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

NCT06181656 | Recruiting DMC

• 2 other identifiers: 2023-0370NCI-2023-10646
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pneumococcal Vaccine; Esophageal Cancer; Lymphopenia; Chemoradiation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

Pneumonia vaccine BIOLOGICAL

Given by SC

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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 hepatocellular carcinoma.
• Group 2B
• a. Patients currently receiving, planning to receive, or recently completed definitive IMRT for unresectable hepatocellular carcinoma.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Esophageal Neoplasms; Lymphopenia

Interventions

SARS-CoV-2 inactivated vaccines

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Steven H Lin, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven H Lin, MD

CONTACT

(713) 563-8490; shlin@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 26, 2023
• Study Start: February 5, 2024
• Primary Completion (Estimated): July 4, 2027
• Study Completion (Estimated): July 4, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)