The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses

NCT ID: NCT02538211

Last Updated: 2017-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-02-28

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

Control group - subjects will receive no antibiotics

followed by Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine

Group Type: PLACEBO_COMPARATOR

Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine

Intervention Type: 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.

Broad-spectrum antibiotics

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

Group Type: ACTIVE_COMPARATOR

Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine

Intervention Type: 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.

Narrow-spectrum antibiotics

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

Group Type: ACTIVE_COMPARATOR

Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine

Intervention Type: 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.

Interventions

Rotavirus 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

RotarixTM, Pneumo 23

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Wageningen University and Research

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

W.J. Wiersinga, MD, PhD

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Willem J. Wiersinga, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Academic Medical Center

Amsterdam, North Holland, Netherlands

Countries

Netherlands

Other Identifiers

NL 52510.018.15

Identifier Type: -

Identifier Source: org_study_id