Pneumococcal VaccineNCT06181656
Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation
An observational study of Pneumococcal Vaccine and Esophageal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn how radiation treatment may affect your responses to vaccines against pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Vaccine, Esophageal Cancer, Lymphopenia
- What is being tested?
- Pneumonia vaccine
- Type of treatment
- Vaccines
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2024to 4 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- Group 1A
- Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with protons.
- Group 1B
- Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with intensity-modulated radiation therapy (IMRT)
- Group 2A
- Patients currently receiving, planning to receive, or recently completed definitive proton therapy for unresectable liver cancer.
Show all 14Show fewer
- Group 2B
- Patients currently receiving, planning to receive, or recently completed definitive IMRT for unresectable liver cancer.
- Group 3
- 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.
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Steven H Lin, MD, 713-563-8490, shlin@mdanderson.org
About this study
To learn how radiation treatment may affect your responses to vaccines against pneumonia.
Read the 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.
- Conditions
- Pneumococcal Vaccine, Esophageal Cancer, Lymphopenia, Chemoradiation
- Being tested
- Pneumonia vaccine
- Medical subject headings
- Esophageal Neoplasms, Lymphopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumonia vaccineBiological
Given by SC
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Biological: Pneumonia vaccine | |
| Group 3 | 20 Healthy Volunteers. Receives: Biological: Pneumonia vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start5 Feb 2024
- Primary completion4 Jul 2027 (estimated)
- Study completion4 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal VaccineStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven H Lin, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181656
- Sponsor's protocol ID
- 2023-0370
- Other IDs
- NCI-2023-10646
- Status last verified
- May 2026
- First submitted
- 13 Dec 2023
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation
- ClinicalTrials.gov ID
- NCT06181656
- Acronym / sponsor ID
- 2023-0370
- Conditions
- Pneumococcal Vaccine, Esophageal Cancer, Lymphopenia, Chemoradiation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 4 Jul 2027 (estimated)
- Study completion
- 4 Jul 2027 (estimated)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Biological: Pneumonia vaccine30 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 | – | Biological: Pneumonia vaccine30 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). |
| Group 3 | – | Biological: Pneumonia vaccine20 Healthy Volunteers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (14 listed)
- Group 1A
- Group 1B
- Group 2A
- Group 2B
- Group 3
Key exclusion criteria (6 listed)
- 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.
- Individuals with severe allergy to any of the vaccine components
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumonia vaccineGiven by SC | Biological | Group 1, Group 2, Group 3 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven H Lin, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Vaccine and Esophageal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven H Lin, MD ((713) 563-8490, shlin@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination (time frame: through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.