Serologic Response to Pneumococcal Vacc… | Clinical Trial

Key information

Conditions

Pneumococcal Vaccine Chemoradiation Cytopenia Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunologic Deficiency Syndromes Leukocyte Disorders Leukopenia Lymphopenia Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Steven H Lin, MD

CONTACT

[email protected]

713-563-8490

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Group 1A

a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with protons.

Group 1B

a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with intensity-modulated radiation therapy (IMRT)

Group 2A

a. Patients currently receiving, planning to receive, or recently completed definitive proton therapy for unresectable liver cancer.

Group 2B

a. Patients currently receiving, planning to receive, or recently completed definitive IMRT for unresectable liver cancer.

Group 3

a. Healthy age- and gender- matched individuals

All Groups

Patients 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

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

Treatment and study plan

Pneumonia vaccine

Biological

Given by SC

Primary outcomes

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

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

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Steven H Lin, MD

CONTACT

[email protected]

(713) 563-8490

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Dec 26, 2023
Registry last updated: May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed