Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules

Libster, Romina; McNeal, Monica; Walter, Emmanuel B.; Shane, Andi L.; Winokur, Patricia L.; Cress, Gretchen A.; Berry, Andrea A.; Kotloff, Karen L.; Sarpong, Kwabena; Turley, Christine B.; Harrison, Christopher J.; Pahud, Barbara; Marbin, Jyothi; Dunn, John; El-Khorazaty, Jill; Barrett, Jill; Edwards, Kathryn M.

doi:10.1542/peds.2015-2603

Cited by 29 publications

(18 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…This testing was performed at the Laboratory for Specialized Clinical Studies, Cincinnati Children's Hospital Medical Centre (CCHMC), Cincinnati, Ohio, USA. Both laboratories used an assay developed in conformance with the WHO Manual of Rotavirus Detection and Characterization Methods [10] , [11] , [12] , [13] . The assays had acceptable accuracy, precision, and linearity at both testing laboratories, with a standard curve modelled using a 4-parameter logistic fit regression function.…”

Section: Discussionmentioning

confidence: 99%

“…While we were able to confirm the immunogenicity of ROTARIX, we avoided making comparisons between ROTARIX and ROTAVAC. A comparison of the immune responses for ROTAVAC vaccines using ELISA with WC3 assay and ROTARIX using ELISA with 89–12 strain was also not conducted as it is well known that ELISAs using homologous strains show higher titres when compared with titre from ELISA using heterologous strain and WC3, considered heterologous strain for 116E strain in rotavirus vaccine was expected to show lower titres [10] , [16] .…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Immunogenicity and safety of two monovalent rotavirus vaccines, ROTAVAC® and ROTAVAC 5D® in Zambian infants

Chilengi

Mwila-Kazimbaya

Chirwa

et al. 2021

Vaccine

View full text Add to dashboard Cite

Background and Aims ROTAVAC® (frozen formulation stored at −20 °C) and ROTAVAC 5D® (liquid formulation stable at 2–8 °C) are rotavirus vaccines derived from the 116E human neonatal rotavirus strain, developed and licensed in India. This study evaluated and compared the safety and immunogenicity of these vaccines in an infant population in Zambia. Methods We conducted a phase 2b, open-label, randomized, controlled trial wherein 450 infants 6 to 8 weeks of age were randomized equally to receive three doses of ROTAVAC or ROTAVAC 5D, or two doses of ROTARIX®. Study vaccines were administered concomitantly with routine immunizations. Blood samples were collected pre-vaccination and 28 days after the last dose. Serum anti-rotavirus IgA antibodies were measured by ELISA, with WC3 and 89–12 rotavirus strains as viral lysates in the assays. The primary analysis was to assess non-inferiority of ROTAVAC 5D to ROTAVAC in terms of the geometric mean concentration (GMC) of serum IgA (WC3) antibodies. Seroresponse and seropositivity were also determined. Safety was evaluated as occurrence of immediate, solicited, unsolicited, and serious adverse events after each dose. Results The study evaluated 388 infants in the per-protocol population. All three vaccines were well tolerated and immunogenic. The post-vaccination GMCs were 14.0 U/mL (95% CI: 10.4, 18.8) and 18.1 U/mL (95% CI: 13.7, 24.0) for the ROTAVAC and ROTAVAC 5D groups, respectively, yielding a ratio of 1.3 (95% CI: 0.9, 1.9), thus meeting the pre-set non-inferiority criteria. Solicited and unsolicited adverse events were similar across all study arms. No death or intussusception case was reported during study period. Conclusions Among Zambian infants, both ROTAVAC and ROTAVAC 5D were well tolerated and the immunogenicity of ROTAVAC 5D was non-inferior to that of ROTAVAC. These results are consistent with those observed in licensure trials in India and support use of these vaccines across wider geographical areas.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Immunogenicity and safety of two monovalent rotavirus vaccines, ROTAVAC® and ROTAVAC 5D® in Zambian infants

Chilengi

Mwila-Kazimbaya

Chirwa

et al. 2021

Vaccine

View full text Add to dashboard Cite

show abstract

“…Current rotavirus vaccines approved by the Food and Drug Administration are RotaTeq ® a pentavalent rotavirus vaccine (RV5) and Rotarix ® (RV1) 7 and both are considered safe and well tolerated and the results of some published studies confirm the high efficacy of both vaccines against severe diarrhoea caused by rotavirus. [8][9][10] However, there is one consideration with oral rotavirus vaccines, as there is a lack of information regarding the absence of evidence of their potential increased risk of a rare but serious cause of bowel obstruction, as a result of an intussusception, in which one portion of the intestine invaginates into another portion.…”

Section: Introductionmentioning

confidence: 99%

Seguridad de la vacuna pentavalente contra el rotavirus en México durante 2011-2017: Informes de vigilancia

Santibañez-Copado¹,

Gómez-Altamirano²,

Romero-Feregrino³

et al. 2020

Revista Latinoamericana De Infectología Pediátrica

View full text Add to dashboard Cite

Las enfermedades diarreicas por rotavirus en niños menores de un año representan una de las principales causas de atención médica. Las vacunas contra el rotavirus han demostrado un impacto en la reducción de la morbilidad y mortalidad por diarrea en todo el mundo. Por ello, la Organización Mundial de la Salud (OMS) las recomienda dentro de los programas nacionales de inmunización. En la actualidad, en México, se utiliza la vacuna pentavalente contra rotavirus en niños menores de ocho meses de edad. Como parte del programa de vigilancia, el monitoreo de eventos adversos ha mejorado en los últimos años, con especial interés en la identificación de la invaginación intestinal. El objetivo del estudio fue identificar y determinar la causalidad de eventos adversos dados por la vacuna pentavalente para rotavirus considerando las notificaciones realizadas en el sistema de vigilancia nacional. Para ello, se llevó a cabo un estudio observacional, descriptivo y retrospectivo para la evaluación de las notificaciones de eventos adversos relacionados a la vacunación (VR5) durante el periodo 2011-2017 en México. Durante el periodo de seguimiento se aplicaron 20,852,313 dosis de vacunas pentavalentes contra rotavirus. Se reportó invaginación intestinal con una tasa de 0.93 por cada 100,000 dosis aplicadas. La vacuna pentavalente contra rotavirus se demostró que es segura en México.

show abstract

“…(3,4) Penggunaan vaksin heterolog telah dilakukan sebelumnya pada beberapa vaksin, seperti vaksin Ebola dan rotavirus, bahkan konsep vaksin heterolog vaksin rotavirus sudah dimulai sejak tahun 2006 di Amerika Serikat. (5) Terdapat dua macam vaksin rotavirus yaitu RotaTeq yang memerlukan tiga dosis dan Roratix yang memerlukan dua dosis pemberian. Kedua vaksin terbukti memiliki efikasi yang tinggi dan aman dalam penggunaannya, karena hanya sedikit sekali kasus intususepsi yang dilaporkan dibandingkan vaksin rotavirus sebelumnya, tetapi pada pelaksanaannya kadang sulit mendapatkan vaksin yang sejenis.…”

unclassified

“…Kedua vaksin terbukti memiliki efikasi yang tinggi dan aman dalam penggunaannya, karena hanya sedikit sekali kasus intususepsi yang dilaporkan dibandingkan vaksin rotavirus sebelumnya, tetapi pada pelaksanaannya kadang sulit mendapatkan vaksin yang sejenis. (5) Penelitian sebelumnya mengadakan uji acak terkontrol yang meneliti penggunaan vaksinasi rotavirus homolog dan heterolog. Penelitian tersebut menggunakan Roratix (RV1) dan RotaTeq (RV5) pada 1.393 bayi berusia 6-14 minggu.…”

unclassified

Strategi mix-and-match vaksin COVID-19, seberapa efektifkah?

Khairani

2021

J Biomedika Kesehat

View full text Add to dashboard Cite

Dibandingkan dengan perkembangan vaksin COVID-19, kemunculan banyak varian baru menyebabkan peningkatan mortalitas dan morbiditas, distribusi vaksin secara global, ketersediaan suplai vaksin yang terbatas dan kejadian ikutan pasca imunisasi. Hal ini memunculkan kekhawatiran penurunan efektivitas vaksin yang telah ada. Setelah laporan kejadian tromboemboli akibat penggunaan ChAdOx1-nCoV-19 dari AstraZeneca, beberapa negara Eropa mulai meneliti tentang penggunaan vaksin yang berbeda dengan dosis pertama atau yang disebut strategi mix-and-match atau vaksin heterolog.(1) Vaksin heterolog melibatkan pemberian antigen penyakit yang sama atau serupa melalui dua tipe vaksin berbeda, dosis pertama untuk membentuk sistem imun dan dosis berikutnya dengan tipe berbeda untuk meningkatkan respon imun.(2) Beberapa jenis vaksin yang banyak diteliti dalam konsep vaksin heterolog ini diantaranya kombinasi vaksin chimpanzee adenovirus-vectored vaccine (ChAdOx 1 nCoV-19) atau AstraZeneca dengan vaksin mRNA-1273 atau vaksin Moderna, dan vaksin BNT162b2 atau vaksin Pfizer.(3,4)

show abstract

Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules

Cited by 29 publications

References 21 publications

Immunogenicity and safety of two monovalent rotavirus vaccines, ROTAVAC® and ROTAVAC 5D® in Zambian infants

Immunogenicity and safety of two monovalent rotavirus vaccines, ROTAVAC® and ROTAVAC 5D® in Zambian infants

Seguridad de la vacuna pentavalente contra el rotavirus en México durante 2011-2017: Informes de vigilancia

Strategi mix-and-match vaksin COVID-19, seberapa efektifkah?

Contact Info

Product

Resources

About