Treatment of enteric infections to improve response to oral poliovirus vaccine

Conditions

None listed

Ira Praharaj, Edward P K Parker, Sidhartha Giri, David J. Allen, Sophia Silas et al. (13 authors)

The Journal of Infectious Diseases2018-09-1951 citations

Changes in the intestinal microbiota following the administration of azithromycin in a randomised placebo-controlled trial among infants in south India.

Parker EPK, Praharaj I, John J, Kaliappan SP, Kampmann B, Kang G, Grassly NC.

2017-08-2361 citations

10.1038/s41598-017-06862-0

The effect of azithromycin on the immunogenicity of oral poliovirus vaccine: a double-blind randomised placebo-controlled trial in seronegative Indian infants.

Grassly NC, Praharaj I, Babji S, Kaliappan SP, Giri S, Venugopal S, Parker EP, Abraham A, Muliyil J, Doss S, Raman U, Liu J, Peter JV, Paranjape M, Jeyapaul S, Balakumar S, Ravikumar J, Srinivasan R, Bahl S, Iturriza-Gómara M, Uhlig HH, Houpt ER, John J, Kang G.

2016-05-0457 citations

10.1016/s1473-3099(16)30023-8

Interventions

Intervention1: Azithromycin: Administered at 10mg/kg/day for 3 days using an oral suspension containing 100mg of azithromycin per 5mL given two weeks prior to one dose of oral polio vaccine (mOPV3) Co

Eligibility

Inclusion criteria

Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for screening. • Infants 6-11 months old. • Live in area under surveillance. • Available for follow up for duration of study (approximately 35 days after enrolment). • Parents/guardians of infant are able to understand and follow screening procedures and agree to participate in the screening process by providing signed informed consent. In addition, subjects must meet the additional following inclusion criteria to be eligible to enrol in the randomized controlled trial. • No current medical condition as determined by medical doctor that precludes study involvement. • Parents/guardians of infant are able to understand and follow study procedures and agree to participate in the study by providing signed informed consent. • Do not have detectable serum NAb to serotype 3 poliovirus

Exclusion criteria

Exclusion criteria: • Infant or infantâ??s mother has syndromic or documented evidence of being immune-compromised. • Infant has history of chronic diarrhoea. • Infant is receiving immunosuppressant medication. • Infant has a history of allergic reaction to previous doses of OPV.

Design outcomes

Primary

Measure	Time frame
Serological response to mOPV3 (â??seroconversionâ??), defined as the detection of poliovirus 3 neutralization by the serum sample at a dilution of 1 in 4 or greater.Timepoint: 3 weeks after immunisation with mOPV3	—

Secondary

Measure	Time frame
Enteric pathogens detected in stool samples using a Taqman card-based RT-PCRTimepoint: Study days 0 and 14;Faecal and serum biomarkers of tropical enteropathy and intestinal inflammation in a subset of 300 infantsTimepoint: Study days 0 and 14;Geometric mean titers (GMTs) of poliovirus-specific serum neutralising antibodiesTimepoint: Study day 35;Poliovirus shedding quantified in stool samples using RT-PCR in a subset of 300 infantsTimepoint: Study days 21 and 35	—

Measure

Time frame

Enteric pathogens detected in stool samples using a Taqman card-based RT-PCRTimepoint: Study days 0 and 14;Faecal and serum biomarkers of tropical enteropathy and intestinal inflammation in a subset of 300 infantsTimepoint: Study days 0 and 14;Geometric mean titers (GMTs) of poliovirus-specific serum neutralising antibodiesTimepoint: Study day 35;Poliovirus shedding quantified in stool samples using RT-PCR in a subset of 300 infantsTimepoint: Study days 21 and 35

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Countries

India

Contacts

Public ContactGagandeep Kang

Christian Medical College

gkang@cmcvellore.ac.in04162282052

Outcome results