Health TrialsbyHealthPanel

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

ConditionHerpes Zoster (HZ)
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Recombinant herpes zoster vaccine with low-dose adjuvant

    Biological/Vaccine

    Candidate 1, Dose Level 1, Intramuscular injection, 0, 2 months schedule

  • Recombinant herpes zoster vaccine with high-dose adjuvant

    Biological/Vaccine

    Candidate 2, Dose Level 2, Intramuscular injection, 0, 2 months schedule

  • Low-dose adjuvant

    Biological/Vaccine

    Adjuvant control 1, Dose Level 1, Intramuscular injection, 0, 2 months schedule

  • High-dose adjuvant

    Biological/Vaccine

    Adjuvant control 2, Dose Level 2, Intramuscular injection, 0, 2 months schedule

  • Shingrix (GSK)

    Biological/Vaccine

    Positive control, Intramuscular injection, 0, 2 months schedule

  • Normal Saline

    Biological/Vaccine

    Placebo control, Intramuscular injection, 0, 2 months schedule

Treatment groups

645 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: SubStudy A (SSA): Group 1Experimental treatment 1 intervention
Group B: SSA: Group 2Experimental treatment 1 intervention
Group C: SSA:Control group 1Placebo comparator 1 intervention
Group D: SSA:Control group 2Placebo comparator 1 intervention
Group E: SSA: Positive controlActive comparator 1 intervention
Group F: SSA: Placebo groupPlacebo comparator 1 intervention
Group G: SubStudy B (SSB): Group 3Experimental treatment 1 intervention
Group H: SSB: Group 4Experimental treatment 1 intervention
Group I: SSB: Positive controlActive comparator 1 intervention
Group J: SSB: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of immediate Adverse Events (AEs)

The occurrence of any adverse events within 30 minutes after each dose of vaccination.

Time frame
30min after each dose of vaccination
2

Percentage of solicited Adverse Events

Adverse events defined by the protocol that occurred to the participant during 0-14 days after each dose of vaccination.

Time frame
14 days after each dose of vaccination
3

Serious Adverse Events (SAE)

That is serious adverse events, any serious adverse events that occurred to the participant during the study period.

Time frame
12 months after the last dose
4

Percentage of unsolicited Adverse Events

Other adverse events that occurred among participants within 0-28/30 days after each vaccination, in addition to the solicited adverse events.

Time frame
28 or 30 days after each dose of vaccination

Secondary outcomes

1

SSB： Cellular immune level

Levels of glycoprotein E (gE)-specific CD4+/CD8+ T cells expressing 2 or more markers of activation.

Time frame
30 days, 6 months, 12months and 24 months after the last dose of vaccination
2

SSB：Humoral immunogenicity level

Levels of GMC (Anti-gE antibody), GMT (Anti-VZV antibody), positive rate and seroconversion rate after receiving 2 doses of vaccine.

Time frame
6 months, 12months and 24 months after the last dose of vaccination

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Institute Of Biological Products

Lead sponsor

Source ClinicalTrials.gov
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