Predictors of Poor Immune Response to Rotavirus Vaccine in Infants (PPIR)
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®.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Predictors of Poor Immune Response to Rotavirus Vaccine in Infants|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Concentration of anti-VP6 antibodies in subjects and maternal serum at baseline and in subjects 4 weeks after the second dose of Rotarix®. Geometric mean titers of anti-VP6 IgG antibodies in maternal serum at baseline [ Time Frame: upto 14-18 weeks of age ] [ Designated as safety issue: No ]
|Study Start Date:||October 2012|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
breastfeeding encouraged versus withheld
Active Comparator: Breastfeeding Withheld
breastfeeding encouraged versus withheld
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700127
|Centre for Health Research and Development Society for Applied Studies|
|New Delhi, Delhi, India, 110016|
|Principal Investigator:||Temsunaro R Chandola, MBBS MSc Epi||Research Scientist, SAS|
|Principal Investigator:||Nita Bhandari, MBBS, PhD||Joint Director, SAS|
|Principal Investigator:||Sunita Taneja, MBBS, PhD||Research Coordinator, SAS|
|Principal Investigator:||Gagandeep Kang, MD PhD FRCPath||Professor and Head,The Wellcome Trust Research Laboratory,Christian Medical College|
|Principal Investigator:||Tor A Strand, MD, PhD||Adjunct Professor, CIH|