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

Recruiting

• Conditions: Lymphopenia; Pneumococcal Vaccine; Esophageal Cancer; Chemoradiation
• Interventions: Biological: Pneumonia vaccine

• Registration Number: NCT06181656
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2023-12-13
• Study First Posted: 2023-12-26
• Study Start: 2024-02-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-14
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. 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

   1. Participants 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

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 3	Pneumonia vaccine	20 Healthy Volunteers.
Group 1	Pneumonia vaccine	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).
Group 2	Pneumonia vaccine	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).

Primary Outcome Measures

Name	Time	Method
Impact of grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination	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.

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States