Study of Safety and Immunogenicity of BVRS-GamVac-Combi

NCT04128059 | Unknown Phase 1

• 1 other identifier: 02-BVRS-GamVac-Combi-2019
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

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.

Conditions

MERS (Middle East Respiratory Syndrome); MERS

Keywords

vaccine; vector based vaccine; Immunologic Factors; MERS-CoV; Middle East respiratory syndrome

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Adverse Events

  Determination of Number of Participants With Adverse Events

  through the whole study, an average of 180 days

• Number of Participants With Serious Adverse Events

  Determination of Number of Participants With Serious Adverse Events

  through the whole study, an average of 180 days

• Number of Participants with Solicited Local and Systemic Adverse Events

  Determination of Number of Participants with Solicited Local and Systemic Adverse Events

  through the whole study, an average of 180 days

• Antibody levels against the MERS-CoV glycoprotein S measured by an enzyme-linked immunosorbent assay (ELISA)

  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)

  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

Secondary Outcomes (2)

• Assessment of antigen-specific cell-mediated immune response

  at 0, 14 and 28 days from the start of vaccination compared to baseline values (phase 1, phase 2) and placebo (phase 2)

• Neutralizing antibody levels

  at days 0, 14 and 28 from the start of vaccination compared to baseline values

Study Arms (5)

phase 1, component 1

EXPERIMENTAL

component 1 of vaccine

Drug: BVRS-GamVac-Combi

phase 1, half dose

EXPERIMENTAL

prime-boost vaccination with component 1 and component 2 with an interval of 21 days in half dose

Drug: BVRS-GamVac-Combi

phase 1, full dose

EXPERIMENTAL

prime-boost vaccination with component 1 and component 2 with an interval of 21 days in full dose

Drug: BVRS-GamVac-Combi

phase 2, selected dose

EXPERIMENTAL

prime-boost vaccination with component 1 and component 2 with an interval of 21 days in selected dose

Drug: BVRS-GamVac-Combi

phase 2, placebo

PLACEBO COMPARATOR

vaccination with placebo with an interval of 21 days

Other: placebo

Interventions

BVRS-GamVac-Combi DRUG

"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

phase 1, component 1; phase 1, full dose; phase 1, half dose; phase 2, selected dose

placebo OTHER

placebo

phase 2, placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• written informed consent;
• 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);
• males and females within the age range from 18 to 55 years;
• Consent to the use of effective methods of contraception during the entire period of participation in the study;
• subject body mass index (BMI): 18.5 ≤ BMI ≤ 30;
• absence of acute infectious diseases at the time of vaccination and 7 days before vaccination;
• absence of severe allergic diseases in the medical history
• no serious post-vaccination complications in patient's history following the earlier administration of immunobiological products;
• subject has a negative result of the blood or urine pregnancy test (for females of childbearing age);
• subject has negative tests for HIV, hepatitis B and С, syphilis;
• subject has a negative result of the urine test for residual narcotic drugs;
• Negative alcohol test;
• 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)
• absence of inflammatory or dystrophic myocardial changes based on ECG data

You may not qualify if:

• Volunteer participation in any other study over the past 90 days;
• Any vaccination in the last 30 days;
• Acute infectious and non-infectious diseases, exacerbations of chronic diseases within 4 weeks prior to screening;
• subject has received treatment with steroids for the last 10 days;
• subject has received immunoglobulins or other blood products over the last 3 months;
• subject has received immunosuppressive and/or immunomodulating agents within 6 months prior to the start of the study;
• Pregnancy or lactation;
• 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;
• 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.);
• Diabetes mellitus or other forms of impaired glucose tolerance;
• 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);
• subject has a a history of neoplasms (ICD codes C00-D09);
• blood donation (at least 450 ml of blood or plasma) by subject in less than 2 months prior to the start of the study;
• Reception of narcotic and psychostimulating drugs at present or in the anamnesis;
• 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;

Sponsors & Collaborators

• Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation: lead
• Acellena Contract Drug Research and Development: collaborator

Study Sites (1)

ECO-Safety

Saint Petersburg, Russia

RECRUITING

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Tatiana Zubkova, MD, PhD

  ECO-Safety

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inna Dolzhikova, PhD

CONTACT

1933001; info@gamaleya.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This clinical trial is designed as a double blind randomized placebo-controlled study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: November 6, 2019
• Primary Completion: July 1, 2021
• Study Completion: December 31, 2021
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)