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Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 18 Years and Above

NCT05636436 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2024-11-20

No results posted yet for this study

Summary

The purposes of the study are to evaluate the safety and tolerability of different dose levels of recombinant herpes zoster vaccine (CHO Cells) with 2 doses at 2-month intervals in healthy subjects aged 18 years and older, and to preliminarily explore immunogenicity.

Conditions

  • Herpes Zoster

Interventions

BIOLOGICAL

Low Dose Recombinant Herpes Zoster Vaccine (CHO cells)

0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with low dose MA105.

BIOLOGICAL

High Dose Recombinant Herpes Zoster Vaccine (CHO cells)

0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with high dose MA105.

BIOLOGICAL

Low dose adjuvant

0.5 mL per dose, containing low dose MA105 adjuvant.

BIOLOGICAL

High dose adjuvant

0.5 mL per dose, containing high dose MA105 adjuvant.

BIOLOGICAL

Positive control

0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.

BIOLOGICAL

Placebo

0.5 mL per dose, containing 4.5 mg sodium chloride.

Sponsors & Collaborators

  • Henan Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • MAXVAX Biotechnology Limited Liability Company

    lead INDUSTRY

Principal Investigators

  • Yanxia Wang · Henan Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-07
Primary Completion
2024-12-30
Completion
2024-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT05636436 on ClinicalTrials.gov