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NISH (NITAG Support Hub) 8: Vaccines against enteric diseases: Rotavirus vaccines

This Library Guide is a collection of useful documents & evidence on the efficacy, effectiveness and impact of vaccines against enteric diseases (Typhoid, Cholera, Rotavirus) to support NITAG members and other policy makers across Africa in making eviden

References used in WHO Position Paper on Rotavirus vaccines (1)

Parashar, U. D., Hummelman, E. G., Bresee, J. S., Miller, M. A., & Glass, R. I. (2003). Global illness and deaths caused by rotavirus disease in children. Emerging infectious diseases9(5), 565. https://pmc.ncbi.nlm.nih.gov/articles/PMC2972763/pdf/02-0562.pdf   OR https://wwwnc.cdc.gov/eid/article/9/5/02-0562_article

Tate, J. E., Burton, A. H., Boschi-Pinto, C., Parashar, U. D., World Health Organization–Coordinated Global Rotavirus Surveillance Network, Agocs, M., ... & Paladin, F. (2016). Global, regional, and national estimates of rotavirus mortality in children< 5 years of age, 2000–2013. Clinical Infectious Diseases62(suppl_2), S96-S105. https://doi.org/10.1093/cid/civ1013

Clark, A., Black, R., Tate, J., Roose, A., Kotloff, K., Lam, D., ... & Steele, D. (2017). Estimating global, regional and national rotavirus deaths in children aged< 5 years: current approaches, new analyses and proposed improvements. PloS one12(9), e0183392. . https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0183392&type=printable

Tedros, A. G., & Christopher, J. L. M. (2017). Global burden of disease study 2017. Lancet5, 1-27. (NOT OA)

Troeger, C., Khalil, I. A., Rao, P. C., Cao, S., Blacker, B. F., Ahmed, T., ... & Reiner, R. C. (2018). Rotavirus vaccination and the global burden of rotavirus diarrhea among children younger than 5 years. JAMA pediatrics172(10), 958-965. https://watermark.silverchair.com/jamapediatrics_troeger_2018_oi_180045_1638554933.97986.pdf

Patel, M. M., Pitzer, V. E., Alonso, W. J., Vera, D., Lopman, B., Tate, J., ... & Parashar, U. D. (2013). Global seasonality of rotavirus disease. The Pediatric infectious disease journal32(4), e134-e147. 10.1097/INF.0b013e31827d3b68

Curns, A. T., Panozzo, C. A., Tate, J. E., Payne, D. C., Patel, M. M., Cortese, M. M., & Parashar, U. D. (2011). Remarkable postvaccination spatiotemporal changes in United States rotavirus activity. The Pediatric infectious disease journal30(1), S54-S55. (NOT OA)

Baker, J. M., & Alonso, W. J. (2018). Rotavirus vaccination takes seasonal signature of childhood diarrhea back to pre-sanitation era in Brazil. Journal of Infection76(1), 68-77. https://doi.org/10.1016/j.jinf.2017.10.001 (NOT OA)

Quee, F. A., de Hoog, M. L., Schuurman, R., & Bruijning-Verhagen, P. (2020). Community burden and transmission of acute gastroenteritis caused by norovirus and rotavirus in the Netherlands (RotaFam): a prospective household-based cohort study. The Lancet Infectious Diseases20(5), 598-606. https://doi.org/10.1016/S1473-3099(20)30058-X (NOT OA)

Matthijnssens, J., Otto, P. H., Ciarlet, M., Desselberger, U., Van Ranst, M., & Johne, R. (2012). VP6-sequence-based cutoff values as a criterion for rotavirus species demarcation. Archives of virology157, 1177-1182. (NOT OA)

Lewis, K. D., Dallas, M. J., Victor, J. C., Ciarlet, M., Mast, T. C., Ji, M., ... & Neuzil, K. M. (2012). Comparison of two clinical severity scoring systems in two multi-center, developing country rotavirus vaccine trials in Africa and Asia. Vaccine30, A159-A166. (NOT OA)

Gladstone, B. P., Ramani, S., Mukhopadhya, I., Muliyil, J., Sarkar, R., Rehman, A. M., ... & Kang, G. (2011). Protective effect of natural rotavirus infection in an Indian birth cohort. New England Journal of Medicine365(4), 337-346. (NOT OA)

Velázquez, F. R., Matson, D. O., Calva, J. J., Guerrero, M. L., Morrow, A. L., Carter-Campbell, S., ... & Ruiz-Palacios, G. M. (1996). Rotavirus infection in infants as protection against subsequent infections. New England Journal of Medicine335(14), 1022-1028. (NOT OA)

Bennett, A., Bar-Zeev, N., Jere, K. C., Tate, J. E., Parashar, U. D., Nakagomi, O., ... & Cunliffe, N. A. (2015). Determination of a viral load threshold to distinguish symptomatic versus asymptomatic rotavirus infection in a high-disease-burden African population. Journal of clinical microbiology53(6), 1951-1954. (NOT OA)

Diarrhoea: why children are still dying and what can be done. Geneva, WHO/ UNICEF, 2009. http://apps.who.int/iris/bitstream/hand le/10665/44174/9789241598415_eng.pdf?sequence=1

Pneumonia and diarrhoea: tackling the deadliest diseases for the world’s poorest children. New York, UNICEF, 2012.  https://data.unicef.org/resources/pneumoniaand-diarrhoea-tackling-the-deadliest-diseases-for-the-worlds-poorest-children/

World Health Organization. (2006). Oral rehydration salts: Production of the new ORS (No. WHO/FCH/CAH/06.1). World Health Organization.https://iris.who.int/bitstream/handle/10665/69227/WHO_FCH_CAH_06.1.pdf?sequence=1

Angel, J., Franco, M. A., & Greenberg, H. B. (2012). Rotavirus immune responses and correlates of protection. Current opinion in virology2(4), 419-425. (NOT OA)

Mohan, V. R., Karthikeyan, R., Babji, S., McGrath, M., Shrestha, S., Shrestha, J., ... & Etiology, Risk Factors, and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development (MAL-ED) Network Investigators. (2017). Rotavirus infection and disease in a multisite birth cohort: results from the MAL-ED study. The Journal of infectious diseases216(3), 305-316.  https://doi.org/10.1093/infdis/jix199

Bîrcă, I. (2023). Politici globale de vaccinare în infecția rotavirală. Sănătate Publică, Economie şi Management în Medicină95(2), 28-37. https://doi.org/10.52556/2587-3873.2023.2(95).04

Groome, M. J., & Madhi, S. A. (2012). Five-year cohort study on the burden of hospitalisation for acute diarrhoeal disease in African HIV-infected and HIV-uninfected children: potential benefits of rotavirus vaccine. Vaccine30, A173-A178. (NOT OA)

Cunliffe, N. A., Gondwe, J. S., Kirkwood, C. D., Graham, S. M., Nhlane, N. M., Thindwa, B. D., ... & Hart, C. A. (2001). Effect of concomitant HIV infection on presentation and outcome of rotavirus gastroenteritis in Malawian children. The Lancet358(9281), 550-555. (NOT OA)

Patel, M., Glass, R. I., Jiang, B., Santosham, M., Lopman, B., & Parashar, U. (2013). A systematic review of anti-rotavirus serum IgA antibody titer as a potential correlate of rotavirus vaccine efficacy. The Journal of infectious diseases208(2), 284-294. https://doi.org/10.1093/infdis/jit166

World Health Organization. (2020). The immunological basis for immunization series. Module 21: rotavirus vaccines. World Health Organization. https://books.google.co.za/books?https://books.google.co.za/books?

Guidelines to assure the quality, safety and efficacy of live attenuated rotavirus vaccines. Annex 3. Geneva, World Health Organization, 2007, WHO technical report series 941 

World Health Organization. (2013). Rotavirus vaccines: WHO position paper—January 2013. Weekly Epidemiological Record= Relevé épidémiologique hebdomadaire88(05), 49-64. https://cdn.who.int/media/docs/default-source/biologicals/vaccine-quality/guidelines-to-assure-the-quality-safety-and-efficacy-of-live-attenuated-rotavirus-vaccines-(oral)5531481d-18e9-4ba6-a13d-e3178b1b10ef.pdf

WHO prequalified vaccines. Rotavirus RotaTeq single dose tube. Geneva: World Health Organization https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/norms-and-standards/vaccine-standardization/rotavirus

WHO prequalified vaccines. Rotavirus Rotasiil vials. Geneva: World Health Organization (https://extranet.who.int/pqweb/content/rotasiil). 

WHO prequalified vaccines. Rotavirus Rotasiil vials. Geneva: World Health Organization (https://extranet.who.int/pqweb/content/rotasiil-).

WHO prequalified vaccines. Rotavirus Rotasiil Thermo vials. Geneva: World Health Organization (https://extranet.who.int/pqweb/content/rotasiil%C2%AEthermo).

WHO prequalified vaccines. Rotavirus Rotasiil Thermo vials. Geneva: World Health Organization (https://extranet.who.int/pqweb/content/rotasiil%C2%AEthermo-0).

Systematic review and meta-analysis of the safety, effectiveness and efficacy of childhood schedules using rotavirus vaccines – Cochrane Response. October 2020 SAGE Meeting. Rotavirus vaccines – Session 6. Background documents

Studies in the Cochrane review were stratified into low, medium and high mortality based on the UN Inter-agency Group for Child Mortality Estimation list of country under-five infant, child, and neo-natal mortality in 2019 https://childmortality.org/

Goveia, M. G., Rodriguez, Z. M., Dallas, M. J., Itzler, R. F., Boslego, J. W., Heaton, P. M., ... & REST Study Team. (2007). Safety and efficacy of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine in healthy premature infants. The Pediatric infectious disease journal26(12), 1099-1104. (NOT OA)

Burnett, E., Parashar, U. D., & Tate, J. E. (2020). Real-world effectiveness of rotavirus vaccines, 2006–19: a literature review and meta-analysis. The Lancet Global Health8(9), e1195-e1202. https://www.thelancet.com/action/showPdf?pii=S2214-109X%2820%2930262-X

 

 

 

References used in WHO Position Paper on Rotavirus vaccines (2)

Clark, A., Tate, J., Parashar, U., Jit, M., Hasso-Agopsowicz, M., Henschke, N., ... & Sanderson, C. (2019). Mortality reduction benefits and intussusception risks of rotavirus vaccination in 135 low-income and middle-income countries: a modelling analysis of current and alternative schedules. The Lancet Global Health7(11), e1541-e1552.https://www.thelancet.com/action/showPdf?pii=S2214-109X%2819%2930412-7

Leshem, E., Lopman, B., Glass, R., Gentsch, J., Bányai, K., Parashar, U., & Patel, M. (2014). Distribution of rotavirus strains and strain-specific effectiveness of the rotavirus vaccine after its introduction: a systematic review and meta-analysis. The lancet infectious diseases14(9), 847-856. (NOT OA)

Aliabadi, N., Antoni, S., Mwenda, J. M., Weldegebriel, G., Biey, J. N., Cheikh, D., ... & Cohen, A. L. (2019). Global impact of rotavirus vaccine introduction on rotavirus hospitalisations among children under 5 years of age, 2008–16: findings from the Global Rotavirus Surveillance Network. The Lancet Global Health7(7), e893-e903. https://www.thelancet.com/action/showPdf?pii=S2214-109X%2819%2930207-4

Burnett, E., Parashar, U. D., & Tate, J. E. (2020). Global impact of rotavirus vaccination on diarrhea hospitalizations and deaths among children< 5 years old: 2006–2019. The Journal of infectious diseases222(10), 1731-1739.  https://watermark.silverchair.com/jiaa081.pdf

Giaquinto, C., Dominiak-Felden, G., Van Damme, P., Htar Myint, T. T., Maldonado, Y. A., Spoulou, V., ... & Staat, M. A. (2011). Summary of effectiveness and impact of rotavirus vaccination with the oral pentavalent rotavirus vaccine: a systematic review of the experience in industrialized countries. Human vaccines7(7), 734-748. https://doi.org/10.4161/hv.7.7.15511

Shioda, K., de Oliveira, L. H., Sanwogou, J., Rey-Benito, G., Azzad, D. N., Castillo, R. E., ... & Pitzer, V. E. (2020). Identifying signatures of the impact of rotavirus vaccines on hospitalizations using sentinel surveillance data from Latin American countries. Vaccine38(2), 323-329. (NOT OA)

Clark, A., van Zandvoort, K., Flasche, S., Sanderson, C., Bines, J., Tate, J., ... & Jit, M. (2019). Efficacy of live oral rotavirus vaccines by duration of follow-up: a meta-regression of randomised controlled trials. The Lancet Infectious Diseases19(7), 717-727.  https://www.thelancet.com/action/showPdf?pii=S1473-3099%2819%2930126-4

Vesikari, T., Karvonen, A., Ferrante, S. A., & Ciarlet, M. (2010). Efficacy of the pentavalent rotavirus vaccine, RotaTeq®, in Finnish infants up to 3 years of age: the Finnish Extension Study. European journal of pediatrics169, 1379-1386. https://acrobat.adobe.com/id/urn:aaid:sc:EU:2c791b2b-dd80-44c1-9242-eaaaa58ef7ab

Phua, K. B., Lim, F. S., Lau, Y. L., Nelson, E. A. S., Huang, L. M., Quak, S. H., ... & Han, H. H. (2012). Rotavirus vaccine RIX4414 efficacy sustained during the third year of life: a randomized clinical trial in an Asian population. Vaccine30(30), 4552-4557. (NOT OA)

Rogawski, E. T., Platts-Mills, J. A., Colgate, E. R., Haque, R., Zaman, K., Petri, W. A., & Kirkpatrick, B. D. (2018). Quantifying the impact of natural immunity on rotavirus vaccine efficacy estimates: a clinical trial in Dhaka, Bangladesh (PROVIDE) and a simulation study. The Journal of infectious diseases217(6), 861-868. https://doi.org/10.1093/infdis/jix668

Pitzer, V. E., Bennett, A., Bar-Zeev, N., Jere, K. C., Lopman, B. A., Lewnard, J. A., ... & Cunliffe, N. A. (2019). Evaluating strategies to improve rotavirus vaccine impact during the second year of life in Malawi. Science translational medicine11(505), eaav6419.  (NOT OA)

Church, J. A., Parker, E. P., Kirkpatrick, B. D., Grassly, N. C., & Prendergast, A. J. (2019). Interventions to improve oral vaccine performance: a systematic review and meta-analysis. The Lancet Infectious Diseases19(2), 203-214.  https://www.thelancet.com/action/showPdf?pii=S1473-3099%2818%2930602-9

Parker, E. P., Ramani, S., Lopman, B. A., Church, J. A., Iturriza-Gomara, M., Prendergast, A. J., & Grassly, N. C. (2018). Causes of impaired oral vaccine efficacy in developing countries. Future microbiology13(1), 97-118. https://doi.org/10.2217/fmb-2017-0128

Neuzil, K. M., Zaman, K., & Victor, J. C. (2014). A proposed framework for evaluating and comparing efficacy estimates in clinical trials of new rotavirus vaccines. Vaccine32, A179-A184. https://doi.org/10.1016/j.vaccine.2014.04.074

Libster, R., McNeal, M., Walter, E. B., Shane, A. L., Winokur, P., Cress, G., ... & VTEU Rotavirus Vaccine Study Work Group. (2016). Safety and immunogenicity of sequential rotavirus vaccine schedules. Pediatrics137(2). (NOT OA)

Cortese, M. M., Immergluck, L. C., Held, M., Jain, S., Chan, T., Grizas, A. P., ... & Vázquez, M. (2013). Effectiveness of monovalent and pentavalent rotavirus vaccine. Pediatrics132(1), e25-e33. (NOT OA)

Payne, D. C., Sulemana, I., Parashar, U. D., & New Vaccine Surveillance Network. (2016). Evaluation of effectiveness of mixed rotavirus vaccine course for rotavirus gastroenteritis. JAMA pediatrics170(7), 708-710. https://watermark.silverchair.com/pld160001.pdf

Isanaka, S., Guindo, O., Langendorf, C., Matar Seck, A., Plikaytis, B. D., Sayinzoga-Makombe, N., ... & Grais, R. F. (2017). Efficacy of a low-cost, heat-stable oral rotavirus vaccine in Niger. New England Journal of Medicine376(12), 1121-1130. (NOT OA)

Taddio, A., Flanders, D., Weinberg, E., Lamba, S., Vyas, C., Ilersich, A. F., ... & McNair, C. (2015). A randomized trial of rotavirus vaccine versus sucrose solution for vaccine injection pain. Vaccine33(25), 2939-2943. (NOT OA)

mondiale de la Santé, O., & World Health Organization. (2015). Reducing pain at the time of vaccination: WHO position paper—September 2015. Weekly Epidemiological Record= Relevé épidémiologique hebdomadaire90(39), 505-510.https://iris.who.int/bitstream/handle/10665/242426/WER9039_505-510.PDF

Vesikari, T., Matson, D. O., Dennehy, P., Van Damme, P., Santosham, M., Rodriguez, Z., ... & Heaton, P. M. (2006). Safety and efficacy of a pentavalent human–bovine (WC3) reassortant rotavirus vaccine. New England Journal of Medicine354(1), 23-33. https://www.nejm.org/doi/pdf/10.1056/NEJMoa052664

Ruiz-Palacios, G. M., Pérez-Schael, I., Velázquez, F. R., Abate, H., Breuer, T., Clemens, S. C., ... & O'Ryan, M. (2006). Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. New England Journal of Medicine354(1), 11-22. https://www.nejm.org/doi/pdf/10.1056/NEJMoa052434

Rha, B., Tate, J. E., Weintraub, E., Haber, P., Yen, C., Patel, M., ... & Parashar, U. D. (2014). Intussusception following rotavirus vaccination: an updated review of the available evidence. Expert Review of Vaccines13(11), 1339-1348. (NOT OA)

 

References used in WHO Position Paper on Rotavirus vaccines (3)

Tate, J. E., Mwenda, J. M., Armah, G., Jani, B., Omore, R., Ademe, A., ... & Parashar, U. D. (2018). Evaluation of intussusception after monovalent rotavirus vaccination in Africa. New England Journal of Medicine378(16), 1521-1528. https://www.nejm.org/doi/pdf/10.1056/NEJMoa1713909

Groome, M. J., Tate, J. E., Arnold, M., Chitnis, M., Cox, S., De Vos, C., ... & Parashar, U. D. (2020). Evaluation of intussusception after oral monovalent rotavirus vaccination in South Africa. Clinical Infectious Diseases70(8), 1606-1612. https://doi.org/10.1093/cid/ciz431

Reddy, S. N., Nair, N. P., Tate, J. E., Thiyagarajan, V., Giri, S., Praharaj, I., ... & Kang, G. (2020). Intussusception after rotavirus vaccine introduction in India. New England Journal of Medicine383(20), 1932-1940. (NOT OA)

Das, M. K., Arora, N. K., Poluru, R., Tate, J. E., Gupta, B., Sharan, A., ... & Garge, S. (2021). Risk of intussusception after monovalent rotavirus vaccine (Rotavac) in Indian infants: A self-controlled case series analysis. Vaccine39(1), 78-84. https://doi.org/10.1016/j.vaccine.2020.09.019

Bhandari, N., Antony, K., Balraj, V., Rongsen-Chandola, T., Kumar, T., Sinha, B., ... & Kabra, M. (2020). Assessment of risk of intussusception after pilot rollout of rotavirus vaccine in the Indian public health system. Vaccine38(33), 5241-5248. https://doi.org/10.1016/j.vaccine.2020.05.093

World Health Organization. (2021) Rotavirus vaccine safety update. https://www.who.int/groups/global-advisory-committee-on-vaccine-safety/topics/rotavirus-vaccines/safety-vaccine

mondiale de la Santé, O., & World Health Organization. (2020). Global Advisory Committee on Vaccine Safety, 4–5 December 2019–Comité consultatif mondial pour la sécurité des vaccins, 4-5 décembre 2019. Weekly Epidemiological Record= Relevé épidémiologique hebdomadaire95(04), 25-36.  https://iris.who.int/bitstream/handle/10665/330608/WER9504-25-36-eng-fre.pdf

McClenahan, S. D., Krause, P. R., & Uhlenhaut, C. (2011). Molecular and infectivity studies of porcine circovirus in vaccines. Vaccine29(29-30), 4745-4753. (NOT OA)

Hasso-Agopsowicz, M., Ladva, C. N., Lopman, B., Sanderson, C., Cohen, A. L., Tate, J. E., ... & Clark, A. (2019). Global Rotavirus Surveillance Network and Rotavirus Age Study Collaborators. Global review of the age distribution of rotavirus disease in children aged< 5 years before the introduction of rotavirus vaccination. Clin. Infect. Dis69, 1071-1078.  (NOT OA)

Rotavirus vaccines:an update. (2009). Releve epidemiologique hebdomadaire84(50), 533–540. 

Patel, M. M., Clark, A. D., Sanderson, C. F., Tate, J., & Parashar, U. D. (2012). Removing the age restrictions for rotavirus vaccination: a benefit-risk modeling analysis. https://doi.org/10.1371/journal.pmed.1001330

Zaman, K., Fleming, J. A., Victor, J. C., Yunus, M., Bari, T. I. A., Azim, T., ... & Neuzil, K. M. (2016). Noninterference of rotavirus vaccine with measles-rubella vaccine at 9 months of age and improvements in antirotavirus immunity: a randomized trial. The Journal of Infectious Diseases213(11), 1686-1693. https://doi.org/10.1093/infdis/jiw024

Haidara, F. C., Tapia, M. D., Sow, S. O., Doumbia, M., Coulibaly, F., Diallo, F., ... & Neuzil, K. (2018). Evaluation of a booster dose of pentavalent rotavirus vaccine coadministered with measles, yellow fever, and meningitis A vaccines in 9-month-old Malian infants. The Journal of infectious diseases218(4), 606-613.https://doi.org/10.1093/infdis/jiy215

Bertram, M. Y., Lauer, J. A., De Joncheere, K., Edejer, T., Hutubessy, R., Kieny, M. P., & Hill, S. R. (2016). Cost–effectiveness thresholds: pros and cons. Bulletin of the World Health Organization94(12), 925. doi: 10.2471/BLT.15.164418

Debellut, F., Clark, A., Pecenka, C., Tate, J., Baral, R., Sanderson, C., ... & Atherly, D. (2019). Re-evaluating the potential impact and cost-effectiveness of rotavirus vaccination in 73 Gavi countries: a modelling study. The Lancet Global Health7(12), e1664-e1674. https://www.thelancet.com/action/showPdf?pii=S2214-109X%2819%2930439-5

Debellut, F., Clark, A., Pecenka, C., Tate, J., Baral, R., Sanderson, C., ... & Atherly, D. (2021). Evaluating the potential economic and health impact of rotavirus vaccination in 63 middle-income countries not eligible for Gavi funding: a modelling study. The Lancet Global Health9(7), e942-e956. https://www.thelancet.com/action/showPdf?pii=S2214-109X%2821%2900167-4

World Health Organization. (2013). Ending preventable child deaths from pneumonia and diarrhoea by 2025: the integrated global action plan for pneumonia and diarrhoea (GAPPD). https://iris.who.int/bitstream/handle/10665/79200/9789241505239_eng.pdf