This clinical trial is to study the safety and tolerability of a recombinant herpes zoster vaccine (LZ901) and sponsored by Beijing Luzhu Biotechnology Co., Ltd. It is a phase I, randomized, double-blind, placebo-controlled, dose escalation study in healthy people aged 50 to 70 years inclusive. The study is to protect adults against shingles (herpes zoster / varicella zoster virus(VZV)). There will be about 66 participators who will receive two-dose injection at the upper arm. LZ901 vaccine is made up of a tetramer of VZV glycoprotein E (VZV gE-Fc) and adsorbed with aluminum hydroxide adjuvant. This adjuvant can raise the immune response to a lot of antigens. It is the most widely used and safe adjuvant in various types of vaccines worldwide. In this study: 1. The participation is voluntary. 2. Before the study, participants will receive some tests for screening. If qualified, investigators will officially invite them to join this study. 3. The study vaccine is LZ901 with two different dose levels (50μg/0.5 mL, 100μg/0.5 mL). The placebo, which is saline solution, has no active drug. Participants will receive one of three as above mentioned. 4. Participants will be enrolled in one of four cohorts. If participants are enrolled in Cohorts 1 or 2, they will receive LZ901. If participants are enrolled in Cohorts 3 or 4, they will have a 2 out of 3 chance (66%) of receiving LZ901 and 1 out of 3 chance (33%) of receiving placebo. 5. In Cohort 3 and 4, the study staff and participants will not know which study treatment participants will be receiving. However, the study doctor can get this information in case of an emergency. 6. Participants will stay at the clinic for 30 minutes after each vaccination to observe if there are any uncomfortable. 7. This study will last about 8 months and will include about 8 study visits to the clinic. During this period, participants will receive a follow-up phone call and/or email by the study staff to follow the condition closely for safety, and record on diary/contact card. 8. Participants will receive some tests during the study, include safety tests such as physical examination, vital signs measurements, blood tests, urinalysis. Participants will be measured the levels of specific antibodies to see if the vaccine works well. This study is for research purposes only. Participants may not receive any direct benefits from participating in this study but have a chance to be in a study that may help others in the future.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
66
0.5 mL per dose, containing a total of 50 µg recombinant herpes zoster virus glycoprotein E, adjuvanted with alumina adjuvant.
0.5 mL per dose, containing a total of 100 µg recombinant herpes zoster virus glycoprotein E, adjuvanted with alumina adjuvant.
0.5 mL per dose, containing 4.5 mg sodium chloride.
Frontage Clinical Services, Inc.
Secaucus, New Jersey, United States
RECRUITINGSolicited AEs
A solicited AE is a pre-specified outcome that the subject is asked to record as present or not. The solicited AEs can be classified as vaccination site (local) AEs and Solicited systemic AEs based on the occurrence site.
Time frame: From Day 0 through Day 6 after each vaccination.
Unsolicited AEs
Unsolicited AEs include all AEs, except solicited AEs reported Days 0\~6 after the study intervention.
Time frame: From Days 0~29 after each vaccination.
AEs leading to withdrawal
The incidence of AEs leading subjects to withdrawal according to criteria for subject treatment discontinuation and withdrawal from study.
Time frame: From Day 0 until the outcome is clear after the following up, up to the end of study.
SAEs and MAAEs
The incidence of all serious adverse events (SAEs) and medically attended adverse events (MAAEs).
Time frame: From Day 0 through 6 months after the full course vaccination.
Abnormal laboratory tests results
The incidence of abnormal laboratory tests results.
Time frame: On Day 3 (+ 1 day) after each study intervention.
The seropositivity rate of anti-gE antibody
The percentage of seropositive subjects of anti-gE antibody.
Time frame: On Day 30 after each study intervention.
The seropositivity rate of anti-VZV antibody
The percentage of seropositive subjects of anti-VZV antibody.
Time frame: On Day 30 after each study intervention.
Geometric mean concentration (GMC) of anti-gE
Measured by ELISA.
Time frame: On Day 30 after each study intervention.
Geometric mean titer (GMT) of anti-VZV
Measured by fluorescent antibody to the membrane antigen (FAMA).
Time frame: On Day 30 after each study intervention.
The seroconversion rate of anti-VZV antibody
Seroconversion refers to at least a 4-fold increase in the anti-VZV antibody titer at the endpoint as compared to the prevaccination concentration (for subjects seropositive pre-vaccination) or a 4-fold increase at the endpoint as compared to the anti-VZV antibody titer cut-off value for seropositivity (for subjects seronegative pre-vaccination).
Time frame: On Day 30 after each study intervention.
The seroconversion rate of anti-gE antibody
Seroconversion refers to at least a 4-fold increase in the anti-gE Ab concentration at the endpoint as compared to the prevaccination concentration (for subjects seropositive pre-vaccination) or a 4-fold increase at the endpoint as compared to the anti-gE Ab cut-off value for seropositivity (for subjects seronegative pre-vaccination).
Time frame: On Day 30 after each study intervention.
Change of anti-Fc antibody
Change of anti-Fc antibody on Day 30 after each study intervention compared with pre-immunization.
Time frame: From pre-immunization to Day 30 after each study intervention.
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