Safety, and Immunogenicity Study of the Recombinant Two-component COVID-19 Vaccine (CHO Cell)
- 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.
- Acronym
- ReCOV
- Short title
- Safety, and Immunogenicity Study of the Recombinant Two-component COVID-19 Vaccine (CHO Cell)
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2023-02-09
- First posted
- 2021-10-20
- Registry last updated
- 2024-02-29
- Primary completion date
- 2022-08-18
- Start date
- 2022-01-31
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Jiangsu Rec-Biotechnology Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05084989
- ClinicalTrials.gov ID
- NCT05084989
- Registry record
- Open registry record
- 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
Part1, Primary Safety
Timeframe: Day 7 after first dose and up to Day 28 after second dose
Number of Participants with AEs
Part1, Primary immunogenicity
Timeframe: 14 days after 2 doses vaccination
To evaluate SARS-CoV-2 Specific Neutralizing Antibody
Part2, Primary immunogenicity
Timeframe: 14 days after 2 doses vaccination
To evaluate SARS-CoV-2 Specific Neutralizing Antibody
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.
Part2, safety and reactogenicity
Timeframe: 7 days, 28days and 6 months after the booster vaccination
The occurrence of AEs
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Healthy volunteers
- Yes
-
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.
-
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.
-
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.
- The Health CentrumRoxas City, Philippines
- PubMed 38529685Related publication
- PubMed 38103161Related publication
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- COVID-19 Primary condition