Study on Long-Term Effects and Safety of Herpes Zoster Vaccine with Recombinant Varicella Zoster Virus Glycoprotein E in Older Adults

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What is this study about?

This clinical trial is focused on studying Herpes Zoster, commonly known as shingles, which is a painful skin rash caused by the reactivation of the chickenpox virus. The study is evaluating a vaccine called Shingrix, which is designed to prevent shingles. Shingrix is a type of vaccine that uses a part of the virus, known as a recombinant varicella zoster virus glycoprotein E, to help the body build protection against the disease.

The purpose of this study is to assess how well the Shingrix vaccine works over a long period, how safe it is, and how long the immune response lasts in older adults. Participants in the study will receive one or two additional doses of the vaccine. The study will follow participants for several years to monitor their health and the effectiveness of the vaccine in preventing shingles.

Throughout the study, participants will have regular check-ups to track their immune response and any side effects. The study will also look at the number of confirmed cases of shingles among participants and measure specific immune cells and antibodies that help protect against the virus. This information will help determine the long-term benefits and safety of the Shingrix vaccine for preventing shingles in older adults.

1 joining the study

Upon joining the study, participants are required to provide written or witnessed/thumb printed informed consent. This consent is necessary before any study-specific procedures are performed.

Participants must be medically stable, as determined by a medical history review and clinical examination.

2 initial visit

During the initial visit, participants will receive the **Shingrix** vaccine, which is a **Herpes zoster** vaccine. This vaccine is administered as a **suspension for injection**.

The vaccine is given **intramuscularly**, meaning it is injected into a muscle.

3 follow-up visits

Participants are required to return for follow-up visits at specific intervals: **Months 12, 24, 36, and 48**.

During these visits, blood samples may be taken to measure **anti-gE antibody concentrations** and the frequency of specific immune cells.

4 monitoring and documentation

Participants are expected to complete **Herpes zoster-specific diary cards** and **quality of life questionnaires** throughout the study.

These documents help track any symptoms or side effects experienced during the study.

5 end of study

The study is expected to conclude by **August 23, 2027**.

Participants will have a final evaluation to assess the long-term efficacy and safety of the vaccine.

Who Can Join the Study?

  • Participants who, in the opinion of the study doctor, can and are willing to follow the study rules. This includes completing specific diary cards and questionnaires about their quality of life, attending follow-up visits, and being available for scheduled contacts during the study. If a participant has a caregiver, the caregiver must also be able and willing to follow these rules.
  • Participants must provide written consent to join the study. If they cannot write, a witness can help, or they can use a thumbprint to show their agreement.
  • Participants must be medically stable, meaning their health condition is steady and not likely to change suddenly, as determined by their medical history and a physical examination before joining the study.
  • Participants must have completed the ZOSTER-049 study, which means they received at least one dose of the HZ/su vaccine in the previous ZOSTER-006 or ZOSTER-022 studies.

Who Cannot Join the Study?

  • Patients who have a current or past diagnosis of Herpes Zoster (also known as shingles) cannot participate.
  • Individuals who are not within the specified age range for the study are excluded.
  • Participants who are part of a vulnerable population, which means they might need special protection or care, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Oční ordinace MUDr. Hanák, s.r.o. Brno Czechia
Albera Salut S.L.P. Peralada Spain
Cabinet medical du Dr Boucher Mûrs-Erigné France
Cabinet medical du Dr Remaud Angers France
Praxis Dr. med. Michael Müller Freiberg Germany
Hautarztpraxis Dr. Gerlach Dresden Germany
Allgemeinarztpraxis Stephan Morscher Rednitzhembach Germany
Gemeinschaftspraxis Drs. Josef und Wilma Großkopf Wallerfing Germany
Hospital Clinico San Carlos Madrid Spain
Rokotetutkimuskeskus Finvac Oy Tampere Finland

Other Sites

Site Name City Country Status
Region Oestergoetland Linkoping Sweden
Region Oerebro Laen Orebro Sweden
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Eap Osona Sud Alt Congost S.L.P. Centelles Spain
Medizentrum Essen Borbeck Essen Germany
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Equip D’assistencia Primaria Vic S.L.P. Vic Spain
Smo Md GmbH Magdeburg Germany
medicoKIT GmbH Goch Germany
Kliiniliste Uuringute Keskus OÜ Tartu Estonia
Velocity Clinical Research Germany GmbH Hamburg Germany
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
IRCCS Ospedale Policlinico San Martino Genoa Italy
Klinische Forschung Berlin GbR Berlin Germany
KliFoCenter GmbH Witten Germany
Akardo AB Stockholm Sweden
Equip D’atencio Primaria Barcelona Sardenya S.L.P. Barcelona Spain
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Zentrum für Klinische Forschung Allgäu Oberschwaben Wangen im Allgäu Germany
Aktsiaselts Medicum Tervishoiuteenused Tallin Estonia
Uyw Klgbltlqt Fieaowfxq Essen Germany
Mrvkk Rvvnxxei Ppaxgvij Ceske Budejovice Czechia
Pftjsfhsv Ssrcxdwll I Slqvqrf Shdx Barcelona Spain
Cmigffz mjlwjen dh Da Tcxolpr Rosiers d’Egletons France
Cfxznig muaewes dw Dt Bdmr Laval France
Msaepyhp Gdlz Weinheim Germany
Btjkjuxh Tiafqrxs Hihlpusfm Karlskrona Sweden
Sf Cdojmlvf Relbocck Clgigzh Upplands Vasby Sweden
Fxtnpdlne Pouk Ec Foigliz Ds Lt Isvbjndylezql Simrhpxwn Y Bntmlcmfk Db Lu Cywzpxszc Vbwipjzwwp Valencia Spain
Puckta Die Jyhjpe Svbcqiz Hochheim Am Main Germany
Uybvuxc Uogbvhneaq Hcgtedyx Uppsala Sweden
Lhosbkiv Ai Boras Sweden
Fxbvxddky Pqaz Lc Iylpuxkvzrbdt Bjapmnzpw Dqb Hettzcbc Uxpavvulpvdfu Lw Prf Madrid Spain
Zgtrrrg fyv kmpgjyacj Fyvwieqoj Cologne Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
08.10.2022
Estonia Estonia
Not recruiting
08.10.2022
Finland Finland
Not recruiting
08.10.2022
France France
Not recruiting
08.10.2022
Germany Germany
Not recruiting
08.10.2022
Italy Italy
Not recruiting
08.10.2022
Spain Spain
Not recruiting
08.10.2022
Sweden Sweden
Not recruiting
08.10.2022

Trial locations

Herpes Zoster Subunit Vaccine
This vaccine is designed to protect against shingles, a painful rash caused by the reactivation of the chickenpox virus in the body. The vaccine works by boosting the immune system’s ability to fight off the virus, reducing the risk of developing shingles. In this study, researchers are looking at how well the vaccine works over a long period and how safe it is for older adults. They are also checking if additional doses can help maintain the immune response.

Investigated diseases:

Herpes Zoster – Herpes Zoster, also known as shingles, is a viral infection caused by the reactivation of the varicella-zoster virus, which also causes chickenpox. It typically presents as a painful rash that develops on one side of the body or face, often in a stripe or band-like pattern. The rash is usually accompanied by blisters that scab over in 7 to 10 days. Before the rash appears, there may be pain, itching, or tingling in the area where it will develop. The condition can also cause fever, headache, and fatigue. Over time, the rash and blisters heal, but some individuals may experience lingering pain known as postherpetic neuralgia.

Trial ID:
2023-505255-51-00
Protocol code:
217917
NCT ID:
NCT05371080
Trial Phase:
Therapeutic confirmatory (Phase III)

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