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Trial record 25 of 33 for:    "Pneumonia, Pneumococcal"

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

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ClinicalTrials.gov Identifier: NCT02538211
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : July 25, 2017
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Wageningen University and Research
Information provided by (Responsible Party):
W.J. Wiersinga, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

Condition or disease Intervention/treatment Phase
Rotavirus Infections Intestinal Bacteria Flora Disturbance Reaction - Vaccine Nos Tetanus Streptococcal Pneumonia Biological: Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine Not Applicable

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  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses
Actual Study Start Date : September 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : February 2017


Arm Intervention/treatment
Placebo Comparator: Control

Control group - subjects will receive no antibiotics

followed by Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine

Biological: 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.
Other Name: RotarixTM, Pneumo 23

Active Comparator: 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

Biological: 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.
Other Name: RotarixTM, Pneumo 23

Active Comparator: 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

Biological: 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.
Other Name: RotarixTM, Pneumo 23




Primary Outcome Measures :
  1. Height of serum anti-rotavirus Immunoglobulin A (IgA) response [ Time Frame: 28 days post-vaccination ]
    Geometric Mean Concentration (GMC)


Secondary Outcome Measures :
  1. Time to positivity for serum anti-rotavirus Immunoglobulin A (IgA) and G (IgG) response [ Time Frame: day 0 through day 28 post vaccination ]
    (days)

  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538211


Locations
Netherlands
Academic Medical Center
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Centers for Disease Control and Prevention
Wageningen University and Research
Investigators
Principal Investigator: Willem J. Wiersinga, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Responsible Party: W.J. Wiersinga, MD, PhD, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02538211     History of Changes
Other Study ID Numbers: NL 52510.018.15
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Pneumonia, Pneumococcal
Pneumonia
Rotavirus Infections
Dysbiosis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Pathologic Processes
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Anti-Bacterial Agents
Antibiotics, Antitubercular
Immunologic Factors
Physiological Effects of Drugs
Anti-Infective Agents
Antitubercular Agents