The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses (Rota-biome)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Completed

Conditions: Streptococcal Pneumonia; Reaction - Vaccine Nos; Intestinal Bacteria Flora Disturbance; Rotavirus Infections; Tetanus

Treatments: Biological: Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02538211

NL 52510.018.15

Details and patient eligibility

About

The purpose of this study is to evaluate if the intestinal microbiota influences rotavirus vaccine immune responses in healthy adult volunteers.

Full 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).

Enrollment: 63 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Control group - subjects will receive no antibiotics followed by Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine

Treatment:

Biological: Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine

Broad-spectrum antibiotics

Active Comparator group

Description:

Subjects will receive 7 days of pre-treatment (days -9 to -3) with: * Ciprofloxacin 500mg 2dd1 * Vancomycin 250mg 3dd2 * Metronidazole 500mg 3dd1 followed by Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine

Treatment:

Biological: Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine

Narrow-spectrum antibiotics

Active Comparator group

Description:

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

Treatment:

Biological: Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine