Clinical Trial to Assess Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Сov-2) Infection

NCT ID: NCT04640233

Last Updated: 2021-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2021-09-30

Brief Summary

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Phase II/III Adaptive Clinical Trial to Assess the Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for SARS-Сov-2 Infection in Indian Healthy Subjects.

Detailed Description

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Phase II/III Adaptive Clinical Trial to Assess the Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for SARS-Сov-2 Infection in Indian Healthy Subjects.

In phase II trial, 100 subjects of immunogenicity group will be enrolled in 3:1 (Test:Placebo) ratio. These 100 subjects will be assessed for safety and immunogenicity outcomes till Day 28 post the first dose of investigational medicinal product (IMP)/placebo administration and will continue with study assessments till Day 180. Safety and immunogenicity data collected till Day 28 will be submitted to the regulatory authority for recommendation to proceed with Phase III recruitment.

In Phase III trial, 1500 subjects will be enrolled and randomized in the ratio of 3:1 (Gam-COVID--Vac : Placebo).

Each subject will participate in this adaptive study phase II/III clinical trial for 180±14 days after the first dose of the IMP/placebo and will have one screening visit and seven on-site visits during the trial period. The IMP/placebo will be administered intramuscularly during vaccination Visits 1 and 3 (Day 1 and Day 21±2). The observation Visits 2, 4, 5, 6, and 7 will be made on Day 19±2, Day 28±2, Day 42±2, Day 90±7, and Day 180±14, respectively. During the observation visits, vital indicators will be assessed in all subjects and changes in the subjects' condition and well being compared to the previous visit will be recorded. The schedule of examination procedures is mentioned in the Schedule of Event tables.

Additionally, the subjects will be able to have remote consultations with the study physician through the weekly telephonic follow-up.

Blood samples will be taken from immunogenicity group of phase II (all 100) and phase III (284 out of 1500) trials during the following visits to assess the immunogenicity parameters.

Conditions

COVID-19 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, 0.5 ml/dose + 0.5 ml/dose prime-boost immunization on day 1 (component I rAd26-S) and on day 21 (component II rAd5-S)

Group Type: EXPERIMENTAL

Gam-COVID-Vac

Intervention Type: BIOLOGICAL

Vaccine for intramuscular injection

Control Group

Placebo, 0.5 ml/dose + 0.5 ml/dose immunization on 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+ years

3. Negative human immunodeficiency virus (HIV 1 & 2) and hepatitis B and C test results

4. Negative immunoglobulin M (IgM) and immunoglobulin G (IgG) SARS-CoV-2 antibodies through enzyme immunoassay test result

5. Negative COVID-2019 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit (72 hours prior to Visit 1 [Day 1])

6. No COVID-2019 in the medical history

7. History of no contact with COVID-2019 persons within at least 14 days before the enrolment (according to subjects)

8. Consent for using effective methods of contraception during the entire trial 1

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

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

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

Exclusion Criteria

1. Any vaccination/immunization within 30 days before the enrolment

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

3. Immunosuppressors therapy finished within 3 months before the enrolment

4. Pregnancy or breast-feeding

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

6. Tuberculosis, chronic systemic infections

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

8. Subjects who are on drugs that could have potential drug interactions with adenovirus vaccine

9. Medical history of malignancy

10. Donated blood or plasma (450+ mL) within 2 months before the enrolment

11. Splenectomy in the medical history

12. Neutropenia (absolute neutrophil count less than 1,000 mm3), agranulocytosis, significant blood loss,severe anaemia (haemoglobin less than 80 g/L), immunodeficiency including autoimmune disorders in the medical history within 6 months before the enrolment

13. Active form of a disease caused by the HIV and hepatitis B or C

14. Anorexia, protein deficiency of any origin

15. Tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the IMP or placebo administration

16. Alcohol or drug addiction in the medical history.

17. Participation in any other interventional clinical trial within 1 month prior to the Screening

18. Any other medical condition that would limit the participation of the subject as per Investigator discretion

19. Study centre staff or other employees directly involved in the trial and their families

20. Subjects contraindicated for vaccination

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

Sponsors

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

OTHER

Sponsor Role: collaborator

Russian Direct Investment Fund

INDUSTRY

Sponsor Role: collaborator

CRO: JSS Medical Research India Pvt. Ltd.

UNKNOWN

Sponsor Role: collaborator

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

S N Medical College

Agra, , India

MGM Medical College and Hospital

Aurangabad, , India

KLE Prabhakar Kore Hospital

Belagavi, , India

Apollo Hospital

Delhi, , India

Batra Hospital

Delhi, , India

HIMSR with CHRD-SAS

Delhi, , India

ESIC Medical College & Hospital

Faridabad, , India

AIG hospital

Hyderabad, , India

Maharaja Agrasen Superspecialty Hospital

Jaipur, , India

GSVM Medical College

Kanpur, , India

Peerless Hospital

Kolkata, , India

Atharva Hospital

Lucknow, , India

St. George's Hospital

Mumbai, , India

JSS Hospital

Mysore, , India

INCLEN trust and Gurunanak Hospital

Palwal, , India

PIMS

Puducherry, , India

BJ Sassoon Hospital

Pune, , India

KEM Hospital

Pune, , India

Noble Hospital Private Limited

Pune, , India

BAPS hospital

Sūrat, , India

Rhythm Heart Institute

Vadodara, , India

Sumandeep Vidyapeeth

Vadodara, , India

Christian Medical College

Vellore, , India

Countries

India

Other Identifiers

CTRI/2020/11/029234

Identifier Type: OTHER

Identifier Source: secondary_id

RDI-GCV-001

Identifier Type: -

Identifier Source: org_study_id