Serologic Response to Pneumococcal Vaccination Among Esop... | NCT06181656

ID	Type	Description	Link
NCI-2023-10646	Other Identifier	NCI-CTRP Clinical Registry

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 5, 2024Actual

Primary Completion Date

Jul 4, 2027Estimated

Completion Date

Jul 4, 2027Estimated

First Submitted Date

Dec 13, 2023

First Submission Date that Met QC Criteria

Dec 13, 2023

First Posted Date

Dec 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2026

Last Update Posted Date

May 20, 2026Actual

Description Module

Brief 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 Module

Arm Groups

Label	Description	Intervention Names
Group 1	30 participants currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer. This group will be subdivided into Group 1A, which will comprise 15 participants treated with proton therapy, and Group 1B, which will comprise 15 patients treated with intensity modulated radiation therapy (IMRT).	Biological: Pneumonia vaccine
Group 2	30 participants currently receiving, planning to receive, or recently completed chemoradiation for hepatocellular carcinoma. This group will be subdivided into Group 2A, which will comprise 15 participants treated with proton therapy, and Group 2B, which will comprise 15 patients treated with intensity modulated radiation therapy (IMRT).	Biological: Pneumonia vaccine
Group 3	20 Healthy Volunteers.	Biological: Pneumonia vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pneumonia vaccine	Biological	Given by SC	Group 1 Group 2 Group 3

Measure	Description	Time Frame
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.	through study completion; an average of 1 year

Eligibility Module

Eligibility Criteria

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
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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

MD Anderson Cancer Center will enroll 30 esophageal cancer patients. Massachusetts General Hospital in Boston, MA will enroll 30 HCC patients. MD Anderson Cancer Center & Massachusetts General Hospital in Boston will jointly enroll up to 20 health volunteers.

Sampling Method

Non-Probability Sample

ID	Term
D004938	Esophageal Neoplasms
D008231	Lymphopenia

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms
D004066	Digestive System Diseases
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D007970	Leukopenia
D000095542	Cytopenia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007960	Leukocyte Disorders
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases