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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| Wageningen University and Research | OTHER |
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The purpose of this study is to evaluate if the intestinal microbiota influences rotavirus vaccine immune responses in healthy adult volunteers.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Control group - subjects will receive no antibiotics followed by Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine |
|
| Broad-spectrum antibiotics | Active Comparator | Subjects will receive 7 days of pre-treatment (days -9 to -3) with:
followed by Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine |
|
| Narrow-spectrum antibiotics | Active Comparator | Subjects will receive 7 days of pre-treatment (days -9 to -3) with: • Vancomycine 250mg 3dd2 followed by Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Height of serum anti-rotavirus Immunoglobulin A (IgA) response | Geometric Mean Concentration (GMC) | 28 days post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Time to positivity for serum anti-rotavirus Immunoglobulin A (IgA) and G (IgG) response | (days) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Willem J. Wiersinga, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Amsterdam | North Holland | 1105 AZ | Netherlands |
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|
| 28 days post-vaccination |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| D013742 | Tetanus |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D022243 | Rotavirus Vaccines |
| D013745 | Tetanus Toxoid |
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D014121 | Toxoids |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
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