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)
Overview
- Phase
- Phase 1
- Intervention
- Lyophilized COVID-19 mRNA Vaccine
- Conditions
- COVID-19 Pandemic
- Sponsor
- Wuhan Rhegen Biotechnology Co., Ltd.
- Primary Endpoint
- Reactogenicity
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
- •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
Exclusion Criteria
- •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:
- •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;
Arms & Interventions
test product group
Intervention: Lyophilized COVID-19 mRNA Vaccine
placebo group
Intervention: Sodium chloride
Outcomes
Primary Outcomes
Reactogenicity
Time Frame: Day0 to Day7
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.
Unsolicited Treatment Emergent Adverse Events (TEAEs):
Time Frame: Day0 to Day28
Incidence of unsolicited TEAEs after IMP vaccination.
Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs):
Time Frame: Day0-Day90
Incidence of AESIs and SAEs after IMP vaccination.
Secondary Outcomes
- geometric mean titre (GMT)(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)
- T-Cell Responses(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)
- geometric mean increase (GMI)(Day 7, Day 21, Day 28, Day 60 and Day 90)