Repeated KLH immunization in healthy volunteers

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

1. Signed informed consent prior to any study-mandated procedure;
2. Healthy male subjects, 18 to 45 years of age (inclusive). Health status is defined by absence or evidence of any
active or chronic disease following a detailed medical and surgical history, a complete physical examination
including vital signs, 12-lead ECG, haematology, blood chemistry, blood serology and urinalysis. In the case of
uncertain or questionable results, tests performed during screening may be repeated before randomization to
confirm eligibility or judged to be clinically irrelevant for healthy subjects;
3. Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum bodyweight of 50 kg;’
4. Fitzpatrick skin type I-III.
5. Has the ability to communicate well with the Investigator in the Dutch language and willing and able to comply
with the study restrictions.

Exclusion Criteria

1. Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead electrocardiogram (ECG)). Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance;
2. Clinically significant abnormalities, as judged by the Investigator, in laboratory test results (including haematology panel, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests
performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects;
3. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening;
4. Any disease associated with immune system impairment, including immune mediated diseases, transplantation patients and any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug or multiple drug allergies (non-active hay fever is acceptable);
5. Use of any medications (prescription or over-the-counter [OTC]), within 21 days prior to initial KLH immunization, or less than 5 half-lives (whichever is longer). An exception is made for paracetamol (up to 4 g/day). Other exceptions will only be made if the rationale is clearly documented by the Investigator;
6. Use of immunosuppressive or immunomodulatory medication within 30 days prior to initial KLH immunization or planned to use during the course of the study;
7. Any vaccination within 30 days prior to initial KLH immunization or planned during the course of the study with exception of vaccination for SARS-CoV-2;
8. Vaccination for SARS-CoV-2 within 14 days prior to initial KLH immunization, or planned during the course of the study;
9. Use of antibiotic therapy within 90 days prior to initial KLH immunization or planned to use during the course of the study;
10. Alcohol will not be allowed from at least 24 hours before screening and each scheduled visit. At other times during the course of the study no more than 2 units of alcohol per day will be allowed;
11. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 14 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillisers, or any other addictive agent;
12. Positive test for drugs of abuse or alcohol breath test at screening;
13. Smoker of more than 5 cigarettes per day prior to screening or who use tobacco products equivalent to more than 5 cigarettes per day and unable to abstain from smoking whilst in the unit.
14. Previous known exposure to Immucothel® or KLH;
15. History of Schistosomiasis (infection with Schistosoma parasite);
16. Participation in an investigational drug or device study (last dosing of previous study was within 90 days prior to initial KLH immunization of this study and participation more than 4 times a year);
17. Loss or donation of blood over 500 mL within 90 days prior to screening or intention to donate blood or blood products during the study;
18. Have any current and / or recurrent clinically significant skin condition at the treatment area (i.e. atopic dermatit

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• KLH-specific B cell responses<br>• KLH-specific T cell responses<br>• KLH-driven skin response after intradermal KLH challenge

Secondary Outcome Measures

Name	Time	Method
• KLH-specific immune response (T and B cells)<br>• KLH-driven skin response after intradermal KLH challenge (LSCI / Multispectral)<br>• Treatment-emergent (serious) adverse events ((S)AEs)<br>• Concomitant medication<br>• Toxicity Grading Scale