The Safety and Immunogenicity Study of the Recombinant Zoster Vaccine (CHO Cell)

NCT05769049 | Completed Phase 1 DMC

• 1 other identifier: REC610C102
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, observer-blinded, active-controlled Phase I study to evaluate the safety, reactogenicity, and immunogenicity of REC610, when administered as 2 intramuscular (IM) injections in healthy adults aged 40 years and older, who do not have known HZ and history of varicella or HZ vaccination. The recombinant HZ vaccine, Shingrix® (GlaxoSmithKline), will be used as the active control.

Conditions

Herpes Zoster

Outcome Measures

Primary Outcomes (5)

• Incidence of related AE

  The incidence of investigational product (IP)-related adverse events (AEs) within 30 days after each dose vaccination.

  within 30 days after each dose vaccination

• Incidence of solicited AE

  The incidence of solicited local and systemic AEs within 7 days after each dose vaccination.

  within 7 days after each dose vaccination

• Incidence of unsolicited AEs

  The incidence of unsolicited AEs within 30 days after each dose vaccination.

  within 30 days after each dose vaccination

• Incidence of clinically significant abnormalities in clinical laboratory tests

  The incidence of clinically significant abnormalities in clinical laboratory tests (hematology, blood chemistry, and urinalysis) on Day 7 after the first dose vaccination

  Day 7 after the first dose vaccination

• Occurrence of serious adverse events (SAEs) and adverse events of special interests (AESIs)

  The occurrence of serious adverse events (SAEs) and adverse events of special interests (AESIs) till 6 months after the second dose vaccination

  6 months after the second dose vaccination

Secondary Outcomes (5)

• The seroconversion rate (SCR) at timepoints during the study

  60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination

• The geometric mean titer (GMT) at timepoints during the study

  60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination

• The geometric mean increase (GMI) at timepoints during the study

  60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination

• Frequencies of CD4+ T cells secreting at least one of gE specific cytokines (e.g., IFN-γ, IL-2, TNF-α, CD40L) per 106 CD4+ T cells, and the cell mediated immunity (CMI) response rates at timepoints during the study

  60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination

• Frequencies of CD4+ T cells secreting at least two of gE specific cytokines (e.g., IFN-γ, IL-2, TNF-α) per 106 CD4+ T cells, and the cell mediated immunity (CMI) response rates at timepoints during the study

  60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination

Study Arms (2)

REC610

EXPERIMENTAL

Lyophilized gE antigen: white cake or powder. clear to opalescent, colorless liquid after reconstitution with water for injection BFA01 adjuvant suspension: opalescent white liquid After reconstitution: opalescent white liquid. Each dose (0.5 mL) contains 50 μg of Quillaja Saponin (QS-21), 50 μg of MPL, 1 mg of dioleoyl phosphatidylcholine, and 0.25 mg of cholesterol

Biological: REC610

Shingrix

ACTIVE COMPARATOR

Lyophilized gE antigen: white cake or powder. clear to opalescent, colorless liquid after reconstitution with water for injection AS01B adjuvant suspension: opalescent, colorless to pale brownish liquid suspension After reconstitution: opalescent, colorless to pale brownish liquid. Each dose (0.5 mL) contains 50 μg of QS-21, 50 μg of MPL, 1 mg of dioleoyl phosphatidylcholine, and 0.25 mg of cholesterol

Biological: Shingrix

Interventions

REC610 BIOLOGICAL

administered as 2 intramuscular (IM) injections in healthy adults aged 40 years and older

Also known as: Recombinant Zoster Vaccine (CHO cell)

REC610

Shingrix BIOLOGICAL

Shingrix

Also known as: Recombinant Zoster Vaccine (CHO cell)

Shingrix

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 40 years and older.
• Able and willing to comply with all study requirements.
• Willing to allow the investigators to discuss the volunteers' medical history with his/her general practitioner/personal doctors and access all medical records which are relevant to study procedures.

You may not qualify if:

• Known history of COVID-19 within 6 months prior to randomization, or being defined as SARS-CoV-2 infection by RT-PCR assay during the screening.
• Fever (oral temperature ≥ 37.5°C / axillary temperature ≥ 37.3°C) on the day of vaccination, or having fever within recent 72 hours before the vaccination.
• Known history of herpes zoster.
• History of varicella or herpes zoster vaccination.
• Having abnormal results of clinical laboratory testing during screening, which is judged by the investigator with clinical significance, including the hematology, blood chemistry, and urinalysis.
• History of severe allergic diseases or reactions likely to be exacerbated by any component of investigational vaccine, including the adjuvant components (e.g., QS-21, MPL, common in foamer for beverage, emulsive flavor composition, vitamin E, mildew preventive, and part of Chinese herbal medicine, e.g., ginseng, balloon-flower root, liquorice), such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local hypersensitive necrosis reaction (Arthus reaction), prior history of serious adverse reaction to any vaccine or drug, such as acute allergy, urticaria eczema, dyspnea, and angioneurotic edema.
• Having malignant tumors (except for skin basal cell carcinoma or carcinoma uterine cervix in situ), immune diseases (e.g., known documented human immunodeficiency virus \[HIV\] infection, systemic lupus erythematosus, rheumatoid arthritis, alienia or splenectomy, and others that may influence immune response at the investigator's discretion).

Sponsors & Collaborators

• Jiangsu Rec-Biotechnology Co., Ltd.: lead

Study Sites (1)

Pharma Peak Research Philippines,Inc.

Makati City, National Capital Region, Philippines

Location

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

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

Study Officials

• Loreta Zoleta- De Jesus, Dr.

  Silang Specialists Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Observer-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Totally 48 eligible participants, 24 for each age group, will be enrolled in the study with a 2:1 randomization ratio to receive REC610 (50 μg) or Shingrix® (50 μg) respectively.

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: March 15, 2023
• Study Start: February 9, 2023
• Primary Completion: December 6, 2023
• Study Completion: December 6, 2023
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)