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COVID-19 PandemicPhase 1NCT05366296

Safety, Reactogenicity, and Immunogenicity Study of a Lyophilized COVID-19 mRNA Vaccine

A Phase 1 study testing A Lyophilized COVID-19 mRNA Vaccine in people with COVID-19 Pandemic, run by Wuhan Recogen Biotechnology Co., Ltd..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen that causes a coronavirus-associated acute respiratory disease called coronavirus disease 19 (COVID-19), which is spreading all over the world. This virus can cause acute respiratory distress syndrome (ARDS) with a high fatality rate. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19 Pandemic
What is being tested?
A Lyophilized COVID-19 mRNA Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Jul 2022to Jan 2023
Phase
Phase 1
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Aged 18 to 60 years (included) at screening.
  • Have a body mass index (BMI) between 18.5 and 35.0 kg/m2 (included)
  • Able and willing to comply with all study requirements.
  • Willing to allow the Investigator to discuss the volunteers'participant's medical history with his/her general practitioner/personal doctors and access all medical records which are relevant to study procedures.
  • Participants who are of general good health, or with medically stable, well-controlled comorbidities according to the Investigator's assessment, based on medical history at the time of screening and clinical evaluations.
  • Have completed three doses vaccination by any mRNA COVID-19 vaccine 3~12 months (90~365 days, included) prior to the study vaccination.
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  • Females of childbearing potential who are involved in heterosexual sexual activity, must be willing to practice continuous effective contraception until 90 days after the study vaccination and have negative pregnancy tests before study vaccination.
  • 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 the 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 sexual activity must agree to practice adequate contraception (as described above) and refrain from donating sperm until 90 days after the study vaccination.
  • Agreement to refrain from blood donation during the study from time of informed consent until end of study visit.
  • Provide written informed consent form (ICF) prior to any study screening activity.

Who cannot join

  • Laboratory confirmed SARS-CoV-2 infection (history), defined by the result of SARS-CoV-2 RT-PCR assay is positive, and/or SARS-CoV-2 nucleocapsid protein antibody is positive.
  • Documented medical history of COVID-19 disease.
  • Fever (oral temperature ≥ 37.5°C / axillary temperature ≥ 37.3°C) on the day of vaccination. Or having fever within 72 hours before the vaccination.
  • Having abnormal results of clinical laboratory testing during screening, which is judged by the Investigator to be clinically significant, including hematology, clinical chemistry, urinalysis, and coagulation.
  • History of severe allergic disease or reactions likely to be exacerbated by any component of investigational vaccine, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic 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., documented 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 (including history of myocarditis or pericarditis), 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.
  • 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 emergency use authorized vaccines during the study.
  • Prior receipt of any investigational or licensed COVID-19 vaccine except for the mRNA vaccines according to the protocol, or plan to receive any COVID-19 vaccine except for the investigational product (IP)s 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 the 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

About this study

Official title: A Randomized, Observer-Blinded, Placebo-Controlled Phase I Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of One Dose Booster by A Lyophilized COVID-19 mRNA Vaccine in Adults Aged 18 to 60 Years

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen that causes a coronavirus-associated acute respiratory disease called coronavirus disease 19 (COVID-19), which is spreading all over the world. This virus can cause acute respiratory distress syndrome (ARDS) with a high fatality rate. In this phase I first-in-human clinical trial, healthy volunteers in two dose cohorts will be vaccinated Lyophilized COVID-19 mRNA Vaccine (RH109) The aim of the study is to assess the safety, reactogenicity and Immunogenicity of the candidate vaccine and to characterize its immunogenicity.

Read the detailed description

Participants will be enrolled into 2 ascending dose (RH109 low-dose 25 μg, high-dose 50 μg) cohorts randomly. Approximately 24 eligible participants, 12 for each cohort, will be randomized with a 3:1 ratio (RH109 : Placebo). The study will progress in a sequential manner, with the low-dose cohort being enrolled and dosed first. Dose escalation from low-dose to high-dose cohort is contingent on a review of safety data of the low-dose cohort through to 7 days following the vaccination by a Safety Monitoring Committee (SMC)

Being tested
A Lyophilized COVID-19 mRNA Vaccine, Placebo
Medical subject headings
COVID-19

What participants receive

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

  • A Lyophilized COVID-19 mRNA VaccineBiological

    Also called RH109

    Active substance: NTD-RBD derived from S protein of Omicron variant Excipient: ALC-0315 (4- hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2- hexyldecanoate), ALC-0159 (2-[(polyethylene glycol)-2000]-N, N-ditetradecylacetamide), DSPC [1,2- distearoyl-sn-glycero-3-phosphocholine], Cholesterol, Trometamol and Sucrose

  • PlaceboBiological

    Also called Normal saline

    Normal saline (0.9% sodium chloride solution

Study groups in NCT05366296
Study groupRoleWhat they receive
: A Lyophilized COVID-19 mRNA Vaccine(RH109)Active comparatorParticipants received A Lyophilized COVID-19 mRNA Vaccine 0.5ml reconstituted by sterile water, 1 shots at Day0, intramuscular injection
Receives: Biological: A Lyophilized COVID-19 mRNA Vaccine
Placebo controlPlacebo comparatorParticipants received placebo of 0.5ml normal saline (0.9% sodium chloride solution), 1 shots at Day0, intramuscular injection
Receives: Biological: Placebo

What is being measured

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

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

    Measured: Within 7days after each does

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

    Measured: Time Frame: within 28 days after the booster vaccination

  3. The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs) until 6 months after the booster vaccination

    Measured: Until 6 months after the booster vaccination

Secondary outcomes (6)

  1. Geometric mean titer (GMT) of live-virus neutralizing antibody against SARS-CoV-2 Omicron variant (e.g., BA.1 and BA.2) and SARS-CoV-2 prototype

    Measured: At 14 days, 28 days, 3 months, and 6 months after the booster vaccination.

  2. Seroconversion rate (SCR) of live-virus neutralizing antibody against SARS-CoV-2 Omicron variant (e.g., BA.1 and BA.2) and SARS-CoV-2 prototype

    Measured: At 14 days, 28 days, 3 months and 6 months after the booster vaccination.

  3. Geometric mean increase (GMI) of live-virus neutralizing antibody against SARS-CoV-2 Omicron variant (e.g., BA.1 and BA.2) and SARS-CoV-2 prototype

    Measured: At 14 days, 28 days, 3 months, and 6 months after the booster vaccination.

  4. The GMT of anti-N-terminal domain (NTD) and anti-receptor binding domain (RBD) specific IgG at 14 days, 28 days, 3 months and 6 months after the booster vaccination.

    Measured: At 14 days, 28 days, 3 months and 6 months after the booster vaccination.

  5. The SCR of anti-N-terminal domain (NTD) and anti-receptor binding domain (RBD) specific IgG at 14 days, 28 days, 3 months and 6 months after the booster vaccination.

    Measured: At 14 days, 28 days, 3 months and 6 months after the booster vaccination.

  6. The GMI of anti-N-terminal domain (NTD) and anti-receptor binding domain (RBD) specific IgG at 14 days, 28 days, 3 months and 6 months after the booster vaccination

    Measured: At 14 days, 28 days, 3 months 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 posted9 May 2022
  2. Study startJul 2022 (estimated)
  3. Primary completionSep 2022 (estimated)
  4. Study completionJan 2023 (estimated)

Why it stopped: business stragety

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05366296
Sponsor's protocol ID
R520A101
Status last verified
Apr 2023
First submitted
3 May 2022
Last updated
27 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make individual participant data (IPD) available

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing A Lyophilized COVID-19 mRNA Vaccine in people with COVID-19 Pandemic, run by Wuhan Recogen Biotechnology Co., Ltd..

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 12 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: withdrawn, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was withdrawn before enrolling participants, so there are no results.

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?

The occurrence of solicited local and systemic adverse events (AEs) within 7 days after the booster vaccination (time frame: Within 7days after each does). 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 NCT05366296.

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 27 Apr 2023.

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