Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Recombinant Herpes Zoster Vaccine (SCTV04C) Low-Dose

    Biological/Vaccine

    Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Immunization procedure: 2 doses, 60 days apart;

  • Recombinant Herpes Zoster Vaccine (SCTV04C) High-Dose

    Biological/Vaccine

    Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Immunization procedure: 2 doses, 60 days apart;

  • Placebo control: Saline

    Biological/Vaccine

    The placebo in this study is 0.9% sodium chloride (normal saline) injection; Immunization procedure: 2 doses, 60 days apart;

  • Shingrix®

    Biological/Vaccine

    Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Dosage of vaccination: 50 μg; Immunization procedure: 2 doses, 60 days apart

  • Ganwei®

    Biological/Vaccine

    Route of vaccination: subcutaneous injection into the lateral deltoid of the upper arm; Dosage of vaccination: 0.5 mL; Immunization procedure: saline will be administered at Day 0, and Ganwei® will be administered at Day 60；

Treatment groups

540 Participants
are divided into 5 treatment groups
Group A: Low-Dose Vaccine GroupExperimental treatment 1 intervention
Group B: High-Dose Vaccine GroupExperimental treatment 1 intervention
Group C: Placebo GroupPlacebo comparator 1 intervention
Group D: Shingrix® GroupActive comparator 1 intervention
Group E: Ganwei® GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

phase 1: Incidence and intensity of solicited adverse events (AEs)

Time frame
within 14 days after each vaccination
2

phase 1: Incidence and intensity of unsolicited AEs

Time frame
within 30 days after each vaccination
3

phase 2: Geometric mean concentration (GMC) and seroconversion rate of antigen-specific antibody

Time frame
at 30 days after full vaccination

Secondary outcomes

1

phase 1: Geometric mean titer (GMT)/ GMC, Geometric mean fold increase (GMI), and seroconversion rate of antigen-, and VZV-specific antibody

Time frame
at 30 days after the first vaccination, before the second vaccination, and at 30 days after full vaccination
2

phase 1:Frequency and response rate of CD4+ T cells with antigen-specific TNF-α and/or IFN-γ and/or IL-2 and/or CD40L secretion/expression as determined by intracellular cytokine staining (ICS)

Time frame
at 30 days after the first vaccination, before the second vaccination, and at 30 days after full vaccination
3

phase 1: Incidence of Serious adverse events (SAEs) and Adverse events of special interest (AESIs)

Time frame
during the study (from the first vaccination to 12 months after full vaccination)
4

phase 1: Incidence and intensity of abnormal laboratory tests indicators

Time frame
3 days after each vaccination

Other outcomes

Sponsors and contacts

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

Sinocelltech Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: