RotavirusNCT03031743
The Influence of the Microbiome on Rotavirus Vaccine Immunogenic Response in Infants in Karachi, Pakistan
An observational study of Rotavirus, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Pakistan.
Trial summary
This is a nested case-control study within an ongoing rotavirus vaccine immunogenicity trial in 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. Read more about this study
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 6 weeks to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants living in a peri-urban slum outside of Karachi, Pakistan
Who may be able to join
- Infants already consented and enrolled in the overarching study: Immunogenicity of Rotavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast Feeding around the Time of Vaccination on the Immunogenicity or Rotarix Vaccine trial (NCT01199874)
- Overarching study (NCT01199874)inclusion criteria:
- 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
- written informed consent obtained from parents or guardians for overarching study Nested study additional inclusion criteria
- written informed consent obtained from parents or legal guardians for this nested study
- availability of a baseline, pre-vaccination fecal sample
Who cannot join
- Overarching study (NCT01199874)exclusion criteria
- 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 trials
Show all 9Show fewer
- birth weight less than 1500 grams; or if birthweight 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 IgA (> or= 20U/mL) at 6 weeks of age, indicative of rotavirus infection prior to vaccination
Trial locations and contacts
1 site in 1 country.
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 nested case-control study within an ongoing rotavirus vaccine immunogenicity trial in 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.
- Conditions
- Rotavirus
- Keywords
- rotavirus vaccine, human microbiome, fecal microbiome, vaccine immunogenicity, Rotarix, immune response, mucosal
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 |
|---|---|---|
| rotavirus (Rotarix TM) vaccination | Infants who received rotavirus vaccination (Rotarix TM) at 6 and 10 weeks, 10 and 14 weeks or 6,10, and 14 weeks. This is a nested study and infants received the vaccination in the overarching study: The Immunogenicity of ROtavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast Feeding around the Time of Vaccination on the Immunogenicity of Rotarix Vaccine (clinicaltrials.gov: NCT01199874) |
What is being measured
The primary outcome is the main question the study is designed to answer.
differences in fecal microbiota composition
The primary study objective is to see if there are significant differences in the fecal microbiota composition between rotavirus vaccine (Rotarix TM) immune responders (defined as anti-RV IgA antibodies at a concentration of > or = to 20 U/ml in a previously seronegative individual 4 weeks after the last Rotarix dose) and rotavirus vaccine immune non-responders (defined as anti-RV IgA antibodies at a concentration of <20 U/mL 4 weeks after the last Rotarix dose)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RotavirusStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University, Wageningen University, University of Padova, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Vanessa Harris, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Vanessa C Harris, MD, Principal investigator, Amsterdam Institute for Global Health and Development; Academic Medical Center, Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031743
- Sponsor's protocol ID
- AIGHD-CSP2013-001
- Status last verified
- Jan 2017
- First submitted
- 12 Jul 2016
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. 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
- NCT03031743
- Acronym / sponsor ID
- AIGHD-CSP2013-001
- Conditions
- Rotavirus
- Keywords
- rotavirus vaccine, human microbiome, fecal microbiome, vaccine immunogenicity, Rotarix, immune response, mucosal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Aga Khan University, Wageningen University, University of Padova, Centers for Disease Control and Prevention
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 26 Jan 2017 (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 nested case-control study within an ongoing rotavirus vaccine immunogenicity trial in 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
- 1
| Arm | Type | Receives |
|---|---|---|
| rotavirus (Rotarix TM) vaccination | – | –Infants who received rotavirus vaccination (Rotarix TM) at 6 and 10 weeks, 10 and 14 weeks or 6,10, and 14 weeks. This is a nested study and infants received the vaccination in the overarching study: The Immunogenicity of ROtavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast Feeding around the Time of Vaccination on the Immunogenicity of Rotarix Vaccine (clinicaltrials.gov: NCT01199874) |
Who may qualify
- Ages
- 6 weeks to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants living in a peri-urban slum outside of Karachi, Pakistan
Key inclusion criteria (7 listed)
- Infants already consented and enrolled in the overarching study: Immunogenicity of Rotavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast Feeding around the Time of Vaccination on the Immunogenicity or Rotarix Vaccine trial (NCT01199874)
- 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
- written informed consent obtained from parents or guardians for overarching study Nested study additional inclusion criteria
- written informed consent obtained from parents or legal guardians for this nested study
Key exclusion criteria (9 listed)
- Overarching study (NCT01199874)exclusion criteria
- 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
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
differences in fecal microbiota composition
Time frame: 2 years
The primary study objective is to see if there are significant differences in the fecal microbiota composition between rotavirus vaccine (Rotarix TM) immune responders (defined as anti-RV IgA antibodies at a concentration of > or = to 20 U/ml in a previously seronegative individual 4 weeks after the last Rotarix dose) and rotavirus vaccine immune non-responders (defined as anti-RV IgA antibodies at a concentration of <20 U/mL 4 weeks after the last Rotarix dose)
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 26 Jan 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.
Vanessa C Harris, MD principal investigator
Amsterdam Institute for Global Health and Development; Academic Medical Center, Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotavirus, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Pakistan.
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 7 inclusion and 9 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 26 Jan 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 Pakistan. 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. 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?
differences in fecal microbiota composition (time frame: 2 years). 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 26 Jan 2017.