NCT05636436

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: MAXVAX Biotechnology Limited Liability Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The clinical trial will be a single-center, randomized, blind, controlled study in which two dose levels of vaccine will be tested in healthy adults aged 18 to 49 years and 50 years and older, with progression from low dose level to high dose level and younger age group to the older age group based on assessment of safety and tolerability. The younger cohort (aged 18 to 49 years) will consist of 60 subjects, 30 per dose level, and these 30 subjects will be randomized into three subgroups, including vaccine group, adjuvant group and normal saline group, with randomization ratio of 2:2:1. The older cohort (aged 50 years and older) will consist of 72 subjects, 36 per dose level, and these 36 subjects will be randomized into four subgroups, including vaccine group, adjuvant group, Shingrix® group and normal saline group, with randomization ratio of 2:2:1:1.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-07
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2022-12-05
• Last updated: 2024-11-20

Locations

1 site across 1 country: China