Rotavirus InfectionsRota-biomeNCT02538211
The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses
A study testing Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine in people with Rotavirus Infections and Intestinal Bacteria Flora Disturbance, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The purpose of this study is to evaluate if the intestinal microbiota influences rotavirus vaccine immune responses in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Infections, Intestinal Bacteria Flora Disturbance, Reaction - Vaccine Nos
- What is being tested?
- Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Center
Amsterdam, North Holland, 1105 AZ
About this study
The purpose of this study is to evaluate if the intestinal microbiota influences rotavirus vaccine immune responses in healthy adult volunteers.
Read the 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
- Being tested
- Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine
- Medical subject headings
- Rotavirus Infections, Tetanus, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccineBiological
Also called RotarixTM, Pneumo 23
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Control group - subjects will receive no antibiotics
followed by Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine Receives: Biological: Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine |
| Broad-spectrum antibiotics | Active comparator | 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 Receives: Biological: Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine |
| Narrow-spectrum antibiotics | Active comparator | 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 Receives: Biological: Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height of serum anti-rotavirus Immunoglobulin A (IgA) response
Geometric Mean Concentration (GMC)
Measured: 28 days post-vaccination
Secondary outcomes (6)
Time to positivity for serum anti-rotavirus Immunoglobulin A (IgA) and G (IgG) response
(days)
Measured: day 0 through day 28 post vaccination
Change in pre and post-vaccination anti-rotavirus (anti-RV) serum neutralizing antibodies measured by Geometric Mean Concentration (GMC)
Measured: 28 days post-vaccination
Change in pre and post-vaccination anti-RV serum IgG response measured by Geometric Mean Concentration (GMC)
Measured: day 0 through day 28 post vaccination
Change in serum tetanus toxoid IgG response, measured as pre and post vaccination titer (international units/mL) ratio
Measured: day 0 through day 28 post vaccination
Change in serum pneumococcal poly-saccharide-specific IgG for all vaccine strains , measure in pre and post vaccination titer (micrograms/mL) ratio
Measured: day 0 through day 28 post vaccination
Composition of the fecal micro biome before and after antibiotics and between groups measured by the HITChip and bacterial 16S rRNA sequencing
Measured: day -9 and day 0 pre vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotavirus InfectionsStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Wageningen University and Research
- Responsible party
- Principal investigator, W.J. Wiersinga, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Willem J. Wiersinga, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538211
- Sponsor's protocol ID
- NL 52510.018.15
- Acronym
- Rota-biome
- Status last verified
- Jul 2017
- First submitted
- 27 Aug 2015
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses
- ClinicalTrials.gov ID
- NCT02538211
- Acronym / sponsor ID
- Rota-biome / NL 52510.018.15
- Conditions
- Rotavirus Infections, Intestinal Bacteria Flora Disturbance, Reaction - Vaccine Nos, Tetanus, Streptococcal Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Wageningen University and Research
- Study start
- Sep 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Biological: Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccineControl group - subjects will receive no antibiotics followed by Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine |
| Broad-spectrum antibiotics | Active comparator | Biological: Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccineSubjects 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 |
| Narrow-spectrum antibiotics | Active comparator | Biological: Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccineSubjects will receive 7 days of pre-treatment (days -9 to -3) with: • Vancomycine 250mg 3dd2 followed by Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccineAlso: RotarixTM, Pneumo 23All subjects will be given an oral dose of the rotavirus vaccine, RotarixTM, and intramuscular injections of the Tetanus vaccine and Pneumococcal vaccine, Pneumo 23. | Biological | Broad-spectrum antibiotics, Control, Narrow-spectrum antibiotics |
Primary outcome
Height of serum anti-rotavirus Immunoglobulin A (IgA) response
Time frame: 28 days post-vaccination
Geometric Mean Concentration (GMC)
6 secondary outcomes
Time to positivity for serum anti-rotavirus Immunoglobulin A (IgA) and G (IgG) response
Time frame: day 0 through day 28 post vaccination
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Willem J. Wiersinga, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine in people with Rotavirus Infections and Intestinal Bacteria Flora Disturbance, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height of serum anti-rotavirus Immunoglobulin A (IgA) response (time frame: 28 days post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.