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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

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ClinicalTrials.gov Identifier: NCT04640233
Recruitment Status : Recruiting
First Posted : November 23, 2020
Last Update Posted : January 29, 2021
Sponsor:
Collaborators:
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
RDIF (Russian Direct Investment Fund)
CRO: JSS Medical Research India Pvt. Ltd.
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

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.

Condition or disease Intervention/treatment Phase
COVID-19 Prevention Biological: Gam-COVID-Vac Other: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 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
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
Biological: Gam-COVID-Vac
Vaccine for intramuscular injection

Placebo Comparator: Control Group
Placebo, 0.5 ml/dose + 0.5 ml/dose immunization on days 1 and 21
Other: Placebo
Placebo comparator




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: For Phase II study - at Day 28; For Phase III study - till day 180 after first dose ]

    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


  2. Immunogenicity [ Time Frame: For Phase II study - Day 28 after first dose ]

    For Phase II study -

    - Seroconversion rate of SARS-CoV-2 glycoprotein-specific antibodies in immunogenicity group


  3. Immunogenicity [ Time Frame: For Phase III study - Day 42 after first dose ]
    For Phase III study - Geometric mean titre ratio of SARS-CoV-2 glycoprotein-specific antibodies between IMP and placebo in immunogenicity group


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Baseline to Day 180 ]

    Incidence and severity of adverse events after injecting the first dose of the IMP/placebo

    Incidence of SAE following vaccination


  2. Immunogenicity assessment [ Time Frame: Baseline, Day 21, Day 28, Day 42, Day 90, and Day 180 ]

    Seroconversion rate of SARS-CoV-2 glycoprotein-specific antibodies in immunogenicity group

    Seroconversion rate of SARS-CoV-2 virus-neutralizing antibodies in immunogenicity group


  3. Immunogenicity assessment [ Time Frame: Baseline, Day 21, Day 28, Day 42, Day 90, and Day 180 ]
    Geometric mean virus-neutralizing antibodies titre in immunogenicity group

  4. Immunogenicity assessment [ Time Frame: Baseline, Day 28, Day 42, Day 90 and Day 180 ]
    Interferon gamma concentration in T-cells after restimulation with the SARS-CoV-2 glycoprotein in cell mediated immunogenicity group

  5. Immunogenicity assessment [ Time Frame: Baseline, Day 28, Day 42, Day 90 and Day 180 ]
    The number of proliferating cluster of differentiation 4 (CD4) cell and cluster of differentiation 8 (CD8) cells in response to mitogen stimulation in cell mediated immunogenicity group

  6. Percentage of subjects with mild, moderate, severe coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose of the vaccine/placebo [ Time Frame: Baseline to Day 180 ]
    Comparing percentage of subjects developing COVID-19 disease between Gam-COVID-Vac combined vector vaccine and placebo based on severity course

  7. Incidence of coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose in trial subjects [ Time Frame: Baseline to Day 180 ]
    Comparing incidence of COVID-19 disease between Gam-COVID-Vac combined vector vaccine and placebo



Information from the National Library of Medicine

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

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): NCT04640233


Contacts
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Contact: Dr. Lalit Lakhwani, MD 7337341886 lalitkl@drreddys.com
Contact: Dr. Agam Shah, MD 9825465938 agam.shah@drreddys.com

Locations
Show Show 23 study locations
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
RDIF (Russian Direct Investment Fund)
CRO: JSS Medical Research India Pvt. Ltd.
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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT04640233    
Other Study ID Numbers: RDI-GCV-001
CTRI/2020/11/029234 ( Other Identifier: Clinical Trial Registry of India )
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 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 Dr. Reddy's Laboratories Limited:
Sputnik
Gamaleya
Additional relevant MeSH terms:
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Infection