Flu Shot for Skin Cancer

Recruiting at 1 trial location

Overseen By Karam Khaddour, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Investigational cancer agents

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 2 weeks

25 Participants Needed

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 had hepatitis C but am cured, or I'm being treated with no detectable virus.

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.

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

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

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Findings from Research

Fluzone Intradermal, approved by the FDA in 2011, is the first influenza vaccine in the USA that uses a microinjection system for intradermal delivery, requiring a lower antigen content (9 µg) compared to conventional intramuscular vaccines (15 µg).

Clinical trials demonstrated that Fluzone Intradermal is safe and has immunogenicity comparable to traditional intramuscular vaccines, which may help improve influenza vaccination rates among adults aged 18 to 64.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluzone(®) Intradermal vaccine: a promising new chance to increase the acceptability of influenza vaccination in adults. Ansaldi, F., de Florentiis, D., Durando, P., et al.[2011]

The intradermal (ID) influenza vaccine demonstrated immune responses comparable to the intramuscular (IM) vaccine in a study of 4292 adults, meeting non-inferiority criteria for antibody levels against all three virus strains tested (H1N1, H3N2, and B).

While local injection site reactions were more frequent with the ID vaccine, they were mostly mild and transient, indicating that the ID vaccine is a well-tolerated alternative to the IM vaccine despite slightly higher rates of local discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18-64 years of age. Gorse, GJ., Falsey, AR., Fling, JA., et al.[2018]

Fluzone High-Dose is an injectable influenza vaccine specifically designed for individuals aged 65 and older, containing a higher amount of hemagglutinin antigen to improve immune response compared to standard vaccines.

The FDA approved Fluzone High-Dose for this age group due to their increased risk of severe influenza outcomes, although the Advisory Committee on Immunization Practices did not express a preference for it over other vaccines.

NCBI (Pubmed)

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]

In a study of 127 lung cancer patients receiving nivolumab, influenza vaccination did not significantly increase the incidence of immune-related adverse events (irAEs) compared to non-vaccinated patients, with rates of 26% for vaccinated and 22% for non-vaccinated individuals.

The study found no significant differences in serious irAEs, treatment discontinuation, death, or tumor response between vaccinated and non-vaccinated groups, suggesting that influenza vaccination is safe and should be encouraged for lung cancer patients undergoing anti-PD-1 therapy.

NCBI (Pubmed)

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. Wijn, DH., Groeneveld, GH., Vollaard, AM., et al.[2019]

The Fluzone Intradermal (ID) vaccine was found to be as immunogenic as the standard intramuscular (IM) vaccine, showing no significant differences in antibody responses for all three viral strains tested.

While the ID vaccine had higher rates of local reactions like erythema and swelling compared to the IM vaccine, it was well-tolerated overall, with no serious adverse events reported, indicating it can be safely used for annual revaccination in adults.

NCBI (Pubmed)

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. Gorse, GJ., Falsey, AR., Johnson, CM., et al.[2013]

Fluzone Intradermal Quadrivalent vaccine, introduced for the 2015-2016 season, includes two B-strain lineage viruses, enhancing its effectiveness against influenza by providing broader protection.

The vaccine utilizes a unique microinjection system, which not only improves the delivery method but also aims to alleviate logistical challenges for healthcare providers during vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluzone® Intradermal Quadrivalent Influenza Vaccine. Robertson, CA., Tsang, P., Landolfi, VA., et al.[2018]

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]

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]

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]

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]

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]

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

Fluzone® Intradermal Quadrivalent Influenza Vaccine. [2018]