Flu Shot for Skin Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Karam Khaddour, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Investigational cancer agents

Disqualifiers: Organ transplant, Guillain-Barré, uncontrolled illness, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is investigating the effects on immune cells of injecting the influenza vaccine (also known as "flu shot") into cutaneous squamous cell carcinoma (CSCC) tumors prior to having standard-of-care Mohs excision surgery. The study will help understand if the addition of the influenza vaccine could improve the immune system response against the cancer. The names of the study drug involved in this study is: -Fluzone Influenza vaccine (flu shot)

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on investigational cancer treatments, you may not be eligible to participate.

Is the flu shot safe for humans?

The flu shot, including versions like Fluzone Intradermal and Fluzone High-Dose, has been shown to be safe in adults, with studies supporting its safety and effectiveness in people aged 18-64 and those 65 and older. ^{1 2 3 4 5}

How is the Fluzone Influenza vaccine treatment different from other skin cancer treatments?

The Fluzone Influenza vaccine is unique for skin cancer treatment because it uses a microinjection system for intradermal delivery, which is different from the typical administration routes for cancer treatments. This method involves a smaller needle and lower antigen content, potentially increasing patient acceptance compared to traditional methods. ^{1 2 3 5 6}

Research Team

Karam Khaddour, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for patients with cutaneous squamous cell carcinoma (CSCC), a type of skin cancer, who are scheduled for Mohs surgery. Participants should not have received the flu shot recently or be allergic to it.

Inclusion Criteria

My skin cancer has been confirmed by a biopsy.

I am eligible for skin cancer removal surgery.

I am 18 years old or older.

Exclusion Criteria

History of allergic reactions attributed to the seasonal flu vaccine.

My skin cancer is aggressive, invading deep tissues or is larger than 3.9 cm.

My skin cancer has spread to nearby lymph nodes or other parts of the body.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive the Fluzone influenza vaccine injected into CSCC tumors

2 weeks

3 visits (in-person)

Surgery

Participants undergo standard-of-care Mohs excision surgery and tissue collection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including suture removal and additional follow-up

3 weeks

2 visits (in-person)

Treatment Details

Interventions

• Fluzone Influenza vaccine (Cancer Vaccine)

Trial Overview The study tests injecting the Fluzone influenza vaccine directly into CSCC tumors before surgical removal. It aims to see if this can boost the body's immune response against cancer cells.

Participant Groups

Group I: Fluzone Vaccine in Cutaneous Squamous Cell Carcinoma Experimental Treatment 1 Intervention

Enrolled participants will complete: * Baseline visit * Days 1 and 8: Flu shot injection once * Day 15: Standard-of-care Mohs excision surgery and tissue collection. * Day 21 follow up visit with suture removal. * Day 38 follow up visit

Fluzone Influenza vaccine is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Fluzone for:

• Influenza prophylaxis

🇪🇺 Approved in European Union as Fluzone for:

• Influenza prophylaxis

🇨🇦 Approved in Canada as Fluzone for:

• Influenza prophylaxis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Brigham and Women's Hospital Boston, MA

Dana-Farber Cancer Institute Boston, MA

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1128

Patients Recruited

382,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Fluzone(®) Intradermal vaccine: a promising new chance to increase the acceptability of influenza vaccination in adults. [2011] On May 9 2011, the US FDA approved Sanofi Pasteur's Fluzone(®) Intradermal influenza vaccine, the first influenza vaccine licensed in the USA that uses a new microinjection system for intradermal delivery of vaccines (Soluvia™, Becton Dickinson). Its antigen content is lower (9 µg hemagglutinin per strain) than the conventional intramuscular vaccine (15 µg) and it is indicated for active immunization of adults aged between 18 and 64 years. Data from the clinical trial assessing immunogenicity and safety of Fluzone Intradermal in adults were consistent with substantial experience accumulated with Intanza(®) 9 µg, the intradermal vaccine licensed on February 26 2009 and launched during the 2010/2011 season in Europe. Fluzone Intradermal is safe and its immunogenicity comparable with that of conventional intramuscular vaccines. Obtaining optimal acceptability of intradermal vaccines may represent an additional asset to help increase the coverage of influenza vaccination in young adults.

2. Netherlands pubmed.ncbi.nlm.nih.gov

Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18-64 years of age. [2018] To increase vaccine acceptance, intradermal (ID) influenza vaccine (Fluzone(®) Intradermal, Sanofi Pasteur Inc.) may be an attractive alternative to intramuscular (IM) vaccination due to smaller needle and volume injected.

3. United States pubmed.ncbi.nlm.nih.gov

Licensure of a high-dose inactivated influenza vaccine for persons aged >or=65 years (Fluzone High-Dose) and guidance for use - United States, 2010. [2017] Persons aged >or=65 years are at greater risk for hospitalization and death from seasonal influenza compared with other age groups, and they respond to vaccination with lower antibody titers to influenza hemagglutinin (an established correlate of protection against influenza) compared with younger adults. On December 23, 2009, the Food and Drug Administration (FDA) licensed an injectable inactivated trivalent influenza vaccine (Fluzone High-Dose, Sanofi-Pasteur) that contains an increased amount of influenza virus hemagglutinin antigen compared with other inactivated influenza vaccines such as Fluzone. Fluzone High-Dose is licensed as a single dose for use among persons aged >or=65 years and will be available beginning with the 2010-11 influenza season. The Advisory Committee on Immunization Practices (ACIP) reviewed data from prelicensure clinical trials on the safety and immunogenicity of Fluzone High-Dose and expressed no preference for the new vaccine over other inactivated trivalent influenza vaccines. This report summarizes the FDA-approved indications for Fluzone High-Dose and provides guidance from ACIP for its use.

4. England pubmed.ncbi.nlm.nih.gov

Influenza vaccination in patients with lung cancer receiving anti-programmed death receptor 1 immunotherapy does not induce immune-related adverse events. [2019] Influenza vaccination is recommended in patients with cancer to reduce influenza-related complications. Recently, more immune-related adverse events (irAEs) were demonstrated in patients with lung cancer who were vaccinated with the trivalent seasonal influenza vaccine during anti-programmed death receptor 1 (PD-1) immunotherapy. Confirmation of these findings is essential before recommendations on influenza vaccination may be revoked.

5. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of revaccination with reduced dose intradermal and standard dose intramuscular influenza vaccines in adults 18-64 years of age. [2013] This clinical trial examined the safety and immunogenicity of annual revaccination with Fluzone(®) Intradermal (Sanofi Pasteur, Swiftwater, PA) vaccine compared to a standard intramuscular (IM) split-virion trivalent influenza vaccine (Fluzone(®), Sanofi Pasteur).

6. England pubmed.ncbi.nlm.nih.gov

Fluzone® Intradermal Quadrivalent Influenza Vaccine. [2018] An intradermal version of Fluzone® split-virion inactivated trivalent influenza vaccine, containing 9 µg hemagglutinin per strain of A/H1N1, A/H3N2, and one B lineage virus (Fluzone Intradermal, Sanofi Pasteur), became available in the US during the 2011-2012 influenza season for adults 18-64 years of age. In advance of the 2015-2016 season, Fluzone Intradermal was replaced with Fluzone Intradermal Quadrivalent vaccine, which contains 9 µg hemagglutinin per strain of the two A-strain viruses and both B-strain lineage viruses (Victoria and Yamagata).