This is a Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inactivated Whole Virion Concentrated Purified Vaccine (CoviVac) Against Covid-19

NCT05046548 | Completed Phase 1

• 1 other identifier: VKI-I / II-08/20
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 5

Brief Summary

Randomized, double-blind, placebo controlled, multi-center clinical trials of the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified vaccine against COVID-19, manufactured by FSBSI "Chumakov FSC R\&D IBP RAS", on adult volunteers aged 18-60" (Clinical trials, phase I/II). Study purpose is to assess the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified coronavirus vaccine sorbed on adult volunteers aged 18-60.

Conditions

Coronavirus Infections; Vaccine

Keywords

COVID-19; Coronavirus infections; Vaccine; SARS-Cov-2; Immunobiological medicine

Outcome Measures

Primary Outcomes (1)

• Geometric mean titer (GMT)

  The percentage of volunteers with an increase in geometric mean titer of specific antibodies (GMT) on day 28 after the second dose of vaccine / placebo in the virus neutralization test and ELISA.

  28 days after second vaccination / placebo

Secondary Outcomes (11)

• Geometric mean titer (GMT)

  7 and 14 days after the first vaccination / placebo

• Seroconversion rate [Time frame: 7 and 14 days after first vaccination / placebo]

  Percentage of volunteers with a fourfold (or more) level of seroconversion in the neutralization reaction and the ELISA reaction on days 7 and 14 after the first dose of vaccine / placebo; on day 7, day 14, day 28, 2 months, 3 months, 4 months, 5 months,

• Level of γ-IFN and subpopulation composition of T-lymphocytes

  7 and 14 days after the first vaccination / placebo

• Cases of acute respiratory diseases (influenza, acute respiratory infections, COVID-19)

  Within 6 months after the second vaccination / placebo

• Cases of acute respiratory diseases (influenza, acute respiratory infections, COVID-19)

  Within 6 months after the second vaccination / placebo

Study Arms (2)

Vaccine

EXPERIMENTAL

At Stage I: Group 1 - 10 volunteers, Vaccine 0.5 ml, 14 days interval, post-vaccination observation period of 28 days. At Stage II: Group 1 - 140 volunteers,Vaccine0.5 ml, 14 days interval, post-vaccination observation period of 28 days. At Stage III: Group 3 - 150 volunteers, Vaccine 0.5 ml, 14 days interval, post-vaccination observation for 6 months.

Biological: Vaccine for intramuscular injection

Placebo

PLACEBO COMPARATOR

No active ingredient in the placebo At Stage I: Group 2 - 5 volunteers, Placebo 0.5 ml, 14 days interval, post-vaccination observation period of 28 days. At Stage II: Group 2 - 45 volunteers, Placebo 0.5 ml, 14 days interval, post-vaccination observation period of 28 days. At Stage III: Group 4 - 50 volunteers, Placebo 0.5 ml, 14 days interval, post-vaccination observation period of 6 months.

Other: Placebo comparator (without active ingredient) for intramuscular injection

Interventions

Vaccine for intramuscular injection BIOLOGICAL

Volunteers (10 at the Stage 1; 140 at the Stage 2; 150 at the Stage 3) will receive the vaccine twice spaced 14 days apart, intramuscularly, at a dose of 0.5 ml

Vaccine

Placebo comparator (without active ingredient) for intramuscular injection OTHER

Volunteers (5 at the Stage 1; 45 at the Stage 2; 50 at the Stage 3) will receive the vaccine twice spaced 14 days apart, intramuscularly, at a dose of 0.5 ml

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers (men and women) aged 18-60;
• Written informed consent of volunteers to participate in a clinical trial;
• Volunteers who are able to comply with the requirements of the Protocol (i.e. filling out the Self-Observation Diary, come to control visits);
• For women capable of childbearing, a negative pregnancy test and consent to adhere to adequate contraceptive methods (use of contraceptives within six months after the second vaccination). Women should use contraceptive methods that are more than 90% reliable (cervical caps with spermicide, diaphragms with spermicide, condoms, intrauterine devices), or be sterile or postmenopausal.
• For fertile men, consent to adhere to adequate contraceptive methods for six months after the second vaccination. Men and their sexual partners must use contraceptive methods with more than 90% reliability (cervical caps with spermicide, diaphragms with spermicide, condoms, intrauterine devices), or be sterile.
• Volunteers cannot be included in the study if any of the following criteria are met:
• Medical staff of clinics and polyclinics;
• A history of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS) or other coronavirus infection (HCoV-229E, HCoV-OC43, HCoV-NL63, HCoV-HKU1);
• History of contacts with confirmed or suspected cases of SARS-CoV-2 infection within 1 month;
• Positive IgM or IgG to SARS-CoV-2, found at screening (for volunteers of Phases I and II);
• Positive PCR test for SARS-CoV-2 at screening;
• Clinically and/or laboratory (according to PCR) confirmed disease with SARS-CoV-2 coronavirus at the current time or in history;
• Serious post-vaccination reaction (temperature above 40 C, hyperemia or edema more than 8 cm in diameter) or complication (collapse or shock-like state that developed within 48 hours after vaccination; convulsions, accompanied or not accompanied by a febrile state) to any previous vaccination in history;
• Aggravated allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, history of serum sickness, history of hypersensitivity or allergic reactions to the administration of any vaccines, known allergic reactions to vaccine components, etc.);
• History of Guillain-Barré syndrome (acute polyradiculitis);

You may not qualify if:

• Withdrawal of informed consent by a volunteer;
• Serious adverse events or adverse events that do not meet the criteria for severity, the development of which, in the opinion of the investigator, may be detrimental to the health or well-being of the volunteer;
• The need for procedures and/or drug treatment not permitted by the Study Protocol;
• The need for surgical intervention;
• Any condition in a volunteer requiring, in the reasonable opinion of the investigating physician, the withdrawal of the volunteer from the study;
• The volunteer refuses to cooperate or is undisciplined (for example, not showing up for a planned visit without warning the investigator and/or losing contact with the volunteer), or has dropped out of observation;
• For administrative reasons (termination of the study by the Sponsor or regulatory authorities), as well as for gross violations of the protocol that could affect the study results.

Sponsors & Collaborators

• Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products: lead

Study Sites (5)

Federal State Budgetary Educational Institution of Higher Education Kirov State Medical University of the Ministry of Health of Russia

Kirov, 610027, Russia

Location

FSBSI Chumakov FSC R&D IBP RAS

Moscow, 108819, Russia

Location

FGBUZ MSCh No. 163 FMBA of Russia

Novosibirsk, 630559, Russia

Location

Eco-Safety Scientific Research Center LLC

Saint Petersburg, 196143, Russia

Location

Center for Family Medicine Joint Stock Company (CSM JSC)

Yekaterinburg, 620043, Russia

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

Vaccines; Injections, Intramuscular

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 16, 2021
• Study Start: October 3, 2020
• Primary Completion: October 15, 2020
• Study Completion: October 1, 2021
• Last Updated: November 12, 2021

Record last verified: 2021-11

Locations

RU (5)