7 research outputs found

    Influenza vaccination of pregnant women and protection of their infants

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    BACKGROUND There are limited data on the efficacy of vaccination against confirmed influenza in pregnant women with and those without human immunodeficiency virus (HIV) infection and protection of their infants. METHODS We conducted two double-blind, randomized, placebo-controlled trials of trivalent inactivated influenza vaccine (IIV3) in South Africa during 2011 in pregnant women infected with HIV and during 2011 and 2012 in pregnant women who were not infected. The immunogenicity, safety, and efficacy of IIV3 in pregnant women and their infants were evaluated until 24 weeks after birth. Immune responses were measured with a hemagglutination inhibition (HAI) assay, and influenza was diagnosed by means of reverse-transcriptase–polymerase-chain-reaction (RT-PCR) assays of respiratory samples. RESULTS The study cohorts included 2116 pregnant women who were not infected with HIV and 194 pregnant women who were infected with HIV. At 1 month after vaccination, seroconversion rates and the proportion of participants with HAI titers of 1:40 or more were higher among IIV3 recipients than among placebo recipients in both cohorts. Newborns of IIV3 recipients also had higher HAI titers than newborns of placebo recipients. The attack rate for RT-PCR–confirmed influenza among both HIV-uninfected placebo recipients and their infants was 3.6%. The attack rates among HIV-uninfected IIV3 recipients and their infants were 1.8% and 1.9%, respectively, and the respective vaccine-efficacy rates were 50.4% (95% confidence interval [CI], 14.5 to 71.2) and 48.8% (95% CI, 11.6 to 70.4). Among HIV-infected women, the attack rate for placebo recipients was 17.0% and the rate for IIV3 recipients was 7.0%; the vaccine-efficacy rate for these IIV3 recipients was 57.7% (95% CI, 0.2 to 82.1). CONCLUSIONS Influenza vaccine was immunogenic in HIV-uninfected and HIV-infected pregnant women and provided partial protection against confirmed influenza in both groups of women and in infants who were not exposed to HIV. (Funded by the Bill and Melinda Gates Foundation and others; ClinicalTrials.gov numbers, NCT01306669 and NCT01306682.)The Bill and Melinda Gates Foundation (OPP1002747), the National Institutes of Health, National Center for Advancing Translational Sciences Colorado Clinical and Translational Sciences Institute (UL1 TR000154, for REDCap), the South African Research Chairs Initiative of the Department of Science and Technology and National Research Foundation in Vaccine-Preventable Diseases, and the Respiratory and Meningeal Pathogens Research Unit of the Medical Research Council.http://www.nejm.org/am201

    Global respiratory syncytial virus–related infant community deaths

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    BACKGROUND : Respiratory syncytial virus (RSV) is a leading cause of pediatric death, with >99% of mortality occurring in low and lower middle-income countries. At least half of RSV-related deaths are estimated to occur in the community, but clinical characteristics of this group of children remain poorly characterized. METHODS : The RSV Global Online Mortality Database (RSV GOLD), a global registry of under-5 children who have died with RSV-related illness, describes clinical characteristics of children dying of RSV through global data sharing. RSV GOLD acts as a collaborative platform for global deaths, including community mortality studies described in this supplement. We aimed to compare the age distribution of infant deaths <6 months occurring in the community with in-hospital. RESULTS : We studied 829 RSV-related deaths <1 year of age from 38 developing countries, including 166 community deaths from 12 countries. There were 629 deaths that occurred <6 months, of which 156 (25%) occurred in the community. Among infants who died before 6 months of age, median age at death in the community (1.5 months; IQR: 0.8−3.3) was lower than in-hospital (2.4 months; IQR: 1.5−4.0; P < .0001). The proportion of neonatal deaths was higher in the community (29%, 46/156) than in-hospital (12%, 57/473, P < 0.0001). CONCLUSIONS : We observed that children in the community die at a younger age. We expect that maternal vaccination or immunoprophylaxis against RSV will have a larger impact on RSV-related mortality in the community than in-hospital. This case series of RSV-related community deaths, made possible through global data sharing, allowed us to assess the potential impact of future RSV vaccines.The Bill & Melinda Gates Foundation.am2023Medical Virolog

    Global Respiratory Syncytial Virus-Related Infant Community Deaths.

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    BACKGROUND: Respiratory syncytial virus (RSV) is a leading cause of pediatric death, with >99% of mortality occurring in low- and lower middle-income countries. At least half of RSV-related deaths are estimated to occur in the community, but clinical characteristics of this group of children remain poorly characterized. METHODS: The RSV Global Online Mortality Database (RSV GOLD), a global registry of under-5 children who have died with RSV-related illness, describes clinical characteristics of children dying of RSV through global data sharing. RSV GOLD acts as a collaborative platform for global deaths, including community mortality studies described in this supplement. We aimed to compare the age distribution of infant deaths <6 months occurring in the community with in-hospital. RESULTS: We studied 829 RSV-related deaths <1 year of age from 38 developing countries, including 166 community deaths from 12 countries. There were 629 deaths that occurred <6 months, of which 156 (25%) occurred in the community. Among infants who died before 6 months of age, median age at death in the community (1.5 months; IQR: 0.8-3.3) was lower than in-hospital (2.4 months; IQR: 1.5-4.0; P < .0001). The proportion of neonatal deaths was higher in the community (29%, 46/156) than in-hospital (12%, 57/473, P < 0.0001). CONCLUSIONS: We observed that children in the community die at a younger age. We expect that maternal vaccination or immunoprophylaxis against RSV will have a larger impact on RSV-related mortality in the community than in-hospital. This case series of RSV-related community deaths, made possible through global data sharing, allowed us to assess the potential impact of future RSV vaccines

    Management of severely ill children at first-level health facilities in sub-Saharan Africa when referral is difficult

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    OBJECTIVES: To quantify the main reasons for referral of infants and children from first-level health facilities to referral hospitals in sub-Saharan Africa and to determine what further supplies, equipment, and legal empowerment might be needed to manage such children when referral is difficult. METHODS: In an observational study at first-level health facilities in Uganda, the United Republic of Tanzania, and Niger, over 3-5 months, we prospectively documented the diagnoses and severity of diseases in children using the standardized Integrated Management of Childhood Illness (IMCI) guidelines. We reviewed the facilities for supplies and equipment and examined the legal constraints of health personnel working at these facilities. FINDINGS: We studied 7195 children aged 2-59 months, of whom 691 (9.6%) were classified under a severe IMCI classification that required urgent referral to a hospital. Overall, 226 children had general danger signs, 292 had severe pneumonia or very severe disease, 104 were severely dehydrated, 31 had severe persistent diarrhoea, 207 were severely malnourished, and 98 had severe anaemia. Considerably more ill were 415 young infants aged one week to two months: nearly three-quarters of these required referral. Legal constraints and a lack of simple equipment (suction pumps, nebulizers, and oxygen concentrators) and supplies (nasogastric tubes and 50% glucose) could prevent health workers from dealing more appropriately with sick children when referral was not possible. CONCLUSION: When referral is difficult or impossible, some additional supplies and equipment, as well as provision of simple guidelines, may improve management of seriously ill infants and children
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