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Study of Safety and Immunogenicity of BVRS-GamVac-Combi

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04128059
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : January 14, 2021
Sponsor:
Collaborator:
Acellena Contract Drug Research and Development
Information provided by (Responsible Party):
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Tracking Information
First Submitted Date  ICMJE October 14, 2019
First Posted Date  ICMJE October 16, 2019
Last Update Posted Date January 14, 2021
Actual Study Start Date  ICMJE November 6, 2019
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2019)
  • Number of Participants With Adverse Events [ Time Frame: through the whole study, an average of 180 days ]
    Determination of Number of Participants With Adverse Events
  • Number of Participants With Serious Adverse Events [ Time Frame: through the whole study, an average of 180 days ]
    Determination of Number of Participants With Serious Adverse Events
  • Number of Participants with Solicited Local and Systemic Adverse Events [ Time Frame: through the whole study, an average of 180 days ]
    Determination of Number of Participants with Solicited Local and Systemic Adverse Events
  • Antibody levels against the MERS-CoV glycoprotein S measured by an enzyme-linked immunosorbent assay (ELISA) [ Time Frame: Time Frame for group 1 phase 1: at days 0, 7, 14, 21, 28, 42, 56 and 90. Time Frame for group 2 phase 1 and phase 2: at days 0, 7, 14, 21, 28, 35, 42, 56 and 90 ]
    Determination of antibody levels against the MERS-CoV glycoprotein S measured by an ELISA vs. baseline values (phase 1, phase 2) and placebo (phase 2)
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2019)
  • A safety assessment [ Time Frame: through the whole study, an average of 180 days ]
    recording adverse events during the study
  • Level of seroconversion [ Time Frame: on days 0, 7, 14, 21, 28, 35, 42, 56 and 90 from the start of immunization-phase 1, on days 0, 7, 14, 21, 28, 42, 56 and 90 from the start of immunization -phase 2 ]
    determining the titer of specific antibodies by ELISA as compared to the background values (day 0) and placebo
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2019)
  • Assessment of antigen-specific cell-mediated immune response [ Time Frame: at 0, 14 and 28 days from the start of vaccination compared to baseline values (phase 1, phase 2) and placebo (phase 2) ]
    determination of specific T-cell- mediated response vs. baseline values and placebo
  • Neutralizing antibody levels [ Time Frame: at days 0, 14 and 28 from the start of vaccination compared to baseline values ]
    Determination of the neutralizing antibody titer for a virus in virus neutralization reaction vs. baseline values and placebo
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2019)
the antigen-specific cellular immune response [ Time Frame: at 0, 14 and 28 days from the start of vaccination compared to baseline values (day 0) ]
specific T-cell response to the MERS-CoV glycoprotein
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Safety and Immunogenicity of BVRS-GamVac-Combi
Official Title  ICMJE Double-blind, Placebo-controlled Study With an Open Dose Selection Period for Assessing the Safety and Immunogenicity of the Drug "BVRS-GamVac-Combi", a Combined Vector Vaccine for the Prevention of the Middle East Respiratory Syndrome, Lyophilisate for the Preparation of a Solution for Intramuscular Administration, With the Participation of Healthy Volunteers
Brief Summary

The Middle East respiratory syndrome coronavirus (MERS-CoV) was identified in 2012 during the first Middle East respiratory syndrome (MERS) outbreak. MERS-CoV causes an acute lower-respiratory infection in humans, with a fatality rate of ~34.5%.

The aim of the study is to assess the safety and immunogenicity of heterologous adenoviral-based vaccine against MERS - BVRS-GamVac-Combi.

Detailed Description

The study will include volunteers of both sexes, aged 18-55 years inclusive. The study will involve 268 (will receive the vaccine or placebo) healthy volunteers.

At the first stage, it is planned:

  • study the safety of component 1 - 40 volunteers and 4 spares *
  • study the safety of prime-boost vaccination with component 1 and component 2 with an interval of 21 days in half and full dose - 40 volunteers and 4 spares * At the second phase, it is planned to study the safety and immunogenicity of the vaccine as part of a placebo-controlled randomized trial - 188 people, of whom 138 will receive the vaccine, and 50 will make up the control group of observation - they will be given a placebo. Data from 20 volunteers from the first phase who received the drug in selected dose will be included in the analysis of safety and immunogenicity of the second phase.

    • Volunteers are replaced by spares before the introduction of the drug, if the volunteer took the drug, then the replacement is not performed.

Any volunteer who received a dose of the vaccine will be considered as included in the study, the data available on it will be used in assessing the safety and tolerability of the drug.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
This clinical trial is designed as a double blind randomized placebo-controlled study
Primary Purpose: Prevention
Condition  ICMJE
  • MERS (Middle East Respiratory Syndrome)
  • MERS
Intervention  ICMJE
  • Drug: BVRS-GamVac-Combi
    "BVRS-GamVac-Combi", a combined vector vaccine for the prevention of Middle East respiratory syndrome, lyophilisate for the preparation of a solution for intramuscular administration
  • Other: placebo
    placebo
Study Arms  ICMJE
  • Experimental: phase 1, component 1
    component 1 of vaccine
    Intervention: Drug: BVRS-GamVac-Combi
  • Experimental: phase 1, half dose
    prime-boost vaccination with component 1 and component 2 with an interval of 21 days in half dose
    Intervention: Drug: BVRS-GamVac-Combi
  • Experimental: phase 1, full dose
    prime-boost vaccination with component 1 and component 2 with an interval of 21 days in full dose
    Intervention: Drug: BVRS-GamVac-Combi
  • Experimental: phase 2, selected dose
    prime-boost vaccination with component 1 and component 2 with an interval of 21 days in selected dose
    Intervention: Drug: BVRS-GamVac-Combi
  • Placebo Comparator: phase 2, placebo
    vaccination with placebo with an interval of 21 days
    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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 14, 2019)
268
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

IInclusion Criteria

  1. written informed consent;
  2. absence of a history, as well as according to a screening examination of pathology from the gastrointestinal tract, liver, kidneys, cardiovascular system, central nervous system, musculoskeletal system, urogenital, immune and endocrine systems, blood, which may affect volunteer safety and evaluation of the results of the study (clinical, instrumental and laboratory studies did not reveal diseases or clinically significant deviations);
  3. males and females within the age range from 18 to 55 years;
  4. Consent to the use of effective methods of contraception during the entire period of participation in the study;
  5. subject body mass index (BMI): 18.5 ≤ BMI ≤ 30;
  6. absence of acute infectious diseases at the time of vaccination and 7 days before vaccination;
  7. absence of severe allergic diseases in the medical history
  8. no serious post-vaccination complications in patient's history following the earlier administration of immunobiological products;
  9. subject has a negative result of the blood or urine pregnancy test (for females of childbearing age);
  10. subject has negative tests for HIV, hepatitis B and С, syphilis;
  11. subject has a negative result of the urine test for residual narcotic drugs;
  12. Negative alcohol test;
  13. The indicators of the complete blood count test and biochemical analysis of blood on the screen within 1,1*ULN/LLN (upper limit of normal/lower limit of normal)
  14. absence of inflammatory or dystrophic myocardial changes based on ECG data

Exclusion Criteria:

  1. Volunteer participation in any other study over the past 90 days;
  2. Any vaccination in the last 30 days;
  3. Acute infectious and non-infectious diseases, exacerbations of chronic diseases within 4 weeks prior to screening;
  4. subject has received treatment with steroids for the last 10 days;
  5. subject has received immunoglobulins or other blood products over the last 3 months;
  6. subject has received immunosuppressive and/or immunomodulating agents within 6 months prior to the start of the study;
  7. Pregnancy or lactation;
  8. subject has systolic blood pressure less than 100 mm Hg or greater than 139 mm Hg; diastolic blood pressure less than 60 mm Hg or greater than 90 mm Hg; heart rate lower than 60 beats per minute or above 100 beats per minute;
  9. A burdened allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, a history of serum sickness, hypersensitivity or allergic reactions to the introduction of any vaccines in history, known allergic reactions to vaccine components, etc.);
  10. Diabetes mellitus or other forms of impaired glucose tolerance;
  11. presence of a concomitant illness in decompensation stage which might affect the course of the study (CNS organic lesion, decompensated cardiovascular diseases, any manifestations of kidney or acute liver failure, oncological diseases, diabetes mellitus);
  12. subject has a a history of neoplasms (ICD codes C00-D09);
  13. blood donation (at least 450 ml of blood or plasma) by subject in less than 2 months prior to the start of the study;
  14. Reception of narcotic and psychostimulating drugs at present or in the anamnesis;
  15. subject has a history of the consumption of more than 5 units alcohol per week, alcohol intake within 48 hours before the injection of the test drug;
  16. subject smokes more than 10 cigarettes a day;
  17. subject has a planned hospitalization and / or surgery during the period of participation in the study, as well as 4 weeks before the estimated date of vaccination.
  18. subject has any condition that, according to the researcher's doctor, may be a contraindication to participation in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Inna Dolzhikova, PhD 1933001 info@gamaleya.org
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04128059
Other Study ID Numbers  ICMJE 02-BVRS-GamVac-Combi-2019
Has Data Monitoring Committee No
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 Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Acellena Contract Drug Research and Development
Investigators  ICMJE
Principal Investigator: Tatiana Zubkova, MD, PhD ECO-Safety
PRS Account Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Verification Date January 2021

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