Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation

Study Overview
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Brief Summary
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To learn how radiation treatment may affect your responses to vaccines against pneumonia.

Detailed Description
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Primary Objectives - Determine the impact of Grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination. Secondary Objectives Determine the impact of chemoradiation on serologic responses to pneumococcal vaccination. Determine the impact of radiation modality on serologic responses to pneumococcal vaccination. Determine the impact of radiation modality on systemic immunity. Determine the incidence of pneumonia among patients treated with a pneumococcal vaccine. Determine the impact of radiation modality on pathologic response. Determine the impact of radiation modality on intratumoral immunity. Determine the relationship between changes in systemic and intratumoral immunity and clinical outcomes (i.e., incidence of pneumonia and pathologic response) Determine the impact of tumor histology on serologic responses to pneumococcal vaccination.

Official Title
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Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation

Conditions
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Pneumococcal Vaccine, Esophageal Cancer, Lymphopenia, Chemoradiation

Intervention / Treatment
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* Biological: Pneumonia vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Group 1A a. Participants currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with protons. 2. Group 1B a. Participants currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with intensity-modulated radiation therapy (IMRT) 3. Group 2A a. Participants currently receiving, planning to receive, or recently completed definitive proton therapy for unresectable hepatocellular carcinoma. 4. Group 2B a. Participants currently receiving, planning to receive, or recently completed definitive IMRT for unresectable hepatocellular carcinoma. 5. Group 3 a. Healthy age- and gender- matched individuals 6. All Groups Participants of all genders, races and nationalities will be solicited. Age >18 years Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Participants with compromised immunologic responses due to an uncontrolled intercurrent immunodeficiency (e.g., Human immunodeficiency virus (HIV), X-linked agammaglobulinemia) or previous or current immune suppressive therapy a. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Participants receiving intravenous immunoglobulin (IVIG) during the study or in the three months prior to study enrollment. Participants with psychiatric illness/social situations that would limit compliance with study requirements. Participants with previous pneumococcal vaccination Participants with severe allergy to any of the vaccine components

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>This group will be subdivided into Group 1A, which will comprise fifteen participants treated with proton therapy, and Group 1B, which will include 15 participants treated with intensity modulated radiation therapy (IMRT). | Biological: Pneumonia vaccine<br>* Given by SC<br>|
| Group 2<br>This group will also be subdivided into Group 2A, which will comprise fifteen participants treated with proton therapy, and Group 2B, which will include 15 participants treated with intensity modulated radiation therapy (IMRT). | Biological: Pneumonia vaccine<br>* Given by SC<br>|
| Group 3<br>Include family members of our participants who are traveling with them for their appointments. | Biological: Pneumonia vaccine<br>* Given by SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and adverse events (AEs) | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | Through study completion; an average of 1 year. |