Health TrialsbyHealthPanel

Safety and Immunogenicity of CVI-VZV-001 in Adults Aged 50 Years and Above

ConditionHerpes Zoster
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorCHA Vaccine Institute Co., Ltd.

About this trial

To evaluate the immunogenicity of the investigational product (IP) in healthy adults aged 50 years or older and to explore differences in immune responses between the experimental and control groups, and to determine the optimal dose of the IP.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adults aged 50 years or older

Able to understand the study procedures and provide written informed consent

Females and males of reproductive potential must agree to use medically acceptable contraception until 3 months after the last vaccination

Females of childbearing potential must have a negative pregnancy test prior to vaccination

Disqualifiers

History of herpes zoster prior to screening

History of severe allergic reaction to vaccines or vaccine components

Known immunodeficiency or immune dysfunction

Prior vaccination with varicella or herpes zoster vaccine

Trial design

Design model

Parallel

Treatments tested in this trial

  • Shingrix

    Biological/Vaccine

    Licensed herpes zoster vaccine used as an active comparator.

  • CVI-VZV-001

    Biological/Vaccine

    Investigational herpes zoster vaccine.

Treatment groups

135 Participants
are divided into 3 treatment groups
Group A: CVI-VZV-001 Low DoseExperimental treatment 1 intervention
Group B: CVI-VZV-001 High DoseExperimental treatment 1 intervention
Group C: ShingrixActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Geometric Mean Fold Rise (GMFR) of Anti-VZV gE Antibody

Geometric mean fold rise (GMFR) of anti-VZV gE antibodies measured by ELISA from baseline to 4 weeks after the second vaccination.

Time frame
Baseline to 4 weeks after the second vaccination

Secondary outcomes

1

Geometric Mean Fold Rise (GMFR) of Anti-VZV gE Antibody at Additional Time Points

Geometric mean fold rise (GMFR) of anti-VZV glycoprotein E (gE) antibody levels measured by ELISA relative to baseline.

Time frame
Before the second vaccination and at 8 and 24 weeks after the second vaccination
2

Geometric Mean Concentration (GMC) of Anti-VZV gE Antibody

Geometric mean concentration (GMC) of anti-VZV glycoprotein E (gE) antibody levels measured by ELISA.

Time frame
Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination
3

Vaccine Response Rate (VRR) of Anti-VZV gE Antibody

Proportion of participants achieving a predefined vaccine response in anti-VZV glycoprotein E (gE) antibody levels measured by ELISA.

Time frame
Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination
4

Polyfunctional CD4+ T Cell Response

Frequency of polyfunctional CD4+ T cells defined as CD4+ T cells producing at least two activation markers (IFN-γ, IL-2, TNF-α, CD40L \[CD154\]) following stimulation with VZV glycoprotein E peptides.

Time frame
4 and 8 weeks after the second vaccination

Other outcomes

Sponsors and contacts

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

CHA Vaccine Institute Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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