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

NCT05856084 | Active Not Recruiting Phase 2

• 1 other identifier: MKKCT-100-002
• Study Type: interventional
• Target: 924
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Herpes Zoster

Outcome Measures

Primary Outcomes (11)

• Geometric mean concentration (GMC) of anti-gE antibody

  Measured by ELISA.

  Month 1 after the last vaccination

• Seropositivity rate of anti-gE antibody

  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.

  Month 1 after the last vaccination

• Seroresponse rate of anti-gE antibody

  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.

  Month 1 after the last vaccination

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

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

  Month 1 after the last vaccination

• Four-fold increase rate of anti-gE antibody concentration

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

  Month 1 after the last vaccination

• Cell-Mediated Immunity (CMI) response

  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.

  Month 1 after the last vaccination

• Vaccine Response Rate (VRR)

  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.

  Month 1 after the last vaccination

• The incidence and severity of adverse events

  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.

  Within 30 minutes after each vaccination

• The incidence and severity of adverse events

  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.

  Within 7 days after each vaccination

• The incidence and severity of adverse events

  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.

  Day 8 to 30 after each vaccination

• The incidence and severity of adverse events

  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.

  Within 30 days after each vaccination

Secondary Outcomes (13)

• The incidence of Serious Adverse Events

  From the first vaccination to 12 months after the last vaccination

• Potential Immune-Mediated Diseases

  From the first vaccination to 12 months after the last vaccination

• Geometric mean concentration (GMC) of anti-VZV antibody

  Month 1 after the last vaccination

• Seropositivity rate of anti-VZV antibody

  Month 1 after the last vaccination

• Seroresponse rate of anti-VZV antibody

  Month 1 after the last vaccination

Study Arms (7)

Low dose vaccine group in adults aged 30 to 49 years

EXPERIMENTAL

Participants aged 30 to 49 years will be vaccinated with 2 doses of low dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM).

Biological: Low dose Recombinant Herpes Zoster Vaccine (CHO cells)

High dose vaccine group in adults aged 30 to 49 years

EXPERIMENTAL

Participants aged 30 to 49 years will be vaccinated with 2 doses of high dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM).

Biological: High dose Recombinant Herpes Zoster Vaccine (CHO cells)

Placebo group in adults aged 30 to 49 years

PLACEBO COMPARATOR

Participants aged 30 to 49 years will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).

Biological: Placebo

Low dose vaccine group in adults aged 50 years and older

EXPERIMENTAL

Participants aged 50 years and older will be vaccinated with 2 doses of low dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM).

Biological: Low dose Recombinant Herpes Zoster Vaccine (CHO cells)

High dose vaccine group in adults aged 50 years and older

EXPERIMENTAL

Participants aged 50 years and older will be vaccinated with 2 doses of high dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM).

Biological: High dose Recombinant Herpes Zoster Vaccine (CHO cells)

Shingrix® group in adults aged 50 years and older

ACTIVE COMPARATOR

Participants aged 50 years and older will be vaccinated with 2 doses of Shingrix® on a 0, 2 month schedule, administered intramuscularly (IM).

Biological: Positive control

Placebo group in adults aged 50 years and older

PLACEBO COMPARATOR

Participants aged 50 years and older will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).

Biological: Placebo

Interventions

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.

Low dose vaccine group in adults aged 30 to 49 years; Low dose vaccine group in adults aged 50 years and older

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.

High dose vaccine group in adults aged 30 to 49 years; High dose vaccine group in adults aged 50 years and older

Positive control BIOLOGICAL

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

Also known as: Shingrix®

Shingrix® group in adults aged 50 years and older

Placebo BIOLOGICAL

0.5 mL per dose, containing 4.5 mg sodium chloride.

Also known as: Normal Saline for injection

Placebo group in adults aged 30 to 49 years; Placebo group in adults aged 50 years and older

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• MAXVAX Biotechnology Limited Liability Company: lead
• Henan Center for Disease Control and Prevention: collaborator

Study Sites (1)

Yanjin Center for Disease Control and Prevention

Xinxiang, Henan, 453200, China

Location

MeSH Terms

Conditions

Herpes Zoster

Interventions

Saline Solution; Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yanxia Wang

  Henan Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 12, 2023
• Study Start: May 7, 2023
• Primary Completion: December 28, 2024
• Study Completion: March 31, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)