Intestinal Bacteria Flora Disturbance, Reaction - Vaccine Nos, Rotavirus Infections, Streptococcal Pneumonia, Tetanus
Conditions
Brief summary
The purpose of this study is to evaluate if the intestinal microbiota influences rotavirus vaccine immune responses in healthy adult volunteers.
Detailed description
This study will alter the intestinal microbiota in healthy adults using antibiotics and subsequently measure immune reactions to the rotavirus vaccine (Rotarix), the tetanus vaccine and the pneumococcal vaccine (Pneumo23).
Interventions
BIOLOGICALRotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine
All subjects will be given an oral dose of the rotavirus vaccine, RotarixTM, and intramuscular injections of the Tetanus vaccine and Pneumococcal vaccine, Pneumo 23.
Sponsors
Centers for Disease Control and Prevention
Wageningen University and Research
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion 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 -98). 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
* 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 * Subjects with a history of any type of malignancy * Subject with a history of thrombocytopenia or bleeding disorder * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Height of serum anti-rotavirus Immunoglobulin A (IgA) response | 28 days post-vaccination | Geometric Mean Concentration (GMC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pre and post-vaccination anti-RV serum IgG response measured by Geometric Mean Concentration (GMC) | day 0 through day 28 post vaccination | — |
| Change in serum tetanus toxoid IgG response, measured as pre and post vaccination titer (international units/mL) ratio | day 0 through day 28 post vaccination | — |
| Change in serum pneumococcal poly-saccharide-specific IgG for all vaccine strains , measure in pre and post vaccination titer (micrograms/mL) ratio | day 0 through day 28 post vaccination | — |
| Change in pre and post-vaccination anti-rotavirus (anti-RV) serum neutralizing antibodies measured by Geometric Mean Concentration (GMC) | 28 days post-vaccination | — |
| Composition of the fecal micro biome before and after antibiotics and between groups measured by the HITChip and bacterial 16S rRNA sequencing | day -9 and day 0 pre vaccination | — |
| Time to positivity for serum anti-rotavirus Immunoglobulin A (IgA) and G (IgG) response | day 0 through day 28 post vaccination | (days) |
Countries
Netherlands
Outcome results
None listed