A Phase Ⅲ Clinical Study to Evaluate Protective Efficacy and Safety of a Recombinant Herpes Zoster Vaccine
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40+
SponsorBeijing Luzhu Biotechnology Co., Ltd.
About this trial
This clinical trial is to study protective efficacy and safety of a recombinant herpes zoster vaccine (LZ901) and sponsored by Beijing Luzhu Biotechnology Co., Ltd. It is a phase Ⅲ, randomized, double-blind, placebo-controlled in healthy people aged 40 years and older. The study is to protect adults against shingles (herpes zoster / varicella zoster virus(VZV)). There will be about 26000 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males and females able to provide legal identity certificate, aged ≥ 40 years inclusive at the time of signing the ICF;
Able to understand the study procedures, voluntarily agree to participate in the study, and sign the ICF;
Female subjects are not pregnant or lactating. Female subjects with childbearing potential should take reliable contraceptive measures, and have no pregnancy and fertility plan within 7 months;
Axillary temperature ≤ 37.0℃ on the day of enrollment;
Disqualifiers
Subjects who have had herpes zoster within the previous 5 years;
Previous vaccination against varicella or shingles (including use of a registered product or participation in a clinical trial of varicella or shingles vaccine);
Hypersensitivity to any of the components of the test vaccine: or prior hypersensitivity to any recombinant vaccine of CHO cell origin [e.g., recombinant hepatitis B vaccine (CHO cell)], polysorbate, etc.; or prior history of severe allergy* to any of the vaccinations;
Developed immunodeficiency diseases (congenital or acquired immunodeficiency diseases, human immunodeficiency virus infection) or received immunosuppressive/cytotoxic treatments (cancer chemotherapy, organ transplantation, or treatment planned during a clinical trial in the 6 months prior to vaccination);
Trial design
Design model
Parallel
Treatments tested in this trial
Recombinant Herpes Zoster Vaccine
Biological/VaccineThe active ingredient of the recombinant herpes zoster vaccine is varicella-zoster virus glycoprotein E fusion protein expressed in CHO cells by gene recombination technology. The LZ901 cell line carrying this gene is cultured in chemically defined medium. The harvest cell culture is purified by multi-step liquid chromatography. After Low pH incubation and virus removal filter package Nanofiltration inactivation/virus removal process, the bulk containing high-purity recombinant herpes zoster virus glycoprotein E is obtained. Finally, an alumina adjuvant is added to the formulated final product.
Recombinant Herpes Zoster Vaccine Placebo
Biological/VaccineAlumina adjuvant
Treatment groups
4 Participants
are divided into 4 treatment groupsGroup A: Treatment main groupExperimental treatment 1 intervention
Group B: Placebo main groupPlacebo comparator 1 intervention
Group C: Treatment immunization groupExperimental treatment 1 intervention
Group D: Placebo immunization groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The Vaccine Efficacy
To evaluate the Vaccine Efficacy in the prevention of HZ compared to placebo based on the number of confirmed cases of HZ
Time frame
30 days after full immunizationSecondary outcomes
1
Solicited AE
Incidence of Solicited AE include site of vaccination (local) and non-site of vaccination (systemic)
Time frame
from 0 to 7 days after each dose2
Unsolicited AE
Incidence of unsolicited AEs, include all AEs, except solicited AEs reported Days 0\~6 after the study intervention.
Time frame
From 0 to 30 days after each dose3
AE
Incidence of AE refers to any untoward medical occurrence in a subject administered the investigational vaccine.
Time frame
Within 30 minutes after each dose4
Adverse Events of Special Interest
Confirmed cases of HZ within 30 days after the first dose and full immunization
Time frame
From initial dose to 30 days after full immunizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov