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

Brief Title

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

Official Title

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

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).
    


Study Type

Interventional


Primary Outcome

Height of serum anti-rotavirus Immunoglobulin A (IgA) response

Secondary Outcome

 Time to positivity for serum anti-rotavirus Immunoglobulin A (IgA) and G (IgG) response

Condition

Rotavirus Infections

Intervention

Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

63

Start Date

September 2015

Completion Date

February 2017

Primary Completion Date

January 2017

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
      

Gender

Male

Ages

18 Years - 35 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Willem J. Wiersinga, MD, PhD, , 

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT02538211

Organization ID

NL 52510.018.15


Responsible Party

Principal Investigator

Study Sponsor

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

Collaborators

 Centers for Disease Control and Prevention

Study Sponsor

Willem J. Wiersinga, MD, PhD, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)


Verification Date

July 2017