Infections

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Influenza, Human

Virus Diseases

Communicable Diseases

Respiratory Tract Infections

Orthomyxoviridae Infections

RNA Virus Infections

Respiratory Tract Diseases

All Drugs and Chemicals

Vaccines

Immunologic Factors

Each subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22

7.5 ug of HA antigen; adjuvanted; monovalent

adjuvanted A(H1N1) influenza vaccine

15ug of HA antigen, non-adjuvanted; trivalent

non-adjuvanted A(H1N1) influenza vaccine

15 mcg of antigen; non-adjuvanted; trivalent

This is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine in subjects with Solid Invasive Tumors and to compare safety and immunogenicity data with a contemporaneously enrolled control group of age-comparable, healthy subjects.

Because certain individuals may be hypo-responsive to influenza vaccination, additional studies with high-risk groups are warranted in order to determine the optimal vaccine formulation and dosing schedule for prevention of novel H1N1 virus infection.

Clinical Trial to Compare the Immunogenicity, Safety, and Tolerability of an Adjuvanted A(H1N1) Influenza Vaccine Versus Non-Adjuvanted A(H1N1) Influenza Vaccines in Patients With Invasive Solid Tumors

A Phase III, Randomized, Controlled, Open Label Study to Evaluate the Immunogenicity, Safety, and Tolerability of an Adjuvanted A(H1N1) Vaccine Versus Non-Adjuvanted Vaccines Against Novel H1N1 Virus in Patients With Invasive Solid Tumors

Chiltern Pesquisa Clinica Ltda

Children and young adults identified as having influenza infections by the St. Jude Children's Research Hospital diagnostic microbiology will be approached to participate in the study. Biological samples will be collected on Day 0 within 72 hours of the diagnosis of influenza, and at 7, 14, 21, and 28 days later.

Interventions: Symptom checklist, Blood sample, Nasal swab, Oropharyngeal swab, Stool sample.

Blood samples will be drawn and analyzed at Day 0, 7, 14, 21, and 28

Blood sample

Nasal swab

Oropharyngeal swab

Stool sample

Symptom checklist

Elisabeth E. Adderson, MD, MSc

The purpose of the proposed study is to gather critical information that may be useful in designing effective prevention and treatment strategies for control of seasonal influenza and an influenza pandemic. In particular, the critical questions are related to the virus' ability to adapt to efficient replication and spread in humans.

Influenza is a contagious respiratory illness caused by influenza A and B viruses. Influenza infections result in about 230,000 hospitalizations and 36,000 deaths annually in the United States. Children with cancer are more likely to have serious influenza and complications than those who have no underlying medical problems. They are also more likely to have prolonged influenza illnesses and to shed influenza viruses from their noses for long periods of time (sometimes for months). Recent studies suggest that influenza viruses may also be carried and shed from the gastrointestinal tract. New types of influenza viruses emerge frequently through mutations that occur when the viruses replicate. These mutations allow the virus to escape from killing by the immune system and are, in large part, responsible for seasonal epidemics of influenza that occur in the fall or winter months. It is possible that viruses can mutate when they are carried in the respiratory or gastrointestinal tracts for long periods, potentially giving rise to viruses that spread more easily to other persons, cause more severe disease, lead to new influenza epidemics or make the viruses resistant to drugs used to treat influenza.

Researchers at St. Jude Children's Research Hospital want to learn about how influenza viruses mutate in immunocompromised children. They will investigate how long children with cancer carry influenza viruses in their nose, throat and gastrointestinal tract and the characteristics of any mutations that are found in these viruses.

Participants will have nasal, oral and stool specimens obtained at the time they are diagnosed with influenza infections, and 7, 14, 21 and 28 days later. The genome of influenza viruses that are isolated from these participants will be sequenced and compared to one another and to standard influenza strains.

PRIMARY OBJECTIVE:

* To determine the proportion of pediatric oncology patients with nasal and oropharyngeal shedding of influenza viruses at 7, 14, 21 and 28 days following the diagnosis of infection.

SECONDARY OBJECTIVES:

* To determine the proportion of gastrointestinal shedding of human influenza viruses.
* To determine the frequency and pattern of mutations in influenza viruses isolated from pediatric oncology patients.
* To explore the biological consequences of mutations in influenza viruses isolated from pediatric oncology patients.

A Pilot Study of Influenza Viruses Isolated From Immunocompromised Children and Adolescents

Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of pediatric oncology patients with nasal shedding of influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.

Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of pediatric oncology patients with oropharyngeal shedding of influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.

Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as proportion of gastrointestinal shedding of human influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided. Frequency of gastrointestinal shedding of human influenza virus and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.

Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as proportion of human influenza viruses with mutations and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.

Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the type of mutations observed in human influenza viruses at days 7, 14, 21, and 28 days will be provided to show the pattern of mutations. Genetic variants are defined to meet a minimum minor allele frequency of 20%.

Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of mutations observed in human influenza viruses at days 7, 14, 21, and 28 days that are associated with antiviral resistance will be provided to show the biological consequences. Two-sample t-tests or Wilcoxon rank-sum tests will be performed as appropriate to compare isolates to parental influenza isolates from the same patients.

St. Jude Children's Research Hospital

Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma

Leukemia

Leukemia, Lymphoid

Lymphoma, Non-Hodgkin

Hematologic Neoplasms

Pneumonia

Leukemia, Lymphocytic, Chronic, B-Cell

Monoclonal Gammopathy of Undetermined Significance

Lymphocytosis

Lymphoma, B-Cell

Smoldering Multiple Myeloma

Waldenstrom Macroglobulinemia

Paraproteinemias

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Blood Protein Disorders

Hemorrhagic Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Hypergammaglobulinemia

Leukocytosis

Leukocyte Disorders

Lymphosarcoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

B-cell Lymphoma

All adult patients who are newly diagnosed at Aurora Health Care with the following B-Cell Hematologic Malignancies: Monoclonal gammopathy of undetermined significance (MGUS), Smoldering multiple myeloma (SMM), Multiple myeloma (MM), Waldenstroms Macroglobulinemia (WM), Monoclonal B-cell lymphocytosis (MBL), Chronic lymphocytic leukemia (CLL), or B-Cell Non-Hodgkin lymphoma (NHL).

Michael Thompson, MD, PhD

The goal of this study is to develop a vaccination registry system for Aurora Health Care patients newly diagnosed with MM and other B-Cell Hematologic Malignancies in order to prospectively characterize vaccination history and outcomes such as infection in these patients at Aurora Health Care. Additionally hospitalization rates, cost analysis, infection (influenza, pneumonia, other) related to vaccination in this patient population will be evaluated.

This is a prospective registry study on the immunizations in patients with B-Cell Hematologic Malignancies at Aurora Health Care. This observational study will consist of prospective medical record review of Aurora Health Care patients newly diagnosed B-Cell Hematologic Malignancies and will be used to characterize vaccination history, infection rate, and hospitalization rate. This is the second study in the series of studies designed to provide important information about the best way and time to vaccinate patients with MM and similar cancers to flu and pneumonia and to gather additional information about immune function in this patient population.

The registry will include all adult patients who are newly diagnosed with the following B-Cell Hematologic Malignancies: Monoclonal gammopathy of undetermined significance (MGUS), Smoldering multiple myeloma (SMM), Multiple myeloma (MM), Waldenstroms Macroglobulinemia (WM), Monoclonal B-cell lymphocytosis (MBL), Chronic lymphocytic leukemia (CLL), or B-Cell Non-Hodgkin lymphoma (NHL). The prevalence of newly diagnosed B-Cell Hematologic Malignancies at Aurora Health Care is approximately 1000 patients annually. This registry will be ongoing to collect real time data, with no definite sample size planned; however, data will be collected for at least 10 years. This time frame is based on Surveillance, Epidemiology, and End Results Program (SEER) data. There is a 50% survival rate at 5 years after diagnosis for MM, so the 10 year time frame will be able to capture long term outcome in patients.

Medical record information will be obtained through electronic data capture by Aurora Health Care staff with access to the electronic medical records. Data will be manually reviewed by the coordinator, Investigator and co-investigators for accuracy and completeness, to the extent available in the clinical medical record. Additionally, a biostatistician will assist in data analysis.

Descriptive statistics such as counts, proportions or percentages for category variables and mean and standard deviation for continuous variables will be computed for the all the variables. Depending upon the distribution of the category variables appropriate statistical tests such as chi-square and/or Fisher exact test will be used to find out the statistical significance. For continuous variables an appropriate statistical test such as t-tests and/or F test will be used.

This registry will be used for this research study, and may be queried for internal quality improvement projects as well. The principal investigator will be responsible for the overall monitoring of the data and safety of study participants/data integrity, with the assistance of other study team members.

B-Cell Hematologic Malignancy Vaccination Registry

Information regarding vaccination history will be collected historically and throughout data collection, expected to continue for about 10 years.

Survival status will be collected throughout data collection, expected to continue for about 10 years.

Information about any infections (influenza, pneumonia, other) such as numbers, types will be collected throughout data collection, expected to continue for about 10 years.

Information regarding hospitalization will be collected throughout data collection, expected to continue for about 10 years.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Trial to Compare the Immunogenicity, Safety, and Tolerability of an Adjuvanted A(H1N1) Influenza Vaccine Versus Non-Adjuvanted A(H1N1) Influenza Vaccines in Patients With Invasive Solid Tumors	NCT01031719	H1N1 Influenza ... Invasive Solid ...	adjuvanted A(H1... non-adjuvanted ... non-adjuvanted ...	2 Years - 70 Years	Chiltern Pesquisa Clinica Ltda
A Pilot Study of Influenza Viruses Isolated From Immunocompromised Children and Adolescents	NCT02352389	Influenza, Huma...	Blood sample Nasal swab Oropharyngeal s... Stool sample Symptom checkli...	- 21 Years	St. Jude Children's Research Hospital
B-Cell Hematologic Malignancy Vaccination Registry	NCT02298816	Monoclonal Gamm... Multiple Myelom... Waldenstrom Mac... Lymphocytosis Lymphoma, Non-H... B-Cell Chronic ... Hematological M...		-	Aurora Health Care
B-Cell Hematologic Malignancy Vaccination Registry	NCT02298816	Monoclonal Gamm... Multiple Myelom... Waldenstrom Mac... Lymphocytosis Lymphoma, Non-H... B-Cell Chronic ... Hematological M...		-	Aurora Health Care
A Pilot Study of Influenza Viruses Isolated From Immunocompromised Children and Adolescents	NCT02352389	Influenza, Huma...	Blood sample Nasal swab Oropharyngeal s... Stool sample Symptom checkli...	- 21 Years	St. Jude Children's Research Hospital

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