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ACTIVE NOT RECRUITING
NCT05636436
PHASE1

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

Sponsor: MAXVAX Biotechnology Limited Liability Company

View on ClinicalTrials.gov

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.

Official title: A Phase I, Single Center, Randomized, Blinded, Controlled Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 18 Years and Above

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2022-12-07

Completion Date

2024-12-30

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

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.

Locations (1)

Yanjin District Center for Disease Control and Prevention

Xinxiang, Henan, China