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The Safety and Immunogenicity Study of the Recombinant Zoster Vaccine (CHO Cell)

NCT05769049 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-03-01

No results posted yet for this study

Summary

This is a randomized, observer-blinded, active-controlled Phase I study to evaluate the safety, reactogenicity, and immunogenicity of REC610, when administered as 2 intramuscular (IM) injections in healthy adults aged 40 years and older, who do not have known HZ and history of varicella or HZ vaccination. The recombinant HZ vaccine, Shingrix® (GlaxoSmithKline), will be used as the active control.

Conditions

  • Herpes Zoster

Interventions

BIOLOGICAL

REC610

administered as 2 intramuscular (IM) injections in healthy adults aged 40 years and older

BIOLOGICAL

Shingrix

Shingrix

Sponsors & Collaborators

  • Jiangsu Rec-Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Loreta Zoleta- De Jesus, Dr. · Silang Specialists Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-09
Primary Completion
2023-12-06
Completion
2023-12-06

Countries

  • Philippines

Study Locations

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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 NCT05769049 on ClinicalTrials.gov