Innate Immune ResponsePPIRNCT01700127
Predictors of Poor Immune Response to Rotavirus Vaccine in Infants
A study testing Breastfeeding in people with Innate Immune Response, run by Society for Applied Studies at 1 site in India.
Trial summary
This will be a randomized study with the primary objective of assessing the impact of withholding versus encouraging breastfeeding on the immunogenicity of Rotarix® in infants. Enrolled subjects will all be administered Rotarix®, at ages 6 to 7 weeks, and at10 -14 weeks. Read more about this study
- Who is it for?
- Ages 6 to 7 weeksHealthy volunteers can take part
- Conditions the study is for
- Innate Immune Response
- What is being tested?
- Breastfeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2012to May 2013
- 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 6 to 7 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures
- Subjects aged 6 to 7 weeks at recruitment
- No plans to move in the next 4 months
- Weight for age not ≤ -3 SD of WHO child growth standards
Who cannot join
- Infant not breastfed
- Administration of rotavirus vaccine in the past
- Known immunodeficiency disease, including HIV infection in the subject or the mother
- Known chronic enteric disease
- Diarrhea on the day of enrollment (temporary exclusion)
- Any illness requiring hospitalization (temporary exclusion)
- Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems 'ill', investigators suspects neglect)
Trial locations and contacts
1 site in 1 country.
India1 site
Centre for Health Research and Development Society for Applied Studies
New Delhi, National Capital Territory of Delhi, 110016
About this study
This will be a randomized study with the primary objective of assessing the impact of withholding versus encouraging breastfeeding on the immunogenicity of Rotarix® in infants.
Enrolled subjects will all be administered Rotarix®, at ages 6 to 7 weeks, and at10 -14 weeks. The subjects will be randomized into one of the two study arms. In one of the group caregivers will be advised to breastfeed immediately prior to and after each dose of the vaccine while in the other group caregivers will be advised to withhold breastfeeding for 30 minutes before and after each dose of the vaccine. The other childhood vaccines i.e. OPV and Pentavalent will be administered at least 30 minutes after administration of Rotarix®, The enrolled subjects will be followed up for 4 weeks after the 2nd dose of Rotarix®.
Read the detailed description
Infants ≤7 weeks and pregnant women will be identified through a household survey.Families of infants aged 6-7 weeks will be called to the study clinic for consenting, screening and enrollment.All enrolled subjects will be administered 2 doses of Rotarix® at 6 to 7 weeks and at 10-14 weeks of age. Other childhood vaccines will also be offered.
At enrollment, a blood specimen and breast milk specimen will be obtained from the mother and a blood, salivary and stool specimens will be obtained from the subject before administering the Rotarix® vaccine.
At the time of the 2nd administration, a breast milk specimen will be obtained from the mother and a salivary specimen will be obtained from the subject before administering the Rotarix® vaccine. At 28 days (±) 5 after the 2nd dose of Rotarix® vaccine, a blood, salivary and stool specimen will be obtained from the subject.
Whenever the family comes to the study clinic at 6-7 weeks, consent will be administered and a clinical examination conducted.If the family is willing for the mother and the child to be part of the study and the child meets the eligibility criteria, the child will be enrolled.
Depending on the group allocation the mothers will be advised to withhold or encourage breastfeeding for 30 minutes before and after receipt of Rotarix®.
subjects will be observed for 30 minutes after receipt of the vaccines to assess for immediate adverse events.
All minor illnesses that do not require hospital referral will be managed by the study physician using current practices.
All hospitalizations and deaths will be reported and reviewed by an Independent Safety Monitor.
- Conditions
- Innate Immune Response
- Being tested
- Breastfeeding
- Keywords
- immune response, infants, rotavirus vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreastfeedingOther
breastfeeding encouraged versus withheld
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding | Other | Breastfeeding Encouraged Receives: Other: Breastfeeding |
| Breastfeeding Withheld | Active comparator | Breastfeeding Withheld Receives: Other: Breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who seroconvert as measured by a 4-fold rise in serum anti-VP6 IgA antibodies between baseline and 4 weeks after the second dose of Rotarix®.
Measured: 14-18 weeks of age
Secondary outcomes (1)
Concentration of anti-VP6 antibodies in saliva of subjects before the first and second dose of Rotarix®. Proportion of subjects with enteric pathogens detected in stools. Vitamin D status of subjects enrolled in the study.
Measured: 14-18 weeks of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Innate Immune ResponseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Society for Applied Studies
- Sponsor type
- University, hospital or other
- Collaborators
- Christian Medical College, Vellore, India, Norwegian Institute of Public Health
- Responsible party
- Sponsor
- Investigators
- Temsunaro R Chandola, MBBS MSc Epi, Principal investigator, Research Scientist, SASNita Bhandari, MBBS, PhD, Principal investigator, Joint Director, SASSunita Taneja, MBBS, PhD, Principal investigator, Research Coordinator, SASGagandeep Kang, MD PhD FRCPath, Principal investigator, Professor and Head,The Wellcome Trust Research Laboratory,Christian Medical CollegeTor A Strand, MD, PhD, Principal investigator, Adjunct Professor, CIH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700127
- Sponsor's protocol ID
- SAS/RCN/201208
- Acronym
- PPIR
- Status last verified
- Jun 2013
- First submitted
- 28 Sep 2012
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Rongsen-Chandola T, Strand TA, Goyal N, Flem E, Rathore SS, Arya A, Winje BA, Lazarus R, Shanmugasundaram E, Babji S, Sommerfelt H, Vainio K, Kang G, Bhandari N. Effect of withholding breastfeeding on the immune response to a live oral rotavirus vaccine in North Indian infants. Vaccine. 2014 Aug 11;32 Suppl 1:A134-9. doi: 10.1016/j.vaccine.2014.04.078.
PubMed 25091668Rongsen-Chandola T, Winje BA, Goyal N, Rathore SS, Mahesh M, Ranjan R, Arya A, Rafiqi FA, Bhandari N, Strand TA. Compliance of mothers following recommendations to breastfeed or withhold breast milk during rotavirus vaccination in North India: a randomized clinical trial. Trials. 2014 Jun 28;15:256. doi: 10.1186/1745-6215-15-256.
PubMed 24976452
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Poor Immune Response to Rotavirus Vaccine in Infants
- ClinicalTrials.gov ID
- NCT01700127
- Acronym / sponsor ID
- PPIR / SAS/RCN/201208
- Conditions
- Innate Immune Response
- Keywords
- immune response, infants, rotavirus vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Society for Applied StudiesUniversity, hospital or other
- Collaborators
- Christian Medical College, Vellore, India, Norwegian Institute of Public Health
- Study start
- Oct 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 4 Oct 2012 (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 will be a randomized study with the primary objective of assessing the impact of withholding versus encouraging breastfeeding on the immunogenicity of Rotarix® in infants.
Enrolled subjects will all be administered Rotarix®, at ages 6 to 7 weeks, and at10 -14 weeks. The subjects will be randomized into one of the two study arms. In one of the group caregivers will be advised to breastfeed immediately prior to and after each dose of the vaccine while in the other group caregivers will be advised to withhold breastfeeding for 30 minutes before and after each dose of the vaccine. The other childhood vaccines i.e. OPV and Pentavalent will be administered at least 30 minutes after administration of Rotarix®, The enrolled subjects will be followed up for 4 weeks after the 2nd dose of Rotarix®.
Detailed description
Infants ≤7 weeks and pregnant women will be identified through a household survey.Families of infants aged 6-7 weeks will be called to the study clinic for consenting, screening and enrollment.All enrolled subjects will be administered 2 doses of Rotarix® at 6 to 7 weeks and at 10-14 weeks of age. Other childhood vaccines will also be offered.
At enrollment, a blood specimen and breast milk specimen will be obtained from the mother and a blood, salivary and stool specimens will be obtained from the subject before administering the Rotarix® vaccine.
At the time of the 2nd administration, a breast milk specimen will be obtained from the mother and a salivary specimen will be obtained from the subject before administering the Rotarix® vaccine. At 28 days (±) 5 after the 2nd dose of Rotarix® vaccine, a blood, salivary and stool specimen will be obtained from the subject.
Whenever the family comes to the study clinic at 6-7 weeks, consent will be administered and a clinical examination conducted.If the family is willing for the mother and the child to be part of the study and the child meets the eligibility criteria, the child will be enrolled.
Depending on the group allocation the mothers will be advised to withhold or encourage breastfeeding for 30 minutes before and after receipt of Rotarix®.
subjects will be observed for 30 minutes after receipt of the vaccines to assess for immediate adverse events.
All minor illnesses that do not require hospital referral will be managed by the study physician using current practices.
All hospitalizations and deaths will be reported and reviewed by an Independent Safety Monitor.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding | Other | Other: BreastfeedingBreastfeeding Encouraged |
| Breastfeeding Withheld | Active comparator | Other: BreastfeedingBreastfeeding Withheld |
Who may qualify
- Ages
- 6 to 7 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures
- Subjects aged 6 to 7 weeks at recruitment
- No plans to move in the next 4 months
- Weight for age not ≤ -3 SD of WHO child growth standards
Key exclusion criteria (7 listed)
- Infant not breastfed
- Administration of rotavirus vaccine in the past
- Known immunodeficiency disease, including HIV infection in the subject or the mother
- Known chronic enteric disease
- Diarrhea on the day of enrollment (temporary exclusion)
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 |
|---|---|---|
| Breastfeedingbreastfeeding encouraged versus withheld | Other | Breastfeeding, Breastfeeding Withheld |
Primary outcome
Proportion of subjects who seroconvert as measured by a 4-fold rise in serum anti-VP6 IgA antibodies between baseline and 4 weeks after the second dose of Rotarix®.
Time frame: 14-18 weeks of age
1 secondary outcome
Concentration of anti-VP6 antibodies in saliva of subjects before the first and second dose of Rotarix®. Proportion of subjects with enteric pathogens detected in stools. Vitamin D status of subjects enrolled in the study.
Time frame: 14-18 weeks of age
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 Jun 2013.
- Derived from this study: PubMed 25091668Rongsen-Chandola T, Strand TA, Goyal N, Flem E, Rathore SS, Arya A, Winje BA, Lazarus R, Shanmugasundaram E, Babji S, Sommerfelt H, Vainio K, Kang G, Bhandari N. Effect of withholding breastfeeding on the immune response to a live oral rotavirus vaccine in North Indian infants. Vaccine. 2014 Aug 11;32 Suppl 1:A134-9. doi: 10.1016/j.vaccine.2014.04.078.
- Derived from this study: PubMed 24976452Rongsen-Chandola T, Winje BA, Goyal N, Rathore SS, Mahesh M, Ranjan R, Arya A, Rafiqi FA, Bhandari N, Strand TA. Compliance of mothers following recommendations to breastfeed or withhold breast milk during rotavirus vaccination in North India: a randomized clinical trial. Trials. 2014 Jun 28;15:256. doi: 10.1186/1745-6215-15-256.
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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.
Temsunaro R Chandola, MBBS MSc Epi principal investigator
Research Scientist, SAS
Nita Bhandari, MBBS, PhD principal investigator
Joint Director, SAS
Sunita Taneja, MBBS, PhD principal investigator
Research Coordinator, SAS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding in people with Innate Immune Response, run by Society for Applied Studies at 1 site in India.
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 7 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 Jun 2013. 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 India. 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?
Proportion of subjects who seroconvert as measured by a 4-fold rise in serum anti-VP6 IgA antibodies between baseline and 4 weeks after the second dose of Rotarix®. (time frame: 14-18 weeks of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01700127, which also lists 2 linked publications.
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 Jun 2013.