Vaccine Responses in Cancer | NCT06605625

Studies
Vaccine Responses in Cancer

NCT06605625

Sponsor

Abramson Cancer Center at Penn Medicine

Status

Active, not recruiting

Last Update Posted

Oct 28, 2025Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Viral Vaccines

Interventions

Influenza vaccination
SARS-CoV-2 vaccine
Zoster Vaccine Recombinant

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UPCC27922	Other Identifier	University of Pennsylvania Cancer Center

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 4, 2022Actual

Primary Completion Date

Oct 2027Estimated

Completion Date

Oct 2028Estimated

First Submitted Date

Sep 18, 2024

First Submission Date that Met QC Criteria

Sep 18, 2024

First Posted Date

Sep 20, 2024Actual

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

Oct 27, 2025

Last Update Posted Date

Oct 28, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators are conducting a prospective unblinded study of individuals diagnosed with cancer who will receive one or more of the following: influenza, SARS-CoV2 and shingles.

Detailed Description

Vaccinations are indicated for all adults, but the immunogenicity of vaccination has not been assessed in all situations. In particular, immune responses following vaccination have not been studied in the setting of cancer and in the context of various anti-tumor treatments. In this study, the investigators will look at the immune response of subjects receiving vaccination.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with Cancer		Patients with cancer who are clinically indicated to receive influenza, recombinant shingles and/or SARS-CoV2 vaccine	Biological: Influenza vaccination Biological: SARS-CoV-2 vaccine Biological: Zoster Vaccine Recombinant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Influenza vaccination	Biological	one annual dose of inactivated influenza vaccine	Patients with Cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neutralizing antibody response	The neutralizing antibody titer will be assessed by measurement of the hemagglutinin-inhibition titer before and after influenza vaccination in order to determine the seroconversion rate. The late blood draw may occur between days 45-90 following vaccination.	45-90 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adults over age 18 who are able to provide consent, who have a diagnosis of cancer, and are willing to receive the influenza, recombinant shingles, and/or SARS-CoV-2 vaccines.

Exclusion Criteria:

allergic to influenza, shingles, and/or SARS-CoV-2 vaccination; have HIV infection; have a history of solid organ or bone marrow transplant.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with cancer who are clinically indicated to receive influenza, recombinant shingles (Shingrix) and/or SARS-CoV-2 vaccine

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
E. John Wherry, PhD	Univeristy of Pennsylvania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007251	Influenza, Human

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007252	Influenza Vaccines
D000086663	COVID-19 Vaccines

Ancestor Terms

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

Browse Leaves

Not provided

Browse Branches

Not provided