Efficacy, Safety and Immunogenicity Study of the Recombinant Two-component COVID-19 Vaccine (CHO Cell)(Recov)

NCT05398848 | Completed Phase 3 DMC

• 1 other identifier: REC611C303
• Study Type: interventional
• Target: 7,623
• Locations: 2 countries
• Sites: 11

Brief Summary

This is a multicenter designed Phase III clinical trial. About 10000 participants plan to be enrolled.The objectives of this study are to evaluate the efficacy, safety and immunogenicity of the recombinant two-component COVID-19 vaccine (CHO cell) in adults

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of ReCOV in preventing Reverse Transcription-Polymerase Chain Reaction (RT-PCR) confirmed symptomatic COVID-19 in adults

  RT-PCR confirmed symptomatic COVID-19 cases (regardless of severity) that occurred \> 14 days after 3 doses vaccination.

  > 14 days after 3 doses vaccination.

Secondary Outcomes (9)

• Evaluate the safety and reactogenicity

  within 7 days after each vaccination

• Evaluate the safety and reactogenicity

  from the 1st dose to 28 days after the 3rd vaccination.

• Evaluate the safety and reactogenicity

  from the 1st dose to the end of study.

• To evaluate the efficacy of ReCOV in preventing RT-PCR confirmed symptomatic COVID-19 with various severity in adults

  > 14 days after 3 doses vaccination.

• To evaluate the efficacy of ReCOV in preventing RT-PCR confirmed symptomatic COVID-19 with various severity in adults

  > 14 days after 3 doses vaccination.

Other Outcomes (1)

• Exploratory :

  > 14 days after the first dose vaccination

Study Arms (2)

Recombinant two-component COVID-19 vaccine (CHO cell)

EXPERIMENTAL

Antigen: NTD-RBD-foldon protein, Adjuvant (BFA03)

Biological: Recombinant two-component COVID-19 vaccine (CHO cell)

Placebo

PLACEBO COMPARATOR

Adjuvant (BFA03)

Biological: Placebo

Interventions

Recombinant two-component COVID-19 vaccine (CHO cell) BIOLOGICAL

Before reconstitution: Lyophilized powder for reconstitution in single-use vials After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter

Recombinant two-component COVID-19 vaccine (CHO cell)

Placebo BIOLOGICAL

Before reconstitution: Lyophilized powder for reconstitution in single-use vials After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years and older.
• Able and willing to comply with all study requirements.
• Willing to allow investigators to discuss the medical history with his/her general practitioner/personal doctors and access all medical records which are relevant to study procedures.

You may not qualify if:

• For females of childbearing potential only, willing to practice continuous effective contraception until 90 days after the final dose vaccination, and have negative pregnancy tests before each dose vaccination.
• Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal. A follicle-stimulating hormone (FSH) level and the amenorrhea duration (e.g. amenorrhea for ≥ 12 consecutive months prior to screening without an alternative medical cause) may be measured at the discretion of investigator to confirm postmenopausal status.
• The effective contraceptive methods include sexual abstinence or adequate contraceptive measures such as intrauterine or implanted contraceptive device, oral contraceptives, injected or implanted contraceptives, sustained-release topical contraceptives, condoms (male), diaphragm, and cervical cap, etc.
• Males participating in this study who are involved in heterosexual sexual activity must agree to practice adequate contraception (as described above) and refrain from donating sperm until 90 days after receiving the final dose vaccination.
• Agreement to refrain from blood donation during the study.
• Provide written informed consent form (ICF) prior to study enrollment.
• Laboratory confirmed SARS-CoV-2 infection defined by RT-PCR assay at screening. Participants with negative result for rapid antigen testing can be enrolled before having the result of RT-PCR assay, however, the participant needs to be withdrawn the following vaccination if the RT-PCR result shows positive.
• SARS-CoV-2 antibodies (IgM or IgG) positive at screening.
• Medical history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS) and COVID-19 within 6 months prior to the randomization.
• Fever (oral temperature ≥ 37.5°C / axillary temperature ≥ 37.3°C) on the day of vaccination or within recent 72 hours.
• History of severe allergic disease or reactions likely to be exacerbated by any component of ReCOV, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopaenic purpura, local hypersensitive necrosis reaction (Arthus reaction), or prior history of serious adverse reaction to any vaccine or drug, such as allergy, urticaria eczema, dyspnea, and angioneurotic edema.
• Have malignant tumor (except for skin basal cell carcinoma or carcinoma uterine cervix in situ) and immune disease (e.g., documented human immunodeficiency virus \[HIV\] infection, systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy, and other immune disease that may influence immune response at investigator's discretion).
• Have other severe and/or uncontrolled conditions, including but not limited to, acute infectious disease, cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, hematology disease, endocrine disorder, psychiatric condition and neurological illness. Uncontrolled condition is defined as significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
• Have bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.
• Received immunosuppressant or other immunomodulators, antiallergic therapy, or cytotoxicity therapy for 14 or more consecutive days within 6 months before receiving the investigational product (IP). Local administration of immunosuppressant or immunomodulator is allowed (e.g., ointment, eye drops, inhalation, or nasal spray). Drugs for local administration should not be given at a dose over the recommended level in package insert or participants should have no signs of systemic exposure.

Sponsors & Collaborators

• Jiangsu Rec-Biotechnology Co., Ltd.: lead

Study Sites (11)

B.P. Koirala Institute of Health Sciences

Dharān, Nepal

Location

Aramil City Hospital

Aramil, Russia

Location

LLC Medical Service solutions

Izhevsk, Russia

Location

'Federal State Budgetary Scientific Institution "Russian Scientific Centre of Surgery named after academician B.V. Petrovsky"

Moscow, Russia

Location

'Joint Stock Company "Clinical and diagnostic center "Euromedservice"

Moscow, Russia

Location

State Regional Budgetary Institution of Healthcare "Murmansk Regional Clinical Hospital named after P.A. Bayandin"

Murmansk, Russia

Location

LLC Professorskaya klinika

Perm, Russia

Location

UZI 4D Clinic LLC

Pyatigorsk, Russia

Location

Klinika Zvyezdnaya LLC

Saint Petersburg, Russia

Location

Limited Liability Company "Sfera-Med"

Saint Petersburg, Russia

Location

Research Center Eco-safety

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 1, 2022
• Study Start: October 31, 2022
• Primary Completion: September 4, 2023
• Study Completion: December 29, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (10); NE (1)