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      Causes of impaired oral vaccine efficacy in developing countries

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          Abstract

          Oral vaccines are less immunogenic when given to infants in low-income compared with high-income countries, limiting their potential public health impact. Here, we review factors that might contribute to this phenomenon, including transplacental antibodies, breastfeeding, histo blood group antigens, enteric pathogens, malnutrition, microbiota dysbiosis and environmental enteropathy. We highlight several clear risk factors for vaccine failure, such as the inhibitory effect of enteroviruses on oral poliovirus vaccine. We also highlight the ambiguous and at times contradictory nature of the available evidence, which undoubtedly reflects the complex and interconnected nature of the factors involved. Mechanisms responsible for diminished immunogenicity may be specific to each oral vaccine. Interventions aiming to improve vaccine performance may need to reflect the diversity of these mechanisms.

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          Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis.

          Guillermo Ruiz-Palacios, Irene Pérez-Schael, F Velázquez … (2006)
          The safety and efficacy of an attenuated G1P[8] human rotavirus (HRV) vaccine were tested in a randomized, double-blind, phase 3 trial. We studied 63,225 healthy infants from 11 Latin American countries and Finland who received two oral doses of either the HRV vaccine (31,673 infants) or placebo (31,552 infants) at approximately two months and four months of age. Severe gastroenteritis episodes were identified by active surveillance. The severity of disease was graded with the use of the 20-point Vesikari scale. Vaccine efficacy was evaluated in a subgroup of 20,169 infants (10,159 vaccinees and 10,010 placebo recipients). The efficacy of the vaccine against severe rotavirus gastroenteritis and against rotavirus-associated hospitalization was 85 percent (P<0.001 for the comparison with placebo) and reached 100 percent against more severe rotavirus gastroenteritis. Hospitalization for diarrhea of any cause was reduced by 42 percent (95 percent confidence interval, 29 to 53 percent; P<0.001). During the 31-day window after each dose, six vaccine recipients and seven placebo recipients had definite intussusception (difference in risk, -0.32 per 10,000 infants; 95 percent confidence interval, -2.91 to 2.18; P=0.78). Two oral doses of the live attenuated G1P[8] HRV vaccine were highly efficacious in protecting infants against severe rotavirus gastroenteritis, significantly reduced the rate of severe gastroenteritis from any cause, and were not associated with an increased risk of intussusception. (ClinicalTrials.gov numbers, NCT00139347 and NCT00263666.) Copyright 2006 Massachusetts Medical Society.
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            Effect of human rotavirus vaccine on severe diarrhea in African infants.

            Shabir Madhi, Nigel Cunliffe, Duncan Steele … (2010)
            Rotavirus is the most common cause of severe gastroenteritis among young children worldwide. Data are needed to assess the efficacy of the rotavirus vaccine in African children. We conducted a randomized, placebo-controlled, multicenter trial in South Africa (3166 infants; 64.1% of the total) and Malawi (1773 infants; 35.9% of the total) to evaluate the efficacy of a live, oral rotavirus vaccine in preventing severe rotavirus gastroenteritis. Healthy infants were randomly assigned in a 1:1:1 ratio to receive two doses of vaccine (in addition to one dose of placebo) or three doses of vaccine--the pooled vaccine group--or three doses of placebo at 6, 10, and 14 weeks of age. Episodes of gastroenteritis caused by wild-type rotavirus during the first year of life were assessed through active follow-up surveillance and were graded with the use of the Vesikari scale. A total of 4939 infants were enrolled and randomly assigned to one of the three groups; 1647 infants received two doses of the vaccine, 1651 infants received three doses of the vaccine, and 1641 received placebo. Of the 4417 infants included in the per-protocol efficacy analysis, severe rotavirus gastroenteritis occurred in 4.9% of the infants in the placebo group and in 1.9% of those in the pooled vaccine group (vaccine efficacy, 61.2%; 95% confidence interval, 44.0 to 73.2). Vaccine efficacy was lower in Malawi than in South Africa (49.4% vs. 76.9%); however, the number of episodes of severe rotavirus gastroenteritis that were prevented was greater in Malawi than in South Africa (6.7 vs. 4.2 cases prevented per 100 infants vaccinated per year). Efficacy against all-cause severe gastroenteritis was 30.2%. At least one serious adverse event was reported in 9.7% of the infants in the pooled vaccine group and in 11.5% of the infants in the placebo group. Human rotavirus vaccine significantly reduced the incidence of severe rotavirus gastroenteritis among African infants during the first year of life. (ClinicalTrials.gov number, NCT00241644.) 2010 Massachusetts Medical Society
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              Intestinal microbiota promote enteric virus replication and systemic pathogenesis.

              Sharon K. Kuss, Gavin Best, Chris Etheredge … (2011)
              Intestinal bacteria aid host health and limit bacterial pathogen colonization. However, the influence of bacteria on enteric viruses is largely unknown. We depleted the intestinal microbiota of mice with antibiotics before inoculation with poliovirus, an enteric virus. Antibiotic-treated mice were less susceptible to poliovirus disease and supported minimal viral replication in the intestine. Exposure to bacteria or their N-acetylglucosamine-containing surface polysaccharides, including lipopolysaccharide and peptidoglycan, enhanced poliovirus infectivity. We found that poliovirus binds lipopolysaccharide, and exposure of poliovirus to bacteria enhanced host cell association and infection. The pathogenesis of reovirus, an unrelated enteric virus, also was more severe in the presence of intestinal microbes. These results suggest that antibiotic-mediated microbiota depletion diminishes enteric virus infection and that enteric viruses exploit intestinal microbes for replication and transmission.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Future Microbiol
                Journal ID (iso-abbrev): Future Microbiol
                Journal ID (publisher-id): FMB
                Title: Future Microbiology
                Publisher: Future Medicine Ltd (London, UK )
                ISSN (Print): 1746-0913
                ISSN (Electronic): 1746-0921
                Publication date (Print): January 2018
                Publication date (Electronic): 08 December 2017
                Publication date PMC-release: 08 December 2017
                Volume: 13
                Issue: 1
                Pages: 97-118
                Affiliations
                [1 ]Department of Infectious Disease Epidemiology, St Mary's Campus, Imperial College London, London, W2 1PG, UK
                [2 ]Baylor College of Medicine, Houston, TX 77060, USA
                [3 ]Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA
                [4 ]Centre for Paediatrics, Blizard Institute, Queen Mary University of London, London, E1 2AT, UK
                [5 ]Centre for Global Vaccine Research, Institute of Infection & Global Health, University of Liverpool, Liverpool, L69 7BE, UK
                Author notes
                *Author for correspondence: edward.parker@ 123456imperial.ac.uk
                Article
                DOI: 10.2217/fmb-2017-0128
                PMC ID: 7026772
                PubMed ID: 29218997
                SO-VID: 17e31e77-8bed-4aaa-a865-f31a1acd6e6f
                Copyright © © 2018 Edward Parker
                License:

                This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License

                History
                Date received : 29 June 2017
                Date accepted : 13 September 2017
                Date: 08 December 2017
                Categories
                Subject: Review

                Keywords: cholera,enteropathy,histo blood group antigens,immunogenicity,malnutrition,microbiota,oral vaccines,poliovirus,rotavirus
                Data availability:
                Keywords: cholera, enteropathy, histo blood group antigens, immunogenicity, malnutrition, microbiota, oral vaccines, poliovirus, rotavirus

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