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NCT Number: NCT05856084

Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above

The purposes of the study are to evaluate the immunogenicity and safety of different dose levels of recombinant herpes zoster vaccine (CHO Cells) with 2 doses at 2-month intervals in healthy subjects aged 30 years and older.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yanjin Center for Disease Control and Prevention

Xinxiang, Henan, 453200, China

About this study

The clinical trial will be a single-center, randomized, blind, controlled study in which two dose levels of vaccine will be tested in healthy adults aged 30 to 49 years and 50 years and older. A total of 924 participants will be enrolled, including 396 participants aged 30 to 49 years and 528 participants aged 50 years and older. Participants aged 30 to 49 years will be randomized into three subgroups (low dose vaccine group, high dose vaccine group and placebo group) in a 1:1:1 ratio. Participants aged 50 years and older will be randomized into four subgroups (low dose vaccine group, high dose vaccine group, Shingrix® group and placebo group) in a 1:1:1:1 ratio.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Permanent residents aged 30 years and above;
  • Subjects voluntarily agree to participate in the study and signed an informed consent;
  • Be able to participate in all scheduled visits and comply with the protocol requirements.

Exclusion criteria

  • Axillary temperature>37.0℃;
  • History of herpes zoster within 5 years before vaccination;
  • Prior vaccination with chickenpox vaccine or herpes zoster vaccine;
  • Female participant who is pregnant ( urine pregnancy test was positive) or breastfeeding, or has pregnancy plans within 1 year after the last vaccination;
  • Receipt of live vaccine within 28 days, or any other vaccine within 14 days prior to vaccination;
  • Receipt of immunoglobulin or intravenous immunoglobulin within 3 months before vaccination;
  • Acute diseases or acute exacerbation of chronic disease within 3 days before vaccination;
  • A known allergy to any components of the study vaccine (especially allergic to aminoglycoside antibiotics), or history of severe allergy to any previous vaccination;
  • History of convulsions, epilepsy, encephalopathy (such as congenital brain dysplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection disease, nerve tissue damage caused by chemical drug poisoning, etc.) or mental illness and family history;
  • Asplenia or functional asplenia, or splenectomy caused by any condition;
  • Primary or secondary impairment of immune function or diagnosed congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases;
  • Receipt of immunosuppressive therapy within 3 months before vaccination (such as long-term use of systemic glucocorticoid ≥14 days, dose ≥2mg/kg/day or ≥20mg/day prednisone or equivalent dose), but inhaled, intra-articular and topical steroids are acceptable;
  • Severe cardiovascular disease(eg. Pulmonary heart disease, Pulmonary Edema); Severe liver or kidney disease; or diabetes with complication;
  • History of thrombocytopenia or other coagulation disorders, which may cause intramuscular injection contraindications;
  • Abnormal blood pressure during physical examination before vaccination (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mmHg);
  • Current or history of alcohol and/or drug abuse;
  • Any condition that, in the opinion the investigator, may affect the safety of the subject or the evaluation of the study results.

Treatment and study plan

Low Dose Recombinant Herpes Zoster Vaccine (CHO cells)

Biological

0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with low dose MA105.

High Dose Recombinant Herpes Zoster Vaccine (CHO cells)

Biological

0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with high dose MA105.

Positive control

Biological

0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.

Other names: Shingrix®

Placebo

Biological

0.5 mL per dose, containing 4.5 mg sodium chloride.

Other names: Normal Saline for injection

Primary outcomes

  1. Geometric mean concentration (GMC) of anti-gE antibody

    Time frame: Month 1 after the last vaccination

    Measured by ELISA.

  2. Seropositivity rate of anti-gE antibody

    Time frame: Month 1 after the last vaccination

    The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.

  3. Seroresponse rate of anti-gE antibody

    Time frame: Month 1 after the last vaccination

    The seroresponse rate is defined as the percentage of subjects who have at least a: 4-fold increase in the antibody concentration as compared to the pre vaccination antibody concentration, for subjects who are seropositive at baseline, OR, 4-fold increase in the antibody concentration as compared to the antibody concentration cut-off value for seropositivity, for subjects who are seronegative at baseline.

  4. Geometric Mean Fold Rise (GMFR) of anti-gE antibody concentration

    Time frame: Month 1 after the last vaccination

    The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).

  5. Four-fold increase rate of anti-gE antibody concentration

    Time frame: Month 1 after the last vaccination

    The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).

  6. Cell-Mediated Immunity (CMI) response

    Time frame: Month 1 after the last vaccination

    CMI response is defined as the frequency of CD4+ T cells producing at least 2 activation markers (IFN-γ, IL-2, TNF-α and/or CD40L) upon in vitro stimulation by gE peptide pools.

  7. Vaccine Response Rate (VRR)

    Time frame: Month 1 after the last vaccination

    VRR is defined as the percentage of participants with T-cell frequencies are ≥Cut-off value, for participants with T-cell frequencies<Cut-off at baseline, OR, at least a 2-fold increase as compared to baseline for participants with T-cell frequencies ≥Cut-off value at baseline.

  8. The incidence and severity of adverse events

    Time frame: Within 30 minutes after each vaccination

    Incidence and severity of adverse events within 30 minutes after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.

  9. The incidence and severity of adverse events

    Time frame: Within 7 days after each vaccination

    Incidence and severity of adverse events within 7 days after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.

  10. The incidence and severity of adverse events

    Time frame: Day 8 to 30 after each vaccination

    Incidence and severity of adverse events during Day 8 to 30 after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.

  11. The incidence and severity of adverse events

    Time frame: Within 30 days after each vaccination

    Incidence and severity of adverse events within 30 days after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.

Secondary outcomes

  1. The incidence of Serious Adverse Events

    Time frame: From the first vaccination to 12 months after the last vaccination

    Incidence of Serious Adverse Events (SAEs) from the first vaccination to 12 months after the last vaccination.

  2. Potential Immune-Mediated Diseases

    Time frame: From the first vaccination to 12 months after the last vaccination

    Incidence of Potential Immune-Mediated Diseases (pIMDs) from the first vaccination to 12 months after the last vaccination.

  3. Geometric mean concentration (GMC) of anti-VZV antibody

    Time frame: Month 1 after the last vaccination

    measured by ELISA.

  4. Seropositivity rate of anti-VZV antibody

    Time frame: Month 1 after the last vaccination

    The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.

  5. Seroresponse rate of anti-VZV antibody

    Time frame: Month 1 after the last vaccination

    The seroresponse rate is defined as the percentage of subjects who have at least a: 4-fold increase in the antibody concentration as compared to the pre vaccination antibody concentration, for subjects who are seropositive at baseline, OR, 4-fold increase in the antibody concentration as compared to the antibody concentration cut-off value for seropositivity, for subjects who are seronegative at baseline.

  6. Geometric Mean Fold Rise (GMFR) of anti-VZV antibody

    Time frame: Month 1 after the last vaccination

    The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).

  7. Four-fold increase rate of anti-VZV antibody

    Time frame: Month 1 after the last vaccination

    The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).

  8. Geometric mean concentration (GMC) of anti-gE antibody

    Time frame: At 6, 12 and 24 months after the last vaccination

    measured by ELISA.

  9. Seropositivity rate of anti-gE antibody

    Time frame: At 6, 12 and 24 months after the last vaccination

    The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.

  10. Geometric mean concentration (GMC) of anti-VZV antibody

    Time frame: At 6, 12 and 24 months after the last vaccination

    measured by ELISA.

  11. Seropositivity rate of anti-VZV antibody

    Time frame: At 6, 12 and 24 months after the last vaccination

    The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.

  12. Cell-Mediated Immunity (CMI) response

    Time frame: At 6, 12 and 24 months after the last vaccination

    CMI response is defined as the frequency of CD4+ T cells producing at least 2 activation markers (IFN-γ, IL 2, TNF-α and/or CD40L) upon in vitro stimulation by gE peptide pools.

  13. Vaccine Response Rate (VRR)

    Time frame: At 6, 12 and 24 months after the last vaccination

    VRR is defined as the percentage of participants with T-cell frequencies are ≥Cut-off value, for participants with T-cell frequencies<Cut-off at baseline, OR, at least a 2-fold increase as compared to baseline for participants with T-cell frequencies ≥Cut-off value at baseline.

Sponsors and collaborators

Lead sponsor

MAXVAX Biotechnology Limited Liability Company

Industry

Collaborators

  • Henan Center for Disease Control and Prevention

Registry information

Official study title

A Phase II, Single Center, Randomized, Blind, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
May 12, 2023
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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