Safety and immunogenicity study of varicella-zoster virus (VZV) vaccine in healthy subjects.

A randomized, open label clinical trial to evaluate the safety and immunogenicity of varicella-zoster virus (VZV) vaccine in healthy subjects - Nil

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/090136

Enrollment

Registered

2025-07-03

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Varicella-zoster virus (VZV) vaccine by Cadila Pharmaceuticals Limited, India: Dose: Two Intramuscular (IM) injection of 50 microgram, 75 microgram and 100 microgram. Each dose to be g

2. Day 0 and Day 56

3. Day 0 and Day 84). Control Intervention1: Nil: Not applicable

Eligibility

Inclusion criteria

Inclusion criteria: Healthy adult subjects of either gender with 18 years or more of age. Subject s BMI within normal limit of 18.50-30.00 kg/m2 (inclusive both). Subjects in good health at the time of randomization into the study. Subjects able to understand and provide the written informed consent. Subject willing to follow all study requirements. Subjects with documented negative test for human HIV-1/2, HBsAg and HCV. Female subjects of childbearing potential.

Exclusion criteria

Exclusion criteria: Subject with history of chicken pox /herpes zoster disease. Subjects with history of vaccination with any chicken pox vaccine, varicella or zoster vaccine. Subjects with history of allergy or hypersensitivity reaction to any vaccine component. Subject is having a history of disease or any underlying medical conditions. Subject having drug intake in the past 2 weeks of proposed vaccination date. Subjects using any immunosuppressive therapy, use of nontopical antiviral therapy with activity against herpes virus. Subject is having a history of adverse reactions during previous vaccinations. Any clinically significant abnormal laboratory findings during screening. Any other vaccine administration within the last 30 days or planned to be administered during the study period. Pregnant and lactating girls and female subjects of child bearing age not using acceptable contraceptive measures. Subjects who have received blood transfusion or participated in another clinical trial during past 3 month.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and reactogenicity based on Frequency of and percentage AE and SAE for recommendation of dose and dosing regimen for Phase-II clinical trial.Timepoint: Within 7 days post- each vaccination	—

Secondary

Measure	Time frame
To evaluate the immunogenicity results of the test vaccine, based on IgG antibody response.Timepoint: On second vaccination and Day 42 after second vaccination;To evaluate the safety profile of test vaccineTimepoint: After day 7 of each vaccination	—

Countries

India

Contacts

Public ContactDr Sanjay Patel

Cadila Pharmaceuticals Limited

ashish.a@cadilapharma.com9925002565

Outcome results