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The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT02538211•Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 35 years

Sex

MALE

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

Locations (1)

Academic Medical Center

Amsterdam, North Holland, Netherlands

Key Dates

Start Date

September 1, 2015

Primary Completion Date

January 1, 2017

Completion Date

February 1, 2017

Last Updated

July 25, 2017

Enrollment

ACTUAL participants

Conditions

Rotavirus InfectionsIntestinal Bacteria Flora DisturbanceReaction - Vaccine NosTetanusStreptococcal Pneumonia

Interventions

Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine

BIOLOGICAL

CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP) in Healthy Adults

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Rotavirus Infections

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COMPLETEDPHASE2

A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine

NCT03483116

Rotavirus Infections

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COMPLETEDNA

Allium Extracts on the Intestinal Microbiota in Healthy Resident Volunteers.

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 25, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP) in Healthy Adults

A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine

Allium Extracts on the Intestinal Microbiota in Healthy Resident Volunteers.

Evaluation of the Effect of Palm Olein Free Formula on Intestinal Flora and Gastrointestinal Tolerance

Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study

RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)