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

NCT00492648 | Completed Phase 2 Results

• 2 other identifiers: 109671109674
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Herpes Zoster

Keywords

GSK Biologicals; Varicella Zoster Virus (VZV); Intracellular cytokine staining (ICS); Vaccine; Cell mediated immunity (CMI); Herpes Zoster (HZ); Shingles

Outcome Measures

Primary Outcomes (4)

• 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).

  The analysis focused on those gE-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, and CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to gE was performed, since no long-term vaccine effect on gE-specific CD8 T cell response was detected.

  At Month 30 after the first vaccination.

• 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).

  The analysis focused on those VZV-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to VZV was performed, since no long-term vaccine effect on VZV-specific CD8 T cell response was detected.

  At Month 30 after the first vaccination

• Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L).

  The analysis focused on those gE-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to gE was performed, since no long-term vaccine effect on gE-specific CD8 T cell response was detected.

  At Month 42 after the first vaccination

• 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).

  The analysis focused on those VZV-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to VZV was performed, since no long-term vaccine effect on VZV-specific CD8 T cell response was detected.

  At Month 42 after the first vaccination

Secondary Outcomes (7)

• 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.

  At Months 30 and 42 after the first vaccination

• Anti-gE Antibody (Ab) Concentrations

  At months 30 and 42 after the first vaccination

• Anti-VZV Ab Concentrations

  At months 30 and 42 after the first vaccination

• Frequencies of gE-specific Memory B Cells

  At months 30 and 42 after the first vaccination

• Frequencies of VZV-specific Memory B Cells

  At months 30 and 42 after the first vaccination

Study Arms (2)

GSK1437173A 18-30 Years Old Group

EXPERIMENTAL

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

Procedure: Blood sampling for assay of persistence of immunogenicity

GSK1437173A 50-70 Years Old Group

EXPERIMENTAL

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

Procedure: Blood sampling for assay of persistence of immunogenicity

Interventions

Blood sampling for assay of persistence of immunogenicity PROCEDURE

Two blood samples: 30 and 42 months after first vaccination

GSK1437173A 18-30 Years Old Group; GSK1437173A 50-70 Years Old Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Ghent, 9000, Belgium

Location

Related Publications (2)

• 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.

  PMID: 30975567 DERIVED

• 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.

  PMID: 22872734 DERIVED

MeSH Terms

Conditions

Herpes Zoster; Chickenpox

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2007
• First Posted: June 27, 2007
• Study Start: June 25, 2007
• Primary Completion: June 23, 2008
• Study Completion: June 23, 2008
• Last Updated: June 26, 2019
• Results First Posted: December 19, 2018

Record last verified: 2019-06

Locations

BE (1)