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

NCT04640233 | Unknown Phase 2 DMC

• 2 other identifiers: RDI-GCV-001CTRI/2020/11/029234
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 23

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.

Conditions

COVID-19 Prevention

Keywords

Sputnik; Gamaleya

Outcome Measures

Primary Outcomes (3)

• Adverse Events

  For Phase II study - - Incidence \& severity of adverse events (AEs) after first dose of IMP/Placebo For Phase III study - \- Incidence of related serious adverse events (SAEs) following vaccination during the study

  For Phase II study - at Day 28; For Phase III study - till day 180 after first dose

• Immunogenicity

  For Phase II study - \- Seroconversion rate of SARS-CoV-2 glycoprotein-specific antibodies in immunogenicity group

  For Phase II study - Day 28 after first dose

• Immunogenicity

  For Phase III study - Geometric mean titre ratio of SARS-CoV-2 glycoprotein-specific antibodies between IMP and placebo in immunogenicity group

  For Phase III study - Day 42 after first dose

Secondary Outcomes (7)

• Adverse Events

  Baseline to Day 180

• Immunogenicity assessment

  Baseline, Day 21, Day 28, Day 42, Day 90, and Day 180

• Immunogenicity assessment

  Baseline, Day 21, Day 28, Day 42, Day 90, and Day 180

• Immunogenicity assessment

  Baseline, Day 28, Day 42, Day 90 and Day 180

• Immunogenicity assessment

  Baseline, Day 28, Day 42, Day 90 and Day 180

Study Arms (2)

Primary Group

EXPERIMENTAL

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)

Biological: Gam-COVID-Vac

Control Group

PLACEBO COMPARATOR

Placebo, 0.5 ml/dose + 0.5 ml/dose immunization on days 1 and 21

Other: Placebo

Interventions

Gam-COVID-Vac BIOLOGICAL

Vaccine for intramuscular injection

Primary Group

Placebo OTHER

Placebo comparator

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent of a subject to participate in the trial
• Males and females aged 18+ years
• Negative human immunodeficiency virus (HIV 1 \& 2) and hepatitis B and C test results
• Negative immunoglobulin M (IgM) and immunoglobulin G (IgG) SARS-CoV-2 antibodies through enzyme immunoassay test result
• Negative COVID-2019 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit (72 hours prior to Visit 1 \[Day 1\])
• No COVID-2019 in the medical history
• History of no contact with COVID-2019 persons within at least 14 days before the enrolment (according to subjects)
• Consent for using effective methods of contraception during the entire trial 1
• Negative urine pregnancy test at the screening visit (for child-bearing age women)
• No evident vaccine-induced reactions or complications after receiving immunobiological products in the medical history
• No acute infectious and/or respiratory diseases within at least 14 days before the enrolment.

You may not qualify if:

• Any vaccination/immunization within 30 days before the enrolment
• Steroids (except hormonal contraceptives) and immunoglobulins or other blood products therapy not finished 30 days before the enrolment
• Immunosuppressors therapy finished within 3 months before the enrolment
• Pregnancy or breast-feeding
• Acute coronary syndrome or stroke suffered less than one year before the enrolment
• Tuberculosis, chronic systemic infections
• 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
• Subjects who are on drugs that could have potential drug interactions with adenovirus vaccine
• Medical history of malignancy
• Donated blood or plasma (450+ mL) within 2 months before the enrolment
• Splenectomy in the medical history
• 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
• Active form of a disease caused by the HIV and hepatitis B or C
• Anorexia, protein deficiency of any origin
• Tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the IMP or placebo administration

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead
• Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation: collaborator
• Russian Direct Investment Fund: collaborator
• CRO: JSS Medical Research India Pvt. Ltd.: collaborator

Study Sites (23)

S N Medical College

Agra, India

Location

MGM Medical College and Hospital

Aurangabad, India

Location

KLE Prabhakar Kore Hospital

Belagavi, India

Location

Apollo Hospital

Delhi, India

Location

Batra Hospital

Delhi, India

Location

HIMSR with CHRD-SAS

Delhi, India

Location

ESIC Medical College & Hospital

Faridabad, India

Location

AIG hospital

Hyderabad, India

Location

Maharaja Agrasen Superspecialty Hospital

Jaipur, India

Location

GSVM Medical College

Kanpur, India

Location

Peerless Hospital

Kolkata, India

Location

Atharva Hospital

Lucknow, India

Location

St. George's Hospital

Mumbai, India

Location

JSS Hospital

Mysore, India

Location

INCLEN trust and Gurunanak Hospital

Palwal, India

Location

PIMS

Puducherry, India

Location

BJ Sassoon Hospital

Pune, India

Location

KEM Hospital

Pune, India

Location

Noble Hospital Private Limited

Pune, India

Location

BAPS hospital

Sūrat, India

Location

Rhythm Heart Institute

Vadodara, India

Location

Sumandeep Vidyapeeth

Vadodara, India

Location

Christian Medical College

Vellore, India

Location

MeSH Terms

Interventions

Gam-COVID-Vac vaccine

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 23, 2020
• Study Start: November 30, 2020
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (23)