A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorShanghai Institute Of Biological Products

About this trial

The purpose of this clinical study is to evaluate the safety and immunogenicity of receiving two doses of recombinant herpes zoster vaccine (CHO cells) (RHZV) in healthy individuals aged 40 years and above. This study will be conducted in 2 substudies: Substudy A (Phase I) and Substudy B (Phase Ⅱ).

Eligibility criteria

Qualifiers

Age ≥ 40 years old on the day of enrollment, gender not limited.

Can provide legal proof of identity.

Be able to understand the experimental procedure and sign a written informed consent form, expressing agreement to participate in the experiment.

Be able to participate in all planned follow-up visits and comply with all trial procedures.

Disqualifiers

Individuals with a history of herpes zoster in the past.

Individuals with a history of vaccination against chickenpox or shingles.

Individuals who have had close contact with patients with chickenpox or shingles in the past 2 years.

Women of childbearing age who have a positive urine pregnancy test, are breastfeeding, pregnant, or plan to become pregnant within 6 months after the start of the test and the full exemption period.

Trial design

Treatments tested in this trial

  • Recombinant herpes zoster vaccine with low-dose adjuvant
  • Recombinant herpes zoster vaccine with high-dose adjuvant
  • Low-dose adjuvant
  • High-dose adjuvant
  • Shingrix (GSK)
  • Normal Saline

Treatment groups

645 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.