A Study to Evaluate Safety and Tolerability of a Recombinant Herpes Zoster Vaccine
Status:
Not yet recruiting
Trial end date:
2024-03-15
Target enrollment:
Participant gender:
Summary
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.