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)

NCT05609045 Phase 1 WITHDRAWN

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).

Details

Lead sponsor	Wuhan Rhegen Biotechnology Co., Ltd.
Phase	Phase 1
Status	WITHDRAWN
Start date	2023-06
Completion	2023-12

Conditions

• COVID-19 Pandemic

Interventions

• Lyophilized COVID-19 mRNA Vaccine
• Sodium chloride

Primary outcomes

• Reactogenicity — 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): — Day0 to Day28
  Incidence of unsolicited TEAEs after IMP vaccination.
• Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs): — Day0-Day90
  Incidence of AESIs and SAEs after IMP vaccination.