Last updated: March 23, 2023
Sponsor: Beijing Luzhu Biotechnology Co., Ltd.
Overall Status: Active - Recruiting
Phase
1
Condition
Shingles
Chickenpox (Varicella Zoster Infection)
Herpes Simplex Infections
Treatment
N/AClinical Study ID
NCT05750017
LZ901-1
Ages 50-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Males and females able to provide legal identity certificate, aged 50 to 70 yearsinclusive at the time of signing the ICF;
- Able to understand the study procedures, voluntarily agree to participate in thestudy, and sign the ICF;
- Subjects are healthy or have well controlled mild medical conditions as determined bythe investigator;
- Female subjects are not pregnant or lactating. Female subjects with childbearingpotential* should take reliable contraceptive measures**, and have no pregnancy andfertility 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;
- have had natural menses at any time in the preceding 12 consecutive months (withoutan alternative medical cause). Post-menopausal should be confirmed with FSH andEstradiol levels. **Reliable, medically acceptable forms of contraception:
- For 3 months prior to screening - hormonal contraceptive (e.g., oral, patch,injectable, depot or vaginal ring), or implantable device (implantable rod orintrauterine device), or
- For at least 1 month prior to screening - a double barrier method (e.g.,diaphragm, cervical cap, or condom in conjunction with spermicide or sponge), or
- Subjects of reproductive age that are abstinent are acceptable provided theyagree to a double barrier method should they become sexually active during thestudy.
- and subjects agree to continue birth control for at least 7 months.
- Able to attend all scheduled follow-up visits and able to comply with protocolrequirements;
- Oral temperature < 37.5℃/99.5℉.
Exclusion
Exclusion Criteria:
- Subjects with a personal history or family history of convulsion, epilepsy,encephalopathy, and psychosis;
- Subjects who received immunosuppressive therapy within 3 months before vaccination (e.g., long-term use of systemic glucocorticoids for ≥ 14 days, dose ≥ 2 mg/kg/day or ≥ 20 mg/day prednisone or equivalence);
- Allergic to any component of the investigational vaccine, or have a history of asevere allergy to any vaccination;
- Impaired immune function or diagnosed with congenital or acquired immunodeficiencydisease, positive serology for Hepatitis B Surface Antigen, Hepatitis C Antibody andhuman immunodeficiency virus (HIV);
- History of varicella or herpes zoster vaccination;
- History of HZ;
- Received an inactivated or recombinant vaccine within 14 days or any live vaccinewithin 28 days prior to vaccination;
- Subjects who have acute diseases within 3 days before vaccination, or acute stage orexacerbation of chronic diseases within 1 month before vaccination;
- Subjects with tattoos to the upper arm deltoid area or have infectious skin disease;
- History of thrombocytopenia or other coagulation disorders, which may causecontraindications to intramuscular injection;
- History of asplenia or functional asplenia, and asplenia or splenectomy due to anycondition;
- Subjects with ≥ Grade 2 laboratory abnormalities and Grade 1 laboratory abnormalitiesthat the investigator consider clinically significant;
- Participating in other clinical studies of investigational or un-registered products (drugs, vaccines or devices, etc.), or planning to participate in other clinicalstudies before the end of this clinical study;
- Any conditions that in the opinion of the investigator may affect subject safety orassessments (disease factors such as extensive psoriasis, unexplained skin rash,eczema, chronic pain syndrome, or social factors such as plans to move elsewherebefore the end of the study).
- A positive screen for alcohol, drugs of abuse at screening period and Day 0 (beforevaccination).
Study Design
Total Participants: 66
Study Start date:
March 23, 2023
Estimated Completion Date:
March 15, 2024
Connect with a study center
Frontage Clinical Services, Inc.
Secaucus, New Jersey 07094
United StatesActive - Recruiting

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