the SARS-СoV-2-induced coronavirus infection.

The trial subjects will be randomized into five age strata: 18-30, 31-40, 41-50, 51-60, and 60+ years.

The PCR test for SARS-CoV-2 RNA detection at the visit is performed during screening and before the second administration of the vaccine/placebo

Each subject will participate in the trial for 180±14 days after the first dose of the study drug/placebo and will have one screening visit and five on-site visits to the study physician during the said period. The study drug/placebo will be administered intramuscularly during vaccination visits 1 and 2 (day 0 and day 21±2). Subsequent observation visits 3, 4, and 5 will be made on days14±2, 28±2, 35±2,42±2, and 180±14 respectively. During the observation visits, vital signs will be assessed in all trial subjects and changes in the subjects' condition and wellbeing compared to the previous visit will be recorded. Observation visits may be remote, through the telemedicine consultation (TMC).

Additionally, the trial subjects will be able to have remote consultations with the physician through the TMC.

Blood samples will be taken from certain subjects during the following visits to assess the immunogenicity parameters listed below:

Virus-neutralizing activity (300 subjects) ×3 Interferon gamma (107 subjects) ×3 CD4 and CD8 cell count and ratio (50 subjects) SARS-CoV-2 glycoprotein-specific antibodies titer (9,520 subjects) ×3 Determination of the titer of SARS-CoV-2 nucleocleocapsid protein-specific antibodies(9,520 subjects) ×3

Blood sampling will be performed on the day of injecting the first dose of the study drug/placebo immediately prior to the study drug administration Blood sampling for immunogenicity parameters assessment will be only carried out in specially selected study centers.

Blood samples will be taken from 9,520 trial subjects. All four immunogenicity parameters may be assessed in one trial subject.

Trial subjects data will be collected using electronic case report forms and electronic questionnaires to be filled by trial subjects.

Conditions

Covid19 Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Primary Group

Gam-COVID-Vac combined vector vaccine, 0,5ml/dose+0,5 ml/dose prime-boost immunization in days 1 (component I rAd26-S) and 21(component II rAd5-S)

Group Type: EXPERIMENTAL

Gam-COVID-Vac

Intervention Type: BIOLOGICAL

vaccine for intramuscular injection

Control Group

placebo, 0,5ml/dose+0,5 ml/dose immunization in days 1 and 21

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

placebo comparator

Interventions

Gam-COVID-Vac

vaccine for intramuscular injection

Intervention Type: BIOLOGICAL

placebo

placebo comparator

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Written informed consent of a subject to participate in the trial

2. Males and females aged ≥18 y.o.;

3. Negative HIV, hepatitis, and syphilis test results

4. Negative anti-SARS CoV2 IgM and IgG antibodies test carried out with the enzyme immunoassay method

5. Negative COVID-2019 PCR test result at the screening visit

6. No COVID-2019 in the past medical history

7. No contact with COVID-2019 diseased persons within at least 14 days before the enrollment (according to trial subjects)

8. Consent to use effective contraception methods during the trial

9. Negative urine pregnancy test at the screening visit (for child-bearing age women)

10. Negative drugs or psychostimulants urine test at the screening visit

11. Negative alcohol test at the screening visit

12. No evident vaccine-induced reactions or complications after receiving immunobiological products in the past medical history

13. No acute infectious and/or respiratory diseases within at least 14 days before the enrollment.

Exclusion Criteria

1. Any vaccination/immunization within 30 days before the enrollment;

2. Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment

3. Immunosuppressors therapy finished within 3 months before the enrollment

4. Pregnancy or breast-feeding

5. Acute coronary syndrome or stroke suffered less than one year before the enrollment

6. Tuberculosis, chronic systemic infections

7. Drug allergy (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study drug components, acute exacerbation of allergic diseases on the enrollment day

8. Neoplasms in the past medical history (ICD codes C00-D09)

9. Donated blood or plasma (450+ ml) within 2 months before the enrollment

10. History of splenectomy;

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

12. Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B or C

13. Anorexia, protein deficiency of any origin

14. Big-size tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the study drug/placebo administration

15. Alcohol or drug addiction in the past medical history

16. Participation in any other interventional clinical trial

17. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol

18. Study center staff or other employees directly involved in the trial, or their families.

If a subject has any contraindications to vaccination based on the Guidelines on Detection, Investigation and Prevention, of Vaccination-induced Side Reactions (approved by the Ministry of Healthcare of Russia on Apr. 12, 2019, the vaccination may be postponed for a period of time specified in the document.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 111 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Government of the city of Moscow

UNKNOWN

Sponsor Role: collaborator

CRO: Crocus Medical BV

UNKNOWN

Sponsor Role: collaborator

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elena Smolyarchuk, MD, PhD

Role: STUDY_CHAIR

Study Coordinator

Sergey Zyryanov, MD, PhD

Role: STUDY_CHAIR

Study Coordinator

Locations

ARCHIMED V Clinic of new medical technologies limited liability company

Moscow, , Russia

Hadassah LTD

Moscow, , Russia

Medsi Group of companies joint-stock company"

Moscow, , Russia

Niarmedic Plus

Moscow, , Russia

State budgetary healthcare institution of the city of Moscow "City clinical hospital No. 52 of the Moscow city health Department"

Moscow, , Russia

State Budgetary Healthcare Institution, Moscow, Consultation and Diagnosis Polyclinic No. 121, Moscow Healthcare Department

Moscow, , Russia

State Budgetary Healthcare Institution, Moscow, M. Konchalovsky Municipal Clinical Hospital, Moscow Healthcare Department

Moscow, , Russia

State Budgetary Healthcare Institution, Moscow, M. Zhadkevich Municipal Clinical Hospital, Moscow Healthcare Department

Moscow, , Russia

State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 115, Moscow Healthcare Department

Moscow, , Russia

State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 2, Moscow Healthcare Department

Moscow, , Russia

State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 210, Moscow Healthcare Department

Moscow, , Russia

State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 212, Moscow Healthcare Department

Moscow, , Russia

State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 219, Moscow Healthcare Department

Moscow, , Russia

State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 220, Moscow Healthcare Department

Moscow, , Russia

State Budgetary Healthcare Institution, Municipal Polyclinic No. 62, Moscow Healthcare Department

Moscow, , Russia

State budgetary institution of health care of the city of Moscow " city polyclinic No. 109 Of the Department of health of the city of Moscow"

Moscow, , Russia

State budgetary institution of health care of the city of Moscow " city polyclinic No. 170 Of the Department of health of the city of Moscow"

Moscow, , Russia

State budgetary institution of health care of the city of Moscow " city polyclinic No. 36 Of the Department of health of the city of Moscow"

Moscow, , Russia

State budgetary institution of health care of the city of Moscow " city polyclinic No. 46 Of the Department of health of the city of Moscow"

Moscow, , Russia

State budgetary institution of health care of the city of Moscow " city polyclinic No. 6 Of the Department of health of the city of Moscow"

Moscow, , Russia

State budgetary institution of health care of the city of Moscow " city polyclinic No. 68 Of the Department of health of the city of Moscow"

Moscow, , Russia

State budgetary institution of health care of the city of Moscow "Diagnostic center No. 5 with polyclinic Department Of the Department of health of the city of Moscow"

Moscow, , Russia

State budgetary institution of health care of the city of Moscow "Diagnostic clinical center No. 1 Of the Department of health of the city of Moscow"

Moscow, , Russia

Countries

Russia

References

Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, Kovyrshina AV, Lubenets NL, Grousova DM, Erokhova AS, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Egorova DA, Shmarov MM, Nikitenko NA, Gushchin VA, Smolyarchuk EA, Zyryanov SK, Borisevich SV, Naroditsky BS, Gintsburg AL; Gam-COVID-Vac Vaccine Trial Group. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet. 2021 Feb 20;397(10275):671-681. doi: 10.1016/S0140-6736(21)00234-8. Epub 2021 Feb 2.

Reference Type: DERIVED

PMID: 33545094 (View on PubMed)

Other Identifiers

04-Gam-COVID-Vac-2020

Identifier Type: -

Identifier Source: org_study_id