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

ConditionHerpes Zoster
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorSinocelltech Ltd.

About this trial

The purposes of the study are to evaluate the Safety, Tolerability, and Immunogenicity of different dose levels of recombinant herpes zoster vaccine with 2 doses 60 days apart in healthy subjects aged 40 years and older.

Eligibility criteria

Qualifiers

Male or female subjects ≥ 40 years of age;

The subject can and fully understand the trial procedures and voluntarily sign the ICF;

The subject is in a healthy state or has stable underlying diseases according to investigator's assessment based on medical history and related physical examination results;

The subject can comply with the requirements of the protocol;

Disqualifiers

History of herpes zoster before enrollment, or close contact with a varicella/herpes zoster patient within 30 days prior to enrollment;

Previous vaccination against herpes zoster and varicella (including vaccines that have been registered or under clinical research);

Allergic to any component of the study vaccine, or history of severe allergy to any vaccination, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis reaction, angioneurotic edema, etc.

History or family history of convulsions, epilepsy, and psychiatric disorders;

Trial design

Treatments tested in this trial

  • Recombinant Herpes Zoster Vaccine (SCTV04C) Low-Dose
  • Recombinant Herpes Zoster Vaccine (SCTV04C) High-Dose
  • Placebo control: Saline
  • Shingrix®
  • Ganwei®

Treatment groups

540 Participants
are divided into 5 treatment groups

Sponsors and collaborators