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

NCT05726084 | Unknown Phase 2

• 1 other identifier: 02-COVAC-02/22
• Study Type: interventional
• Target: 16,304
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

COVID-19; Coronavirus Infections; Respiratory Tract Infections; COVID-19 Respiratory Infection

Keywords

COVID-19; cellular immunity; nucleocapsid protein; recombinant vaccine; SPbSRIVS; SARS-CoV-2; Convacell

Outcome Measures

Primary Outcomes (2)

• Change in titer of IgG antibodies to N-protein of SARS-CoV-2 (Stage IIb)

  Outcome Measure is analyzed separately in the 18-60 and \>60 age subgroups.

  Days 0, 42

• Frequency of symptomatic COVID-19 with laboratory-confirmed infection within 6 months after vaccination compared with the placebo group (Stage III)

  Laboratory confirmation of SARS-CoV-2 infection in accordance with current clinical guidelines can be a PCR study or an antigen test of a swab from the nasopharynx or oropharynx. The symptomatic form of COVID-19 is the presence of at least one of the following symptoms: fever/chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body pain, headache, loss of the sense of taste or smell, sore throat, nasal congestion or runny nose, nausea or vomiting, diarrhea. Outcome Measure is analyzed separately in the 18-60 and \>60 age subgroups.

  Days 0-180 (6 months)

Secondary Outcomes (24)

• Change in titer of IgM antibodies to N-protein of SARS-CoV-2 on day 42 after initial vaccination (Stage IIb)

  Days 0, 42

• Proportion of SARS-CoV-2 seropositive participants on day 42 after initial vaccination (Stage IIb)

  Days 0, 42

• Change in titer of IgG antibodies to N-protein of SARS-CoV-2 on day 42 after initial vaccination (Stage IIb)

  Days 0, 42

• The frequency of seroconversion (appearance of specific antibodies to SARS-CoV-2 N-protein) on day 42 after initial vaccination (Stage IIb)

  Days 0, 42

• Change from Baseline in the Mean Specifically Sensitized T-lymphocytes (Stage IIb)

  Days 0, 42

Study Arms (4)

Convacell, 1 dose (Stage IIb)

EXPERIMENTAL

Participants (230) will be vaccinated Convacell Vaccine, recombinant subunit vaccine for prevention of coronavirus infection, once intramuscularly. A cohort of participants will be allocated (115 participants) for evaluating cell-mediated immunity parameters.

Biological: Subunit recombinant vaccine for the prevention of coronavirus infection

Convacell, 2 doses (Stage IIb)

EXPERIMENTAL

Participants (230) will be vaccinated Convacell Vaccine, recombinant subunit vaccine for prevention of coronavirus infection, twice intramuscularly. A cohort of participants will be allocated (115 participants) for evaluating cell-mediated immunity parameters.

Biological: Subunit recombinant vaccine for the prevention of coronavirus infection

Convacell, chosen regimen (Stage III)

EXPERIMENTAL

Participants (10 562) will be vaccinated Convacell Vaccine, recombinant subunit vaccine for prevention of coronavirus infection, the regimen chosen in Stage IIb intramuscularly.

Biological: Subunit recombinant vaccine for the prevention of coronavirus infection

Placebo, chosen regimen (Stage III)

PLACEBO COMPARATOR

Participants (5 282) will be vaccinated Placebo, the regimen chosen in Stage IIb intramuscularly.

Biological: Placebo

Interventions

Subunit recombinant vaccine for the prevention of coronavirus infection BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Also known as: Convacell

Convacell, 1 dose (Stage IIb); Convacell, 2 doses (Stage IIb); Convacell, chosen regimen (Stage III)

Placebo BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Placebo, chosen regimen (Stage III)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• History of Quincke's edema;
• Positive blood test results for HIV, syphilis, hepatitis B/C according to the examination during the screening period (only for Stage IIb) or according to the history (for Stage III). It is acceptable to use the results of previously performed tests, if their prescription does not exceed 60 days before the date of the screening or based on history;
• Volunteers who received immunoglobulin during the last three months before the trial;
• History of long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs for six months before the trial;
• Treatment with glucocorticosteroids, including in small doses, as well as local use of drugs containing steroids (\> 10 mg of prednisolone or its equivalent for more than 14 days before the screening);

Sponsors & Collaborators

• St. Petersburg Research Institute of Vaccines and Sera: lead

Study Sites (6)

Limited Liability Company "OLLA-MED"

Moscow, Russia

Location

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

Location

Limited Liability Company "Scientific Research Center Eco-Safety"

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

Limited Liability Company "Otkrytaya Meditsina"

Tolyatti, Russia

Location

Limited Liability Company "Meditsinskiy Diagnosticheskiy Tsentr"

Yaroslavl, Russia

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Ellina Ruzanova

  St. Petersburg Research Institute of Vaccines and Sera

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 13, 2023
• Study Start: October 24, 2022
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

RU (6)