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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04640233
Recruitment Status : Active, not recruiting
First Posted : November 23, 2020
Last Update Posted : June 2, 2021
Sponsor:
Collaborators:
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Russian Direct Investment Fund
CRO: JSS Medical Research India Pvt. Ltd.
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Tracking Information
First Submitted Date  ICMJE November 17, 2020
First Posted Date  ICMJE November 23, 2020
Last Update Posted Date June 2, 2021
Actual Study Start Date  ICMJE November 30, 2020
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2020)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE COVID-19 Prevention
Intervention  ICMJE
  • Biological: Gam-COVID-Vac
    Vaccine for intramuscular injection
  • Other: Placebo
    Placebo comparator
Study Arms  ICMJE
  • 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)
    Intervention: Biological: Gam-COVID-Vac
  • Placebo Comparator: Control Group
    Placebo, 0.5 ml/dose + 0.5 ml/dose immunization on days 1 and 21
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 20, 2020)
1600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04640233
Other Study ID Numbers  ICMJE RDI-GCV-001
CTRI/2020/11/029234 ( Other Identifier: Clinical Trial Registry of India )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Dr. Reddy's Laboratories Limited
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
  • Russian Direct Investment Fund
  • CRO: JSS Medical Research India Pvt. Ltd.
Investigators  ICMJE Not Provided
PRS Account Dr. Reddy's Laboratories Limited
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP