Immunogenicity and Safety Study of Recombinant Two-Component COVID-19 Vaccine (CHO Cell)(ReCOV)

NCT05323435 | Completed Phase 2 DMC

• 1 other identifier: REC611C302
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, observer-blinded, active-controlled Phase II study to evaluate the immunogenicity, safety and reactogenicity of the low dose (20μg) and high dose (40μg) of ReCOV, when administered as a booster to healthy adults aged 18 to 65 years who have completed two or three doses vaccination (prioritized two doses). Estimate 300 participants.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (5)

• Immunogenicity at Phase II Study

  The GMT of live-virus neutralizing antibody against SARS-CoV-2 prototype at 14 days after the booster vaccination.

  at 14 days after the booster vaccination

• Immunogenicity at Phase II Study

  The SCR of live-virus neutralizing antibody against SARS-CoV-2 prototype at 14 days after the booster vaccination

  at14 days after the booster vaccination

• Safety at Phase II Study

  The occurrence of solicited local and systemic adverse events (AEs) within 7 days after the booster vaccination

  within 7 days after the booster vaccination

• Safety at Phase II Study

  The occurrence of unsolicited AEs within 28 days after the booster vaccination

  within 28 days after the booster vaccination

• Safety at Phase II Study

  The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs) till 6 months after the booster vaccination

  till 6 months after the booster vaccination

Study Arms (3)

Recombinant Two-Component COVID-19 Vaccine (CHO cell), 20μg

EXPERIMENTAL

Antigen: NTD-RBD-foldon protein, sodium dihydrogen phosphate, disodium hydrogen phosphate, sucrose, glycine, polysorbate 80 Adjuvant (BFA03): squalene, alpha-tocopherol, polysorbate 80, sodium chloride, potassium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate (ReCOV for short, 20μg)

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

Recombinant Two-Component COVID-19 Vaccine (CHO cell), 40μg

EXPERIMENTAL

Antigen: NTD-RBD-foldon protein, sodium dihydrogen phosphate, disodium hydrogen phosphate, sucrose, glycine, polysorbate 80 Adjuvant (BFA03): squalene, alpha-tocopherol, polysorbate 80, sodium chloride, potassium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate (ReCOV for short, 40μg)

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

COVID-19 Vaccine (Vero Cell), Inactivated

ACTIVE COMPARATOR

Antigen: inactivated SARS-CoV-2 Virus (19nCoV-CDC-Tan-HB02 strain) Adjuvant: aluminum hydroxide Excipients: disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride

Biological: COVID-19 Vaccine (Vero Cell), Inactivated

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

Also known as: ReCOV

Recombinant Two-Component COVID-19 Vaccine (CHO cell), 20μg; Recombinant Two-Component COVID-19 Vaccine (CHO cell), 40μg

COVID-19 Vaccine (Vero Cell), Inactivated BIOLOGICAL

Milky-white suspension.Stratified precipitate may form which can be dispersed by shaking

COVID-19 Vaccine (Vero Cell), Inactivated

Eligibility Criteria

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

You may qualify if:

• Aged 18 to 65 years (included).
• Able and willing to comply with all study requirements.
• Willing to allow the investigators to discuss the volunteers' 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:

• Have completed two doses vaccination by inactivated COVID-19 vaccine prior to the study vaccination. The duration since the last primary vaccination is 90\~365 days (included) for both Phase II and Phase III stages.
• For females of childbearing potential only, willing to practice continuous effective contraception till 90 days after the study vaccination, and have negative pregnancy tests before study vaccination.
• Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to Screening without an alternative medical cause). A follicle-stimulating hormone (FSH) level 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 activity must agree to practice adequate contraception (as described above) and refrain from donating sperm till 90 days after receiving the study 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 the result of SARS-CoV-2 RT-PCR assay is positive.
• Medical history of COVID-19 disease with confirmed clinical diagnosis.
• Fever (oral temperature ≥ 37.5°C / axillary temperature ≥ 37.3°C) on the day of vaccination. Or having fever within recent 72 hours before the vaccination.
• Having abnormal results of clinical laboratory testing during screening, which is judged by the investigator with clinical significance, including the hematology, liver function, renal function, other blood chemistry, and coagulation function.
• History of severe allergic disease or reactions likely to be exacerbated by any component of ReCOV or COVID-19 Vaccine (Vero Cell), Inactivated, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopaenic purpura, local hypersensitive necrosis reaction (Arthus reaction), prior history of serious adverse reaction to any vaccine or drug, such as allergy, urticaria eczema, dyspnea, and angioneurotic edema.
• Having malignant tumor (except for skin basal cell carcinoma or carcinoma uterine cervix in situ), immune disease (e.g., human immunodeficiency virus \[HIV\] infection, systemic lupus erythematosus, rheumatoid arthritis, alienia or splenectomy, and other immune disease that may influence immune response at the investigator's discretion).
• Having severe and/or uncontrolled conditions, including but not limited to, acute infectious disease, cardiovascular disease, respiratory disease (including tuberculosis under anti-tuberculosis therapy), gastrointestinal disease, liver disease, renal disease, hematology disease, endocrine disorder, psychiatric condition and neurological illness (e.g., medical or family history of seizure, epilepsy, encephalopathy). Mild/moderate well-controlled comorbidities are allowed to participate.
• Having bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.

Sponsors & Collaborators

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

Study Sites (1)

AI Kuwait Hospital

Dubai, 7272, United Arab Emirates

Location

Related Publications (1)

• Balgos A, Hannawi S, Chen WL, Abuquta A, Safeldin L, Hassan A, Alamadi A, Tirador L, Jaen AM, Villalobos RE, Mo C, Yue ZJ, Ma Y, Wang QS, Wen RD, Yao Z, Yu JP, Yao WR, Zhang JH, Hong KX, Liu Y, Li JX. Immunogenicity and safety of boosting with a recombinant two-component SARS-CoV-2 vaccine: two randomized, parallel-controlled, phase 2 studies. Expert Rev Vaccines. 2024 Jan-Dec;23(1):419-431. doi: 10.1080/14760584.2024.2334423. Epub 2024 Apr 2.

  PMID: 38529685 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Suad Al Hannawi, Dr.

  AI Kuwait Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 12, 2022
• Study Start: May 30, 2022
• Primary Completion: July 5, 2022
• Study Completion: January 16, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)