vaccin immunogeniciteit immunity rotavirus vaccine
Conditions
Interventions
Intervention:
Arm 1 (control): no antibiotic depletion then RotarixTM, Tetanus and
Pneumococcus vaccination
Arm 2: broad-spectrum antibiotic depletion (ciprofloxacin, vancomyin,
metronidazole) then RotarixTM, Tetanus, and Pneumococcus vaccination
Arm 3: Gram-positive depletion (oral vancomycin) then RotarixTM, Tetanus, and
Pneumococcus vaccination
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Healthy, as determined by a responsible physician, based on a medical evaluation including medical history, physical examination and laboratory tests carried out within 28 days prior to starting antibiotics (day -9). A subject with a clinical abnormality or laboratory parameter outside the reference range may be included if the investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures * Male between 18 and 35 years of age, inclusive at the time of signing the informed consent * Capable of giving written informed consent and able to comply with the requirements and restrictions listed in the informed consent form * Normal defecation pattern (defined as *3x/ day and *3x/week)
Exclusion criteria
Exclusion criteria: * Baseline anti-rotavirus immunglobluin A level greater than 20 IU/mL or equivalent geometric mean titer. * Subject has had a major illness in the past 3 months or any significant chronic medical illness that the investigator would deem unfavorable for enrollment, including inflammatory diseases. * Subject with any history of immunodeficiency Subject with a history of thrombocytopenia or bleeding disorder * Subjects with a history of any type of malignancy * Subject has a past or current gastrointestinal disease which may influence the gut microbiota * Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) * History of alcoholism and/or drinking more than an average of 5 units of alcohol per day * The subject has received an investigational product within three months of day 0 of the current study * Use of prescription or non-prescription drugs and herbal and dietary supplements within 6 months unless in the opinion of the investigator the medication will not interfere with the study procedures or compromise subject safety * Recent (28 kg/m2 * Any other issue that, in the opinion of the investigator, could be harmful to the subject or compromise interpretation of the data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: The main study endpoint is the 28-day post vaccination anti-RV IgA serum response. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are the height, slope and time to positivity of the post-vaccination anti-RV IgA, anti-pneumococcal antibodies and anti-tetanus toxoid antibodies, and fecal rotavirus antigen shedding days 1-7 post rotavirus vaccination. Differences in the composition and diversity of the intestinal microbiota before and after antibiotic use and between groups. Isolation and stimulation of peripheral blood mononuclear cells (PBMC) pre and post vaccination with vaccines. Correlation between self-reported diet (4 day log) and microbiome composition. | — |
Countries
Netherlands
Outcome results
None listed