Rotavirus InfectionsNCT02220439
Does the Fecal Microbiome Influence Rotarix Immunogenicity
An observational study of Rotavirus Infections and Reaction - Vaccine Nos, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Trial summary
This is a proposal for a nested case-control study within an ongoing rotavirus vaccine immunogenicity clinical trial Karachi, Pakistan. The primary study aim is to compare the fecal microbiota composition and diversity of infants who do (control) and do not (case) demonstrate immune seroconversion to rotavirus… Read more about this study
- Who is it for?
- Ages 4 weeks and older
- Conditions the study is for
- Rotavirus Infections, Reaction - Vaccine Nos, Intestinal Bacteria Flora Disturbance
- Type of treatment
- Vaccines
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Nov 2013
- Phase
- Observational
- 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 4 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will be nested within an existing rotavirus immunogenicity study being conducted in Karachi, Pakistan (clinicaltrials.gov: NCT01199874) . The physical setting is a peri-urban slum outside of Karachi, primarily populated by fishermen. Parents and legal guardians of infants participating in NCT01199874 will provide new informed consent for inclusion in this study.
Who may be able to join
- 6 weeks 0 days to 7 weeks 6 days age at the time of enrollment.
- Healthy infant free of chronic or serious medical condition as determined by history and physical exam at time of enrollment into in the study.
- Written informed consent obtained from the parents or guardians.
- Availability of baseline fecal sample collected before Rotarix vaccination
- Written informed consent obtained from the parents or guardians for nested study
Who cannot join
- Hypersensitivity to any of the vaccine components
- Use of any investigational drug or vaccine other than the study vaccine within 30 days of first dose of study vaccine or during the study.
- Use of any immunosuppressive drugs.
- Previous intussusceptions or abdominal surgery.
- Enrollment in any other trial (besides NCT01199874).
- Birth weight less than 1500 grams; or if birth weight is unknown, weight less than 2000 grams on or before 28 days.
- Immunoglobulin and/or blood products use since birth or during the study period. Nested study additional exclusion criteria:
- Positive serum anti-rotavirus Immunoglobulin A (> 20 U/ml) at 6 weeks of age, indicative of prior rotavirus infection
About this study
Official title: Nested Case-control Analysis of the Influence of the Microbiome on Rotavirus Vaccine Immunogenic Response in Infants in Karachi, Pakistan
This is a proposal for a nested case-control study within an ongoing rotavirus vaccine immunogenicity clinical trial Karachi, Pakistan. The primary study aim is to compare the fecal microbiota composition and diversity of infants who do (control) and do not (case) demonstrate immune seroconversion to rotavirus vaccination. The infants will be matched for vaccination dose, age and breast-feeding practices.
- Keywords
- rotavirus, immunogenicity, enteric vaccine, vaccine immunogenicity, rotavirus vaccine, gut microbiome, microbiome
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case: non-rotavirus seroconverters | Infants not demonstrating seroconversion to rotavirus vaccination, as measured anti-RV Immunoglobulin A < 20 U/ml | |
| Control: rotavirus seroconverters | Infants demonstrating seroconversion to rotavirus vaccination, as measured by anti-rotavirus Immunoglobulin A > 20 U/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
microbiome diversity (Shannon's index) and composition (relative abundance)
Microbiota composition will be measured by calculating and comparing a % of the phylogenetic groups present in both groups
Diversity will be measured by calculating a comparing a Shannon's reciprocal index of diversity, 1/D in both groups
The relative abundance of microbial groups will be measured by calculating and comparing the ribosomal ribonucleic acid gene copy per gram of feces over time in both groups
Measured: at 6 weeks of age, pre-rotavirus vaccination
Secondary outcomes (1)
microbiome diversity (Shannon's index) and composition (relative abundance)
Microbiota composition post vaccination will be measured by calculating and comparing a % of the phylogenetic groups present in both groups
Diversity post vaccination will be measured by calculating a comparing a Shannon's reciprocal index of diversity, 1/D in both groups
The relative abundance of microbial groups post vaccination will be measured by calculating and comparing the ribosomal ribonucleic acid gene copy per gram of feces over time in both groups
Measured: at 1 to 3 years of age post-rotavirus vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startSep 2013
- Primary completionNov 2013
- Study completionNov 2013
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University, Centers for Disease Control and Prevention, University of Padova, Wageningen University and Research
- Responsible party
- Principal investigator, Vanessa Harris, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Vanessa C Harris, MD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220439
- Sponsor's protocol ID
- AIGHD-CSP2013-001a
- Status last verified
- Aug 2014
- First submitted
- 10 Jun 2014
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nested Case-control Analysis of the Influence of the Microbiome on Rotavirus Vaccine Immunogenic Response in Infants in Karachi, Pakistan
- ClinicalTrials.gov ID
- NCT02220439
- Acronym / sponsor ID
- AIGHD-CSP2013-001a
- Keywords
- rotavirus, immunogenicity, enteric vaccine, vaccine immunogenicity, rotavirus vaccine, gut microbiome, microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Aga Khan University, Centers for Disease Control and Prevention, University of Padova, Wageningen University and Research
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 20 Aug 2014 (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.
This is a proposal for a nested case-control study within an ongoing rotavirus vaccine immunogenicity clinical trial Karachi, Pakistan. The primary study aim is to compare the fecal microbiota composition and diversity of infants who do (control) and do not (case) demonstrate immune seroconversion to rotavirus vaccination. The infants will be matched for vaccination dose, age and breast-feeding practices.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case: non-rotavirus seroconverters | – | –Infants not demonstrating seroconversion to rotavirus vaccination, as measured anti-RV Immunoglobulin A < 20 U/ml |
| Control: rotavirus seroconverters | – | –Infants demonstrating seroconversion to rotavirus vaccination, as measured by anti-rotavirus Immunoglobulin A > 20 U/ml |
Who may qualify
- Ages
- 4 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be nested within an existing rotavirus immunogenicity study being conducted in Karachi, Pakistan (clinicaltrials.gov: NCT01199874) . The physical setting is a peri-urban slum outside of Karachi, primarily populated by fishermen. Parents and legal guardians of infants participating in NCT01199874 will provide new informed consent for inclusion in this study.
Key inclusion criteria (5 listed)
- 6 weeks 0 days to 7 weeks 6 days age at the time of enrollment.
- Healthy infant free of chronic or serious medical condition as determined by history and physical exam at time of enrollment into in the study.
- Written informed consent obtained from the parents or guardians.
- Availability of baseline fecal sample collected before Rotarix vaccination
- Written informed consent obtained from the parents or guardians for nested study
Key exclusion criteria (8 listed)
- Hypersensitivity to any of the vaccine components
- Use of any investigational drug or vaccine other than the study vaccine within 30 days of first dose of study vaccine or during the study.
- Use of any immunosuppressive drugs.
- Previous intussusceptions or abdominal surgery.
- Enrollment in any other trial (besides NCT01199874).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
microbiome diversity (Shannon's index) and composition (relative abundance)
Time frame: at 6 weeks of age, pre-rotavirus vaccination
Microbiota composition will be measured by calculating and comparing a % of the phylogenetic groups present in both groups Diversity will be measured by calculating a comparing a Shannon's reciprocal index of diversity, 1/D in both groups The relative abundance of microbial groups will be measured by calculating and comparing the ribosomal ribonucleic acid gene copy per gram of feces over time in both groups
1 secondary outcome
microbiome diversity (Shannon's index) and composition (relative abundance)
Time frame: at 1 to 3 years of age post-rotavirus 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 20 Aug 2014.
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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.
Vanessa C Harris, MD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Questions about this trial
What is this clinical trial studying?
An observational study of Rotavirus Infections and Reaction - Vaccine Nos, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
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 5 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 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
microbiome diversity (Shannon's index) and composition (relative abundance) (time frame: at 6 weeks of age, pre-rotavirus 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 20 Aug 2014.