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• Typhoid Vaccine Acceleration Consortium Malawi: A Phase III, Randomized, Double-blind, Controlled Trial of the Clinical Efficacy of Typhoid Conjugate Vaccine Among Children in Blantyre, Malawi

  Meiring, J.E.; Laurens, M.B.; Patel, P. (Oxford University Press, 2019)

  BACKGROUND: Typhoid fever is an acute infection characterized by prolonged fever following the ingestion and subsequent invasion of Salmonella enterica serovar Typhi (S. Typhi), a human-restricted pathogen. The incidence of typhoid fever has been most reported in children 5-15 years of age, but is increasingly recognized in children younger than 5 years old. There has been a recent expansion of multidrug-resistant typhoid fever globally. Prior typhoid vaccines were not suitable for use in the youngest children in countries with a high burden of disease. This study aims to determine the efficacy of a typhoid conjugate vaccine (TCV) that was recently prequalified by the World Health Organization, by testing it in children 9 months through 12 years of age in Blantyre, Malawi. METHODS: In this Phase III, individually randomized, controlled, double-blind trial of the clinical efficacy of TCV, 28 000 children 9 months through 12 years of age will be enrolled and randomized in a 1:1 ratio to receive either Vi-TCV or a meningococcal serogroup A conjugate vaccine. A subset of 600 of these children will be further enrolled in an immunogenicity and reactogenicity sub-study to evaluate the safety profile and immune response elicited by Vi-TCV. Recruiting began in February 2018. RESULTS: All children will be under passive surveillance for at least 2 years to determine the primary outcome, which is blood culture-confirmed S. Typhi illness. Children enrolled in the immunogenicity and reactogenicity sub-study will have blood drawn before vaccination and at 2 timepoints after vaccination to measure their immune response to vaccination. They will also be followed actively for adverse events and serious adverse events. CONCLUSIONS: The introduction of a single-dose, efficacious typhoid vaccine into countries with high burden of disease or significant antimicrobial resistance could have a dramatic impact, protecting children from infection and reducing antimicrobial usage and associated health inequity in the world's poorest places. This trial, the first of a TCV in Africa, seeks to demonstrate the impact and programmatic use of TCVs within an endemic setting. CLINICAL TRIALS REGISTRATION: NCT03299426. © The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America.
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  UM School of Medicine Receives $2 Million Grant for HIV Research in Malawi

  2017-08-02
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  School-age Children Are a Reservoir of Malaria Infection in Malawi

  Walldorf, Jenny Anne; Laufer, Miriam K. (2015)

  Background: Malaria surveillance and interventions in endemic countries often target young children at highest risk of malaria morbidity and mortality. School-age children and adults not captured in surveillance may contribute to malaria transmission. Methods: Cross-sectional surveys were conducted in one rainy and one dry season in southern Malawi. Demographic and health information was collected for all household members. Blood samples were obtained from individuals aged greater than six months for microscopic and PCR identification of Plasmodium falciparum. Results: Specimens were collected from 5,796 individuals. PCR prevalence of malaria infection was 5%, 10%, and 20% in dry, and 9%, 15%, and 32% in rainy seasons in Blantyre, Thyolo, and Chikhwawa, respectively. Over 88% of those infected were asymptomatic. Participants aged 6-15 years were at higher risk of infection (OR = 4.8; 95% CI, 4.0-5.8) and asymptomatic infection (OR = 4.2; 95% CI, 2.7-6.6) than younger children in all settings. School-age children used bednets less frequently than other age groups. Compared to young children, school-age children were brought less often for treatment and more often to unreliable treatment sources. Conclusions: School-age children represent an underappreciated reservoir of malaria infection and have limited exposure to antimalarial interventions. Malaria control and elimination strategies may need to expand to include this age group.