Efficacy, Immunogenicity, and Safety of Two Doses of a Tetravalent Rotavirus Vaccine RRV-TV in Ghana With the First Dose Administered During the Neonatal Period. Armah, G. E, Kapikian, A. Z, Vesikari, T., Cunliffe, N., Jacobson, R. M, Burlington, D B., & Ruiz, J. The Journal of infectious diseases, 208(3):423–431, August, 2013. doi abstract bibtex Background. Oral rhesus/rhesus-human reassortant rotavirus tetravalent vaccine (RRV-TV) was licensed in 1998 but withdrawn in 1999 due to a rare association with intussusception, which occurred disproportionately in infants receiving their first dose at ≥90 days of age. This study examined RRV-TV for the prevention of rotavirus gastroenteritis (RV-GE) in Ghana, West Africa, with infants receiving the first dose during the neonatal period and the second before 60 days of age. Methods. In a double-blinded, randomized, placebo-controlled trial in Navrongo, Ghana, we recruited neonates to receive 2 doses of RRV-TV or placebo and followed them to age 12 months. Results. In the intention-to-treat population of 998 infants, we measured a vaccine efficacy of 63.1% against RV-GE of any severity associated with any of the 4 serotypes represented in the vaccine and 60.7% against RV-GE associated with any rotavirus serotype. Conclusions. RRV-TV in a 2-dose schedule with the first dose during the neonatal period is efficacious in preventing RV-GE in rural Ghana. Neonatal dosing results in early protection and may be the optimum schedule to avoid or significantly reduce intussusception, now reported to be associated in international settings with the 2 most widely marketed, licensed, live virus, oral rotavirus vaccines.
@article{armah_efficacy_2013,
title = {Efficacy, {Immunogenicity}, and {Safety} of {Two} {Doses} of a {Tetravalent} {Rotavirus} {Vaccine} {RRV}-{TV} in {Ghana} {With} the {First} {Dose} {Administered} {During} the {Neonatal} {Period}},
volume = {208},
issn = {1537-6613},
doi = {10.1093/infdis/jit174},
abstract = {Background. Oral rhesus/rhesus-human reassortant rotavirus tetravalent vaccine (RRV-TV) was licensed in 1998 but withdrawn in 1999 due to a rare association with intussusception, which occurred disproportionately in infants receiving their first dose at ≥90 days of age. This study examined RRV-TV for the prevention of rotavirus gastroenteritis (RV-GE) in Ghana, West Africa, with infants receiving the first dose during the neonatal period and the second before 60 days of age. Methods. In a double-blinded, randomized, placebo-controlled trial in Navrongo, Ghana, we recruited neonates to receive 2 doses of RRV-TV or placebo and followed them to age 12 months. Results. In the intention-to-treat population of 998 infants, we measured a vaccine efficacy of 63.1\% against RV-GE of any severity associated with any of the 4 serotypes represented in the vaccine and 60.7\% against RV-GE associated with any rotavirus serotype. Conclusions. RRV-TV in a 2-dose schedule with the first dose during the neonatal period is efficacious in preventing RV-GE in rural Ghana. Neonatal dosing results in early protection and may be the optimum schedule to avoid or significantly reduce intussusception, now reported to be associated in international settings with the 2 most widely marketed, licensed, live virus, oral rotavirus vaccines.},
language = {eng},
number = {3},
journal = {The Journal of infectious diseases},
author = {Armah, George E and Kapikian, Albert Z and Vesikari, Timo and Cunliffe, Nigel and Jacobson, Robert M and Burlington, D Bruce and Ruiz, Jr, Leonard P},
month = aug,
year = {2013},
pmid = {23599316},
pages = {423--431},
}
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{"_id":"5CFYke6Drc93hrjB4","bibbaseid":"armah-kapikian-vesikari-cunliffe-jacobson-burlington-ruiz-efficacyimmunogenicityandsafetyoftwodosesofatetravalentrotavirusvaccinerrvtvinghanawiththefirstdoseadministeredduringtheneonatalperiod-2013","author_short":["Armah, G. E","Kapikian, A. Z","Vesikari, T.","Cunliffe, N.","Jacobson, R. M","Burlington, D B.","Ruiz, J."],"bibdata":{"bibtype":"article","type":"article","title":"Efficacy, Immunogenicity, and Safety of Two Doses of a Tetravalent Rotavirus Vaccine RRV-TV in Ghana With the First Dose Administered During the Neonatal Period","volume":"208","issn":"1537-6613","doi":"10.1093/infdis/jit174","abstract":"Background. Oral rhesus/rhesus-human reassortant rotavirus tetravalent vaccine (RRV-TV) was licensed in 1998 but withdrawn in 1999 due to a rare association with intussusception, which occurred disproportionately in infants receiving their first dose at ≥90 days of age. This study examined RRV-TV for the prevention of rotavirus gastroenteritis (RV-GE) in Ghana, West Africa, with infants receiving the first dose during the neonatal period and the second before 60 days of age. Methods. In a double-blinded, randomized, placebo-controlled trial in Navrongo, Ghana, we recruited neonates to receive 2 doses of RRV-TV or placebo and followed them to age 12 months. Results. In the intention-to-treat population of 998 infants, we measured a vaccine efficacy of 63.1% against RV-GE of any severity associated with any of the 4 serotypes represented in the vaccine and 60.7% against RV-GE associated with any rotavirus serotype. Conclusions. RRV-TV in a 2-dose schedule with the first dose during the neonatal period is efficacious in preventing RV-GE in rural Ghana. Neonatal dosing results in early protection and may be the optimum schedule to avoid or significantly reduce intussusception, now reported to be associated in international settings with the 2 most widely marketed, licensed, live virus, oral rotavirus vaccines.","language":"eng","number":"3","journal":"The Journal of infectious diseases","author":[{"propositions":[],"lastnames":["Armah"],"firstnames":["George","E"],"suffixes":[]},{"propositions":[],"lastnames":["Kapikian"],"firstnames":["Albert","Z"],"suffixes":[]},{"propositions":[],"lastnames":["Vesikari"],"firstnames":["Timo"],"suffixes":[]},{"propositions":[],"lastnames":["Cunliffe"],"firstnames":["Nigel"],"suffixes":[]},{"propositions":[],"lastnames":["Jacobson"],"firstnames":["Robert","M"],"suffixes":[]},{"propositions":[],"lastnames":["Burlington"],"firstnames":["D","Bruce"],"suffixes":[]},{"propositions":[],"lastnames":["Ruiz"],"firstnames":["Jr"],"suffixes":["Leonard","P"]}],"month":"August","year":"2013","pmid":"23599316","pages":"423–431","bibtex":"@article{armah_efficacy_2013,\n\ttitle = {Efficacy, {Immunogenicity}, and {Safety} of {Two} {Doses} of a {Tetravalent} {Rotavirus} {Vaccine} {RRV}-{TV} in {Ghana} {With} the {First} {Dose} {Administered} {During} the {Neonatal} {Period}},\n\tvolume = {208},\n\tissn = {1537-6613},\n\tdoi = {10.1093/infdis/jit174},\n\tabstract = {Background. Oral rhesus/rhesus-human reassortant rotavirus tetravalent vaccine (RRV-TV) was licensed in 1998 but withdrawn in 1999 due to a rare association with intussusception, which occurred disproportionately in infants receiving their first dose at ≥90 days of age. This study examined RRV-TV for the prevention of rotavirus gastroenteritis (RV-GE) in Ghana, West Africa, with infants receiving the first dose during the neonatal period and the second before 60 days of age. Methods. In a double-blinded, randomized, placebo-controlled trial in Navrongo, Ghana, we recruited neonates to receive 2 doses of RRV-TV or placebo and followed them to age 12 months. Results. In the intention-to-treat population of 998 infants, we measured a vaccine efficacy of 63.1\\% against RV-GE of any severity associated with any of the 4 serotypes represented in the vaccine and 60.7\\% against RV-GE associated with any rotavirus serotype. Conclusions. RRV-TV in a 2-dose schedule with the first dose during the neonatal period is efficacious in preventing RV-GE in rural Ghana. Neonatal dosing results in early protection and may be the optimum schedule to avoid or significantly reduce intussusception, now reported to be associated in international settings with the 2 most widely marketed, licensed, live virus, oral rotavirus vaccines.},\n\tlanguage = {eng},\n\tnumber = {3},\n\tjournal = {The Journal of infectious diseases},\n\tauthor = {Armah, George E and Kapikian, Albert Z and Vesikari, Timo and Cunliffe, Nigel and Jacobson, Robert M and Burlington, D Bruce and Ruiz, Jr, Leonard P},\n\tmonth = aug,\n\tyear = {2013},\n\tpmid = {23599316},\n\tpages = {423--431},\n}\n\n","author_short":["Armah, G. E","Kapikian, A. Z","Vesikari, T.","Cunliffe, N.","Jacobson, R. M","Burlington, D B.","Ruiz, J."],"key":"armah_efficacy_2013","id":"armah_efficacy_2013","bibbaseid":"armah-kapikian-vesikari-cunliffe-jacobson-burlington-ruiz-efficacyimmunogenicityandsafetyoftwodosesofatetravalentrotavirusvaccinerrvtvinghanawiththefirstdoseadministeredduringtheneonatalperiod-2013","role":"author","urls":{},"metadata":{"authorlinks":{}},"html":""},"bibtype":"article","biburl":"https://bibbase.org/zotero/robin.marlow","dataSources":["ix72eqAAMGCuupBaz"],"keywords":[],"search_terms":["efficacy","immunogenicity","safety","two","doses","tetravalent","rotavirus","vaccine","rrv","ghana","first","dose","administered","during","neonatal","period","armah","kapikian","vesikari","cunliffe","jacobson","burlington","ruiz"],"title":"Efficacy, Immunogenicity, and Safety of Two Doses of a Tetravalent Rotavirus Vaccine RRV-TV in Ghana With the First Dose Administered During the Neonatal Period","year":2013}