Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Infections

Digestive System Diseases

Lung Neoplasms

Obesity

Hepatitis A

Hepatitis C

Hepatitis

Liver Neoplasms

Pneumonia

Herpes Zoster

Pneumonia, Bacterial

Colonic Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Liver Diseases

Gastrointestinal Diseases

Communicable Diseases

Blood-Borne Infections

Hepatitis, Viral, Human

Virus Diseases

Flaviviridae Infections

RNA Virus Infections

Respiratory Tract Infections

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Intestinal Diseases

Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

All Drugs and Chemicals

Hematinics

Herbal and Botanical

Vaccines

Liver Extracts

Cola

This arm will contain clinics that utilize the CLOVER intervention

This arm will contain clinics that do not utilize the CLOVER intervention

Electronic population health module which is tailored to increased adherence to USPSTF and CDC recommendations

Epic Healthy Planet Population Health Module

The purpose of CLOVER is to utilize Epic Healthy Planet to increase adherence to United States Preventive Services Task Force (USPSTF) and Centers for Disease Control and Prevention (CDC) recommendations in adults age 50 and older.

Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer

This is the proportion of patients who appropriately completed screenings and vaccinations that they were eligible for

Proportion of eligible patients who completed colon cancer screening.

Proportion of eligible patients who completed lung cancer screening.

Proportion of eligible patients who completed tobacco cessation counseling.

Proportion of eligible patients who completed obesity counseling.

Proportion of eligible patients who completed pneumonia vaccination.

Proportion of eligible patients who completed shingles vaccination.

Proportion of eligible patients who completed hepatitis C screening.

University of California, Irvine

University of California, Davis

Skin and Connective Tissue Diseases

Herpes Simplex

Chickenpox

Varicella Zoster Virus Infection

Herpesviridae Infections

DNA Virus Infections

Immunologic Factors

ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection

ZOSTAVAX

David H. Canaday, MD

This study evaluates if the shingles vaccine works in those persons that receive it before they receive chemotherapy for solid organ tumors. Half of the participants will receive the ZOSTAVAX shingle vaccine and half of the participants will not received anything.

This study is a single blind randomized clinical trial measuring the immunologic efficacy of ZOSTAVAX vs. no vaccine in 60 adults with solid organ tumors before, during and after chemotherapy. The personnel performing the laboratory studies will be blinded to vaccine vs. no vaccine. In a pilot study of an FDA approved vaccine that is being used within the parameters of the package insert and ACIP recommendations, placebo vaccine is not required to access our key primary immunologic endpoint.

ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors

A Pilot Study Using a Randomized Design to Evaluate the Immunologic Efficacy and Safety of ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors

To examine the cellular immunologic efficacy as measured by IFN-gamma assays of ZOSTAVAX given to individuals with solid organ tumors at least 14 days prior to initiation of chemotherapy or surgery and then chemotherapy. Changes in ZOSTAVAX-specific IFN-gamma spot forming units will be measured by ELISPOT.

To asses the safety of ZOSTAVAX given to subjects that will receive chemotherapy or surgery and then chemotherapy for solid organ tumor at least 14 days after vaccination. Safety and tolerability data will be collected for all subjects throughout the study. Each subject will be given a Vaccine Report Card (VRC) to document injection-site adverse experiences, systemic clinical adverse experiences (AEs), concomitant medications, and oral temperatures (only if feeling feverish) noted during the 14-day post-vaccination period. Participants will be asked to notify the study personnel immediately if any unexpected or serious adverse experience (SAE) occurs. At all study visits subjects will be asked about any unreported SAEs. All AEs and SAEs will be recorded on an AE/SAE case report form and relationship to study vaccine will be determined by the site investigator.

Duke University

Louis Stokes VA Medical Center

Associate Director of Research, GRECC

We have the subjects complete a vaccine side effect report card.

ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection

ZOSTAVAX: Shingles vaccine

Control

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. David Canaday

Measuring the Efficacy of ZOSTAVAX in Chemotherapy Patients (Changes in ZOSTAVAX-specific IFN-gamma Spot Forming Units Will be Measured by ELISPOT)

Measuring the Safety of ZOSTAVAX Given to Chemotherapy Patients (Vaccine Report Card (VRC) to Document Injection-site Adverse Experiences, Systemic Clinical Adverse Experiences (AEs), Concomitant Medications, and Oral Temperatures

Overall Study

Skin Diseases

Skin Diseases, Viral

Skin Diseases, Infectious

Subjects received the first dose of GSK 1437173A at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of GSK 1437173A vaccine was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.

Subjects received the first dose of placebo at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of placebo was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.

2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.

GSK 1437173A

2 doses administered by IM injection into the deltoid muscle of the non-dominant arm.

Placebo

GSK Clinical Trials

The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in adults with solid tumours undergoing chemotherapy.

The study will be randomised into two groups based on the vaccination schedule in relation to the start of a chemotherapy cycle:

* The OnChemo group receives their first HZ/su vaccination at the start of a chemotherapy cycle,
* The PreChemo group receives their first HZ/su vaccination at least 10 days before the start of a chemotherapy cycle.

The protocol summary has been updated following Protocol Amendment 2, August 2014, leading to the increase of the enrolment.

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ/su) Vaccine in Adults With Solid Tumours Receiving Chemotherapy

An Observer-blind Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults 18 Years of Age or Older With Solid Tumours Receiving Chemotherapy

IPD for this study will be made available via the Clinical Study Data Request site.

Adjusted geometric means (GMC) of GSK1437173A over placebo for anti-glycoprotein E (gE) antibody enzyme-linked immunosorbent assay (ELISA) concentrations in PreChemo Groups only.

Antibody concentrations as determined by ELISA are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU//mL.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

The number of days with any local symptoms has been assessed during the post-vaccination period.

Assessed solicited general symptoms were fatigue, gastrointestinal \[symptoms included nausea, vomiting, diarrhoea and/or abdominal pain\], headache, myalgia, shivering and fever \[defined as oral, axillary or tympanic temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

The number of days with any general symptoms has been assessed during the post-vaccination period.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE= SAE assessed by the investigator as causally related to the study vaccination.

Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related = pIMDs assessed by the investigator as causally related to the study vaccination.

Vaccine response defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/ml); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.

Descriptive statistics were tabulated for CD4\[2+\] cells, which are gE specific CD4+ T-cells with at least two activation markers (\[2+\]), expressed from the activation markers interferon-gamma (IFN-γ), interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40-ligand (CD40-L), as determined by intracellular cytokine staining (ICS) method.

Vaccine response defined as: For initially seronegative subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x320 Events/10E6 CD4+ T cells); For initially seropositive subjects with pre-vaccination T-cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T-cell frequencies.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as causally related to the study vaccination.

Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

GlaxoSmithKline

GSK1437173A Group

Placebo Group

Geographic ancestry

Race/Ethnicity, Customized

GSK Response Center

The analysis evaluated the anti-gE humoral immune responses at Month 2, following a two-dose administration of the GSK1437173A vaccine, as compared to placebo in subjects with solid tumours receiving chemotherapy (PreChemo Groups only).

Subjects receiving the adjuvanted GSK1437173A vaccine, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.

GSK1437173A-PreChemo

Subjects receiving saline placebo, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.

Placeb-PreChemo

The analysis was performed on the PreChemo groups from the According-to-Protocol (ATP) cohort for Humoral immunogenicity which included all evaluable subjects up to 30 days post last vaccination and who had met all eligibility criteria and complied with the procedures and intervals defined in the protocol for active phase of the study.

Adjusted Geometric Means for Anti-glycoprotein E (gE) Antibodies in PreChemo Groups

The analysis was performed on the ATP cohort for Humoral immunogenicity which included all evaluable subjects for which the active phase time point Month 2 data were obtained from the ATP cohort for Humoral Immunogenicity.

Anti-Varicella Zoster Virus (VZV) gE Antibody Concentrations

Any Pain, Dose 1

Grade 3 Pain, Dose 1

Any Redness, Dose 1

Grade 3 Redness, Dose 1

Any Swelling, Dose 1

Grade 3 Swelling, Dose 1

Any Pain, Dose 2

Grade 3 Pain, Dose 2

Any Redness, Dose 2

Grade 3 Redness, Dose 2

Any Swelling, Dose 2

Grade 3 Swelling, Dose 2

Any Pain, Across doses

Grade 3 Pain, Across doses

Any Redness, Across doses

Grade 3 Redness, Across doses

Any Swelling, Across doses

Grade 3 Swelling, Across doses

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered, who had their symptom sheets filled in.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer	NCT04540081	Colon Cancer Lung Cancer Tobacco Use Ces... Obesity Pneumonia, Bact... Shingles Hepatitis C	Epic Healthy Pl...	50 Years - 80 Years	University of California, Davis
ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors	NCT02444936	Shingles	ZOSTAVAX	50 Years -	Louis Stokes VA Medical Center
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ/su) Vaccine in Adults With Solid Tumours Receiving Chemotherapy	NCT01798056	Herpes Zoster Herpes Zoster V...	GSK 1437173A Placebo	18 Years -	GlaxoSmithKline
ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors	NCT02444936	Shingles	ZOSTAVAX	50 Years -	Louis Stokes VA Medical Center

Spots Global Cancer Trial Database for shingles

Every month we try and update this database with for shingles cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for shingles

Every month we try and update this database with for shingles cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for shingles cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.