A study to characterize the humoral and cellular response following simultaneous immunization with a neo-antigen (KLH) and a recall antigen (tetanus) in healthy volunteers

Overview

No summary available.

Registry

who.int

Start Date

January 30, 2017

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•Eligible subjects must meet all of the following inclusion criteria at screening:
•1\.Healthy male subjects, 18 to 45 years of age (inclusive). The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease following a detailed medical history and a complete physical examination including vital signs, laboratory measurements and 12\-lead ECG;
•2\.Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum bodyweight of 50 kg;
•3\.Previous immunization with tetanus toxoid as reported by the subject;
•4\.Willing to give written informed consent and willing and able to comply with the study protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 15
•F.1\.3 Elderly (\>\=65 years) no

•Eligible subjects must meet none of the following exclusion criteria at screening:
•1\.Any disease associated with immune system impairment, including auto\-immune diseases, HIV, any confirmed history of severe allergic reaction and transplantation patients;
•2\.Known infection requiring antibiotic therapy within the last three months prior to the study
•3\.Previous known exposure to Immucothel® or KLH;
•4\.Any adverse immune reaction following immunization with tetanus toxoid;
•5\.Known allergy against Thiomersal®, which is a stabilizer in the tetanus toxoid immunization;
•6\.Received immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the course of the study;
•7\.Use of medication (prescription or over\-the\-counter) within 21 days of the first study day, or less than 5 half\-lives (whichever is longer), and during the course of the study;
•8\.Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year;
•9\.Previous participation in an investigational drug or device study involving the dosing of a biological targeted at any immune pathway within one year prior to screening;

Not specified