Autoimmune Disorders Clinical Trial
Official title:
Pilot Study to Determine the Immunogenicity of Immucothel and Oral Tolerance Induction With Biosyn Native KLH in Healthy Subjects (ITN047AI)
The purpose of this study is to test the oral tolerance of Keyhole Limpet Hemocyanin (KLH) and to determine if Immucothel by itself is strong enough to trigger the immune response. If not, Immucothel will be tested in combination with an adjuvant to determine if an adequate immune response can be seen.
One type of normal immune response is called "oral tolerance." This is when the immune
system (the body's natural defense system against illness) turns off (e.g. does not respond)
to foods or to other proteins that are eaten. Oral tolerance test is done by feeding people
a protein and then vaccinating them with the same protein. Oral tolerance occurs if the
vaccination does not cause an immune response.
In this study, oral tolerance of Keyhole Limpet Hemocyanin (KLH) will be tested. KLH is a
large protein extracted from a mollusk (a sea animal). The 'native KLH' (which is a large
version of this protein) formulation will be used for oral feeding. Immucothel (a smaller
version of the KLH protein) will be used for vaccination (injection). Immucothel is an
investigational vaccine currently used to treat bladder cancers outside of the US.
Since these particular KLH products have never been used in oral tolerance studies, the
investigators want to make sure in this pilot study that they will work as expected in
healthy participants before studying these two products in patients with auto-immune
disorders.
This study will also determine if Immucothel by itself is strong enough to trigger the
immune response. If not, Immucothel will be tested in combination with an adjuvant (a
substance that can increase the immune response to a protein like KLH) to determine if an
adequate immune response can be seen.
This study consists of two parts. Participants will participate for either 39 days (Part A)
or 65 days (Part B). Regardless of the group assignment, a safety follow-up phone call will
occur 6 months after the last immunization (189 day for Part A or 215 day for part B) to
assess the late onset of adverse events.
Part A of the study will test the experimental vaccine Immucothel by itself or in
combination with an adjuvant. Immucothel is a purified protein from a mollusk. Immucothel
can be given as a sub-q injection (under the skin) alone or with an adjuvant (a small amount
of mineral oil) to help to enhance the immune response. There maybe two groups in this part:
1. Ten evaluable (as defined by protocol) participants will be given Immucothel alone by
injection on two occasions, If Immucothel alone creates an immune response in most of
the participants then Part A will be completed.
2. If Immucothel alone does not create an immune response in most of the participants in
Part A, then 10 new evaluable (as defined by protocol) participants will be asked to
volunteer to test Immucothel in combination with the adjuvant Montanide (mineral oil).
This will be given by injection on two occasions If there is an immune response in most
of the participants to this combination of Immucothel and Montanide then Part A will be
done.
Part B of the study will test the successful Immucothel regimen from Part A with oral KLH.
Ten new evaluable (as defined by protocol) participants will be given the experimental oral
KLH.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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