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RecruitingObservational

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

NCT ID: NCT06181656Sponsor: M.D. Anderson Cancer CenterLast updated: 2026-05-20

Summary

To learn how radiation treatment may affect your responses to vaccines against pneumonia.

Detailed description

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.

Arms & interventions

  • BiologicalPneumonia vaccine

    Given by SC

Outcome measures

Primary

  • Impact of grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination

    Serologic responses will be calculated as the average fold change in antibody titer for each of 20 pneumococcal serotypes between baseline (time 0) and the first post-vaccination blood draw.

    Time frame: through study completion; an average of 1 year

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: Yes
Inclusion Criteria: 1. Group 1A a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with protons. 2. Group 1B a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with intensity-modulated radiation therapy (IMRT) 3. Group 2A a. Patients currently receiving, planning to receive, or recently completed definitive proton therapy for unresectable liver cancer. 4. Group 2B a. Patients currently receiving, planning to receive, or recently completed definitive IMRT for unresectable liver cancer. 5. Group 3 a. Healthy age- and gender- matched individuals 6. All Groups 1. Patients of all genders, races and nationalities will be solicited. 2. Age \>18 years 3. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients 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. * Patients receiving intravenous immunoglobulin (IVIG) during the study or in the three months prior to study enrollment. * Patients with psychiatric illness/social situations that would limit compliance with study requirements. * Individuals with previous pneumococcal vaccination in the last 5 years. * Individuals with severe allergy to any of the vaccine components

Study locations (1)

MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Steven H Lin, MD · Contact
Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation | Cancerify