NCT06654700

Phase III Clinical Trial of Lot-to-lot Consistency of Recombinant Herpes Zoster Vaccine (CHO Cell).

A Randomized, Double-blind Phase III Clinical Trial to Evaluate the Lot-to-lot Consistency of Three Consecutive Batches of Recombinant Herpes Zoster Vaccine (CHO Cell) Produced At a Commercial Scale in Subjects Aged 40 Years and Older.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: MAXVAX Biotechnology Limited Liability Company · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

To evaluate the lot-to lot consistency of three batches of recombinant herpes zoster vaccine (CHO cell) produced on a commercial scale in subjects aged 40 years and older after receiving 2 doses on a 0, 2 month schedule.

Detailed description

A total of 1200 subjects aged 40 years and older were randomly assigned in a 1:1:1 ratio to three commercial-scale batches (batch 1, batch 2, Batch 3) , with 400 subjects in each group. To demonstrate lot-to-lot consistency in terms of anti-gE antibody GMC between three production lots of the HZ vaccine one month after the second dose.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Zoster Vaccine (CHO Cell)	0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with MA105. Intramuscular injection

Timeline

• Start date: 2024-12-09
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-10-23
• Last updated: 2024-11-20

Locations

1 site across 1 country: China