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

NCT05609045 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-07-14

No results posted yet for this study

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

Interventions

BIOLOGICAL

Lyophilized COVID-19 mRNA Vaccine

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.

DRUG

Sodium chloride

0.9% sodium chloride

Sponsors & Collaborators

  • Shenzhen Rhegen Biotechnology Co.,Ltd.

    collaborator INDUSTRY

  • Wuhan Recogen Biotechnology Co., Ltd.

    collaborator INDUSTRY

  • Wuhan Rhegen Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2023-08-31
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05609045 on ClinicalTrials.gov