Vaccine Responses in Cancer

Recruiting

• Conditions: Viral Vaccines
• Interventions: Biological: Influenza vaccination; Biological: SARS-CoV-2 vaccine; Biological: Zoster Vaccine Recombinant

• Registration Number: NCT06605625
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

We 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, we will look at the immune response of subjects receiving vaccination.

Study Timeline

• Study Start: 2022-11-04
• Status Verified: 2024-09
• Study First Submitted: 2024-09-18
• Study First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Study First Posted: 2024-09-20
• Last Update Posted: 2024-09-20
• Primary Completion: 2027-10
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Neutralizing antibody response	45-90 days	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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States