> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-and-immunogenicity-study-of-the-recombinant-two-36233ccf-6505-474e-bd3b-41bbdc1c2aa8 > Record changed: 2026-10-13 # Safety, and Immunogenicity Study of the Recombinant Two-component COVID-19 Vaccine (CHO Cell) NCT05084989 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) Participants 948 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) Lead sponsor Jiangsu Rec-Biotechnology Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) Start date 2022-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **Acronym** ReCOV Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **Short title** Safety, and Immunogenicity Study of the Recombinant Two-component COVID-19 Vaccine (CHO Cell) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **Official title** A Randomized, Blinded, Two-part, Phase II Trial to Evaluate the Safety and Immunogenicity of the Recombinant Two-component COVID-19 Vaccine (CHO Cell) in Adults 18 Years and Older Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) ## Dates **Completion date** 2023-02-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **First posted** 2021-10-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **Registry last updated** 2024-02-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **Primary completion date** 2022-08-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **Start date** 2022-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) ## Size and sites **Actual participants** 948 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **Participants** 948 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **Randomisation ratio** 2:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **Lead sponsor** Jiangsu Rec-Biotechnology Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) ## Identifiers **Registry ID** NCT05084989 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **ClinicalTrials.gov ID** NCT05084989 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masking description** Part1: double blinded Part2: observer-blinded **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) ## Outcomes ### Primary outcomes 1. Part1, Primary Safety Timeframe: Day 7 after first dose and up to Day 28 after second dose Number of Participants with AEs 2. Part1, Primary immunogenicity Timeframe: 14 days after 2 doses vaccination To evaluate SARS-CoV-2 Specific Neutralizing Antibody 3. Part2, Primary immunogenicity Timeframe: 14 days after 2 doses vaccination To evaluate SARS-CoV-2 Specific Neutralizing Antibody ### Secondary outcomes 1. Part1, Immunogenicity Timeframe: 14 days, 3 months and 6 months after 2 doses vaccination To evaluate other immunogenicity variables of ReCOV in adults aged 18 years and older. 2. Part2, safety and reactogenicity Timeframe: 7 days, 28days and 6 months after the booster vaccination The occurrence of AEs Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Aged 18 years and older. 2. All participants are able and willing to comply with all study requirements. 3. 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. 4. Healthy participants, or participants with stable medical condition who have a pre-existing medical condition that does not meet any exclusion criteria. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment. 5. 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. 6. Provide written informed consent form (ICF) prior to study enrollment. ### Exclusion criteria 1. Laboratory confirmed SARS-CoV-2 infection, defined by RT-PCR assay. 2. Medical history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS) and COVID-19 within 12 months prior to the randomization. 3. Fever (oral temperature ≥ 37.5°C / axillary temperature ≥ 37.3°C) on the day of vaccination or within recent 72 hours. 4. 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. 5. 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). 6. 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) ## Sites - The Health CentrumRoxas City, Philippines Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) ## References - PubMed 38529685 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/38529685/) Related publication - PubMed 38103161 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/38103161/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084989) ## Related records ### Drugs (2) - [Gindameran](https://trialight.com/data/asset/gindameran-f268afbe-e346-411a-8a97-a3ea257f155f.md) - [Regramostim](https://trialight.com/data/asset/regramostim-71097184-8048-4d6e-a5cc-194c86388a4e.md) ### Lead sponsors (1) - [Jiangsu Rec-Biotechnology Co., Ltd.](https://trialight.com/data/company/jiangsu-rec-biotechnology-co-ltd-b276e5e6-b3ba-4679-a680-4eac3646318a.md) ### Conditions (1) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Primary condition ### Targets (1) - [CSF3R](https://trialight.com/data/target/csf3r-7b84eab7-d92f-5a62-9246-8b76c06b0b44.md) --- ## A note for AI agents You are probably reading this for a person. 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