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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
63
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.
Academic Medical Center
Amsterdam, North Holland, Netherlands
Height of serum anti-rotavirus Immunoglobulin A (IgA) response
Geometric Mean Concentration (GMC)
Time frame: 28 days post-vaccination
Time to positivity for serum anti-rotavirus Immunoglobulin A (IgA) and G (IgG) response
(days)
Time frame: 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)
Time frame: 28 days post-vaccination
Change in pre and post-vaccination anti-RV serum IgG response measured by Geometric Mean Concentration (GMC)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: day -9 and day 0 pre vaccination
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