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COVID-19Phase 2ReCOVNCT05084989

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

A Phase 2 study testing Part1:Recombinant two-component COVID-19 vaccine (CHO cell), Part2: Recombinant two-component COVID-19 vaccine (CHO cell) and Part2: COVID-19 Vaccine, mRNA in people with COVID-19, run by Jiangsu Rec-Biotechnology Co., Ltd. at 1 site in Philippines.

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

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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Part1:Recombinant two-component COVID-19 vaccine (CHO cell), Part2: Recombinant two-component COVID-19 vaccine (CHO cell) and Part2: COVID-19 Vaccine, mRNA
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
948 participants
Where
1 sitePhilippines
Study dates
31 Jan 2022to 9 Feb 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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Philippines1 site

  • The Health Centrum

    Roxas City

Other trials in Philippines

About this study

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

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.

Read the detailed description

Part 1: Primary Vaccination in Adults Around 340 participants aged 18 years and older who do not have known COVID-19 or COVID-19 vaccination history will be randomized into ReCOV group (40 μg) or placebo group in a ratio of 2:1. Accordingly, around 227 participants will receive 40 μg ReCOV and 113 participants will receive matching placebo, respectively. Participants will be stratified by age (18~59 years, ≥60 years) and status of SARS-CoV-2 antibody at baseline.

After randomization, participants will enter into a double-blinded period (until all participants complete V6) and an open-label long-term follow-up period (after all participants complete V6 until end of the study).

After all participants complete the visit at 7 days after the 2nd vaccination, the safety and reactogenicity data will be summarized by an independent statistic group, while the sponsor, investigators and all study participants will be kept blinded. The safety summary will be submitted to DSMB for review and recommendation on the initiation of Part 2.

The primary analysis of Part 1 is planned after all participants complete the Visit 6 (V3 + 28 days, +7 days) and are unblinded, to evaluate the safety and immunogenicity during the double-blinded period.

The final analysis of Part 1 will be conducted after all participants of the ReCOV group complete the follow-up visit at 6 months after the 2nd vaccination, to evaluate the safety and immunogenicity during this study stage.

Part 2: Booster Vaccination in Adults This study part will enroll participants who have received primary vaccination by an inactivated COVID-19 vaccine (CoronaVac®) within 3 to 12 months (90~365 days). The mRNA COVID-19 vaccine, COMIRNATY ®, will be used as the active control. The immunogenicity induced by the booster vaccination of ReCOV (commercial batch, Lot# TC202205002) will be compared with that of COMIRNATY®. In addition, the immunogenicity of one dose booster of commercial batch ReCOV (Lot# TC202205002) will be compared with that of pilot batch ReCOV (Lot# HA202107009).

About 600 participants will be enrolled into the study. Eligible participants will be 1:1:1 randomized to receive 20 μg ReCOV (Lot# HA202107009), 20 μg ReCOV (Lot# TC202205002), or 30 μg COMIRNATY®, stratified by age (18~59 years, ≥60 years) and the duration since the last primary vaccination (90~180 days, 181~365 days).

All participants will be followed up for safety and reactogenicity. Participants will be observed for 30 minutes at study site after the vaccination. Before leaving the study site, participants will be given participant diaries to record solicited AEs within 7 days after dosing, and unsolicited AEs within 28 days after dosing. The occurrence of SAEs and AESIs will also be monitored till 6 months after the study vaccination.

The interim analysis is planned after all participants complete the Visit 5 at 28 days after the dosing, to evaluate the immunogenicity and safety within this period.

The final analysis will be conducted after all participants complete the follow-up visit at 6 months post the booster vaccination, to evaluate the immunogenicity and safety.

Conditions
COVID-19
Being tested
Part1:Recombinant two-component COVID-19 vaccine (CHO cell), Part1: Placebo, Part2: Recombinant two-component COVID-19 vaccine (CHO cell), Part2: COVID-19 Vaccine, mRNA
Medical subject headings
COVID-19

What participants receive

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

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

    Also called Part1: ReCOV

    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

  • Part1: PlaceboBiological

    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;

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

    Also called Part2: ReCOV

    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

  • Part2: COVID-19 Vaccine, mRNABiological

    Also called Part2: COMIRNATY®

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

Study groups in NCT05084989
Study groupRoleWhat they receive
Part1: Recombinant two-component COVID-19 vaccine (CHO cell)ExperimentalAntigen: 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
Receives: Biological: Part1:Recombinant two-component COVID-19 vaccine (CHO cell)
Part1: Placebo controlPlacebo comparatorAntigen: 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
Receives: 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
Receives: Biological: Part2: Recombinant two-component COVID-19 vaccine (CHO cell)
Part2: COMIRNATY® COVID-19 Vaccine, mRNAActive comparatorAntigen: 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.
Receives: Biological: Part2: COVID-19 Vaccine, mRNA

What is being measured

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

  1. Part1, Primary Safety

    Number of Participants with AEs

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

  2. Part1, Primary immunogenicity

    To evaluate SARS-CoV-2 Specific Neutralizing Antibody

    Measured: 14 days after 2 doses vaccination

  3. Part2, Primary immunogenicity

    To evaluate SARS-CoV-2 Specific Neutralizing Antibody

    Measured: 14 days after 2 doses vaccination

Secondary outcomes (2)

  1. Part1, Immunogenicity

    To evaluate other immunogenicity variables of ReCOV in adults aged 18 years and older.

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

  2. Part2, safety and reactogenicity

    The occurrence of AEs

    Measured: 7 days, 28days and 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 posted20 Oct 2021
  2. Study start31 Jan 2022
  3. Primary completion18 Aug 2022
  4. Study completion9 Feb 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
Parallel groups
Model description
Part1: 2 arms Part2: 2 arms
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
948 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05084989
Sponsor's protocol ID
REC611C301
Acronym
ReCOV
Status last verified
Feb 2024
First submitted
14 Oct 2021
Last updated
29 Feb 2024
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

  • 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.

    PubMed 38103161

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Part1:Recombinant two-component COVID-19 vaccine (CHO cell), Part2: Recombinant two-component COVID-19 vaccine (CHO cell) and Part2: COVID-19 Vaccine, mRNA in people with COVID-19, run by Jiangsu Rec-Biotechnology Co., Ltd. at 1 site in Philippines.

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 7 inclusion and 6 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 29 Feb 2024. 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 Philippines. 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. Some participants in this study may receive a placebo. 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?

Part1, Primary Safety (time frame: Day 7 after first dose and up to Day 28 after second dose). The study lists 3 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 NCT05084989, which also lists 2 linked publications.

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 29 Feb 2024.

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