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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort1: Low dose sentinel group | Experimental | Three subjects will be first enrolled into low dose sentinel group in open-label, prior to initiation of dosing in each dose level main group. |
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| Cohort2: High dose sentinel group | Experimental | After reviewing the safety through 7 days after the first dose of LZ901, if no safety signals occur, another 3 subjects will be enrolled into high dose sentinel group in open-label. |
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| Cohort3: Low dose main group | Placebo Comparator | If also no safety signals occur through 7 days after the first dose of LZ901 in high dose sentinel group, 30 subjects will be randomized in a 2:1 ratio to receive two doses of LZ901 or placebo in a double-blind fashion in low dose main group. |
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| Cohort4: High dose main group | Placebo Comparator | Subjects will be enrolled in high dose main group also after the safety review through 7 days after the first dose of LZ901 or placebo in low dose main group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose Recombinant Herpes Zoster Vaccine (LZ901) | Biological | 0.5 mL per dose, containing a total of 50 µg recombinant herpes zoster virus glycoprotein E, adjuvanted with alumina adjuvant. |
| Measure | Description | Time Frame |
|---|---|---|
| Solicited 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. | 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. | 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. | 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). | From Day 0 through 6 months after the full course vaccination. |
| Abnormal laboratory tests results | The incidence of abnormal laboratory tests results. | On Day 3 (+ 1 day) after each study intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| The seropositivity rate of anti-gE antibody | The percentage of seropositive subjects of anti-gE antibody. | On Day 30 after each study intervention. |
| The seropositivity rate of anti-VZV antibody |
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Inclusion Criteria:
Males and females able to provide legal identity certificate, aged 50 to 70 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;
Subjects are healthy or have well controlled mild medical conditions as determined by the investigator;
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;
*Female subjects of childbearing potential are defined as sexually mature women: 1) have not undergone hysterectomy, bilateral salpingectomy, and bilateral oophorectomy; 2) have had natural menses at any time in the preceding 12 consecutive months (without an alternative medical cause). Post-menopausal should be confirmed with FSH and Estradiol levels.
**Reliable, medically acceptable forms of contraception:
Able to attend all scheduled follow-up visits and able to comply with protocol requirements;
Oral temperature < 37.5℃/99.5℉.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frank Lee, MD | Contact | (201) 416-7745 | (201) 416-7753 | flee@frontagelab.com |
| Sumitha Reddy, MD | Contact | (201) 416-7760 | sreddy@frontagelab.com |
| Name | Affiliation | Role |
|---|---|---|
| Frank Lee, MD | Frontage Clinical Services, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frontage Clinical Services, Inc. | Recruiting | Secaucus | New Jersey | 07094 | United States |
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| High Dose Recombinant Herpes Zoster Vaccine (LZ901) | Biological | 0.5 mL per dose, containing a total of 100 µg recombinant herpes zoster virus glycoprotein E, adjuvanted with alumina adjuvant. |
|
| Placebo | Drug | 0.5 mL per dose, containing 4.5 mg sodium chloride. |
|
|
The percentage of seropositive subjects of anti-VZV antibody.
| On Day 30 after each study intervention. |
| Geometric mean concentration (GMC) of anti-gE | Measured by ELISA. | On Day 30 after each study intervention. |
| Geometric mean titer (GMT) of anti-VZV | Measured by fluorescent antibody to the membrane antigen (FAMA). | 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). | 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). | 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. | From pre-immunization to Day 30 after each study intervention. |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D000079263 | Vaccine-Preventable Diseases |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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