Clinical trial NCT04869982: Efficacy, Immunogenicity and Safety Study of GSKs Recombinant Zoster Vaccine Shingrix (GSK1437173A) in Chinese Adults Aged ≥50 Years
Official title: A Phase IV, Randomized, Observer-blind, Placebo-controlled, Multi-center Study to Assess the Prophylactic Efficacy Against Herpes Zoster, Immunogenicity and Safety of Shingrix When Administered Intramuscularly on a 2-dose Schedule in Chinese Adults Aged 50 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Herpes Zoster
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2021-05-03
Enrollment: 6138
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.

Other exclusions

* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months of last vaccination.
* History of current/chronic alcohol consumption and/or drug abuse.

Primary outcomes:
measure: Incidence Rate of Confirmed Herpes Zoster (HZ) Cases
timeFrame: From Month 3 (30 days after the second vaccination) up to study end (duration of approximately 2 years)
Secondary outcomes:
measure: Incidence Rate of Confirmed HZ Cases, by Age Category
timeFrame: From Month 3 (30 days after the second vaccination) up to study end (duration of approximately 2 years)
measure: 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
timeFrame: Within 7 days after each vaccination (occurring at Day 1 and Month 2)
measure: 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
timeFrame: Within 7 days after each vaccination (occurring at Day 1 and Month 2)
measure: 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
timeFrame: Within 30 days after any vaccination (occurring at Day 1 and Month 2)
measure: 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
timeFrame: 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)
measure: Number of Participants With at Least One SAE and With at Least One Related SAE From First Vaccination (Day 1) up to 12 Months Post Last Vaccination
timeFrame: From first vaccination (Day 1) up to 12 months 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)
measure: Number of Participants With at Least One Related SAE From First Vaccination (Day 1) up to Study End (Duration of Approximately 2 Years)
timeFrame: From first vaccination (Day 1) up to study end (duration of approximately 2 years)
measure: Number of Participants With at Least One SAE Related to Study Participation or to GlaxoSmithKline Concomitant Medication/Vaccine
timeFrame: From the time the participant consented to participate in the study (Day 1) up to study end (duration of approximately 2 years)
measure: Number of Participants With at Least One Fatal SAE and at Least One Related Fatal SAE From First Vaccination (Day 1) up to 30 Days Post Last Vaccination
timeFrame: 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)
measure: Number of Participants With at Least One Fatal SAE and With at Least One Related Fatal SAE From First Vaccination (Day 1) up to 12 Months Post Last Vaccination
timeFrame: From first vaccination (Day 1) up to 12 months 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)
measure: Number of Participants With at Least One Related Fatal SAE From First Vaccination (Day 1) up to Study End (Duration of Approximately 2 Years)
timeFrame: From first vaccination (Day 1) up to study end (duration of approximately 2 years)
measure: Number of Participants With at Least One Potential Immune-mediated Disease (pIMD) and at Least One Related pIMD From First Vaccination (Day 1) up to 30 Days Post Last Vaccination
timeFrame: 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)
measure: Number of Participants With at Least One pIMD and at Least One Related pIMD From First Vaccination (Day 1) up to 12 Months Post Last Vaccination
timeFrame: From first vaccination (Day 1) up to 12 months 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)
measure: Number of Participants With at Least One Related Serious pIMD From 12 Months Post Last Vaccination up to Study End (Duration of Approximately 1 Year)
timeFrame: From 12 months 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) up to study end (duration of approximately 1 year)
Other outcomes:
Locations:
city: Huaian
country: China
facility: GSK Investigational Site
state: Jiangsu
city: Lianyungang
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
Study officials:
References:
citation: 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.