Herpes ZosterPhase 2NCT00492648

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

A Phase 2 study testing Blood sampling for assay of persistence of immunogenicity in people with Herpes Zoster, run by GlaxoSmithKline at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Herpes Zoster
What is being tested?: Blood sampling for assay of persistence of immunogenicity
Type of treatment: Vaccines, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteBelgium
Study dates: 25 Jun 2007to 23 Jun 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

GSK Investigational Site
Ghent, 9000

Other trials in Belgium

About this 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

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.

Read the 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
Being tested: Blood sampling for assay of persistence of immunogenicity
Keywords: GSK Biologicals, Varicella Zoster Virus (VZV), Intracellular cytokine staining (ICS), Vaccine, Cell mediated immunity (CMI), Herpes Zoster (HZ), Shingles
Medical subject headings: Herpes Zoster, Chickenpox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood sampling for assay of persistence of immunogenicityProcedure or surgery
Two blood samples: 30 and 42 months after first vaccination

Study groups in NCT00492648
Study group	Role	What they receive
GSK1437173A 18-30 Years Old Group	Experimental	Subjects aged 18 to 30 years old receiving 2 doses GSK1437173A vaccine in the primary study. Receives: 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. Receives: Procedure: Blood sampling for assay of persistence of immunogenicity

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
The analysis focused on those gE- and VZV-specific CD4 T cells secreting any 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 or VZV was performed, since no long-term vaccine effect on gE- and VZV-specific CD8 T cell response was detected.
Measured: At Months 30 and 42 after the first vaccination
Anti-gE Antibody (Ab) Concentrations
As determined by the Enzyme-Linked Immunosorbent Assay (ELISA) and expressed as ELISA units per milliliter (EL.U/mL).
Measured: At months 30 and 42 after the first vaccination
Anti-VZV Ab Concentrations
As determined by the Enzyme-Linked Immunosorbent Assay (ELISA) and expressed as ELISA units per milliliter (EL.U/mL).
Measured: At months 30 and 42 after the first vaccination
Frequencies of gE-specific Memory B Cells
As determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay.
Measured: At months 30 and 42 after the first vaccination
Frequencies of VZV-specific Memory B Cells
As determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay.
Measured: At months 30 and 42 after the first vaccination
Number of Subjects With Any Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Measured: From Month 30 to study end Month 42 after the first vaccination
Number of Subjects With Clinically Diagnosed Herpes Zoster (HZ) Episodes
This assay tabulated the number of subjects with clinically diagnosed HZ episodes, defined as any cutaneous HZ-like rash.
Measured: From last primary study visit (Month 12) to study end at Month 42 after the first vaccination.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jun 200723 Jun 2008

First posted27 Jun 2007 (estimated)
Study start25 Jun 2007
Primary completion23 Jun 2008
Study completion23 Jun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Herpes ZosterStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00492648
Sponsor's protocol ID: 109671
Other IDs: 109674
Status last verified: Jun 2019
First submitted: 26 Jun 2007
Last updated: 26 Jun 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 30975567
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.
PubMed 22872734

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine

All Herpes Zoster trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00492648
Acronym / sponsor ID: 109671
Conditions: Herpes Zoster
Keywords: GSK Biologicals, Varicella Zoster Virus (VZV), Intracellular cytokine staining (ICS), Vaccine, Cell mediated immunity (CMI), Herpes Zoster (HZ), Shingles
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 25 Jun 2007 (actual)
Primary completion: 23 Jun 2008 (actual)
Study completion: 23 Jun 2008 (actual)
First posted: 27 Jun 2007 (estimated)
Results: Posted 19 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
GSK1437173A 18-30 Years Old Group	Experimental	Procedure: Blood sampling for assay of persistence of immunogenicitySubjects aged 18 to 30 years old receiving 2 doses GSK1437173A vaccine in the primary study.
GSK1437173A 50-70 Years Old Group	Experimental	Procedure: Blood sampling for assay of persistence of immunogenicitySubjects aged 50 to 70 years old receiving 2 doses GSK1437173A vaccine in the primary study.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood sampling for assay of persistence of immunogenicityTwo blood samples: 30 and 42 months after first vaccination	Procedure or surgery	GSK1437173A 18-30 Years Old Group, GSK1437173A 50-70 Years Old Group

Primary outcome

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).
Time frame: At Month 30 after the first vaccination.
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.
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).
Time frame: At Month 30 after the first vaccination
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.
Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L).
Time frame: At Month 42 after the first vaccination
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.
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).
Time frame: At Month 42 after the first vaccination
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.

7 secondary outcomes

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.
Time frame: At Months 30 and 42 after the first vaccination
Anti-gE Antibody (Ab) Concentrations
Time frame: At months 30 and 42 after the first vaccination
Anti-VZV Ab Concentrations
Time frame: At months 30 and 42 after the first vaccination
Frequencies of gE-specific Memory B Cells
Time frame: At months 30 and 42 after the first vaccination
Frequencies of VZV-specific Memory B Cells
Time frame: At months 30 and 42 after the first vaccination
Number of Subjects With Any Serious Adverse Events (SAEs)
Time frame: From Month 30 to study end Month 42 after the first vaccination
Number of Subjects With Clinically Diagnosed Herpes Zoster (HZ) Episodes
Time frame: From last primary study visit (Month 12) to study end at Month 42 after the first vaccination.

Results and safety

Results posted to the registry on 19 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK1437173A 18-30 Years Old Group	4	4
GSK1437173A 50-70 Years Old Group	30	29

Primary outcome: 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).

Time frame: At Month 30 after the first vaccination.. Mean (Standard Deviation). Unit: gE-specific CD4 cells/million CD4 cells

Measure	GSK1437173A 18-30 Years Old Group n = 4	GSK1437173A 50-70 Years Old Group n = 29
Value	NA (NA)	1184.7 (925.8)

Population analysed: The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.

Primary outcome: 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).

Time frame: At Month 30 after the first vaccination. Mean (Standard Deviation). Unit: VZV-specific CD4 cells/million CD4 cells

Measure	GSK1437173A 18-30 Years Old Group n = 4	GSK1437173A 50-70 Years Old Group n = 29
Value	NA (NA)	707.4 (533.1)

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

Time frame: At Month 42 after the first vaccination. Mean (Standard Deviation). Unit: gE-specific CD4 cells/million CD4 cells

Measure	GSK1437173A 18-30 Years Old Group n = 3	GSK1437173A 50-70 Years Old Group n = 20
Value	NA (NA)	899.8 (844.4)

Primary outcome: 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).

Time frame: At Month 42 after the first vaccination. Mean (Standard Deviation). Unit: VZV-specific CD4 cells/million CD4 cells

Measure	GSK1437173A 18-30 Years Old Group n = 3	GSK1437173A 50-70 Years Old Group n = 20
Value	NA (NA)	723.8 (816.4)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events were collected throughout the study, up to Month 42.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK1437173A 18-30 Years Old Group	0 of 4 (0%)	0 of 0	0 of 4
GSK1437173A 50-70 Years Old Group	0 of 30 (0%)	0 of 0	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30975567Keersmaekers 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.
Derived from this study: PubMed 22872734Leroux-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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Blood sampling for assay of persistence of immunogenicity in people with Herpes Zoster, run by GlaxoSmithKline at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). (time frame: At Month 30 after the first vaccination.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00492648, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.