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Vaccination With Tetanus and KLH to Assess Immune Responses.

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ClinicalTrials.gov Identifier: NCT00000105
Recruitment Status : Terminated (Replaced by another study.)
First Posted : November 4, 1999
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

November 3, 1999
November 4, 1999
November 29, 2017
July 2002
March 2012   (Final data collection date for primary outcome measure)
To assess whether patients can mediate an appropriate immune response KLH [ Time Frame: Week 4 post vaccination ]
Not Provided
Complete list of historical versions of study NCT00000105 on ClinicalTrials.gov Archive Site
Tetanus Response [ Time Frame: Throughout study ]
Not Provided
Not Provided
Not Provided
 
Vaccination With Tetanus and KLH to Assess Immune Responses.
Vaccination With Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to Assess Antigen-Specific Immune Responses

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.

Patients will receive each vaccine once only consisting of:

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

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

Arm C: Biosyn KLH 1000 mcg (1 mg) with Montanide ISA51 (now replaced with vegetable (VG) source after 8/31/06 to increase product safety) subcutaneous Tetanus toxoid 0.5 ml intramuscularly (this arm open 3/18/03).

Subjects ineligible for tetanus may still receive KLH on this protocol. This is especially true given the national shortage of tetanus vaccines. Subjects will be eligible for tetanus when it becomes available if there has been no significant change in treatment interventions or overall health status and it is within 3 months of the KLH vaccine.

Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
analysis of blood samples before and 4 weeks postvaccination
Probability Sample
  • Normal volunteers
  • Patients with Cancer (breast, melanoma, hematologic)
  • Transplant patients (umbilical cord blood transplant, autologous transplant)
  • Patients receiving other cancer vaccines
Cancer
  • Biological: Intracel KLH Vaccine
    Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly.
    Other Names:
    • KLH BCI-ImmuneActivator(TM)
    • IntraCel
  • Biological: Biosyn KLH
    Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly.
    Other Names:
    • Immunocyanin
    • IMMUCOTHEL®
    • VACMUNE®
  • Drug: Montanide ISA51
    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.
    Other Name: Montanide ISA 51 VG
  • Biological: Tetanus toxoid
    Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, PUROGENATED® (TT), is a sterile preparation of refined tetanus toxoid for intramuscular use only.
    Other Name: PUROGENATED®
  • 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).
    Interventions:
    • 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).
    Interventions:
    • 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.
    Interventions:
    • Biological: Biosyn KLH
    • Drug: Montanide ISA51
    • Biological: Tetanus toxoid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
112
Not Provided
March 2012
March 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00000105
2002LS032
MT1999-06 ( Other Identifier: Blood and Marrow Transplantation Program )
Yes
Not Provided
Not Provided
Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
Not Provided
Principal Investigator: Jeffrey Miller, MD Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
November 2017