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@article{Grassly:2016:10.1016/S1473-3099(16)30023-8,
author = {Grassly, NC and Praharaj, I and Babji, S and Kaliappan, SP and Giri, S and Venugopal, S and Parker, EP and Abraham, A and Muliyil, J and Doss, S and Raman, U and Liu, J and Peter, JV and Paranjape, M and Jeyapaul, S and Balakumar, S and Ravikumar, J and Srinivasan, R and Bahl, S and Iturriza-Gómara, M and Uhlig, HH and Houpt, ER and John, J and Kang, G},
doi = {10.1016/S1473-3099(16)30023-8},
journal = {Lancet Infectious Diseases},
pages = {905--914},
title = {The effect of azithromycin on the immunogenicity of oral poliovirus vaccine: a double-blind randomised placebo-controlled trial in seronegative Indian infants},
url = {http://dx.doi.org/10.1016/S1473-3099(16)30023-8},
volume = {16},
year = {2016}
}

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TY  - JOUR
AB  - BACKGROUND: Oral poliovirus vaccine is less immunogenic and effective in low-income countries than in high-income countries, similarly to other oral vaccines. The high prevalence of intestinal pathogens and associated environmental enteropathy has been proposed to explain this problem. Because administration of an antibiotic has the potential to resolve environmental enteropathy and clear bacterial pathogens, we aimed to assess whether antibiotics would improve oral poliovirus vaccine immunogenicity. METHODS: We did a double-blind, randomised, placebo-controlled trial of the effect of azithromycin on the immunogenicity of serotype-3 monovalent oral poliovirus vaccine given to healthy infants living in 14 blocks of Vellore district, India. Infants were eligible to participate if they were 6-11 months old, available for the study duration, and lacked serum neutralising antibodies to serotype-3 poliovirus. Infants were randomly assigned (1:1) at enrolment to receive oral 10 mg/kg azithromycin or placebo once daily for 3 days, followed by serotype-3 monovalent oral poliovirus vaccine on day 14. The primary outcome was detection of serum neutralising antibodies to serotype-3 poliovirus at a dilution of one in eight or more on day 35 and was assessed in the per-protocol population (ie, all those who received azithromycin or placebo, oral poliovirus vaccine, and provided a blood sample according to the study protocol). Safety outcomes were assessed in all infants enrolled in the study. The trial is registered with the Clinical Trials Registry India, number CTRI/2014/05/004588. FINDINGS: Between Aug 5, 2014, and March 21, 2015, 754 infants were randomly assigned: 376 to receive azithromycin and 378 to placebo. Of these, 348 (93%) of 376 in the azithromycin group and 357 (94%) of 378 infants in the placebo group completed the study per protocol. In the azithromycin group, 175 (50%) seroconverted to serotype-3 poliovirus compared with 192 (54%) in the placebo group (risk rati
AU  - Grassly,NC
AU  - Praharaj,I
AU  - Babji,S
AU  - Kaliappan,SP
AU  - Giri,S
AU  - Venugopal,S
AU  - Parker,EP
AU  - Abraham,A
AU  - Muliyil,J
AU  - Doss,S
AU  - Raman,U
AU  - Liu,J
AU  - Peter,JV
AU  - Paranjape,M
AU  - Jeyapaul,S
AU  - Balakumar,S
AU  - Ravikumar,J
AU  - Srinivasan,R
AU  - Bahl,S
AU  - Iturriza-Gómara,M
AU  - Uhlig,HH
AU  - Houpt,ER
AU  - John,J
AU  - Kang,G
DO  - 10.1016/S1473-3099(16)30023-8
EP  - 914
PY  - 2016///
SN  - 1473-3099
SP  - 905
TI  - The effect of azithromycin on the immunogenicity of oral poliovirus vaccine: a double-blind randomised placebo-controlled trial in seronegative Indian infants
T2  - Lancet Infectious Diseases
UR  - http://dx.doi.org/10.1016/S1473-3099(16)30023-8
UR  - http://hdl.handle.net/10044/1/33473
VL  - 16
ER  -

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