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Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 18 Years and Above
Sponsor: MAXVAX Biotechnology Limited Liability Company
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
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.
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.
Low dose adjuvant
0.5 mL per dose, containing low dose MA105 adjuvant.
High dose adjuvant
0.5 mL per dose, containing high dose MA105 adjuvant.
Positive control
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.
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