Early exposure of infants to natural rotavirus infection: a review of studies with human rotavirus vaccine RIX4414

BMC Pediatrics

Htay-Htay Han³  Suryakiran Pemmaraju Venkata²  Bernd Benninghoff⁶  Serge Debrus⁶  Carlos Rodrigo¹  Khalequ Zaman⁵  Nigel Cunliffe⁴ 

[1] Germans Trias i Pujol University Hospital, Universidad Autónoma de barcelona, Barcelona, Spain;GSK Pharmaceuticals Pvt Ltd., Bangalore, India;GlaxoSmithKline Vaccines, 2301 Renaissance Boulevard, King of Prussia 19406, PA, U.S.A;University of Liverpool, Liverpool, England;ICDDR,B, Dhaka, Bangladesh;GlaxoSmithKline Vaccines, Wavre, Belgium

关键词: Anti-rotavirus;    Gastroenteritis;    Early protection;    Rotavirus;   

Others  :  1090841
DOI  :  10.1186/s12887-014-0295-2

 received in 2014-05-05, accepted in 2014-11-11,  发布年份 2014

【 摘 要 】

Background

Rotaviruses are the leading cause of severe acute gastroenteritis in children aged <5 years worldwide. A live attenuated human rotavirus vaccine, RIX4414 has been developed to reduce the global disease burden associated with rotavirus gastroenteritis. Serum anti-rotavirus immunoglobulin A (IgA) antibody measured in unvaccinated infants during clinical trials of RIX4414 reflects natural rotavirus exposure, and may inform the optimal timing for rotavirus vaccination.

Methods

We reviewed phase II and III randomized, placebo-controlled clinical trials conducted by GlaxoSmithKline Vaccines, Wavre, Belgium between 2000 and 2008 which used the commercial formulation of RIX4414 lyophilized vaccine. We included trials for which demographic data and pre-dose-1 and post-last-dose anti-rotavirus IgA antibody status were available from placebo recipients.

Results

Sixteen clinical trials met the inclusion criteria. The studies were conducted across Africa (N = 3), Asia (N = 4), Latin America (N = 4), Europe (N = 4) and North America (N = 1). Overall, 46,398 infants were enrolled and among these, 20,099 received placebo. The mean age at pre-dose-1 time point ranged from 6.4 − 12.2 weeks while the mean age at post-last-dose time point ranged from 13.5 − 19.6 weeks. The anti-RV IgA seropositivity rates at both time points were higher in less developed countries of Africa, Asia and Latin America (pre-dose-1: 2.1%-26.3%; post-last-dose: 6.3%-34.8%) when compared to more developed countries of Asia, Europe and North America (pre-dose-1: 0%-9.4%; post-last-dose: 0%-21.3%), indicating that rotavirus infections occurred at a younger age in these regions.

Conclusion

Exposure to rotavirus infection occurred early in life among infants in most geographical settings, especially in developing countries. These data emphasize the importance of timely rotavirus vaccination within the Expanded Program on Immunization schedule to maximize protection.

【 授权许可】

   
2014 Cunliffe et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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