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

NCT05609045 | Withdrawn Phase 1

• 1 other identifier: RH109 CT HK01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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). 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).

Conditions

COVID-19 Pandemic

Outcome Measures

Primary Outcomes (3)

• 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.

  Day0 to Day7

• Unsolicited Treatment Emergent Adverse Events (TEAEs):

  Incidence of unsolicited TEAEs after IMP vaccination.

  Day0 to Day28

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

  Incidence of AESIs and SAEs after IMP vaccination.

  Day0-Day90

Secondary Outcomes (5)

• geometric mean titre (GMT)

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

• geometric mean increase (GMI)

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

• geometric mean concentration (GMC)

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

• seroconversion rate (SCR)

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

• T-Cell Responses

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

Study Arms (2)

test product group

EXPERIMENTAL

Biological: Lyophilized COVID-19 mRNA Vaccine

placebo group

PLACEBO COMPARATOR

Drug: Sodium chloride

Interventions

Lyophilized COVID-19 mRNA Vaccine BIOLOGICAL

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.

test product group

Sodium chloride DRUG

0.9% sodium chloride

placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Wuhan Rhegen Biotechnology Co., Ltd.: lead
• Shenzhen Rhegen Biotechnology Co.,Ltd.: collaborator
• Wuhan Recogen Biotechnology Co., Ltd.: collaborator

MeSH Terms

Conditions

COVID-19

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 8, 2022
• Study Start: June 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share