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A Study to Evaluate Safety and Tolerability of a Recombinant Herpes Zoster Vaccine

NCT05750017 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-03-27

No results posted yet for this study

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.

Conditions

  • Herpes Zoster
  • Vaccine-Preventable Diseases

Interventions

BIOLOGICAL

Low Dose Recombinant Herpes Zoster Vaccine (LZ901)

0.5 mL per dose, containing a total of 50 µg recombinant herpes zoster virus glycoprotein E, adjuvanted with alumina adjuvant.

BIOLOGICAL

High Dose Recombinant Herpes Zoster Vaccine (LZ901)

0.5 mL per dose, containing a total of 100 µg recombinant herpes zoster virus glycoprotein E, adjuvanted with alumina adjuvant.

DRUG

Placebo

0.5 mL per dose, containing 4.5 mg sodium chloride.

Sponsors & Collaborators

  • Beijing Luzhu Biotechnology Co., Ltd.

    lead OTHER

Principal Investigators

  • Frank Lee, MD · Frontage Clinical Services, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-23
Primary Completion
2024-02-01
Completion
2024-03-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05750017 on ClinicalTrials.gov