Efficacy, Immunogenicity and Safety Study of GSKs Recombinant Zoster Vaccine Shingrix (GSK1437173A) in Chinese Adults Aged ≥50 Years

NCT04869982 | Completed Phase 4 Results

• 1 other identifier: 212884
• Study Type: interventional
• Target: 6,138
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study was to assess vaccine efficacy (VE), ability to generate immune response and safety of two doses of the recombinant subunit zoster vaccine (RZV) for prevention of Herpes Zoster (HZ) in Chinese adults aged 50 years and older.

Conditions

Herpes Zoster

Outcome Measures

Primary Outcomes (1)

• Incidence Rate of Confirmed Herpes Zoster (HZ) Cases

  A suspected case of HZ was defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A confirmed case of HZ was diagnosed by Polymerase Chain Reaction (PCR) or by the HZ Ascertainment Committee (HZAC) determination. The incidence rate (n/T) of confirmed HZ cases, expressed in terms of 1000 person-years rate, was calculated as the number of participants reporting at least one confirmed HZ case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 1000.

  From Month 3 (30 days after the second vaccination) up to study end (duration of approximately 2 years)

Secondary Outcomes (14)

• Incidence Rate of Confirmed HZ Cases, by Age Category

  From Month 3 (30 days after the second vaccination) up to study end (duration of approximately 2 years)

• Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit

  Within 7 days after each vaccination (occurring at Day 1 and Month 2)

• Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit

  Within 7 days after each vaccination (occurring at Day 1 and Month 2)

• Number of Participants With at Least One Unsolicited AE, at Least One Grade 3 Unsolicited AE, at Least One Related Unsolicited AE, at Least One Grade 3 Related Unsolicited AE and With at Least One Medically Attended Unsolicited AE

  Within 30 days after any vaccination (occurring at Day 1 and Month 2)

• Number of Participants With at Least One Serious Adverse Event (SAE) and With at Least One Related SAE From First Vaccination (Day 1) up to 30 Days Post Last Vaccination

  From first vaccination (Day 1) up to 30 days post last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)

Study Arms (2)

RZV Group

EXPERIMENTAL

Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.

Biological: RZV

Placebo Group

PLACEBO COMPARATOR

Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.

Drug: Placebo

Interventions

RZV BIOLOGICAL

2 doses of RZV in 0, 2 months schedule, administered intramuscularly in the deltoid region of the non-dominant arm

RZV Group

Placebo DRUG

2 doses of placebo in 0, 2 months schedule, administered intramuscularly in the deltoid region of the non-dominant arm

Placebo Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
• Written or witnessed/thumb printed informed consent obtained from the participant/participant's LAR prior to performance of any study specific procedure.
• A male or female aged 50 years or older at the time of the first vaccination.
• Medically stable participants as established by medical history and history-directed clinical examination before entering into the study.
• Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
• Female participants of childbearing potential may be enrolled in the study, if the subject
• has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test on the day of vaccination
• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series

You may not qualify if:

• Medical conditions
• Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
• History of HZ.
• Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study materials and equipment.
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality as determined by physical examination or laboratory screening tests.
• Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
• Prior/Concomitant therapy
• Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the study period.
• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after the last dose of vaccine administration. However, licensed pneumococcal vaccines and inactivated and subunit influenza vaccines (without adjuvant for seasonal or pandemic flu) may be co- administered with any dose of study vaccine.
• Previous vaccination against varicella or HZ.
• Administration of long-acting immune-modifying drugs at any time during the study period.
• Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study vaccine up to one month post dose 2 (Month 3).
• Planned or chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine. For corticosteroids, this will mean prednisone ≥20mg/day, or equivalent, is not allowed. Inhaled, intra-articular and topical steroids are allowed.
• Prior/Concurrent clinical study experience

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Huaian, Jiangsu, 223005, China

Location

GSK Investigational Site

Lianyungang, 222100, China

Location

GSK Investigational Site

Shanghai, 200001, China

Location

GSK Investigational Site

Shanghai, 200051, China

Location

GSK Investigational Site

Shanghai, 200090, China

Location

GSK Investigational Site

Shanghai, 201620, China

Location

Related Publications (2)

• Alexandra Echeverria Proano D, Zhu F, Sun X, Zoco J, Soni J, Parmar N, Ali SO; Zoster-076 Study Group. Efficacy, reactogenicity, and safety of the adjuvanted recombinant zoster vaccine for the prevention of herpes zoster in Chinese adults >/= 50 years: A randomized, placebo-controlled trial. Hum Vaccin Immunother. 2024 Dec 31;20(1):2351584. doi: 10.1080/21645515.2024.2351584. Epub 2024 Jun 5.

  PMID: 38838170 BACKGROUND

• de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.

  PMID: 37781954 DERIVED

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study was conducted in an observer-blind manner. This means that during the course of the study, the vaccine(s) recipient and those responsible for the evaluation of any study endpoint were all unaware of which study intervention was administered. The laboratory in charge of the laboratory testing was blinded to the treatment, and codes were used to link the participant and study (without any link to the treatment attributed to the participant) to each sample.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 3, 2021
• Study Start: May 14, 2021
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: January 20, 2025
• Results First Posted: September 19, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

CN (6)