A study on the maternal and infant factors determining the performance of Rotavirus vaccines in African, Indian and European infants.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2015/11/006354
• Date of registration: 13-11-2015
• Prospective Registration: Yes
• Primary sponsor: Christian Medical College
• Public title: A study on the maternal and infant factors determining the performance of Rotavirus vaccines in African, Indian and European infants.
• Scientific title: Impact of maternally derived antibodies and infant microbiota on the immunogenicity of rotavirus vaccines in African, Indian and European infants. - RoVI
• Date of first enrolment: 25-11-2015
• Target sample size: 385
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=12901
• Study type: Interventional
• Study design: Non-randomized, Active Controlled Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: Phase 4

Countries of recruitment

India, Malawi, United Kingdom

Contacts

• Name: Dr Gagandeep Kang MD
• Affiliation: Christian Medical College

• Name: Dr Gagandeep Kang MD
• Affiliation: Christian Medical College

Key inclusion & exclusion criteria

Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible to participate in the study:

a) Mothers willing to consent before the baby is born.

b) Babies born full-term with no evident congenital abnormalities or neonatal complications.

c) Families planning to administer rotavirus vaccine per IAP recommended schedule


Exclusion criteria: The subjects will be excluded from the study under the following circumstances:

a) Parent or guardian does not consent or is not available to give the consent.

b) Mother with a known prior diagnosis of congenital immune deficiency, chronic renal or liver failure or other chronic illness which may affect the immune response.

c) Residence outside Vellore.

Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: Injectable polio vaccine at 6 and 10 weeks of age: 90 children will receive injectable polio vaccine at 6 and 10 weeks, and oral polio vaccine at 14 weeks, in addition to the pentavalent vaccine at 6, 10 and 14 weeks and Rotarix vaccine at 6 and 10 weeks
Control Intervention1: Oral polio vaccine at 6 and 10 weeks of age: 165 children will receive oral polio vaccine and pentavalent vaccine at 6, 10 and 14 weeks and Rotarix vaccine at 6 and 10 weeks

Primary Outcome(s)

Anti-rotavirus IgA in infants given two doses of Rotavirus with either oral polio vaccine or injectable polio vaccineTimepoint: At 14 weeks of age

Secondary Outcome(s)

Gut inflammatory markers - Alpha-1 Anti-Trypsin (AAT) and Myeloperoxidase (MPO) in stool.Timepoint: 6 and 14 weeks

Rotavirus sheddingTimepoint: 1 week after each dose of vaccine

Systemic inflammatory marker - Serum/Plasma acid glycoproteinTimepoint: 6 and 14 weeks

Correlation of Rotavirus IgA in infants with maternal IgA and IgGTimepoint: 0 and 14 weeks

Microbiota composition and diversity in infants who seroconvert and those who do notTimepoint: 0 and 14 weeks

Secondary ID(s)

NIL

Source(s) of Monetary Support

Newton-Bhabha Fund: DBT/DFID/MRC Global Research Programme

Ethics review

Status: Approved
Approval date: 03/08/2015
Contact:

Christian Medical College Institutional Review Board