Vaccination With Tetanus and KLH to Assess Immune Responses.

NCT00000105 | Terminated DMC

• 2 other identifiers: 2002LS032MT1999-06
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn how the immune system works in response to vaccines. We will give the vaccines to subjects who have cancer but have not had treatment, and to patients who have had chemotherapy or stem cell transplant. Some patients will get vaccines while they are on treatments which boost the immune system (like the immune stimulating drug interleukin-2 or IL-2). Although we have safely treated many patients with immune boosting drugs, we do not yet know if they improve the body's immune system to respond better to a vaccine. Some healthy volunteers will also be given the vaccines in order to serve as control subjects to get a good measure of the normal immune response. We will compare the patients and the healthy volunteers to study how their immune systems respond to the vaccines. There are several different types of white cells in the blood. We are interested in immune cells in the blood called T-cells. These T-cells detect foreign substances in the body (like viruses and cancer cells). We are trying to learn more about how the body fights these foreign substances. Our goal is to develop cancer vaccines which would teach T-cells to detect and kill cancer cells better. We know that in healthy people the immune system effectively protects against recurrent virus infection. For example, that is why people only get "mono" (mononucleosis) once under normal circumstances. When the body is infected with the "mono" virus, the immune system remembers and prevents further infection. We are trying to use the immune system to prevent cancer relapse. To test this, we will give two vaccines which have been used to measure these immune responses. Blood samples will be studied from cancer patients and will be compared to similar samples from normal subjects.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• To assess whether patients can mediate an appropriate immune response KLH

  Week 4 post vaccination

Secondary Outcomes (1)

• Tetanus Response

  Throughout study

Study Arms (3)

Arm A: Intracel KLH

Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly (this arm closed 1/2/02).

Biological: Intracel KLH Vaccine; Biological: Tetanus toxoid

Arm B: Biosyn KLH

Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly (this arm closed 3/18/03).

Biological: Biosyn KLH; Biological: Tetanus toxoid

Arm C: Biosyn KLH with Montanide ISA51

Biosyn KLH 1000 mcg (1 mg) with Montanide ISA51 (replaced with vegetable (VG) source after 8/31/06) and subcutaneous Tetanus toxoid 0.5 ml intramuscularly.

Biological: Biosyn KLH; Drug: Montanide ISA51; Biological: Tetanus toxoid

Interventions

Intracel KLH Vaccine BIOLOGICAL

Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly.

Also known as: KLH BCI-ImmuneActivator(TM), IntraCel

Arm A: Intracel KLH

Biosyn KLH BIOLOGICAL

Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly.

Also known as: Immunocyanin, IMMUCOTHEL®, VACMUNE®

Arm B: Biosyn KLH; Arm C: Biosyn KLH with Montanide ISA51

Montanide ISA51 DRUG

Emulsify the KLH with Montanide ISA-51. The KLH 1 mg vial will be reconstituted in 0.5 mL sterile water. Once solubilized, add 0.6 mL of Montanide ISA to the vial and administered contents subcutaneously.

Also known as: Montanide ISA 51 VG

Arm C: Biosyn KLH with Montanide ISA51

Tetanus toxoid BIOLOGICAL

Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, PUROGENATED® (TT), is a sterile preparation of refined tetanus toxoid for intramuscular use only.

Also known as: PUROGENATED®

Arm A: Intracel KLH; Arm B: Biosyn KLH; Arm C: Biosyn KLH with Montanide ISA51

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Normal volunteers * Patients with Cancer (breast, melanoma, hematologic) * Transplant patients (umbilical cord blood transplant, autologous transplant) * Patients receiving other cancer vaccines

You may qualify if:

• Patients must have a diagnosis of cancer of any histologic type.
• Patients must have a Karnofsky performance status great or equal to 70%.
• Patients must have an expected survival for at least four months.
• Normal healthy volunteers to serve as control for this study.
• All patients must sign informed consent approved by the Committee on the Use of Human Subjects at the University of Minnesota

You may not qualify if:

• Pregnant or lactating women. Females of child-bearing potential will be asked to take a pregnancy test before receiving vaccines.
• Serious intercurrent medical illnesses which would interfere with the ability of the patient to carry out the follow-up monitoring program.
• Immunization should not be administered during the course of any febrile illness or acute infection.
• Hypersensitivity to any component of the vaccine, including Thimerosal, a mercury derivative.
• The occurrence of any type of neurologic symptoms to tetanus vaccine in th past.
• Patients with a history of seafood allergy are excluded from receiving KLH.
• Subjects who have had tetanus toxoid within the last 7 years are not eligible for tetanus vaccine component of this protocol.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Division of Hematology, Oncology, and Transplantation 420 Delaware St., SE, Box 806 Mayo

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

analysis of blood samples before and 4 weeks postvaccination

MeSH Terms

Conditions

Neoplasms

Interventions

keyhole-limpet hemocyanin; montanide ISA 51; Tetanus Toxoid

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Jeffrey Miller, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: July 1, 2002
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

US (1)