Clinical trial NCT02723773: A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults
Official title: Efficacy, Safety and Immunogenicity of GSK Biologicals' HZ/su Vaccine GSK1437173A in a Phase IIIb, Open-label, Long-term Follow-up Study (ZOE-LTFU) of Studies 110390/113077 (ZOSTER-006/022) and Assessment of Additional Doses in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Keywords: Efficacy
Immunogenicity
Safety
Adults
Herpes zoster
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-03-30
Enrollment: 7534
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was a long-term follow-up of the two studies 110390 and 113077 (ZOSTER-006/022) to assess the efficacy, safety, and immunogenicity persistence of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine and included an assessment of 1 or 2 additional doses in two subgroups of older adults.

Detailed description: This is the long-term follow-up study (ZOE-LTFU) of studies 110390 and 113077 (ZOSTER-006/022) to assess the prophylactic efficacy, safety, and immunogenicity persistence of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine and included an assessment of 1 or 2 additional doses on a 0 or 0, 2-month schedule in two subgroups of older adults.

Eligibility criteria: Inclusion Criteria:

* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, ability to have scheduled contacts to allow evaluation during the study). Or subjects with a caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, availability for follow-up contacts).
* Written informed consent obtained from the subject prior to performance of any study specific procedure.
* Subject who participated in ZOSTER-006 or ZOSTER-022 studies and received at least one dose of HZ/su vaccine.

Additional inclusion criteria for the 1-Additional Dose Revaccination and Control groups, ONLY:

* Female subjects of non-childbearing potential may be enrolled in this study.

  * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
* Female subjects of childbearing potential may be enrolled in this 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 and
  * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational or non-registered product (pharmaceutical product or device) at the time of enrolment or planned use during the study period.
* Previous vaccination against Varicella Zoster Virus (VZV) or HZ and/or planned administration during the study of a VZV or HZ vaccine (including an investigational or non-registered vaccine other than the HZ/su vaccine administered in studies ZOSTER-006/022).
* Chronic administration (defined as ≥ 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to Visit Month 0 of study ZOSTER-049 or expected administration at any time during the study period. For corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent. A prednisone dose of \< 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
* Administration of long-acting immune-modifying drugs (e.g., infliximab, rituximab) within 6 months prior to Visit Month 0 of study ZOSTER-049 or expected administration at any time during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus \[HIV\] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
* Administration of immunoglobulins and/or any blood products within 3 months prior to Visit Month 0 of study ZOSTER-049 or planned administration during the study period.
* Prolonged use (\> 14 consecutive days) of oral and/or parenteral antiviral agents that are active against VZV (acyclovir, valacyclovir, famciclovir, etc. ) and planned to be used during the study period for an indication other than to treat suspected or confirmed HZ or an HZ-related complication (topical use of these antiviral agents is allowed).
* Important underlying illness that in the opinion of the investigator would be expected to interfere significantly during the study.

Additional exclusion criteria for the 1-Additional Dose Revaccination and Control groups, only:

* Subjects who experienced an SAE from first vaccination in the previous ZOSTER-006/022 studies to enrolment in study ZOSTER-049 that was considered related to study vaccine by either the investigator or the sponsor.
* Subjects with a new onset of a pIMD or exacerbation of a pIMD from first vaccination in the previous ZOSTER-006/022 studies to enrolment in study ZOSTER-049.
* Use of any investigational or non-registered product (pharmaceutical product or device) within 30 days preceding the first dose of study vaccine or planned use during the study period.
* Administration or planned administration of any other immunizations within 30 days before the first study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines (i.e., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines for seasonal or pandemic flu, with or without adjuvant) may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation (such as materials that may possibly contain latex-gloves, syringes, etc.). Please note, the vaccine and vials in this study do not contain latex.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential).
* Previous episode/history of HZ.

Primary outcomes:
measure: Number of Participants Having at Least One Confirmed Herpes Zoster (HZ) Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, Overall
timeFrame: During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72)
Secondary outcomes:
measure: Number of Participants Having at Least One Confirmed HZ Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, by Age Ranges
timeFrame: During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72)
measure: Number of Participants Having at Least One Confirmed HZ Case From One Month Post-Dose 2 in ZOSTER-006/022 Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges
timeFrame: From one month post-Dose 2 (Month 3) in ZOSTER-006/022 primary studies until the end of ZOSTER-049:EXT 006-022 study (Month 72), a period of approximately 12 years
measure: Number of Participants Having at Least One Confirmed HZ Case Over the Follow-up Years From One Month Post-Dose 2 in ZOSTER-006/022 Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges
timeFrame: Over the follow-up years (Year 1, Year 2, Year 3, Year 4, Year 6, Year 7, Year 8, Year 9, Year 10 and Year 11) from one month post-Dose 2 (Month 3) in ZOSTER-006/022 primary studies until the end of ZOSTER-049:EXT 006-022 study (Month 72)
measure: Number of Participants Having at Least One Post-herpetic Neuralgia (PHN) Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges
timeFrame: During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72)
measure: Number of Participants Having at Least One PHN Case From One Month Post-Dose 2 in ZOSTER-006/022 Primary Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges
timeFrame: From one month post-Dose 2 (Month 3) in ZOSTER-006/022 primary studies until the end of ZOSTER-049:EXT 006-022 study (Month 72), a period of approximately 12 years
measure: Number of Participants Having at Least One HZ Related Complications (Other Than PHN) Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges
timeFrame: During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72)
measure: Number of Participants Having at Least One HZ Related Complications (Other Than PHN) Case From One Month Post-dose 2 (Month 3) in ZOSTER-006/022 Primary Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges
timeFrame: From one month post-Dose 2 (Month 3) in ZOSTER-006/022 primary studies until the end of ZOSTER-049:EXT 006-022 study (Month 72), a period of approximately 12 years
measure: Anti-glycoprotein (gE) Antibody Concentrations for Humoral Immunity (HI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group
timeFrame: At Years 5, 6, 7, 8, 9, 10, 11 and 12 after the primary vaccination in ZOSTER-006/022 studies
measure: Frequency of Antigen-specific CD4 (2+) T-cells for Cell Mediated Immunity (CMI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group
timeFrame: At Years 5, 6, 7, 8, 9, 10, 11 and 12 after the primary vaccination in ZOSTER-006/022 studies
measure: Anti-gE Antibody Concentrations for Participants in LTFU+Control >=50 YOA Group (With a Confirmed HZ Episode) at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies
timeFrame: At Years 5, 6, 7, 8, 9, 10, 11 and 12 after the primary vaccination in ZOSTER-006/022 studies
measure: Frequency of Antigen-specific CD4 (2+) T-cells for Participants in LTFU+Control >=50 YOA Group (With a Confirmed HZ Episode) at Years 5, 6, 7, 8, 9 and 10 After the Primary Vaccination in ZOSTER-006/022 Studies
timeFrame: At Years 5, 6, 7, 8, 9, and 10 after the primary vaccination in ZOSTER-006/022 studies
measure: Anti-gE Antibody Concentrations for 1-Additional Dose, Revaccination and Control Groups at Month 1 in the Current ZOSTER-049:EXT 006-022 Study
timeFrame: At Month 1 in the current ZOSTER-049:EXT 006-022 study
measure: Frequency of Antigen-specific CD4(2+) T-cells for 1-Additional Dose, Revaccination and Control Groups at Month 1 in the Current ZOSTER-049:EXT 006-022 Study
timeFrame: At Month 1 in the current ZOSTER-049:EXT 006-022 study
measure: Anti-gE Antibody Concentrations for Revaccination and Control Groups at Month 3 in the Current ZOSTER-049:EXT 006-022 Study
timeFrame: At Month 3 in the current ZOSTER-049:EXT 006-022 study
measure: Frequency of Antigen-specific CD4 (2+) T-cells for Revaccination and Control Groups at Month 3 in the Current ZOSTER-049:EXT 006-022 Study
timeFrame: At Month 3 in the current ZOSTER-049:EXT 006-022 study
measure: Anti-gE Antibody Concentrations for 1 Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study
timeFrame: At Month 0 and Years 1, 2, 3, 4, 5 and 6 in the current ZOSTER-049:EXT 006-022 study
measure: Frequency of Antigen-specific CD4(2+) T-cells for 1-Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study
timeFrame: At Month 0 and Years 1, 2, 3, 4, 5 and 6 in the current ZOSTER-049:EXT 006-022 study
measure: Number of Participants With Any and Grade 3 Solicited Local Symptoms
timeFrame: Within 7 days after each vaccination (vaccination occurring at Month 0 for 1-Additional Dose Group and at Months 0 and 2 for Revaccination Group) in the current ZOSTER-049:EXT 006-022 study
measure: Duration in Days of Solicited Local Symptoms
timeFrame: Within 7 days after each vaccination (vaccination occurring at Month 0 for 1-Additional Dose Group and at Months 0 and 2 for Revaccination Group) in the current ZOSTER-049:EXT 006-022 study
measure: Number of Participants With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: Within 7 days after each vaccination (vaccination occurring at Month 0 for 1-Additional Dose Group and at Months 0 and 2 for Revaccination Group) in the current ZOSTER-049:EXT 006-022 study
measure: Duration in Days of Solicited General Symptoms
timeFrame: Within 7 days after each vaccination (vaccination occurring at Month 0 for 1-Additional Dose Group and at Months 0 and 2 for Revaccination Group) in the current ZOSTER-049:EXT 006-022 study
measure: Number of Participants With Any Unsolicited Adverse Events (AEs)
timeFrame: Within 30 days after any vaccination (vaccination occurring at Month 0 for 1-Additional Dose Group and at Months 0 and 2 for Revaccination Group) in the current ZOSTER-049:EXT 006-022 study
measure: Number of Participants With Any and Related Serious Adverse Events (SAEs)
timeFrame: From Month 0 to Month 12 (1-Additional Dose and Control groups) and from Month 0 until 12 months after last HZ/su vaccination (Revaccination group)
measure: Number of Participants With SAEs Related to Investigational Vaccine, Related to Study Participation or to GSK Concomitant Medication/Vaccine
timeFrame: During the total duration of ZOSTER-049:EXT 006-022 study (from Month 0 to Month 72)
measure: Number of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs)
timeFrame: From Month 0 to Month 12 (1-Additional Dose and Control groups) and from Month until 12 months after last HZ/su vaccination (Revaccination group)
Other outcomes:
Locations:
city: Glendale
country: United States
facility: GSK Investigational Site
state: Arizona
city: Mesa
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facility: GSK Investigational Site
state: Arizona
city: Phoenix
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state: Arizona
city: Phoenix
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state: Arizona
city: Spring Valley
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state: California
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state: Idaho
city: Wichita
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state: Kansas
city: Columbia
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state: Maryland
city: Elkridge
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state: Maryland
city: Cary
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state: North Carolina
city: Charlotte
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state: North Carolina
city: Hickory
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facility: GSK Investigational Site
state: North Carolina
city: Salisbury
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facility: GSK Investigational Site
state: North Carolina
city: Wilmington
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facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
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state: North Carolina
city: Beachwood
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state: Ohio
city: Wadsworth
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state: Ohio
city: Pittsburgh
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state: Pennsylvania
city: Uniontown
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state: Pennsylvania
city: Greer
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state: South Carolina
city: Mount Pleasant
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state: South Carolina
city: Bristol
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facility: GSK Investigational Site
state: Tennessee
city: San Antonio
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state: Texas
city: Murray
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state: Utah
city: Newport News
country: United States
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state: Virginia
city: Geelong
country: Australia
facility: GSK Investigational Site
city: Westmead
country: Australia
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city: Wollongong
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facility: GSK Investigational Site
city: Belo Horizonte
country: Brazil
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city: CuritibaPR
country: Brazil
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city: Curitiba
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city: SAo Paulo
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city: SAo Paulo
country: Brazil
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city: Gatineau
country: Canada
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city: Halifax
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city: Montreal
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city: Pointe-Claire
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city: Quebec City
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city: Quebec
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city: Sherbrooke
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city: Victoria
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city: Ceske Budejovice
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city: Hradec Kralove
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city: Tallinn
country: Estonia
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city: Tartu
country: Estonia
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city: Espoo
country: Finland
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country: Finland
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city: Helsinki
country: Finland
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country: Finland
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city: Kokkola
country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
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city: Pori
country: Finland
facility: GSK Investigational Site
city: Seinajoki
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Angers
country: France
facility: GSK Investigational Site
city: Angers
country: France
facility: GSK Investigational Site
city: ChAteau Gontier
country: France
facility: GSK Investigational Site
city: Clermont Ferrand
country: France
facility: GSK Investigational Site
city: Laval
country: France
facility: GSK Investigational Site
city: Montrevault
country: France
facility: GSK Investigational Site
city: Muret
country: France
facility: GSK Investigational Site
city: Murs Erigne
country: France
facility: GSK Investigational Site
city: Nantes
country: France
facility: GSK Investigational Site
city: Rosiers d'Egletons
country: France
facility: GSK Investigational Site
city: SegrE
country: France
facility: GSK Investigational Site
city: Tours
country: France
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Dachau
country: Germany
facility: GSK Investigational Site
city: Dresden
country: Germany
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city: Essen
country: Germany
facility: GSK Investigational Site
city: Essen
country: Germany
facility: GSK Investigational Site
city: Floersheim
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facility: GSK Investigational Site
city: Freiberg
country: Germany
facility: GSK Investigational Site
city: Goch
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facility: GSK Investigational Site
city: Gueglingen
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Koeln
country: Germany
facility: GSK Investigational Site
city: Koethen
country: Germany
facility: GSK Investigational Site
city: Kuenzing
country: Germany
facility: GSK Investigational Site
city: Leipzig
country: Germany
facility: GSK Investigational Site
city: Luebeck
country: Germany
facility: GSK Investigational Site
city: Magdeburg
country: Germany
facility: GSK Investigational Site
city: Mainz
country: Germany
facility: GSK Investigational Site
city: Mannheim
country: Germany
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
city: Rednitzhembach
country: Germany
facility: GSK Investigational Site
city: Rhaunen
country: Germany
facility: GSK Investigational Site
city: Tuebingen
country: Germany
facility: GSK Investigational Site
city: Wallerfing
country: Germany
facility: GSK Investigational Site
city: Wangen
country: Germany
facility: GSK Investigational Site
city: Weinheim
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facility: GSK Investigational Site
city: Witten
country: Germany
facility: GSK Investigational Site
city: Wuerzburg
country: Germany
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country: Hong Kong
facility: GSK Investigational Site
city: Shatin
country: Hong Kong
facility: GSK Investigational Site
city: Chieti
country: Italy
facility: GSK Investigational Site
city: Genova
country: Italy
facility: GSK Investigational Site
city: Monza MB
country: Italy
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
city: Sassari
country: Italy
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Ansan
country: Korea, Republic of
facility: GSK Investigational Site
city: Bucheon-si Kyunggi-do 14584
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Kangwon-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Durango
country: Mexico
facility: GSK Investigational Site
city: Zapopan Jalisco
country: Mexico
facility: GSK Investigational Site
city: Alcover Tarragona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Hostalets De Balenya Ba
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Peralada Girona
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Boras
country: Sweden
facility: GSK Investigational Site
city: Eskilstuna
country: Sweden
facility: GSK Investigational Site
city: Goteborg
country: Sweden
facility: GSK Investigational Site
city: Jonkoping
country: Sweden
facility: GSK Investigational Site
city: Karlskrona
country: Sweden
facility: GSK Investigational Site
city: Linkoping
country: Sweden
facility: GSK Investigational Site
city: Malmo
country: Sweden
facility: GSK Investigational Site
city: Orebro
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Uppsala
country: Sweden
facility: GSK Investigational Site
city: Vallingby
country: Sweden
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Tau-Yuan
country: Taiwan
facility: GSK Investigational Site
city: Atherstone Warwickshire
country: United Kingdom
facility: GSK Investigational Site
city: Belfast
country: United Kingdom
facility: GSK Investigational Site
city: Bradford On Avon Wiltsh
country: United Kingdom
facility: GSK Investigational Site
city: Broughshane
country: United Kingdom
facility: GSK Investigational Site
city: Chorley
country: United Kingdom
facility: GSK Investigational Site
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Strezova A, Diez-Domingo J, Al Shawafi K, Tinoco JC, Shi M, Pirrotta P, Mwakingwe-Omari A; Zoster-049 Study Group. Long-term Protection Against Herpes Zoster by the Adjuvanted Recombinant Zoster Vaccine: Interim Efficacy, Immunogenicity, and Safety Results up to 10 Years After Initial Vaccination. Open Forum Infect Dis. 2022 Oct 23;9(10):ofac485. doi: 10.1093/ofid/ofac485. eCollection 2022 Oct.
citation: Boutry C, Hastie A, Diez-Domingo J, Tinoco JC, Yu CJ, Andrews C, Beytout J, Caso C, Cheng HS, Cheong HJ, Choo EJ, Curiac D, Di Paolo E, Dionne M, Eckermann T, Esen M, Ferguson M, Ghesquiere W, Hwang SJ, Avelino-Silva TJ, Kosina P, Liu CS, Markkula J, Moeckesch B, Murta de Oliveira C, Park DW, Pauksens K, Pirrotta P, Plassmann G, Pretswell C, Rombo L, Salaun B, Sanmartin Berglund J, Schenkenberger I, Schwarz T, Shi M, Ukkonen B, Zahaf T, Zerbini C, Schuind A, Cunningham AL; Zoster-049 Study Group. The Adjuvanted Recombinant Zoster Vaccine Confers Long-Term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70. Clin Infect Dis. 2022 Apr 28;74(8):1459-1467. doi: 10.1093/cid/ciab629.