The purpose of this long-term follow-up (LTFU) study (ZOSTER-024) is to evaluate the cell-mediated and humoral immune responses of subjects who previously participated in study ZOSTER-003 and who were in the group receiving 2 doses of 50µg gE/AS01B…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Skin and subcutaneous tissue disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Cell-Mediated Immunity (CMI) in terms of frequencies of antigen-specific CD4
T cells at Months 48, 60 and 72
2) Antigen-specific Antibody (Ab) concentrations at Months 48, 60 and 72
Secondary outcome
1) Occurrence of Serious Adverse events (SAEs)
2) Occurrence of pre-defined Adverse events (AEs), i.e. herpes zoster episodes
and Potential Immune-Mediated Diseases (pIMDs)
*
Background summary
Herpes Zoster (shingles) is an illness that occurs due to reactivation of the
latent varicella-zoster virus (VZV), which remains in the body after getting
chickenpox during childhood. Shingles most commonly occurs in the elderly: 1
out of every 2 persons at the age of 85 has developed shingles during their
lifetime. Treatment options include the use of antiviral drugs, which prevent
worsening of the disease, and painkilling medication. Zostavax, a vaccine which
has been approved for use in the United States, only partially prevents
shingles, and is less suitable for persons aged 70 and older, and/or persons
with impaired immunity. GSK Biologicals is therefore developing a new shingles
vaccine which contains immunostimulants.
The proposed study is a follow-up to the previous Zoster-003 study (CCMO number
NL14818.000.06), which compared different formulations of the candidate vaccine
against herpes zoster. One of these formulations, 50µg gE/AS01B, has been
chosen for use in future studies.
Study objective
The purpose of this long-term follow-up (LTFU) study (ZOSTER-024) is to
evaluate the cell-mediated and humoral immune responses of subjects who
previously participated in study ZOSTER-003 and who were in the group receiving
2 doses of 50µg gE/AS01B. Long term safety of the study vaccine administered in
ZOSTER-003 will also be evaluated.
Study design
Phase II, open-label, multi-centric , single group study.
Intervention
not applicable
Study burden and risks
Burden: Subjects will be asked about their medical history. They will undergo a
history-directed physical examination once. Subjects are asked to report
Serious Adverse Events throughout the study (2 years). Blood samples will be
collected on each of the 3 visits (30 ml per visit, once a year).
The burden for subjects in this study is low. Collection of blood samples
causes some discomfort, but at an acceptable level. Subjects contribute to the
development of a possibly better vaccine against herpes zoster.
Huis ter Heideweg 62
3705 LZ Zeist
NL
Huis ter Heideweg 62
3705 LZ Zeist
NL
Listed location countries
Age
Inclusion criteria
1) Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g. return for follow-up visits)
2) Previous participation in study ZOSTER-003 as a member of the 50µg gE/AS01B vaccine group
3) Written informed consent obtained from the subject.
Exclusion criteria
1) Having participated in another study at any time after ZOSTER-003 study end in which the subject was exposed to an investigational or non-investigational product (pharmaceutical product or device) or; 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 product (pharmaceutical product or device)
2) Administration of immunoglobulins and/or any blood products within the 3 months preceding the first blood draw
3) Having received a vaccine containing 3-O-desacyl-4*-Monophosphoryl Lipid A (MPL) and/or Quillaja saponaria Molina, fraction 21 (QS21), any time after ZOSTER-003 study end
4) Having received a vaccine against HZ any time after ZOSTER-003 study end
5) Subject who did not receive a complete vaccination course of 2 doses of 50µg gE/AS01B in study ZOSTER-003
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-022248-19-NL |
| CCMO | NL35579.000.11 |