Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial

Armah, George; Sow, Samba O.; Breiman, Robert F.; Dallas, Michael J.; Tapia, Milagritos D.; Feikin, Daniel R.; Binka, Fred; Steele, A. Duncan; Laserson, Kayla F.; Ansah, Nana Akosua; Levine, Myron M.; Lewis, Kristen; Coia, Michele L; Attah-Poku, Margaret; Ojwando, Joel; Rivers, Stephen B.; Victor, John C.; Nyambane, Geoffrey; Hodgson, Abraham; Schödel, Florian; Ciarlet, Max; Neuzil, Kathleen M.

doi:10.1016/s0140-6736(10)60889-6

Cited by 638 publications

(497 citation statements)

References 31 publications

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“…[18][19][20][21][22][23][24] In contrast, studies conducted in low-income countries in Africa and Asia revealed that the efficacy of the 2 vaccines ranged from 56% to 64% in protecting against severe rotavirus gastroenteritis. [25][26][27][28][29][30] In addition, in these settings vaccine efficacy waned between the first and second years after immunisation. [25][26][27][28][29][30] These findings are supported by a recent Cochrane systematic review which revealed that RV1 and RV5 demonstrated diminished efficacy against severe rotavirus gastroenteritis in WHO subregions classified as having "high" rates of childhood mortality and "high" or "very high" rates of adult mortality, compared with subregions with "very low" or "low" rates of child and adult mortality.…”

Section: Introductionmentioning

confidence: 99%

“…[25][26][27][28][29][30] In addition, in these settings vaccine efficacy waned between the first and second years after immunisation. [25][26][27][28][29][30] These findings are supported by a recent Cochrane systematic review which revealed that RV1 and RV5 demonstrated diminished efficacy against severe rotavirus gastroenteritis in WHO subregions classified as having "high" rates of childhood mortality and "high" or "very high" rates of adult mortality, compared with subregions with "very low" or "low" rates of child and adult mortality. This reduced vaccine efficacy persisted after 1 to 2 y of follow-up.…”

Section: Introductionmentioning

confidence: 99%

“…[25][26][27][28][29] The efficacy of RV5 against severe rotavirus gastroenteritis in African infants in their first year of life was 64% (95% CI 40-79), with the vaccine also reducing rotavirus gastroenteritis of any severity by 31% (95% CI 17-42). 25 Results from the Asian infants were comparable, with RV5 reducing severe rotavirus gastroenteritis by 48% (95% CI 22-66) over the complete study period. 27 Point estimates of vaccine efficacy reduced between the first and second year of life, from 51% (95% CI to 46% (95% CI 1-71).…”

Section: Introductionmentioning

confidence: 99%

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Options for improving effectiveness of rotavirus vaccines in developing countries

Tissera

Cowley

Bogdanovic-Sakran

et al. 2017

Human Vaccines & Immunotherapeutics

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Rotavirus gastroenteritis is a leading global cause of mortality and morbidity in young children due to diarrhea and dehydration. Over 85% of deaths occur in developing countries. In industrialised countries, 2 live oral rotavirus vaccines licensed in 2006 quickly demonstrated high effectiveness, dramatically reducing severe rotavirus gastroenteritis admissions in many settings by more than 90%. In contrast, the same vaccines reduced severe rotavirus gastroenteritis by only 30-60% in developing countries, but have been proven life-saving. Bridging this "efficacy gap" offers the possibility to save many more lives of children under the age of 5. The reduced efficacy of rotavirus vaccines in developing settings may be related to differences in transmission dynamics, as well as host luminal, mucosal and immune factors. This review will examine strategies currently under study to target the issue of reduced efficacy and effectiveness of oral rotavirus vaccines in developing settings.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Options for improving effectiveness of rotavirus vaccines in developing countries

Tissera

Cowley

Bogdanovic-Sakran

et al. 2017

Human Vaccines & Immunotherapeutics

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“…Whereas clinical trials of these vaccines demonstrated high efficacy against severe rotavirus gastroenteritis in high-and middle-income countries in the Americas and Europe (85%-98%), trials in low-and middle-income countries in Africa and Asia have demonstrated lower efficacy (61%-64% and 48%, respectively) [6][7][8][9][10]. Despite lower efficacy in lowresource settings, the benefits of vaccination could be substantial in countries with a high baseline burden of severe rotavirus disease.…”

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confidence: 99%

Impact of Rotavirus Vaccination on Hospitalizations and Deaths From Childhood Gastroenteritis in Botswana

et al. 2016

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Background. A monovalent human rotavirus vaccine (RV1) was introduced in Botswana in July 2012. We assessed the impact of RV1 vaccination on childhood gastroenteritis-related hospitalizations and deaths in 2013 and 2014.Methods. We obtained data from registers of 4 hospitals in Botswana on hospitalizations and deaths from gastroenteritis, regardless of cause, among children <5 years of age. Gastroenteritis hospitalizations and deaths during the prevaccine period (January 2009-December 2012) were compared to the postvaccine period (January 2013-December 2014). Vaccine coverage was estimated from data collected through a concurrent vaccine effectiveness study at the same hospitals.Results. By December 2014, coverage with ≥1 dose of RV1 was an estimated 90% among infants <1 year of age and 76% among children 12-23 months of age. In the prevaccine period, the annual median number of gastroenteritis-related hospitalizations in children <5 years of age was 1212, and of gastroenteritis-related deaths in children <2 years of age was 77. In the postvaccine period, gastroenteritis-related hospitalizations decreased by 23% (95% confidence interval [CI], 16%-29%) to 937, and gastroenteritis-related deaths decreased by 22% (95% CI, −9% to 44%) to 60. Declines were most prominent during the rotavirus season (May-October) and among infants <1 year of age, with reductions of 43% (95% CI, 34%-51%) in gastroenteritis hospitalizations and 48% (95% CI, 11%-69%) in gastroenteritis deaths.Conclusions. Following introduction of RV1 into the national immunization program, significant declines in hospitalizations and deaths from gastroenteritis were observed among children in Botswana, suggestive of the beneficial public health impact of rotavirus vaccination.

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“…5 These 2 vaccines have been shown to be safe and efficacious in both developed and some developing countries. [6][7][8] However, the immunogenicity and efficacy of these vaccines are substantially reduced in low-income countries of Africa, Asia and Central America, [9][10][11] where the high mortality due to rotavirus infections occurs. 12,13 In addition, formation of reassortant rotaviruses between vaccine strains and circulating wild-type strains or among vaccine strains can potentially increase virulence as reported recently.…”

Section: Introductionmentioning

confidence: 99%

Tandem truncated rotavirus VP8* subunit protein with T cell epitope as non-replicating parenteral vaccine is highly immunogenic

Wen

Cao

Jones

et al. 2015

Human Vaccines & Immunotherapeutics

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The two currently available live oral rotavirus vaccines, Rotarix Ò and RotaTeq Ò , are highly efficacious in the developed countries. However, the efficacy of such vaccines in resource deprived countries in Africa and Southeast Asia is low. We reported previously that a bacterially-expressed rotavirus P2-P[8] DVP8* subunit vaccine candidate administered intramuscularly elicited high-titers of neutralizing antibodies in guinea pigs and mice and significantly shortened the duration of diarrhea in neonatal gnotobiotic pigs upon oral challenge with virulent human rotavirus Wa strain. To further improve its vaccine potential and provide wider coverage against rotavirus strains of global and regional epidemiologic importance, we constructed 2 tandem recombinant VP8* proteins, P2-P[8] DVP8*-P[8] DVP8* and P2-P[8] DVP8*-P[6] DVP8* based on Escherichia coli expression system. The two resulting recombinant tandem proteins were highly soluble and P2-P[8] DVP8*-P[8] DVP8* was generated with high yield. Moreover, guinea pigs immunized intramuscularly by 3 doses of the P2-P[8] DVP8*-P[8] DVP8* or P2-P[8] DVP8*-P[6] DVP8* vaccine with aluminum phosphate adjuvant developed high titers of homotypic and heterotypic neutralizing antibodies against human rotaviruses bearing G1-G4, G8, G9 and G12 with P[8], P[4] or P[6] combination. The results suggest that these 2 subunit vaccines in monovalent or bivalent formulation can provide antigenic coverage to almost all the rotavirus G (VP7) types and major P (VP4) types of global as well as regional epidemiologic importance.

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Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial

Abstract: PATH (GAVI Alliance grant) and Merck.

Cited by 638 publications

References 31 publications

Options for improving effectiveness of rotavirus vaccines in developing countries

Options for improving effectiveness of rotavirus vaccines in developing countries

Impact of Rotavirus Vaccination on Hospitalizations and Deaths From Childhood Gastroenteritis in Botswana

Tandem truncated rotavirus VP8* subunit protein with T cell epitope as non-replicating parenteral vaccine is highly immunogenic

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