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ACTIVE NOT RECRUITING
NCT05856084
PHASE2

Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above

Sponsor: MAXVAX Biotechnology Limited Liability Company

View on ClinicalTrials.gov

Summary

The purposes of the study are to evaluate the immunogenicity and safety of different dose levels of recombinant herpes zoster vaccine (CHO Cells) with 2 doses at 2-month intervals in healthy subjects aged 30 years and older.

Official title: A Phase II, Single Center, Randomized, Blind, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above

Key Details

Gender

All

Age Range

30 Years - Any

Study Type

INTERVENTIONAL

Enrollment

924

Start Date

2023-05-07

Completion Date

2026-03-31

Last Updated

2024-11-20

Healthy Volunteers

Yes

Conditions

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

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.

Locations (1)

Yanjin Center for Disease Control and Prevention

Xinxiang, Henan, China