The purpose of this clinical study is to evaluate the safety and immunogenicity of receiving two doses of recombinant herpes zoster vaccine (CHO cells) (RHZV) in healthy individuals aged 40 years and above. This study will be conducted in 2 substudies: Substudy A (Phase I) and Substudy B (Phase Ⅱ).
There are two parts of the study. Substudy A: This substudy is the Phase I portion of the study. In this substudy, participants will receive 1 of 2 RHZV candidates (different dose levels) or the approved shingles vaccine (positive control) or adjuvant controls or normal saline intramuscularly. Participants will be divided into 2 age groups: 40-49 years old and ≥ 50 years old. Participants will receive vaccinations on days 0 and 60. Participants will complete a 12-month safety follow-up after two doses of vaccination, and they will take part in this study for about 14 months. Substudy B: This substudy is the Phase Ⅱ portion of the study. In this part of the study, participants will also receive 1 of 2 RHZV candidates (different dose levels) or the approved shingles vaccine (positive control) or normal saline intramuscularly. Participants will be divided into 3 age groups: 40-49 years old, 50-69 years old and ≥ 70 years old. Participants will receive vaccinations on days 0 and 60. Some group(s) will continue into persistence-of-immunity (overtime assessment of effect of vaccine) portion of the study. Those participants will be involved in this study for up to 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
645
Candidate 1, Dose Level 1, Intramuscular injection, 0, 2 months schedule
Candidate 2, Dose Level 2, Intramuscular injection, 0, 2 months schedule
Adjuvant control 1, Dose Level 1, Intramuscular injection, 0, 2 months schedule
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, China
RECRUITINGPercentage of immediate Adverse Events (AEs)
The occurrence of any adverse events within 30 minutes after each dose of vaccination.
Time frame: 30min after each dose of vaccination
Percentage of solicited Adverse Events
Adverse events defined by the protocol that occurred to the participant during 0-14 days after each dose of vaccination.
Time frame: 14 days after each dose of vaccination
Serious Adverse Events (SAE)
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Time frame: 12 months after the last dose
Percentage of unsolicited Adverse Events
Other adverse events that occurred among participants within 0-28/30 days after each vaccination, in addition to the solicited adverse events.
Time frame: 28 or 30 days after each dose of vaccination
Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies
GMC levels o of Anti-gE Antibodies in participants after receiving 2 doses of vaccine.
Time frame: 30 days after the last dose of vaccination
Geometric Mean Titer (GMT) of Anti-VZV Antibodies
GMT levels o of Anti-VZV Antibodies in participants after receiving 2 doses of vaccine.
Time frame: 30 days after the last dose of vaccination
Positive rate of Anti-gE Antibodies
The proportion of individuals in the study population who have achieved Anti-gE antibody positive after immunization.
Time frame: 30 days after the last dose of vaccination
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Adjuvant control 2, Dose Level 2, Intramuscular injection, 0, 2 months schedule
Positive control, Intramuscular injection, 0, 2 months schedule
Placebo control, Intramuscular injection, 0, 2 months schedule
Positive rate of Anti-VZV Antibodies
The proportion of individuals in the study population who have achieved Anti-VZV antibody positive after immunization.
Time frame: 30 days after the last dose of vaccination
Seroconversion rate of Anti-gE Antibodies
The proportion of individuals in the study population who have achieved Anti-gE antibody seroconversion after immunization.
Time frame: 30 days after the last dose of vaccination
Seroconversion rate of Anti-VZV Antibodies
The proportion of individuals in the study population who have achieved Anti-VZV antibody seroconversion after immunization.
Time frame: 30 days after the last dose of vaccination
SSB: Cellular immune level
Levels of glycoprotein E (gE)-specific CD4+/CD8+ T cells expressing 2 or more markers of activation.
Time frame: 30 days, 6 months, 12months and 24 months after the last dose of vaccination
SSB:Humoral immunogenicity level
Levels of GMC (Anti-gE antibody), GMT (Anti-VZV antibody), positive rate and seroconversion rate after receiving 2 doses of vaccine.
Time frame: 6 months, 12months and 24 months after the last dose of vaccination