Lancet
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Randomized Controlled Trial Clinical Trial
Efficacy trial of malaria vaccine SPf66 in Gambian infants.
SPf66 malaria vaccine is a synthetic protein with aminoacid sequences derived from pre-erythrocytic and asexual blood-stage proteins of Plasmodium falciparum. SPf66 was found to have a 31% protective efficacy in an area of intensive malaria transmission in Tanzanian children, 1-5 years old. We report a randomised, double-blind, placebo-controlled trial of SPf66 against clinical P falciparum malaria in Gambian infants. 630 children, aged 6-11 months at time of the first dose, received three doses of SPf66 or injected polio vaccine (IPV). ⋯ No significant differences in parasite rates or in any other index of malaria were found between the two groups of children. The findings of this study differ from previous reports on SPf66 efficacy from South America and from Tanzania. In The Gambia, protection against clinical attacks of malaria during the rainy season after immunisation in children 6-11 months old at time of the first dose was not achieved.
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The perinatal mortality rate is widely used as a summary statistic for evaluating the effectiveness of perinatal care. Since October, 1992, it has been a legal requirement in England and Wales to register fetal deaths at 24-27 completed weeks of gestation as stillbirths (in addition to those after 28 weeks), thereby altering the definition of perinatal death. In a cohort analysis of all babies born to women resident in Wales during 1993, we assessed whether the revised definition of perinatal mortality rate more appropriately measures effectiveness of care. ⋯ At 24-27 weeks' gestation there were 59 (39%) survivors and 93 deaths (52 stillbirths, 36 neonatal deaths [28 early, eight late], and 5 postneonatal deaths). 119 babies had a birthweight below 500 g; one survived and 24 were perinatal deaths. Of the 36 late neonatal deaths all were attributed to perinatally related events. Increased survival of infants at 24-27 weeks' gestation emphasises the importance of including all these infants in the perinatal mortality rate, but it would be a more useful measure of the effectiveness of perinatal care if it excluded babies below 500 g, and included late neonatal deaths.