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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Group 1A

Group 1B

Group 2A

Group 2B

Disqualifiers

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

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pneumonia vaccine

    Biological/Vaccine

    Given by SC

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: Group 11 intervention
Group B: Group 21 intervention
Group C: Group 31 intervention

Trial outcomes

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.

Time frame
through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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