Month 30 & 42 Extension Studies of CRD-004 Primary Study

NCT ID: NCT00492648

Last Updated: 2019-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-25
• Study Completion Date: 2008-06-23

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.

Conditions

Herpes Zoster

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

GSK1437173A 18-30 Years Old Group

Subjects aged 18 to 30 years old receiving 2 doses GSK1437173A vaccine in the primary study.

Group Type: EXPERIMENTAL

Blood sampling for assay of persistence of immunogenicity

Intervention Type: PROCEDURE

Two blood samples: 30 and 42 months after first vaccination

GSK1437173A 50-70 Years Old Group

Subjects aged 50 to 70 years old receiving 2 doses GSK1437173A vaccine in the primary study.

Group Type: EXPERIMENTAL

Blood sampling for assay of persistence of immunogenicity

Intervention Type: PROCEDURE

Two blood samples: 30 and 42 months after first vaccination

Interventions

Blood sampling for assay of persistence of immunogenicity

Two blood samples: 30 and 42 months after first vaccination

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Ghent, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 30975567 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22872734 (View on PubMed)

Other Identifiers

109674

Identifier Type: -

Identifier Source: secondary_id

109671

Identifier Type: -

Identifier Source: org_study_id