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Vaccines

Intratumoral application of an unattenuated influenza vaccine

Influenza Vaccines

Ismail Gögenur, Professor

The aim of this explorative phase II clinical trial is to establish the safety and efficacy of intratumoral influenza vaccine in patients with colorectal cancer, as an additive treatment prior to intended curative surgery.

This is an explorative phase 2 clinical trial which will be conducted in two phases. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with intratumoral influenza vaccine as a down staging and immune response enhancing treatment prior to intended curative surgery.

The first part of the study will be conducted as a pilot study. Six patients with histologically verified or clinically suspicious sigmoid colon cancer who are planned to undergo curative surgery will be included. Patients will be recruited from the Department of Surgery, Zealand University Hospital after their case has been reviewed by the multidisciplinary team (MDT). Standard treatment involves intended curative surgery within two weeks after the diagnosis. The treatment will be performed within a few days and it will be ensured that the experimental treatment will not lead to a significant delay of intended curative surgery.

If the pilot study finishes without violating any stop rules and without any serious adverse events the second part of the study will be initiated. This will be conducted as a phase 2 study where 24 patients with histologically verified or clinically suspicious sigmoid colon cancer and rectal cancer will be included. Patients will be recruited from the Department of Surgery, Zealand University Hospital after their case has been reviewed by the multidisciplinary team (MDT). Standard treatment involves intended curative surgery within two weeks after the diagnosis. The treatment will be performed within a few days and it will be ensured that the experimental treatment will not lead to a significant delay of intended curative surgery.

Intratumoral Influenza Vaccine for Early Colorectal Cancer

To investigate if the treatment will induce a systemic immunologic response.

To assess quality of recovery for patients recruited into this trial. A quality of recovery questionnaire (QoR-15) will be given to patients pre- and post-treatment.

To investigate if intratumoral influenza vaccine is a safe treatment modality for tumor down staging prior to intended curative surgery in patients undergoing treatment for colorectal cancer.

Adverse events / reactions are recorded from day of treatment (Day 0) until the surgery, as it will be difficult to differ between adverse events/reactions to the experimental treatment or surgery. All adverse events / reactions should be described in medical terminology in the patient's file and recorded in case report forms (CRF). The following information must be recorded: start date/date when observed, severity, any initiated treatment, assessment of the AE if it meets the criteria for SAE, end date, and relationship to study drug. For AEs that meet the criteria for SAE, the outcome must be recorded.

To investigate if intratumoral influenza vaccine will induce immunologic invasion of the primary tumor This will be analyzed by immunhistochemistry and NanoString

University of Copenhagen

Zealand University Hospital

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Second dose is given 21 days after the initial dose. The same dose and route of administration are used.

One dose constitutes 0.5mL of suspended vaccine via the intramuscular route.

AS03-adjuvanted H1N1 pandemic influenza vaccine

John Kuruvilla, MD

The purpose of this study is to determine whether adults with hematologic malignancies on active systemic therapy or shortly after bone marrow transplantation need one or two doses of adjuvanted vaccine to achieve best possible rates of protection. An additional research question is whether baseline biomarkers of the cellular and humoral immune systems are associated with an antibody response to vaccination.

The novel influenza H1N1 virus responsible for a world-wide pandemic throughout 2009 (H1N1(2009)) is expected to cause a second wave of infection during the 2009/10 winter season. Vaccines against H1N1(2009) will be available in early November, 2009. Adults with hematologic disorders are at high risk of influenza-related complications, including death. Given that the vaccination dosing for the pandemic vaccine has been developed on healthy individuals, it is unknown whether this subgroup of patients will respond similarly. We will evaluate the safety and efficacy of the pandemic vaccine in patients with lymphoid malignancies receiving active systemic treatment, or who have recently undergone stem cell transplantation. Patients will be randomized to one or two doses of the approved adjuvanted vaccine; immune responses will be measured to identify the optimal regimen. Also, we will look for an association between biomarkers of the immune system and a response to the vaccine; this will be done by measuring baseline CD3, 4, 8, 19, and 56 cells by flow cytometry.

Evaluation of Influenza H1N1 Vaccine in Adults With Lymphoid Malignancies on Chemotherapy

Evaluation of Pandemic H1N1(2009) Influenza Vaccine in Adults With Lymphoid Malignancies on Active Systemic Treatment or Post Stem Cell Transplantation

Princess Margaret Hospital, Canada

University Health Network, Toronto

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intratumoral Influenza Vaccine for Early Colorectal Cancer	NCT04591379	Colorectal Canc...	Influenza Vacci...	18 Years -	Zealand University Hospital
Intratumoral Influenza Vaccine for Early Colorectal Cancer	NCT04591379	Colorectal Canc...	Influenza Vacci...	18 Years -	Zealand University Hospital
Evaluation of Influenza H1N1 Vaccine in Adults With Lymphoid Malignancies on Chemotherapy	NCT01016548	Lymphoma Multiple Myelom... Influenza A Vir...	AS03-adjuvanted...	20 Years - 65 Years	University Health Network, Toronto

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