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1.
Proc Natl Acad Sci U S A ; 111(29): 10604-9, 2014 Jul 22.
Artigo em Inglês | MEDLINE | ID: mdl-25002465

RESUMO

As polio eradication inches closer, the absence of poliovirus circulation in most of the world and imperfect vaccination coverage are resulting in immunity gaps and polio outbreaks affecting adults. Furthermore, imperfect, waning intestinal immunity among older children and adults permits reinfection and poliovirus shedding, prompting calls to extend the age range of vaccination campaigns even in the absence of cases in these age groups. The success of such a strategy depends on the contribution to poliovirus transmission by older ages, which has not previously been estimated. We fit a mathematical model of poliovirus transmission to time series data from two large outbreaks that affected adults (Tajikistan 2010, Republic of Congo 2010) using maximum-likelihood estimation based on iterated particle-filtering methods. In Tajikistan, the contribution of unvaccinated older children and adults to transmission was minimal despite a significant number of cases in these age groups [reproduction number, R = 0.46 (95% confidence interval, 0.42-0.52) for >5-y-olds compared to 2.18 (2.06-2.45) for 0- to 5-y-olds]. In contrast, in the Republic of Congo, the contribution of older children and adults was significant [R = 1.85 (1.83-4.00)], perhaps reflecting sanitary and socioeconomic variables favoring efficient virus transmission. In neither setting was there evidence for a significant role of imperfect intestinal immunity in the transmission of poliovirus. Bringing the immunization response to the Tajikistan outbreak forward by 2 wk would have prevented an additional 130 cases (21%), highlighting the importance of early outbreak detection and response.


Assuntos
Poliomielite/transmissão , Poliomielite/virologia , Poliovirus/fisiologia , Adolescente , Adulto , Distribuição por Idade , Criança , Pré-Escolar , Congo/epidemiologia , Surtos de Doenças/estatística & dados numéricos , Geografia , Humanos , Lactente , Recém-Nascido , Modelos Biológicos , Poliomielite/epidemiologia , Tadjiquistão/epidemiologia
2.
Emerg Infect Dis ; 22(3): 449-56, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26890053

RESUMO

As the global eradication of poliomyelitis approaches the final stages, prompt detection of new outbreaks is critical to enable a fast and effective outbreak response. Surveillance relies on reporting of acute flaccid paralysis (AFP) cases and laboratory confirmation through isolation of poliovirus from stool. However, delayed sample collection and testing can delay outbreak detection. We investigated whether weekly testing for clusters of AFP by location and time, using the Kulldorff scan statistic, could provide an early warning for outbreaks in 20 countries. A mixed-effects regression model was used to predict background rates of nonpolio AFP at the district level. In Tajikistan and Congo, testing for AFP clusters would have resulted in an outbreak warning 39 and 11 days, respectively, before official confirmation of large outbreaks. This method has relatively high specificity and could be integrated into the current polio information system to support rapid outbreak response activities.


Assuntos
Erradicação de Doenças , Surtos de Doenças/prevenção & controle , Diagnóstico Precoce , Paralisia/diagnóstico , Poliomielite/diagnóstico , Análise por Conglomerados , Congo , Monitoramento Epidemiológico , Humanos , Hipotonia Muscular/diagnóstico , Hipotonia Muscular/etiologia , Paralisia/etiologia , Poliomielite/epidemiologia , Poliomielite/fisiopatologia , Somália , Tadjiquistão , Fatores de Tempo
3.
Lancet ; 386(10011): 2413-21, 2015 Dec 12.
Artigo em Inglês | MEDLINE | ID: mdl-26388534

RESUMO

BACKGROUND: Polio eradication needs a new routine immunisation schedule--three or four doses of bivalent type 1 and type 3 oral poliovirus vaccine (bOPV) and one dose of inactivated poliovirus vaccine (IPV), but no immunogenicity data are available for this schedule. We aimed to assess immunogenicity of this vaccine schedule. METHODS: We did an open-label, randomised controlled trial in four centres in India. After informed consent was obtained from a parent or legally acceptable representative, healthy newborn babies were randomly allocated to one of five groups: trivalent OPV (tOPV); tOPV plus IPV; bOPV; bOPV plus IPV; or bOPV plus two doses of IPV (2IPV). The key eligibility criteria were: full-term birth (≥37 weeks of gestation); birthweight ≥2·5 kg; and Apgar score of 9 or more. OPV was administered at birth, 6 weeks, 10 weeks, and 14 weeks; IPV was administered intramuscularly at 14 weeks. The primary study objective was to investigate immunogenicity of the new vaccine schedule, assessed by seroconversion against poliovirus types 1, 2, and 3 between birth and 18 weeks in the per-protocol population (all participants with valid serology results on cord blood and at 18 weeks). Neutralisation assays tested cord blood and sera collected at 14 weeks, 18 weeks, 19 weeks, and 22 weeks by investigators masked to group allocation. This trial was registered with the India Clinical Trials Registry, number CTRI/2013/06/003722. FINDINGS: Of 900 newborn babies enrolled between June 13 and Aug 29, 2013, 782 (87%) completed the per-protocol requirements. Between birth and age 18 weeks, seroconversion against poliovirus type 1 in the tOPV group occurred in 162 of 163 (99·4%, 95% CI 96·6-100), in 150 (98·0%, 94·4-99·6) of 153 in the tOPV plus IPV group, in 153 (98·7%, 95·4-99·8) of 155 in the bOPV group, in 155 (99·4%, 96·5-100) of 156 in the bOPV plus IPV group, and in 154 (99·4%, 96·5-100) of 155 in the bOPV plus 2IPV group. Seroconversion against poliovirus type 2 occurred in 157 (96·3%, 92·2-98·6) of 163 in the tOPV group, 153 (100%, 97·6-100·0) of 153 in the tOPV plus IPV group, 29 (18·7%, 12·9-25·7) of 155 in the bOPV group, 107 (68·6%, 60·7-75·8) of 156 in the bOPV plus IPV group, and in 121 (78·1%, 70·7-84·3) of 155 in the bOPV plus 2IPV group. Seroconversion against poliovirus type 3 was achieved in 147 (90·2%, 84·5-94·3) of 163 in the tOPV group, 152 (99·3%, 96·4-100) of 153 in the tOPV plus IPV group, 151 (97·4%, 93·5-99·3) of 155 in the bOPV group, 155 (99·4%, 96·5-100) of 156 in the bOPV plus IPV group, and 153 (98·7%, 95·4-99·8) of 155 in the bOPV plus 2IPV group. Superiority was achieved for vaccine regimens including IPV against poliovirus type 3 compared with those not including IPV (tOPV plus IPV vs tOPV alone, p=0·0008; and bOPV plus IPV vs bOPV alone, p=0·0153). 12 serious adverse events occurred (six in the tOPV group, one in the tOPV plus IPV group, three in the bOPV group, zero in the bOPV plus IPV group, and two in the bOPV plus 2IPV group), none of which was attributed to the trial intervention. INTERPRETATION: The new vaccination schedule improves immunogenicity against polioviruses, especially against poliovirus type 3. FUNDING: WHO, through a grant from Rotary International (grant number 59735).


Assuntos
Fatores Imunológicos/imunologia , Poliomielite/prevenção & controle , Vacina Antipólio de Vírus Inativado/imunologia , Vacina Antipólio Oral/imunologia , Anticorpos Antivirais/sangue , Formação de Anticorpos/imunologia , Erradicação de Doenças/métodos , Feminino , Humanos , Esquemas de Imunização , Fatores Imunológicos/administração & dosagem , Fatores Imunológicos/efeitos adversos , Recém-Nascido , Masculino , Poliomielite/imunologia , Poliovirus/imunologia , Vacina Antipólio de Vírus Inativado/administração & dosagem , Vacina Antipólio de Vírus Inativado/efeitos adversos , Vacina Antipólio Oral/administração & dosagem , Vacina Antipólio Oral/efeitos adversos , Soroconversão/fisiologia , Vacinação/métodos
4.
N Engl J Med ; 368(5): 416-24, 2013 Jan 31.
Artigo em Inglês | MEDLINE | ID: mdl-23363495

RESUMO

BACKGROUND: To reduce the costs of maintaining a poliovirus immunization base in low-income areas, we assessed the extent of priming immune responses after the administration of inactivated poliovirus vaccine (IPV). METHODS: We compared the immunogenicity and reactogenicity of a fractional dose of IPV (one fifth of a full dose) administered intradermally with a full dose administered intramuscularly in Cuban infants at the ages of 4 and 8 months. Blood was collected from infants at the ages of 4 months, 8 months, 8 months 7 days, and 8 months 30 days to assess single-dose seroconversion, single-dose priming of immune responses, and two-dose seroconversion. Specimens were tested with a neutralization assay. RESULTS: A total of 320 infants underwent randomization, and 310 infants (96.9%) fulfilled the study requirements. In the group receiving the first fractional dose of IPV, seroconversion to poliovirus types 1, 2, and 3 occurred in 16.6%, 47.1%, and 14.7% of participants, respectively, as compared with 46.6%, 62.8%, and 32.0% in the group receiving the first full dose of IPV (P<0.008 for all comparisons). A priming immune response to poliovirus types 1, 2, and 3 occurred in 90.8%, 94.0%, and 89.6% of participants, respectively, in the group receiving the fractional dose as compared with 97.6%, 98.3%, and 98.1% in the group receiving the full dose (P=0.01 for the comparison with type 3). After the administration of the second dose of IPV in the group receiving fractional doses, cumulative two-dose seroconversion to poliovirus types 1, 2, and 3 occurred in 93.6%, 98.1%, and 93.0% of participants, respectively, as compared with 100.0%, 100.0%, and 99.4% in the group receiving the full dose (P<0.006 for the comparisons of types 1 and 3). The group receiving intradermal injections had the greatest number of adverse events, most of which were minor in intensity and none of which had serious consequences. CONCLUSIONS: This evaluation shows that vaccinating infants with a single fractional dose of IPV can induce priming and seroconversion in more than 90% of immunized infants. (Funded by the World Health Organization and the Pan American Health Organization; Australian New Zealand Clinical Trials Registry number, ACTRN12610001046099.).


Assuntos
Anticorpos Antivirais/sangue , Poliomielite/prevenção & controle , Vacina Antipólio de Vírus Inativado/administração & dosagem , Poliovirus/imunologia , Cuba , Feminino , Humanos , Imunização Secundária , Lactente , Injeções Intradérmicas , Injeções Intramusculares , Masculino , Poliomielite/imunologia , Vacina Antipólio de Vírus Inativado/efeitos adversos , Vacina Antipólio de Vírus Inativado/imunologia , Estudos Soroepidemiológicos
5.
J Infect Dis ; 210 Suppl 1: S434-8, 2014 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-25316865

RESUMO

Polio eradication requires the removal of all polioviruses from human populations, whether wild poliovirus or those emanating from the oral poliovirus vaccine (OPV). The Polio Eradication & Endgame Strategic Plan 2013-2018 provides a framework for interruption of wild poliovirus transmission in remaining endemic foci and lays out a plan for the new polio end game, which includes the withdrawal of Sabin strains, starting with type 2, and the introduction of inactivated poliovirus vaccine, for risk mitigation purposes. This report summarizes the rationale and evidence that supports the policy decision to switch from trivalent OPV to bivalent OPV and to introduce 1 dose of inactivated poliovirus vaccine into routine immunization schedules, and it describes the proposed implementation of this policy in countries using trivalent OPV.


Assuntos
Erradicação de Doenças/métodos , Erradicação de Doenças/organização & administração , Poliomielite/epidemiologia , Poliomielite/prevenção & controle , Vacinas contra Poliovirus/administração & dosagem , Vacinas contra Poliovirus/imunologia , Vacinação/métodos , Saúde Global , Humanos , Poliomielite/transmissão
6.
J Infect Dis ; 210 Suppl 1: S459-64, 2014 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-25316868

RESUMO

After polio eradication is achieved, the use of live-attenuated oral poliovirus vaccine (OPV) must be discontinued because of the inherent risk of the Sabin strains to revert to neurovirulence and reacquire greater transmissibility that could potentially result in the reestablishment of polio transmission. In 2008, the World Health Assembly mandated that the World Health Organization establish a strategy for developing more-affordable inactivated poliovirus vaccine (IPV) options for low-income countries. In 2012, the Strategic Advisory Group of Experts (SAGE) on Immunization recommended universal IPV introduction as a risk-mitigation strategy before the phased cessation of OPV (starting with Sabin type 2) and emphasized the need for affordable IPV options. In 2013, SAGE reiterated the importance of attaining the long-term target price of IPV at approximately $0.5 per immunizing dose and encouraged accelerated efforts to develop lower-cost IPV options. This article outlines the 4-pronged approach that is being pursued to develop affordable options and provides an update on the current status and plans to make IPV affordable for developing-country use.


Assuntos
Erradicação de Doenças/métodos , Descoberta de Drogas/métodos , Poliomielite/imunologia , Poliomielite/prevenção & controle , Vacina Antipólio de Vírus Inativado/economia , Vacina Antipólio de Vírus Inativado/isolamento & purificação , Países em Desenvolvimento , Humanos , Vacina Antipólio de Vírus Inativado/imunologia , Organização Mundial da Saúde
8.
Am J Epidemiol ; 178(10): 1579-87, 2013 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-24100955

RESUMO

The "endgame" for worldwide poliomyelitis eradication will entail eventual cessation of the use of oral poliovirus vaccine (OPV) in all countries to prevent the reintroduction of vaccine-derived polioviruses--exposing some populations to an unprecedented, albeit low, risk of poliovirus outbreaks. Inactivated poliovirus vaccine (IPV) is likely to play a large part in post--OPV management of poliovirus risks by reducing the consequences of any reintroduction of poliovirus. In this article, we examine the impact IPV would have on an outbreak in a partially susceptible population after OPV cessation, using a mathematical model of poliovirus transmission with a realistic natural history and case reporting. We explore a range of assumptions about the impact of IPV on an individual's infectiousness, given the lack of knowledge about this parameter. We show that routine use of IPV is beneficial under most conditions, increasing the chance of fadeout and reducing the expected prevalence of infection at the time of detection. The duration of "silent" poliovirus circulation prior to detection lengthens with increasing coverage of IPV, although this only increases the expected prevalence of infection at the time of the OPV response if IPV has a very limited impact on infectiousness. Overall, the model predicts that routine use of IPV will be advantageous for the posteradication management of poliovirus.


Assuntos
Imunização/estatística & dados numéricos , Poliomielite/epidemiologia , Poliomielite/prevenção & controle , Vacina Antipólio de Vírus Inativado/administração & dosagem , Vacina Antipólio Oral/administração & dosagem , Surtos de Doenças , Humanos , Vacina Antipólio de Vírus Inativado/imunologia , Vacina Antipólio Oral/imunologia
9.
Lancet ; 380(9840): 491-8, 2012 Aug 04.
Artigo em Inglês | MEDLINE | ID: mdl-22766207

RESUMO

BACKGROUND: Pakistan and Afghanistan are two of the three remaining countries yet to interrupt wild-type poliovirus transmission. The increasing incidence of poliomyelitis in these countries during 2010-11 led the Executive Board of WHO in January, 2012, to declare polio eradication a "programmatic emergency for global public health". We aimed to establish why incidence is rising in these countries despite programme innovations including the introduction of new vaccines. METHODS: We did a matched case-control analysis based on a database of 46,977 children aged 0-14 years with onset of acute flaccid paralysis between Jan 1, 2001, and Dec 31, 2011. The vaccination history of children with poliomyelitis was compared with that of children with acute flaccid paralysis due to other causes to estimate the clinical effectiveness of oral poliovirus vaccines (OPVs) in Afghanistan and Pakistan by conditional logistic regression. We estimated vaccine coverage and serotype-specific vaccine-induced population immunity in children aged 0-2 years and assessed their association with the incidence of poliomyelitis over time in seven regions of Afghanistan and Pakistan. FINDINGS: Between Jan 1, 2001, and Dec 31, 2011, there were 883 cases of serotype 1 poliomyelitis (710 in Pakistan and 173 in Afghanistan) and 272 cases of poliomyelitis serotype 3 (216 in Pakistan and 56 in Afghanistan). The estimated clinical effectiveness of a dose of trivalent OPV against serotype 1 poliomyelitis was 12·5% (95% CI 5·6-18·8) compared with 34·5% (16·1-48·9) for monovalent OPV (p=0·007) and 23·4% (10·4-34·6) for bivalent OPV (p=0·067). Bivalent OPV was non-inferior compared with monovalent OPV (p=0·21). Vaccination coverage decreased during 2006-11 in the Federally Administered Tribal Areas (FATA), Balochistan, and Khyber Pakhtunkhwa in Pakistan and in southern Afghanistan. Although partially mitigated by the use of more effective vaccines, these decreases in coverage resulted in lower vaccine-induced population immunity to poliovirus serotype 1 in FATA and Balochistan and associated increases in the incidence of poliomyelitis. INTERPRETATION: The effectiveness of bivalent OPV is comparable with monovalent OPV and can therefore be used in eradicating serotype 1 poliomyelitis whilst minimising the risks of serotype 3 outbreaks. However, decreases in vaccination coverage in parts of Pakistan and southern Afghanistan have severely limited the effect of this vaccine. FUNDING: Poliovirus Research subcommittee of WHO, Royal Society, and Medical Research Council.


Assuntos
Doenças Endêmicas/prevenção & controle , Programas de Imunização , Vacinação em Massa , Paralisia/virologia , Poliomielite/epidemiologia , Poliomielite/prevenção & controle , Vacina Antipólio Oral/administração & dosagem , Poliovirus/imunologia , Doença Aguda , Adolescente , Afeganistão/epidemiologia , Estudos de Casos e Controles , Criança , Pré-Escolar , Doenças Endêmicas/estatística & dados numéricos , Feminino , Humanos , Programas de Imunização/organização & administração , Programas de Imunização/tendências , Incidência , Lactente , Recém-Nascido , Modelos Logísticos , Masculino , Vacinação em Massa/métodos , Vacinação em Massa/tendências , Hipotonia Muscular/virologia , Paquistão/epidemiologia , Poliomielite/imunologia , Poliovirus/classificação , Poliovirus/patogenicidade , Organização Mundial da Saúde
10.
N Engl J Med ; 362(25): 2360-9, 2010 Jun 24.
Artigo em Inglês | MEDLINE | ID: mdl-20573924

RESUMO

BACKGROUND: The largest recorded outbreak of a circulating vaccine-derived poliovirus (cVDPV), detected in Nigeria, provides a unique opportunity to analyze the pathogenicity of the virus, the clinical severity of the disease, and the effectiveness of control measures for cVDPVs as compared with wild-type poliovirus (WPV). METHODS: We identified cases of acute flaccid paralysis associated with fecal excretion of type 2 cVDPV, type 1 WPV, or type 3 WPV reported in Nigeria through routine surveillance from January 1, 2005, through June 30, 2009. The clinical characteristics of these cases, the clinical attack rates for each virus, and the effectiveness of oral polio vaccines in preventing paralysis from each virus were compared. RESULTS: No significant differences were found in the clinical severity of paralysis among the 278 cases of type 2 cVDPV, the 2323 cases of type 1 WPV, and the 1059 cases of type 3 WPV. The estimated average annual clinical attack rates of type 1 WPV, type 2 cVDPV, and type 3 WPV per 100,000 susceptible children under 5 years of age were 6.8 (95% confidence interval [CI], 5.9 to 7.7), 2.7 (95% CI, 1.9 to 3.6), and 4.0 (95% CI, 3.4 to 4.7), respectively. The estimated effectiveness of trivalent oral polio vaccine against paralysis from type 2 cVDPV was 38% (95% CI, 15 to 54%) per dose, which was substantially higher than that against paralysis from type 1 WPV (13%; 95% CI, 8 to 18%), or type 3 WPV (20%; 95% CI, 12 to 26%). The more frequent use of serotype 1 and serotype 3 monovalent oral polio vaccines has resulted in improvements in vaccine-induced population immunity against these serotypes and in declines in immunity to type 2 cVDPV. CONCLUSIONS: The attack rate and severity of disease associated with the recent cVDPV identified in Nigeria are similar to those associated with WPV. International planning for the management of the risk of WPV, both before and after eradication, must include scenarios in which equally virulent and pathogenic cVDPVs could emerge.


Assuntos
Poliomielite/etiologia , Vacina Antipólio Oral/efeitos adversos , Poliovirus/patogenicidade , Adolescente , Criança , Pré-Escolar , Humanos , Lactente , Nigéria/epidemiologia , Paraplegia/epidemiologia , Paraplegia/virologia , Poliomielite/epidemiologia , Poliomielite/prevenção & controle , Poliomielite/virologia , Poliovirus/imunologia , Vacina Antipólio Oral/administração & dosagem , Vacina Antipólio Oral/imunologia , Vigilância da População , Índice de Gravidade de Doença , Vacinação/efeitos adversos
11.
J Infect Dis ; 205(10): 1554-61, 2012 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-22448007

RESUMO

BACKGROUND: The eradication of wild-type polioviruses in areas with efficient fecal-oral transmission relies on intestinal mucosal immunity induced by oral poliovirus vaccine (OPV). Mucosal immunity is thought to wane over time but the rate of loss of protection has not been examined. METHODS: We examined the degree and duration of intestinal mucosal immunity in India by measuring the prevalence of vaccine poliovirus in stool samples collected 4-28 days after a "challenge" dose of OPV among 47 574 children with acute flaccid paralysis reported during 2005-2009. RESULTS: Previous vaccination with OPV was protective against excretion of vaccine poliovirus after challenge, but the odds of excretion increased significantly with the time since the child was last exposed to an immunization activity (odds ratio, 1.39 [95% confidence interval .99-1.97], 2.04 [1.28-3.25], and 1.31 [1.00-1.70] comparing ≥6 months with 1 month ago for serotypes 1, 2, and 3, respectively). Vaccine administered during the high season for enterovirus infections (April-September) was significantly less likely to result in excretion, especially in northern states (odds ratio, 0.57 [95% confidence interval, .50-.65], 0.58 [.41-.81], and 0.48 [.40-.57] for serotypes 1, 2, and 3). CONCLUSIONS: Infection with OPV (vaccine "take") is highly seasonal in India and results in intestinal mucosal immunity that appears to wane significantly within a year of vaccination.


Assuntos
Mucosa Intestinal/imunologia , Poliomielite/imunologia , Poliomielite/prevenção & controle , Vacina Antipólio Oral/imunologia , Poliovirus/imunologia , Pré-Escolar , Fezes/virologia , Feminino , Humanos , Imunidade nas Mucosas/imunologia , Índia , Lactente , Modelos Logísticos , Masculino , Poliomielite/virologia , Poliovirus/isolamento & purificação , Poliovirus/fisiologia , Estações do Ano , Fatores de Tempo , Vacinação , Eliminação de Partículas Virais
12.
PLoS Med ; 8(10): e1001109, 2011 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-22028632

RESUMO

BACKGROUND: Outbreaks of poliomyelitis in African countries that were previously free of wild-type poliovirus cost the Global Polio Eradication Initiative US$850 million during 2003-2009, and have limited the ability of the program to focus on endemic countries. A quantitative understanding of the factors that predict the distribution and timing of outbreaks will enable their prevention and facilitate the completion of global eradication. METHODS AND FINDINGS: Children with poliomyelitis in Africa from 1 January 2003 to 31 December 2010 were identified through routine surveillance of cases of acute flaccid paralysis, and separate outbreaks associated with importation of wild-type poliovirus were defined using the genetic relatedness of these viruses in the VP1/2A region. Potential explanatory variables were examined for their association with the number, size, and duration of poliomyelitis outbreaks in 6-mo periods using multivariable regression analysis. The predictive ability of 6-mo-ahead forecasts of poliomyelitis outbreaks in each country based on the regression model was assessed. A total of 142 genetically distinct outbreaks of poliomyelitis were recorded in 25 African countries, resulting in 1-228 cases (median of two cases). The estimated number of people arriving from infected countries and <5-y childhood mortality were independently associated with the number of outbreaks. Immunisation coverage based on the reported vaccination history of children with non-polio acute flaccid paralysis was associated with the duration and size of each outbreak, as well as the number of outbreaks. Six-month-ahead forecasts of the number of outbreaks in a country or region changed over time and had a predictive ability of 82%. CONCLUSIONS: Outbreaks of poliomyelitis resulted primarily from continued transmission in Nigeria and the poor immunisation status of populations in neighbouring countries. From 1 January 2010 to 30 June 2011, reduced transmission in Nigeria and increased incidence in reinfected countries in west and central Africa have changed the geographical risk of polio outbreaks, and will require careful immunisation planning to limit onward spread. Please see later in the article for the Editors' Summary.


Assuntos
Modelos Estatísticos , Poliomielite/epidemiologia , Poliovirus/patogenicidade , África/epidemiologia , Surtos de Doenças/prevenção & controle , Surtos de Doenças/estatística & dados numéricos , Humanos , Poliomielite/virologia
13.
Lancet ; 376(9753): 1682-8, 2010 Nov 13.
Artigo em Inglês | MEDLINE | ID: mdl-20980048

RESUMO

BACKGROUND: Poliovirus types 1 and 3 co-circulate in poliomyelitis-endemic countries. We aimed to assess the immunogenicity of a novel bivalent types 1 and 3 oral poliovirus vaccine (bOPV). METHODS: We did a randomised, double-blind, controlled trial to assess the superiority of monovalent type 2 OPV (mOPV2), mOPV3, or bOPV over trivalent OPV (tOPV), and the non-inferiority of bivalent vaccine compared with mOPV1 and mOPV3. The study was done at three centres in India between Aug 6, 2008, and Dec 26, 2008. Random allocation was done by permuted blocks of ten. The primary outcome was seroconversion after one monovalent or bivalent vaccine dose compared with a dose of trivalent vaccine at birth. The secondary endpoints were seroconversion after two vaccine doses compared with after two trivalent vaccine doses and cumulative two-dose seroconversion. Parents or guardians and study investigators were masked to treatment allocation. Because of multiple comparisons, we defined p≤0·01 as statistically significant. This trial is registered with Current Controlled Trials, ISRCTN 64725429. RESULTS: 900 newborn babies were randomly assigned to one of five vaccine groups (about 180 patients per group); of these 70 (8%) discontinued, leaving 830 (92%) for analysis. After the first dose, seroconversion to poliovirus type 1 was 20% for both mOPV1 (33 of 168) and bOPV (32 of 159) compared with 15% for tOPV (25 of 168; p>0·01), to poliovirus type 2 was 21% (35 of 170) for mOPV2 compared with 25% (42 of 168) for tOPV (p>0·01), and to poliovirus type 3 was 12% (20 of 165) for mOPV3 and 7% (11 of 159) for bOPV compared with 4% (7 of 168) for tOPV (mOPV3 vs tOPV p=0·01; bOPV vs tOPV; p>0·01). Cumulative two-dose seroconversion to poliovirus type 1 was 90% (151 of 168) for mOPV1 and 86% (136 of 159) for bOPV compared with 63% (106 of 168) for tOPV (p<0·0001), to poliovirus type 2 was 90% (153 of 170) for mOPV2 compared with 91% (153 of 168) for tOPV (p>0·01), and to poliovirus type 3 was 84% (138 of 165) for mOPV3 and 74% (117 of 159) for bOPV compared with 52% (87 of 168) for tOPV (p<0·0001). The vaccines were well tolerated. 19 serious adverse events occurred, including one death; however, these events were not attributed to the trial interventions. INTERPRETATION: The findings show the superiority of bOPV compared with tOPV, and the non-inferiority of bOPV compared with mOPV1 and mOPV3. FUNDING: GAVI Alliance, World Health Organization, and Panacea Biotec.


Assuntos
Vacina Antipólio Oral/imunologia , Poliovirus/imunologia , Anticorpos Antivirais/sangue , Método Duplo-Cego , Fezes/virologia , Humanos , Lactente , Recém-Nascido , Masculino , Poliomielite/prevenção & controle , Poliovirus/isolamento & purificação , Vacina Antipólio Oral/efeitos adversos , Vacinação
14.
N Engl J Med ; 359(16): 1666-74, 2008 Oct 16.
Artigo em Inglês | MEDLINE | ID: mdl-18923171

RESUMO

BACKGROUND: The number of cases of paralytic poliomyelitis has declined in Nigeria since the introduction of newly licensed monovalent oral poliovirus vaccines and new techniques of vaccine delivery. Understanding the relative contribution of these vaccines and the improved coverage to the decline in incident cases is essential for future planning. METHODS: We estimated the field efficacies of monovalent type 1 oral poliovirus vaccine and trivalent oral poliovirus vaccine, using the reported number of doses received by people with poliomyelitis and by matched controls as identified in Nigeria's national surveillance database, in which 27,379 cases of acute flaccid paralysis were recorded between 2001 and 2007. Our estimates of vaccine coverage and vaccine-induced immunity were based on the number of doses received by children listed in the database who had paralysis that was not caused by poliovirus. RESULTS: The estimated efficacies per dose of monovalent type 1 oral poliovirus vaccine and trivalent oral poliovirus vaccine against type 1 paralytic poliomyelitis were 67% (95% confidence interval [CI], 39 to 82) and 16% (95% CI, 10 to 21), respectively, and the estimated efficacy per dose of trivalent oral poliovirus vaccine against type 3 paralytic poliomyelitis was 18% (95% CI, 9 to 26). In the northwestern region of Nigeria, which reported the majority of cases during the study period, coverage with at least one dose of vaccine increased from 59 to 78%. Between 2005 and 2007, vaccine-induced immunity levels among children under the age of 5 years more than doubled, to 56%. CONCLUSIONS: The higher efficacy of monovalent type 1 oral poliovirus vaccine (four times as effective as trivalent oral poliovirus vaccine) and the moderate gains in coverage dramatically increased vaccine-induced immunity against serotype 1 in northern Nigeria. Further increases in coverage in Nigerian states with infected populations are required to achieve the levels of vaccine-induced immunity associated with the sustained elimination achieved in other parts of the country.


Assuntos
Poliomielite/prevenção & controle , Vacina Antipólio Oral/imunologia , Poliovirus/isolamento & purificação , Estudos de Casos e Controles , Criança , Pré-Escolar , Fezes/virologia , Feminino , Humanos , Lactente , Modelos Logísticos , Masculino , Nigéria/epidemiologia , Poliomielite/epidemiologia , Poliomielite/imunologia , Poliovirus/classificação , Vacina Antipólio Oral/administração & dosagem , Vacinação/estatística & dados numéricos
18.
Lancet ; 369(9570): 1356-1362, 2007 Apr 21.
Artigo em Inglês | MEDLINE | ID: mdl-17448821

RESUMO

BACKGROUND: A high-potency monovalent oral type 1 poliovirus vaccine (mOPV1) was developed in 2005 to tackle persistent poliovirus transmission in the last remaining infected countries. Our aim was to assess the efficacy of this vaccine in India. METHODS: We estimated the efficacy of mOPV1 used in supplementary immunisation activities from 2076 matched case-control pairs of confirmed cases of poliomyelitis caused by type 1 wild poliovirus and cases of non-polio acute flaccid paralysis in India. The effect of the introduction of mOPV1 on population immunity was calculated on the basis of estimates of vaccination coverage from data for non-polio acute flaccid paralysis. FINDINGS: In areas of persistent poliovirus transmission in Uttar Pradesh, the protective efficacy of mOPV1 was estimated to be 30% (95% CI 19-41) per dose against type 1 paralytic disease, compared with 11% (7-14) for the trivalent oral vaccine. 76-82% of children aged 0-23 months were estimated to be protected by vaccination against type 1 poliovirus at the end of 2006, compared with 59% at the end of 2004, before the introduction of mOPV1. INTERPRETATION: Under conditions where the efficacy of live-attenuated oral poliovirus vaccines is compromised by a high prevalence of diarrhoea and other infections, a dose of high-potency mOPV1 is almost three times more effective against type 1 poliomyelitis disease than is trivalent vaccine. Achieving high coverage with this new vaccine in areas of persistent poliovirus transmission should substantially improve the probability of rapidly eliminating transmission of the disease.


Assuntos
Programas de Imunização/estatística & dados numéricos , Paraplegia/prevenção & controle , Poliomielite/prevenção & controle , Vacinas contra Poliovirus/imunologia , Vigilância da População/métodos , Estudos de Casos e Controles , Pré-Escolar , Humanos , Índia/epidemiologia , Lactente , Modelos Logísticos , Paraplegia/epidemiologia , Paraplegia/imunologia , Poliomielite/epidemiologia , Poliomielite/imunologia , Vacinas contra Poliovirus/classificação
19.
Am J Public Health ; 98(7): 1322-30, 2008 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-18511720

RESUMO

OBJECTIVES: We assessed the costs, risks, and benefits of possible future major policy decisions on vaccination, surveillance, response plans, and containment following global eradication of wild polioviruses. METHODS: We developed a decision analytic model to estimate the incremental cost-effectiveness ratios and net benefits of risk management options for polio for the 20-year period and stratified the world according to income level to capture important variability between nations. RESULTS: For low-, lower-middle-, and upper-middle-income groups currently using oral poliovirus vaccine (OPV), we found that after successful eradication of wild polioviruses, OPV cessation would save both costs and lives when compared with continued use of OPV without supplemental immunization activities. We found cost-effectiveness ratios for switching from OPV to inactivated poliovirus vaccine to be higher (i.e., less desirable) than other health investment opportunities, depending on the actual inactivated poliovirus vaccine costs and assumptions about whether supplemental immunization activities with OPV would continue. CONCLUSIONS: Eradication promises billions of dollars of net benefits, although global health policy leaders face difficult choices about future policies. Until successful eradication and coordination of posteradication policies, health authorities should continue routine polio vaccination and supplemental immunization activities.


Assuntos
Programas de Imunização/economia , Programas de Imunização/tendências , Poliomielite/prevenção & controle , Vacinas contra Poliovirus/economia , Gestão de Riscos/economia , Criança , Análise Custo-Benefício , Surtos de Doenças/prevenção & controle , Saúde Global , Política de Saúde , Humanos , Modelos Econômicos , Vacina Antipólio de Vírus Inativado/economia , Vacina Antipólio Oral/economia , Vacinas contra Poliovirus/uso terapêutico , Saúde Pública , Reprodutibilidade dos Testes , Gestão de Riscos/métodos , Gestão de Riscos/organização & administração
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