NCT06605625

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Nov 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Nov 2022Oct 2028

Study Start

First participant enrolled

November 4, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

October 28, 2025

Status Verified

October 1, 2025

Enrollment Period

4.9 years

First QC Date

September 18, 2024

Last Update Submit

October 27, 2025

Conditions

Keywords

influenza

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients with Cancer

Patients with cancer who are clinically indicated to receive influenza, recombinant shingles and/or SARS-CoV2 vaccine

Biological: Influenza vaccinationBiological: SARS-CoV-2 vaccineBiological: Zoster Vaccine Recombinant

Interventions

one annual dose of inactivated influenza vaccine

Patients with Cancer

dose of SARS CoV2 vaccine

Patients with Cancer

first and/or second vaccination for shingles (Herpes zoster)

Patients with Cancer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza VaccinesCOVID-19 Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • E. John Wherry, PhD

    Univeristy of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 18, 2024

First Posted

September 20, 2024

Study Start

November 4, 2022

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Last Updated

October 28, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations