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Immunogenicity, Efficacy and Safety Trial of the Convacell Vaccine in Healthy Volunteers Aged 18 Years and Older | Clinical Trials | Clareo Health

UNKNOWNPHASE2/PHASE3

Immunogenicity, Efficacy and Safety Trial of the Convacell Vaccine in Healthy Volunteers Aged 18 Years and Older

Multicentre, Double-blind, Randomized, Prospective, Placebo-controlled Trial to Assess the Immunogenicity, Efficacy and Safety of the Coronavirus Vaccine in Healthy Volunteers Aged 18 Years and Older

NCT05726084•St. Petersburg Research Institute of Vaccines and Sera

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to assess the immunogenicity, efficacy and safety of the Convacell vaccine in healthy adult volunteers aged 18 years and older. The main questions it aims to answer are: * To assess the immunogenicity and safety of single and double dose intramuscular administration of the Convacell vaccine; * To assess the epidemiological effectiveness of the Convacell vaccine in the prevention of SARS-CoV-2 infection and development of severe COVID-19 compared with placebo when single or double intramuscular injection.

Detailed Description

The trial will be conducted in two stages (Stage IIb and Stage III). • Stage IIb Participants will be vaccinated one dose or two doses of the Convacell vaccine. Investigators will compare one dose and two doses groups and will choose the best vaccine dosage regimen in terms of immunogenicity and safety. • Stage III Participants will be vaccinated the Convacell vaccine or Placebo. Investigators will use the dosage regimen chosen in IIb stage.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Men and women aged 18 Years and Older
•Written informed consent of the volunteer to participate in the clinical trial (in paper or electronic form)
•BMI within the range of 18.5 ≤ BWI ≤ 30 kg/m2 with the body weight of not less than 55 kg for men, not less than 45 kg for women and not more than 100 kg for volunteers of both sexes
•Absence of clinically significant (according to the investigator) deviations from the reference values of clinical, laboratory and instrumental methods of examination at screening
•Hemodynamic and other vital signs are within normal limits (reference intervals are 60-90 beats/min at rest for HR, up to 22 per minute for RR, body temperature from 35.5 to 36.9 °C; systolic blood pressure (SBP) is considered normal in the range of 100-139 mmHg, diastolic blood pressure (DBP) - in the range of 60-89 mmHg)
•Volunteers able to fulfill requirements of the Protocol (i.e., fill in the electronic patient's diary, come to follow-up visits)
•Abstinence from alcohol from the start of screening until completion of Visit 7 procedures (day 42 ± 2) - for stage 2b
•For fertile women - a negative result of the pregnancy test and consent to observe adequate methods of contraception during the trial and at least two months after vaccination
•For fertile men - consent to observe adequate methods of contraception during the trial and at least two months after vaccination, except for men after vasectomy with documented azoospermia, and their sexual partners should use methods of contraception that ensure more than 90% reliability or be incapable of conception after a surgical sterilization or have a natural menopause for at least 2 years
•Throughout the study, the opportunity to use own smartphone with the ability to fill in the electronic patient's diary

Exclusion Criteria

•History of influenza or acute respiratory viral infection (ARVI) within 2 months before the start of the trial;
•A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema more than 8 cm in diameter) or complications (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions accompanied or not accompanied by a fever due to any previous vaccination);
•Fever, cough, and shortness of breath within 30 days before vaccination;
•History of COVID-19 within 6 months before screening;
•The level of IgG antibodies to the SARS-CoV-2 N-protein according to semi-quantitative test (Architect, Abbott) ≥ 3 (positivity rate) at screening;
•Positive result of the COVID-19 PCR test or antigen COVID-19 test (rapid test);
•Body temperature ≥ 37,3°C.
•History of allergies;
•Any vaccination within 30 days before the screening;
•History of leukemia, tuberculosis, cancer, autoimmune diseases;
+18 more criteria

Locations (6)

Limited Liability Company "OLLA-MED"

Moscow, Russia

State budgetary health care institution of the city of Moscow "City Clinical Hospital No. 24 of the Department of Health of the City of Moscow"

Moscow, Russia

Limited Liability Company "Scientific Research Center Eco-Safety"

Saint Petersburg, Russia

St. Petersburg State Budgetary Health Institution "City Polyclinic No. 117"

Saint Petersburg, Russia

Limited Liability Company "Otkrytaya Meditsina"

Tolyatti, Russia

Limited Liability Company "Meditsinskiy Diagnosticheskiy Tsentr"

Yaroslavl, Russia

Key Dates

Start Date

October 24, 2022

Primary Completion Date

October 30, 2023

Completion Date

December 30, 2023

Last Updated

August 30, 2023

Enrollment

16,304

ESTIMATED participants

Conditions

COVID-19Coronavirus InfectionsRespiratory Tract InfectionsCOVID-19 Respiratory Infection

Interventions

Subunit recombinant vaccine for the prevention of coronavirus infection

BIOLOGICAL

Placebo

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 30, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Immunogenicity, Efficacy and Safety Trial of the Convacell Vaccine in Healthy Volunteers Aged 18 Years and Older

Inclusion Criteria

Exclusion Criteria

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