An Investigator Initiated, Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Safety, Immunogenicity and Efficacy of the Recombinant Two-component COVID-19 Vaccine (CHO Cell) in Adults Aged 18 Years and Older

NCT05679466 | Unknown Early Phase 1

• 1 other identifier: REC611-IIT-1
• Study Type: interventional
• Target: 3,300
• Locations: 1 country
• Sites: 1

Brief Summary

Study Objective(s) To evaluate the safety, immunogenicity and protective efficacy of 1 dose of ReCOV in participants who have received 2 or 3 doses of inactivated SARS-CoV-2 vaccination in Chinese adults aged 18 years and older. Primary objective To demonstrate the safety within 30 days after booster dose. Secondary objective(s) To evaluate the immunogenicity after booster dose. To demonstrate the safety within 6 months after booster dose. To evaluate the protective efficacy of RT-PCR-confirmed SARS-CoV-2 infection and COVID-19 after booster dose. Indications：Prevention of COVID-19 caused by SARS-CoV-2 Population：Participants aged 18 years and older who completed 2 or 3 doses vaccination of inactivated COVID-19 vaccines and whose last dose was given 6-18 months, of which the elderly aged 60 years and older account for about 10% to 15%. Sample Size：Approximately 3,300 participants

Conditions

Prevention of COVID-19 Caused by SARS-CoV-2

Outcome Measures

Primary Outcomes (3)

• solicited (local and systemic) AE

  Incidence of each solicited (local and systemic) AE within 7 days after booster dose.

  7 days after booster dose

• unsolicited AE

  Incidence of each unsolicited AE within 30 days after booster dose.

  within 30 days after booster dose

• AE associated with investigational vaccine

  Incidence of AE associated with investigational vaccine within 30 days after booster dose.

  within 30 days after booster dose

Secondary Outcomes (3)

• Immunogenicity

  on the 14th day, 3 months and 6 months after booster dose

• Safety observation

  6 months after booster dose

• protective efficacy

  14 days after booster dose

Study Arms (2)

ReCOV

ACTIVE COMPARATOR

Biological: randomized, double-blinded, placebo-controlled

ReCOV placebo

PLACEBO COMPARATOR

Biological: randomized, double-blinded, placebo-controlled

Interventions

randomized, double-blinded, placebo-controlled BIOLOGICAL

Approximately 3300 participants will be enrolled, including an immunogenic subgroup of approximately 240. Approximately 10% to 15% of all subjects will be 60 years of age and older. Enrolled subjects will be stratified by age (18-59 years, 60 years and older), number of previous doses of COVID-19 vaccine (2 or 3 doses), and interval from the last previous dose (180-365 days, 366-540 days). Participants will be randomized in a 1:1 ratio to receive 1 dose of the ReCOV or placebo on Day 0.

ReCOV; ReCOV placebo

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years and older. 2.Previous completion of 2 or 3 doses of inactivated COVID-19 vaccine and compliance with the vaccination procedures in the current instructions. The last dose of vaccination is 6 to 18 months (180 to 540 days, including the threshold) after the investigational vaccination, and proof of previous vaccination can be provided.
• Understand the content of the ICF, and voluntarily sign the ICF. 4.Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
• Healthy participants or participants with mild underlying disease \[in a stable state without exacerbation (no admission to hospital or no major adjustment to treatment regimen, etc.) for at least 3 months prior to enrollment in this study\].
• Female participants
• Surgically sterilized or ≥ 2 years post-menopause, or negative urine pregnancy test and willing to use effective contraception (e.g., condoms, IUDs) within 90 days of investigational vaccination. Contraceptive use is not allowed.
• Consent to not breastfeed during the study and for at least 90 days after investigational vaccination。 male participants Subjects of childbearing potential who agree to use effective contraception (e.g., condoms, spermicide) within 90 days of study vaccination.

You may not qualify if:

• Positive SARS-CoV-2 antigen during the screening period. 2.History of SARS, MERS, COVID-19 or known asymptomatic SARS-CoV-2 infection within 6 months prior to screening.
• Fever (axillary temperature ≥37.3 ℃) within 72 hours prior to vaccination. 4.History of severe allergy to any component of the experimental vaccine, including adjuvant components (squalene, alpha-tocopherol, and polysorbate 80, etc.), such as anaphylaxis, anaphylactic laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local anaphylactic necrotizing reaction (Arthus reaction); or previous history of severe side effects of any vaccine or drug, such as: allergy, urticaria, skin eczema, dyspnea, angioneurotic edema, etc.
• Currently suffering from acute infectious diseases or in the active stage of chronic infectious diseases, including but not limited to hepatitis B, hepatitis C.
• Current cancer, immune disorders (e.g., human immunodeficiency virus \[HIV\] infection, systemic lupus erythematosus, rheumatoid arthritis, absence of spleen or splenectomy, and other immune disorders that the investigator believes may have an impact on immune response), etc.; current other serious chronic diseases such as unstably controlled hypertension, asthma, heart disease, diabetes, liver or kidney disease, thyroid disease, hematologic system disorders (coagulation disorders or bleeding tendency), neurological/psychiatric disorders such as convulsions, epilepsy, etc.
• Undergoing anti-tuberculosis treatment. 8.Prolonged (defined as more than 14 days) use of immunosuppressive or other immunomodulatory drugs, anti-allergy therapy, or cytotoxic therapy within 6 months prior to the vaccine. Inhaled/nebulized, intra-articular, intradural, or topical (skin or eyes) corticosteroids are permitted. Topical doses should not exceed the recommended dose of the drug instructions.
• Have received blood products within 3 months prior to enrollment or plan to receive them during the study period.
• Participants who have received any other investigational product within 1 month prior to enrollment or intent to receive other investigational products during the study period.
• Received an inactivated vaccine or protein vaccine within 14 days prior to enrollment, or a live attenuated vaccine or adenovirus vector vaccine within 1 month, or intent to receive any other vaccine (except seasonal influenza vaccine or vaccine requiring emergency vaccination) during the study period.
• Participants deemed unsuitable for participation in this study based on the investigator's assessment.

Sponsors & Collaborators

• Yu Qin: lead

Study Sites (1)

West China Second University Hospital

Chengdu, China

Location

MeSH Terms

Interventions

Random Allocation; Double-Blind Method

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: senior technologist

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 11, 2023
• Study Start: December 27, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)