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

NCT05084989 | Completed Phase 2 DMC

• 1 other identifier: REC611C301
• Study Type: interventional
• Target: 948
• Locations: 1 country
• Sites: 1

Brief Summary

Part 1: Primary Vaccination in Adults Part 1 will evaluate the safety and immunogenicity of the recombinant two component COVID-19 vaccine (CHO cell) (ReCOV for short) in adults aged 18 years and older, when administered as 2 intramuscular doses, 21 days apart. Part 2: Booster Vaccination in Adults Part 2 will evaluate the immunogenicity and safety and of one booster dose of ReCOV in adult participants who have received primary vaccination with 2 doses of an inactivated COVID-19 vaccine (CoronaVac®). COMIRNATY®, an mRNA COVID-19 vaccine will be used as the active control.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

• Part1, Primary Safety

  Number of Participants with AEs

  Day 7 after first dose and up to Day 28 after second dose

• Part1, Primary immunogenicity

  To evaluate SARS-CoV-2 Specific Neutralizing Antibody

  14 days after 2 doses vaccination

• Part2, Primary immunogenicity

  To evaluate SARS-CoV-2 Specific Neutralizing Antibody

  14 days after 2 doses vaccination

Secondary Outcomes (2)

• Part1, Immunogenicity

  14 days, 3 months and 6 months after 2 doses vaccination

• Part2, safety and reactogenicity

  7 days, 28days and 6 months after the booster vaccination

Study Arms (4)

Part1: Recombinant two-component COVID-19 vaccine (CHO cell)

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

Biological: Part1:Recombinant two-component COVID-19 vaccine (CHO cell)

Part1: Placebo control

PLACEBO COMPARATOR

Antigen: 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

Biological: Part1: Placebo

Part2: Recombinant two-component COVID-19 vaccine (CHO cell)

EXPERIMENTAL

(Lot# HA202107009 and Lot# TC202205002) Recombinant two-component COVID-19 vaccine (CHO cell) 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

Biological: Part2: Recombinant two-component COVID-19 vaccine (CHO cell)

Part2: COMIRNATY® COVID-19 Vaccine, mRNA

ACTIVE COMPARATOR

Antigen: nucleoside-modified messenger RNA (mRNA) encoding the viral Spike (S) glycoprotein of SARS-CoV-2, called tozinameran. Others: ((4-hydroxybutyl) azanediyl) bis (hexane-6,1-diyl) bis (2-hexyldecanoate), 2-\[(polyethylene glycol)-2000\]-N, N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine, and cholesterol, potassium chloride, potassium dihydrogen phosphate, sodium chloride, disodium phosphate dihydrate, sucrose.

Biological: Part2: COVID-19 Vaccine, mRNA

Interventions

Part1:Recombinant two-component COVID-19 vaccine (CHO cell) BIOLOGICAL

2 doses. Before reconstitution:Lyophilized powder for reconstitution in single-use vials; After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter; Unite Does Strengths: 40ug/vial; Does Volume: 0.5ml/dose Routine of administration: Intramuscular (IM) injection

Also known as: Part1: ReCOV

Part1: Recombinant two-component COVID-19 vaccine (CHO cell)

Part1: Placebo BIOLOGICAL

2 doses. Before reconstitution: Lyophilized powder for reconstitution in single-use vials; After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter; Unite Does Strengths: Not Applicable; Does Volume: 0.5ml/dose; Routine of administration: IM injection;

Part1: Placebo control

Part2: Recombinant two-component COVID-19 vaccine (CHO cell) BIOLOGICAL

1 dose.Before reconstitution:Lyophilized powder for reconstitution in single-use vials; After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter; Unite Does Strengths: 40ug/vial; Does Volume: 0.5ml/dose Routine of administrati

Also known as: Part2: ReCOV

Part2: Recombinant two-component COVID-19 vaccine (CHO cell)

Part2: COVID-19 Vaccine, mRNA BIOLOGICAL

1 dose. Intramuscular injection, 30 μg/0.3 mL.

Also known as: Part2: COMIRNATY®

Part2: COMIRNATY® COVID-19 Vaccine, mRNA

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.
• All participants are 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 Part 1, participants should have not received any COVID-19 vaccine before the screening.
• For Part 2, participants should have received complete 2-dose primary vaccination with an inactivated COVID-19 vaccine (CoronaVac®), 90\~365 days (included) prior to the study vaccination.
• Provide written informed consent form (ICF) prior to study enrollment.
• Laboratory confirmed SARS-CoV-2 infection, defined by RT-PCR assay.
• Medical history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS) and COVID-19 within 12 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 or the control vaccine, 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., 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. Mild/moderate well-controlled comorbidities are allowed to participate as deemed appropriate by the investigator.

Sponsors & Collaborators

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

Study Sites (1)

The Health Centrum

Roxas City, Philippines

Location

Related Publications (2)

• 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

• Wynne C, Balgos A, Li J, Hamilton P, Tirador L, Jaen AM, Mo C, Yue Z, Ma Y, Wang Q, Wen R, Yao Z, Yu J, Yao W, Zhang J, Zheng H, Hong K, Zhu F, Liu Y. Safety and Immunogenicity of a Recombinant Two-Component SARS-CoV-2 Protein Vaccine: Randomized, Double-Blind, Placebo-Controlled Phase I and Phase II Studies. Infect Dis Ther. 2024 Jan;13(1):57-78. doi: 10.1007/s40121-023-00896-w. Epub 2023 Dec 16.

  PMID: 38103161 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

RNA, Messenger

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)

RNA; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• fanyue Meng

  cdc jiangsu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part1: double blinded Part2: observer-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part1: 2 arms Part2: 2 arms

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 20, 2021
• Study Start: January 31, 2022
• Primary Completion: August 18, 2022
• Study Completion: February 9, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)