Clinical trial NCT00492648: Month 30 & 42 Extension Studies of CRD-004 Primary Study
Official title: An Extension Study to Evaluate the Persistence of the Immune Responses Induced by GSK Biologicals Zoster Vaccine, GSK324332A, Administered in Healthy Adult Subjects Aged 18-30 Years and 50-70 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Herpes Zoster
Keywords: GSK Biologicals
Varicella Zoster Virus (VZV)
Intracellular cytokine staining (ICS)
Vaccine
Cell mediated immunity (CMI)
Herpes Zoster (HZ)
Shingles
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-06-27
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The safety and immunogenicity of the GSK324332A vaccine has been evaluated up to Month 12 post-vaccination in the primary study. In the extension studies presented here, the persistence of the cellular and humoral immune responses will be evaluated 30 and 42 months after the first vaccination in young and elderly adults who received the GSK324332A vaccine. This protocol posting deals only with objectives \& outcome measures of the extension phase at Months 30 and 42. No new recruitment will be done in these extension phases of the primary study. No vaccines are administered in this phase of the study.

Detailed description: All subjects in these extension phases of the study were previously vaccinated with the investigational herpes zoster vaccine GSK1437173A. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Further details on the primary study can be found on our GSK study register (https://www.gsk-studyregister.com/advanced-search) by searching on the GSK study identifier 101501.

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study;
* Subjects who successfully completed the primary study and who did not receive Varilrix in the primary study;
* Written informed consent obtained from the subject;
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) within 1 month preceding the study start, or planned use during the study period;
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first study procedure, including corticosteroids, except inhaled and topical steroids are allowed;
* Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks before the first study procedure, with the exception of the Influenza vaccine, which can be administered 1 week preceding the first study procedure;
* Previous vaccination against HZ, except the study vaccine administered in the primary study;
* History of HZ (shingles);
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination;
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first study procedure or planned administration during the study period.

Primary outcomes:
measure: Frequencies of Glycoprotein E (gE)-Specific Cluster of Differentiation 4 (CD4) / CD8 T Cells With at Least Two Antigen-specific Cytokines: Interferon Gamma (IFN-γ), Interleukin 2 (IL-2), Tumor Necrosis Factor Alpha (TNF-α), CD 40 Ligand (CD40L).
timeFrame: At Month 30 after the first vaccination.
measure: Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L).
timeFrame: At Month 30 after the first vaccination
measure: Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L).
timeFrame: At Month 42 after the first vaccination
measure: Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L).
timeFrame: At Month 42 after the first vaccination
Secondary outcomes:
measure: Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression.
timeFrame: At Months 30 and 42 after the first vaccination
measure: Anti-gE Antibody (Ab) Concentrations
timeFrame: At months 30 and 42 after the first vaccination
measure: Anti-VZV Ab Concentrations
timeFrame: At months 30 and 42 after the first vaccination
measure: Frequencies of gE-specific Memory B Cells
timeFrame: At months 30 and 42 after the first vaccination
measure: Frequencies of VZV-specific Memory B Cells
timeFrame: At months 30 and 42 after the first vaccination
measure: Number of Subjects With Any Serious Adverse Events (SAEs)
timeFrame: From Month 30 to study end Month 42 after the first vaccination
measure: Number of Subjects With Clinically Diagnosed Herpes Zoster (HZ) Episodes
timeFrame: From last primary study visit (Month 12) to study end at Month 42 after the first vaccination.
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Keersmaekers N, Ogunjimi B, Van Damme P, Beutels P, Hens N. An ODE-based mixed modelling approach for B- and T-cell dynamics induced by Varicella-Zoster Virus vaccines in adults shows higher T-cell proliferation with Shingrix than with Varilrix. Vaccine. 2019 May 1;37(19):2537-2553. doi: 10.1016/j.vaccine.2019.03.075. Epub 2019 Apr 8.
citation: Leroux-Roels I, Leroux-Roels G, Clement F, Vandepapeliere P, Vassilev V, Ledent E, Heineman TC. A phase 1/2 clinical trial evaluating safety and immunogenicity of a varicella zoster glycoprotein e subunit vaccine candidate in young and older adults. J Infect Dis. 2012 Oct;206(8):1280-90. doi: 10.1093/infdis/jis497. Epub 2012 Aug 7.