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COVID-19 PandemicPhase 1NCT05609045

A Phase 1, Randomised, Double-blinded, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Immunogenicity of RH109 as Booster

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

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a randomized, double-blinded, placebo-controlled, dose-escalation study to valuate the safety and immunogenicity of RH109 as booster at 2 dose levels for ealthy adults who have received homologous or heterologous vaccination with 3 doses of COVID-19 inactivated and/or mRNA vaccine(s). 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 Pandemic
What is being tested?
Lyophilized COVID-19 mRNA Vaccine and Sodium chloride
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2023to Dec 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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • A subject is eligible for inclusion in this study if all of the following criteria are met:
  • Informed Consent: The subject (or the subject's legally acceptable representative, if applicable) must be capable of giving written informed consent and, prior to the commencement of any study-specific procedure, must sign an ICF indicating the consent on the subject's voluntary participation in the study and compliance with the requirements and restrictions listed on the ICF.
  • Vaccination Status: The subject must have received homologous or heterologous vaccination with 3 doses of COVID-19 inactivated and/or mRNA vaccine(s) recognized by the local health authorities, with the last dose completed at least 90 days prior to IMP vaccination.
  • Gender and Age: Male or female, at the age of ≥ 18 and ≤ 80 on the day of signing the ICF.
  • Body Weight and BMI: Body weight ≥ 45 kg and BMI ≥ 18.5 kg/m2 and < 30 kg/m2 at screening and baseline.
  • Medical Conditions or Diagnoses: Existence of all of the following medical conditions or diagnoses:
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  • Generally in good health with no clinically significant abnormality, as determined by medical history, physical examination, 12-lead ECG and clinical laboratory tests at screening and baseline;
  • Normal vital signs at screening and baseline, as defined by:
  • Body (tympanic) temperature ≤ 37.5°C;
  • Resting pulse rate ≥ 50 and ≤ 100 bpm; and
  • DBP ≥ 50 and ≤ 90 mmHg and SBP ≥ 90 and ≤ 140 mmHg.
  • Avoidance of Pregnancy: Willingness and agreement to undertake measures to confirm the subject's non-childbearing potential or avoid pregnancy of the subject or the subject's sexual partner(s) as detailed below:
  • A female subject who declares menopause must (i) confirm that she has not experienced a menstrual period for at least 12 consecutive months; and (ii) be willing to receive a FSH test to confirm her postmenopausal status;
  • A female subject who declares completion of surgical sterilization (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal occlusion or ligation) must be able to provide valid medical evidence or permit access to the relevant medical records;
  • A female subject who is a woman of childbearing potential (WOCBP) must be willing and agree to remain abstinent or practise at least one effective contraceptive method from at least 30 days prior to the day of IMP vaccination and for 60 days after IMP vaccination;
  • A male subject (i) who is sexually active with a WOCBP (except who is permanently sterile by bilateral orchiectomy or vasectomy) must be willing and agree to remain abstinent or practise at least one effective contraceptive method from the day of IMP vaccination and until 60 days after IMP vaccination; and (ii) must be willing and agree to refrain from sperm donation during the aforesaid period.
  • Breastfeeding: A female subject must be willing and agree to avoid engagement in breastfeeding at any time from the day of IMP vaccination until 60 days after IMP vaccination.
  • Blood Donation: Willingness and agreement to avoid blood donation from screening to the end of the period of participation in this study.

Who cannot join

  • A subject is excluded from this study if any of the following criteria applies:
  • Medical History: History of any of the following diseases or conditions:
  • COVID-19;
  • SARS;
  • Any significant respiratory diseases (e.g. COPD, asthma);
  • Any significant cardiovascular disease (e.g. angina, cardiac arrhythmias);
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  • Blood dyscrasias or any significant disorder of coagulation;
  • Any chronic liver disease (e.g. autoimmune hepatitis and cirrhosis);
  • Any chronic infection (e.g. hepatitis B, hepatitis C and HIV);
  • Any malignant neoplastic disease;
  • Encephalopathy, neuropathy or unstable central nervous system (CNS) pathology;
  • Any psychiatric disorder, psychotic disorder, major affective disorder or suicidal ideation;
  • Any immunodeficiency or autoimmune disease;
  • Any severe allergic reaction (e.g. anaphylaxis) to any vaccine or substance, which requires hospitalization or emergency medical care;
  • History of alcohol or illicit drug abuse, or used any illicit drug within 6 months prior to screening.
  • Medical Conditions or Diagnoses: Existence of any of the following medical conditions or diagnoses:
  • Positive serum pregnancy test at screening or positive urine pregnancy test at baseline (only for WOCBP);
  • Serum FSH test result at screening indicating a postmenopausal status (only for women declaring menopause for at least 12 consecutive months prior to screening);
  • IgE level > 1,000 IU/ml at screening;
  • Positive Anti-N IgG test result at screening;
  • Positive SARS-CoV-2 test result in deep throat saliva (DTS) within 4 days prior to the day of vaccination;
  • Positive HIV test result at screening;
  • Positive HBsAg test result at screening;
  • Positive HCV antibody test result at screening;
  • Positive urine drug screen test result or positive blood alcohol test result at screening or baseline;
  • Clinically significant abnormality of T3, T4 or TSH at screening;
  • Clinically significant abnormality of PT (INR) or aPTT at screening.
  • Prior/Concomitant Interventions: Use of or undergoing any of the following prior or concomitant medications, therapies or interventions:
  • Any COVID-19 or coronavirus vaccine at any time prior to IMP vaccination (except the inactivated and mRNA vaccines recognized by the local authorities of the respective study sites), or planned use of any such vaccine throughout the study;
  • Any vaccine other than COVID-19 or coronavirus vaccines within 28 days prior to IMP vaccination, or planned use of any such vaccine up to 28 days after IMP vaccination;
  • Any immune-modifying medication/therapy (e.g. immunomodulator and immunosuppressant) within 6 months prior to IMP vaccination, or planned use of any such medication/therapy throughout the study;
  • Any blood product (including blood transfusion) or immunoglobulin within 4 months prior to IMP vaccination, or planned use of any such therapy throughout the study;
  • Any anticoagulation medication within 28 days prior to IMP vaccination, or planned use of any such medication up to 28 days after IMP vaccination;
  • Any psychotropic medication within 28 days prior to IMP vaccination, or planned use of any such medication up to 28 days after IMP vaccination;
  • Any prescription or over-the-counter medication within 7 days prior to IMP vaccination, unless with the investigator's approval;
  • Donated ≥ 450 mL of blood within 28 days prior to IMP vaccination.
  • Prior/Concurrent Clinical Study: Prior or concurrent participation in any other clinical study, including:
  • Prior or current participation in another COVID-19 vaccine study;
  • Prior participation in any interventional clinical study and use of any investigational intervention within 30 days prior to IMP vaccination;
  • Concurrent participation or plan for participation in another interventional clinical study during participation in this study.
  • Other Significant Medical Conditions: Any clinically significant concomitant disease or condition that, in the reasonable opinion of the investigator, may interfere with the subject's participation in this study or pose an unacceptable safety risk for the subject's participation in this study.
  • Special Condition: Existence of the following special condition:
  • Planned to travel overseas at any time during the period from screening to Day 90(±7) visit.

About this study

Official title: A Phase 1, Randomised, Double-blinded, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Immunogenicity of RH109 as Booster for Healthy Adults Who Have Received Homologous or Heterologous Vaccination With 3 Doses of COVID-19 Inactivated and/or mRNA Vaccine(s)

This is a randomized, double-blinded, placebo-controlled, dose-escalation study to valuate the safety and immunogenicity of RH109 as booster at 2 dose levels for ealthy adults who have received homologous or heterologous vaccination with 3 doses of COVID-19 inactivated and/or mRNA vaccine(s).

The purpose of this study is to evaluate the safety and immunogenicity of RH109 as booster for healthy adults who have received homologous or heterologous vaccination with 3 doses of COVID-19 inactivated and/or mRNA vaccine(s).

Being tested
Lyophilized COVID-19 mRNA Vaccine, Sodium chloride
Medical subject headings
COVID-19

What participants receive

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

  • Lyophilized COVID-19 mRNA VaccineBiological

    RH109 is a mRNA-based vaccine encoding the N-Terminal Domain (NTD) - Receptor Binding Domain (RBD) derived from Spike (S) protein of SARS-CoV-2 Omicron variant.

  • Sodium chlorideDrug

    0.9% sodium chloride

Study groups in NCT05609045
Study groupRoleWhat they receive
test product groupExperimentalNot described
Receives: Biological: Lyophilized COVID-19 mRNA Vaccine
placebo groupPlacebo comparatorNot described
Receives: Drug: Sodium chloride

What is being measured

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

  1. Reactogenicity

    Incidence of any solicited local events (pain, tenderness, redness, warmth, itch, welling, induration) and solicited systemic events (fever, headache, malaise, fatigue, yalgia, joint pain, nausea, vomiting, diarrhea, loss of appetite, chills) after IMP vaccination.

    Measured: Day0 to Day7

  2. Unsolicited Treatment Emergent Adverse Events (TEAEs):

    Incidence of unsolicited TEAEs after IMP vaccination.

    Measured: Day0 to Day28

  3. Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs):

    Incidence of AESIs and SAEs after IMP vaccination.

    Measured: Day0-Day90

Secondary outcomes (5)

  1. geometric mean titre (GMT)

    GMT of neutralizing antibodies against Omicron, Wild-type or other selected variants

    Measured: Day 7, Day 21, Day 28, Day 60 and Day 90

  2. geometric mean increase (GMI)

    GMI of anti-Omicron neutralizing antibody, anti-Omicron IgG antibodies

    Measured: Day 7, Day 21, Day 28, Day 60 and Day 90

  3. geometric mean concentration (GMC)

    GMC of anti-Omicron IgG antibodies

    Measured: Day 7, Day 21, Day 28, Day 60 and Day 90

  4. seroconversion rate (SCR)

    SCR of anti-Omicron neutralizing antibody, anti-Omicron IgG antibody

    Measured: Day 7, Day 21, Day 28, Day 60 and Day 90

  5. T-Cell Responses

    Median T-cell responses

    Measured: Day 7, Day 21, Day 28, Day 60 and Day 90

Timeline

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

  1. First posted8 Nov 2022
  2. Study startJun 2023 (estimated)
  3. Primary completionAug 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Why it stopped: business strategy adjustment

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
NCT05609045
Sponsor's protocol ID
RH109 CT HK01
Status last verified
Jul 2023
First submitted
28 Oct 2022
Last updated
14 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lyophilized COVID-19 mRNA Vaccine and Sodium chloride in people with COVID-19 Pandemic, run by Wuhan Rhegen 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 18 inclusion and 43 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 14 Jul 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?

Reactogenicity (time frame: Day0 to Day7). 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 NCT05609045.

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 14 Jul 2023.

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