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Predictors of Poor Immune Response to Rotavirus Vaccine in Infants (PPIR)

This study has been completed.
Sponsor:
Collaborators:
Christian Medical College, Vellore, India
Norwegian Institute of Public Health
Information provided by (Responsible Party):
Society for Applied Studies
ClinicalTrials.gov Identifier:
NCT01700127
First received: September 28, 2012
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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®.


Condition Intervention
Innate Immune Response
Other: Breastfeeding

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Society for Applied Studies:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Enrollment: 400
Study Start Date: October 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Breastfeeding
Breastfeeding Encouraged
Other: Breastfeeding
breastfeeding encouraged versus withheld
Active Comparator: Breastfeeding Withheld
Breastfeeding Withheld
Other: Breastfeeding
breastfeeding encouraged versus withheld

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.

  Eligibility

Ages Eligible for Study:   6 Weeks to 7 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures
  2. Subjects aged 6 to 7 weeks at recruitment
  3. No plans to move in the next 4 months
  4. Weight for age not ≤ -3 SD of WHO child growth standards

Exclusion Criteria:

  1. Infant not breastfed
  2. Administration of rotavirus vaccine in the past
  3. Known immunodeficiency disease, including HIV infection in the subject or the mother
  4. Known chronic enteric disease
  5. Diarrhea on the day of enrollment (temporary exclusion)
  6. Any illness requiring hospitalization (temporary exclusion)
  7. Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems 'ill', investigators suspects neglect)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700127

Locations
India
Centre for Health Research and Development Society for Applied Studies
New Delhi, Delhi, India, 110016
Sponsors and Collaborators
Society for Applied Studies
Christian Medical College, Vellore, India
Norwegian Institute of Public Health
Investigators
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
  More Information

No publications provided by Society for Applied Studies

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Society for Applied Studies
ClinicalTrials.gov Identifier: NCT01700127     History of Changes
Other Study ID Numbers: SAS/RCN/201208
Study First Received: September 28, 2012
Last Updated: June 25, 2013
Health Authority: India: Institutional Review Board
Norway: Regional Ethics Commitee

Keywords provided by Society for Applied Studies:
immune response
infants
rotavirus vaccine

ClinicalTrials.gov processed this record on November 25, 2014