Ignite Creation Date:
2024-05-05 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000105
Status:
TERMINATED
Last Update Posted:
2017-11-29
First Post:
1999-11-03
Brief Title:
Vaccination With Tetanus and KLH to Assess Immune Responses
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Vaccination With Tetanus Toxoid and Keyhole Limpet Hemocyanin KLH to Assess Antigen-Specific Immune Responses
Status:
TERMINATED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Replaced by another study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 bodys 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
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
Detailed Description:
Patients will receive each vaccine once only consisting of
Arm A Intracel KLH 1000 mcg 1 mg without adjuvant subcutaneous Tetanus Toxoid 05 ml intramuscularly this arm closed 1202
Arm B Biosyn KLH 1000 mcg 1 mg without adjuvant subcutaneous tetanus toxoid 05 ml intramuscularly this arm closed 31803
Arm C Biosyn KLH 1000 mcg 1 mg with Montanide ISA51 now replaced with vegetable VG source after 83106 to increase product safety subcutaneous Tetanus toxoid 05 ml intramuscularly this arm open 31803
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
Arm A Intracel KLH 1000 mcg 1 mg without adjuvant subcutaneous Tetanus Toxoid 05 ml intramuscularly this arm closed 1202
Arm B Biosyn KLH 1000 mcg 1 mg without adjuvant subcutaneous tetanus toxoid 05 ml intramuscularly this arm closed 31803
Arm C Biosyn KLH 1000 mcg 1 mg with Montanide ISA51 now replaced with vegetable VG source after 83106 to increase product safety subcutaneous Tetanus toxoid 05 ml intramuscularly this arm open 31803
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MT1999-06 | OTHER | Blood and Marrow Transplantation Program | None |