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COVID-19Phase 2NCT05323435

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

A Phase 2 study testing Recombinant two-component COVID-19 vaccine (CHO cell) and COVID-19 Vaccine (Vero Cell), Inactivated in people with COVID-19, run by Jiangsu Rec-Biotechnology Co., Ltd. at 1 site in United Arab Emirates.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Recombinant two-component COVID-19 vaccine (CHO cell) and COVID-19 Vaccine (Vero Cell), Inactivated
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited Arab Emirates
Study dates
30 May 2022to 16 Jan 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • Healthy adults, or adults 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.
  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.
  • Received immunosuppressant or other immunomodulators, antiallergic therapy, or cytotoxicity therapy for 14 or more consecutive days within 6 months before the study vaccination. Local administration of immunosuppressant or immunomodulator is allowed (e.g., ointment, eye drops, inhalation, or nasal spray). Drugs for local administration should not be given at a dose over the recommended level in package insert or participants should have no signs of systemic exposure.
  • Administration of immunoglobulin and/or blood product within 3 months before the study vaccination or plan to use that during the study.
  • Continuous use of anticoagulants, such as coumarins and related anticoagulants (e.g., warfarin) or novel oral anticoagulants (e.g., apixaban, rivaroxaban, dabigatran and edoxaban).
  • Used other investigational drug or interventional device within 1 month before the study vaccination or plan to use that during the study, or are using other investigational drug or are within 5 half-lives after the last dose of the investigational drug.
  • Used a subunit or inactivated vaccine within 14 days or an attenuated live vaccine within 1 month (30 days) before the study vaccination, or plan to receive any other vaccines except for the seasonal influenza vaccine, or other vaccines for emergency use (e.g., to prevent tetanus and rabies) during the study.
  • Prior receipt of any investigational or licensed COVID-19 vaccine except for the primary vaccination with inactivated vaccines according to the protocol, or plan to receive any COVID-19 vaccine except for the investigational products during the study stage.
  • Suspected or known current alcohol or drug dependency.
  • Having contraindications for intramuscular injection or intravenous blood sampling.
  • Pregnancy, lactation or plan to become pregnant within 90 days after receiving study vaccine.
  • Staff of study site, sponsor, and contract research organization (CRO) taking part in study conduct.
  • At investigator's discretion, any other significant disease, disorder or finding that may increase the risk because of participation in the study, or prevent from participation in the study, or impair interpretation of the study data.

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site

  • AI Kuwait Hospital

    Dubai, 7272

Other trials in United Arab Emirates

About this study

Official title: A Multicenter, Randomized, Observer-Blinded, Active-Controlled Phase II Study to Evaluate the Immunogenicity and Safety of One Dose Booster by Recombinant Two-Component COVID-19 Vaccine (CHO Cell) in Adults Aged 18 Years and Older

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.

Read the detailed description

The study is a multicenter, randomized, observer-blinded, active-controlled trial. About 300 eligible participants will be randomized equally (1:1:1) into 20 μg ReCOV group, 40 μg ReCOV group, and the control vaccine [COVID-19 Vaccine (Vero Cell), Inactivated] group, respectively, stratified by age (18 to < 50 years, ≥ 50 to ≤ 65 years) and the duration since the last dose of primary vaccination (90~180 days, 181~365 days).

All Participants will be observed for 30 minutes after study vaccination at study site if Participants will be asked to record solicited AEs within 7 days and unsolicited AEs within28 days. After 28 days post the study vaccination，all participants will have 2 on-site safety follow-up Visits on Day 90 (±15days) and on Day 180 (±15days) after the study vaccination to collect serious adverse evens (SAEs), adverse events of special interest (AESIs). During the study period, they can spontaneously report any adverse events (AEs) they experienced at any time.

Conditions
COVID-19
Being tested
Recombinant two-component COVID-19 vaccine (CHO cell), COVID-19 Vaccine (Vero Cell), Inactivated
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called ReCOV

    Before reconstitution: Lyophilized powder for reconstitution in single-use vials After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter

  • COVID-19 Vaccine (Vero Cell), InactivatedBiological

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

Study groups in NCT05323435
Study groupRoleWhat they receive
Recombinant Two-Component COVID-19 Vaccine (CHO cell), 20μgExperimentalAntigen: 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)
Receives: Biological: Recombinant two-component COVID-19 vaccine (CHO cell)
Recombinant Two-Component COVID-19 Vaccine (CHO cell), 40μgExperimentalAntigen: 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)
Receives: Biological: Recombinant two-component COVID-19 vaccine (CHO cell)
COVID-19 Vaccine (Vero Cell), InactivatedActive comparatorAntigen: inactivated SARS-CoV-2 Virus (19nCoV-CDC-Tan-HB02 strain) Adjuvant: aluminum hydroxide Excipients: disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride
Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immunogenicity at Phase II Study

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

    Measured: at 14 days after the booster vaccination

  2. Immunogenicity at Phase II Study

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

    Measured: at14 days after the booster vaccination

  3. Safety at Phase II Study

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

    Measured: within 7 days after the booster vaccination

  4. Safety at Phase II Study

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

    Measured: within 28 days after the booster vaccination

  5. 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

    Measured: till 6 months after the booster vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2022
  2. Study start30 May 2022
  3. Primary completion5 Jul 2022
  4. Study completion16 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05323435
Sponsor's protocol ID
REC611C302
Status last verified
Apr 2023
First submitted
11 Apr 2022
Last updated
25 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make individual participant data (IPD) available

Publications

  • 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.

    PubMed 38529685

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Recombinant two-component COVID-19 vaccine (CHO cell) and COVID-19 Vaccine (Vero Cell), Inactivated in people with COVID-19, run by Jiangsu Rec-Biotechnology Co., Ltd. at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunogenicity at Phase II Study (time frame: at 14 days after the booster vaccination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05323435, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.

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