Reduction in morbidity and mortality from childhood diarrhoeal disease after species A rotavirus vaccine introduction in Latin America - a review

Division of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30333 , USA.
Memórias do Instituto Oswaldo Cruz (Impact Factor: 1.59). 12/2011; 106(8):907-11. DOI: 10.1590/S0074-02762011000800002
Source: PubMed


Countries in Latin America were among the first to implement routine vaccination against species A rotavirus (RVA). We evaluate data from Latin America on reductions in gastroenteritis and RVA disease burden following the introduction of RVA vaccine. Published literature was reviewed to identify case-control studies of vaccine effectiveness and population-based studies examining longitudinal trends of diarrhoeal disease reduction after RVA vaccine introduction in Latin American countries. RVA vaccine effectiveness and impact on gastroenteritis mortality and hospitalization rates and RVA hospitalization rates are described. Among middle-income Latin American countries with published data (Mexico, Brazil, El Salvador and Panama), RVA vaccine contributed to a gastroenteritis-associated mortality reduction of 22-41%, a gastroenteritis-associated hospitalization reduction of 17-51% and a RVA hospitalization reduction of 59-81% among children younger than five years of age. In Brazil and El Salvador, case-control studies demonstrated that a full RVA vaccination schedule was 76-85% effective against RVA hospitalization; a lower effectiveness of 46% was seen in Nicaragua, the only low-income country with available data. A growing body of literature offers convincing evidence of "real world" vaccine program successes in Latin American settings, which may be expanded as more countries in the region include RVA vaccine in their immunization programs.

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Available from: Ben A Lopman, Jul 15, 2014
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    • "Recent estimates from Latin America and the Caribbean revealed that, in the absence of vaccination, RV causes up to 229,656 hospitalizations and 6,302 deaths each year among children younger than 5 years of age [Desai et al., 2011]. In Brazil during the pre-vaccine period, RV infections have been estimated to cause 850 annual deaths and 92,453 hospitalizations in children less than five years of age [Sartori et al., 2008]. "
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    ABSTRACT: The monovalent human rotavirus (RV) vaccine, RIX4414 (Rotarix™, GlaxoSmithKline Biologicals) was introduced into Brazil's Expanded Program on Immunization in March 2006. One year after vaccine introduction, the G2P[4] strain was found to be predominant, with an apparent extinction of many non-G2 strains. This study investigated the diversity of circulating strains in the three years following RIX4414 introduction. Between May 2008 and May 2011, stool samples were collected from children aged ≥12 weeks who were hospitalized for severe lab confirmed RV-gastroenteritis (≥3 liquid or semi-liquid motions over a 24-h period for <14 days, requiring ≥1 overnight hospital stay and intravenous rehydration therapy) in Belém, Brazil. RV-gastroenteritis was detected by ELISA and the G- and P-types were determined by RT-PCR assays. During the first year of surveillance nucleotide sequencing was used for typing those samples not previously typed by RT-PCR. A total of 1,726 of 10,030 severe gastroentertis hospitalizations (17.2%) were due to severe RVGE. G2P[4] was detected in 57.2% of circulating strains over the whole study period, however it predominated during the first 20 months from May 2008 to January 2009. G1P[8] increased in the last part of the study period from May 2010 to May 2011 and represented 36.6% (112/306) of the circulating strains. G2P[4] was the predominant RV strain circulating during the first 20 months of the study, followed by G1P[8]. These findings probably reflect a natural fluctuation in RV strains over time, rather than a vaccine-induced selective pressure. J. Med. Virol. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.
    Journal of Medical Virology 04/2015; 87(8). DOI:10.1002/jmv.24183 · 2.35 Impact Factor
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    • "Rotavirus vaccines are recommended for global use by the World Health Organization [19] and evidence from both developing and developed countries demonstrates the impact of these vaccines on disease reduction in young children [20] [21] [22] [23]. Increased risk of intussusception has been detected in Australia, Mexico, Brazil and the USA, but the risks of intussusception outweigh the potential benefits of vaccination in disease and mortality reduction, particularly in areas where diarrheal disease continues to be a major killer of children. "
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    ABSTRACT: Background: Post licensure studies have identified an increased risk of intussusception following vaccination with currently licensed rotavirus vaccines, raising safety concerns generic to all rotavirus vaccines. We describe the surveillance for intussusception in a phase III clinical trial with an oral monovalent rotavirus vaccine developed from the neonatal 116E strain. Methods: Using broad screening criteria and active surveillance, the incidence of intussusception between 6 weeks and 2 years of age was measured in 4532 children who received three doses of vaccine and 2267 children who received a placebo in the clinical trial. Possible intussusceptions were evaluated with a screening ultrasonogram. An independent intussusception case adjudication committee reviewed all intussusceptions and graded them on Brighton Collaboration criteria for diagnostic certainty. Results: We identified twenty-three intussusceptions on ultrasound from 1361 evaluated sentinel events. Eleven were of level 1 diagnostic certainty as determined by the independent intussusception case adjudication committee. None required surgical intervention, and the earliest identified intussusception was at 36 days following the third dose in a placebo recipient. Among vaccine recipients the first event of intussusception occurred 112 days after the third dose. The incidence of ultrasound-diagnosed intussusception was 200/100,000 child-years (95% CI, 120, 320) among those receiving the vaccine and 141/100,000 child-years (95% CI, 50, 310) among those receiving the placebo. The incidence rate of confirmed intussusception among vaccine recipients was 94/100,000 child-years (95% CI, 41, 185) and 71/100,000 child-years (95% CI, 15, 206) among those receiving the placebo. Conclusion: In this licensure study, 23 cases of intussusception were identified through an active surveillance system, but there was no temporal association with rotavirus vaccination. The use of active surveillance with broad criteria intended for ensuring safety of children participating in a trial, identified several transient intussusceptions that were of doubtful clinical significance.
    Vaccine 08/2014; 32, Supplement 1:A104-A109. DOI:10.1016/j.vaccine.2014.03.036 · 3.62 Impact Factor
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    • "For example, in situations where a vaccine is known to be efficacious but the local burden of disease is uncertain, investigators and others should first evaluate study designs other than a placebo-controlled trial that might allow determining the burden of disease (e.g. measuring the burden of gastroenteritis before and after introducing rotavirus vaccines in Latin America Desai, Oliveira [20]). Furthermore, when a placebo-controlled trial is thought to be necessary, it is important to consider a design that combines the investigational vaccine or placebo with a routine vaccination and thus avoids giving participants an additional injection (e.g. "
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    ABSTRACT: Vaccines are among the most cost-effective interventions against infectious diseases. Many candidate vaccines targeting neglected diseases in low- and middle-income countries are now progressing to large-scale clinical testing. However, controversy surrounds the appropriate design of vaccine trials and, in particular, the use of placebo controls when an efficacious vaccine already exists. This paper specifies four situations in which placebo use may be acceptable, provided that the study question cannot be answered in an active-controlled trial design; the risks of delaying or foregoing an efficacious vaccine are mitigated; the risks of using a placebo control are justified by the social and public health value of the research; and the research is responsive to local health needs. The four situations are: (1) developing a locally affordable vaccine, (2) evaluating the local safety and efficacy of an existing vaccine, (3) testing a new vaccine when an existing vaccine is considered inappropriate for local use (e.g. based on epidemiologic or demographic factors), and (4) determining the local burden of disease.
    Vaccine 04/2014; 32(37). DOI:10.1016/j.vaccine.2014.04.022 · 3.62 Impact Factor
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