Immunogenicity and Vaccine Shedding After 1 or 2 Doses of rVSVΔG-ZEBOV-GP Ebola Vaccine (ERVEBO®): Results From a Phase 2, Randomized, Placebo-controlled Trial in Children and Adults.

BACKGROUND: The rVSVΔG-ZEBOV-GP vaccine (ERVEBO®) is a single-dose, live-attenuated, recombinant vesicular stomatitis virus vaccine indicated for the prevention of Ebola virus disease (EVD) caused by Zaire ebolavirus in individuals 12 months of age and older. METHODS: The Partnership for Research on Ebola VACcination (PREVAC) is a multicenter, phase 2, randomized, double-blind, placebo-controlled trial of 3 vaccine strategies in healthy children (ages 1-17) and adults, with projected 5 years of follow-up (NCT02876328). Using validated assays (GP-ELISA and PRNT), we measured antibody responses after 1-dose rVSVΔG-ZEBOV-GP, 2-dose rVSVΔG-ZEBOV-GP (given on Day 0 and Day 56), or placebo. Furthermore, we quantified vaccine virus shedding in a subset of children's saliva using RT-PCR. RESULTS: In total, 819 children and 783 adults were randomized to receive rVSVΔG-ZEBOV-GP (1 or 2 doses) or placebo. A single dose of rVSVΔG-ZEBOV-GP increased antibody responses by Day 28 that were sustained through Month 12. A second dose of rVSVΔG-ZEBOV-GP given on Day 56 transiently boosted antibody concentrations. In vaccinated children, GP-ELISA titers were superior to placebo and non-inferior to vaccinated adults. Vaccine virus shedding was observed in 31.7% of children, peaking by Day 7, with no shedding observed after Day 28 post-dose 1 or any time post-dose 2. CONCLUSIONS: A single dose of rVSVΔG-ZEBOV-GP induced robust antibody responses in children that was non-inferior to the responses induced in vaccinated adults. Vaccine virus shedding in children was time-limited and only observed after the first dose. Overall, these data support the use of rVSVΔG-ZEBOV-GP for the prevention of EVD in at-risk children. Clinical Trials Registration. The study is registered at ClinicalTrials.gov (NCT02876328), the Pan African Clinical Trials Registry (PACTR201712002760250), and the European Clinical Trials Register (EudraCT number: 2017-001798-18).

In the era of humanitarian crisis, young women continue to die in childbirth in Mali.

Maternal mortality occurs mostly in contexts of poverty and health system collapse. Mali has a very high maternal mortality rate and this extremely high mortality rate is due in part to longstanding constraints in maternal health services. The central region has been particularly affected by the humanitarian crisis in recent years, and maternal health has been aggravated by the conflict. Sominé Dolo Hospital is located in Mopti, central region. In the last decade, a high number of pregnant or delivering women have died in this hospital.We conducted a retrospective and exhaustive study of maternal deaths occurring in Mopti hospital. Between 2007 and 2019, 420 women died, with an average of 32 deaths per year. The years 2014-2015 and the last 2 years have been particularly deadly, with 40 and 50 deaths in 2018 and 2019, respectively. The main causes were hypertensive disorders/eclampsia and haemorrhage. 80% of these women's deaths were preventable. Two major explanations result in these maternal deaths in Sominé Dolo's hospital: first, a lack of accessible and safe blood, and second, the absence of a reference and evacuation referral system, all of which are aggravated by security issues in and around Mopti.Access to quality hospital care is in dire need in the Mopti region. There is an urgent need for a safe blood collection system and free of charge for pregnant women. We also strongly recommend that the referral/evacuation system be reinvigorated, and that universal health coverage be strengthened.

Diagnostic Performances of Three Rapid Diagnostic Tests for Detecting HIV Infections in Mali.

Diagnosis of HIV infections in resource-limited countries like Mali is based on Rapid Diagnostic Tests (RDTs). The RDTs are diagnostic assays designed for use at the Point-Of-Care (POC), which is quick, cost-effective and easy to perform. However, in these countries, the tests are commonly used without any initial evaluation or monitoring of their performance despite high levels of HIV strain diversity and rapid evolution of the virus. In this study, the reliability and accuracy of HIV RDTs (Determine™, Multispot™, SD Bioline™) used in Mali, where HIV-1 and HIV-2 co-exist, were evaluated from August 2004 to November 2017. A total of 1303 samples from new HIV-suspect patients in Bamako were tested for HIV-1 and HIV-2 using the RDT Determine™, followed by ELISA and Western Blot (WB). The Determine™ test showed a robust diagnostic sensitivity of 98.7% [CI 95: 97.59-99.37] and a diagnostic specificity of 99.2% [CI 95: 98.22-99.67]. The Multispot™ assay showed a diagnostic sensitivity of 98.77% [CI 95: 97.59-99.37] and a diagnostic specificity of 99.2% [CI 95: 98.22-99.67]. The diagnostic sensitivity and specificity of SD Bioline™ HIV-1/2 were 100% [CI 95:72.25-100] and 88.89% [CI 95: 56.50- 98.71], respectively. These data indicate excellent performance for HIV RDTs in Mali and we recommend the use of Determine™ HIV-1/2 for HIV screening and Multispot™ for discriminating HIV-2 from HIV-1 infections.

[Consent To The Episiotomy About 331 Cases At The Health Reference Center Of The "Commune I" Of The District Of Bamako]. / Consentement A L'Episiotomie A Propos De 331 Cas Au Centre De Sante De Reference De La Commune I Du District De Bamako.

Episiotomy is a surgical act performed during childbirth to widen the vaginal opening; like any other medical procedure, its benefits and risks must be made known to patients in accordance with the legal and regulatory provisions of each country.The principle of immunity of the human body makes that the consent in the care is the keystone of the doctor-patient relationship, this consent is the first legitimization of the medicalact. The consent has to «be free and lit¼ as far as the decision of the patient must be taken without any constraint or pressure having obtained all the necessary information. This practice is not respected most of the time in our countries in spite of the fact that it's not observance engages the responsibility of the practitioner. OBJECTIVE: Study the consent of women who have undergone an episiotomy at the reference health center of "commune I" in the District of Bamako. METHOD AND MATERIAL: This is a prospective cross-sectional study conducted at the Obstetric Gynecology Department of the "Commune I" Health Center of the Bamako District from March 1, 2010 to February 29, 2012, involving 331 patients. We conducted the history and physical examination of women seen in post natal consultation who had undergone an episiotomy, a survey sheet was completed for each of them meeting our criteria. Data capture and analysis was done on SPSS 18; the texts and tables were processed on Microsoft Word Office 2007 software; Graphic representations were processed on Microsoft Excel Office 2007. ETHICAL ASPECTS: Women were informed of the study's objectives and interests; Confidential and anonymous insurance. RESULTS: In our study the practice of the episiotomy concerned 32, 19 % of the cases of assisted childbirths. The average age of the patients was of 25 years with extremes going of 14-46 years, the rigidity of the perineum was the main indication of the episiotomy in 41.1% of cases. Only 32.02% of the participants were previously informed prior to the practice of episiotomy. The information given was well understood in the same proportions is 32, 02% of cases and the assent lit with the episiotomy was obtnained in 29.31%. of cases. The information given was well understood in the same proportions of 32.02% of cases and informed consent to episiotomy was obtained in 29.31% of cases. CONCLUSION: In our study, the majority of our women have undergone episiotomy without any consent; the respect of the fundamental rights of the sick by health personnel, through the search for free and informed consent throughout the process of care, any breach of this duty constitutes a violation of the legal and ethical provisions.

L'épisiotomie est un acte chirurgical pratiqué aucours de l'accouchement pour élargir l'orifice vaginal ; comme tout autre acte médical, ses avantages et risques doivent être mis à la connaissance des patients conformément aux dispositions légales et réglementaires de chaque pays. Le principe d'inviolabilité du corps humain fait que le consentement aux soins est la clé de voûte de la relation médecin-patient, ce consentement est la légitimation première de l'acte médical. Le consentement doit être « libre et éclairé" dans la mesure où la décision du patient doit être prise sans aucune contrainte ou pression après avoir obtenu toutes les informations nécessaires. Cette pratique n'est pas le plus souvent respectée dans nos pays en dépit du fait que la non observance engage la responsabilité du praticien. OBJECTIF GÉNÉRAL: Etudier le consentement des parturientes ayant subi une épisiotomie au centre de santé de référence de la commune I du District de Bamako. OBJECTIFS SPÉCIFIQUES: Déterminer la fréquence des patientes ayant subi l'épisiotomie chez lesquelles l'information est donnée ; Déterminer la fréquence des patientes ayant subi l'épisiotomie ayant parfaitement compris l'information donnée ; Déterminer la fréquence des patientes ayant subi l'épisiotomie chez lesquelles le consentement éclairé à l'épisiotomie est obtenu. RÉSULTATS: Dans notre étude la pratique de l'épisiotomie a concernée 32,19% des cas d'accouchements assistés. L'âge moyen des patientes était de 25 ans avec des extrêmes allant de 14-46 ans. La rigidité du périnée était la principale indication de l'épisiotomie avec 41,1% des cas. Seulement 32,02% des parturientes étaient au préalable informées avant la pratique de l'épisiotomie. Les informations données étaient bien comprises dans les mêmes proportions soit 32,02%des cas et le consentement éclairé à l'épisiotomie a été obtenu dans 29,31%des cas. CONCLUSION: Dans notre étude, la majorité de nos parturientes a subi l'épisiotomie sans aucun consentement ; le respect des droits fondamentaux des malades par le personnel sanitaire, passe par la recherche d'un consentement libre et éclairé tout au long du processus de la prise en charge, tout manquement à ce devoir constitue une violation des dispositions légales et déontologiques.

Assessment of poliovirus antibody seroprevalence in polio high risk areas of West Africa.

We conducted a serological survey of anti-polio antibodies in polio high-risk areas of Mali, Guinea and Cote d'Ivoire to assess risk of future poliovirus outbreaks. Random community sampling of children 6-11 and 36-48 months-old was conducted; neutralizing antibodies against poliovirus were detected using microneutralization assay. We analysed 1059/1064 (99.5%) of enrolled children. Seroprevalence to poliovirus type 1 (PV1) across all age groups and locations ranged between 92 and 100%, for PV2 it was 77-100%, and 89-95% for PV3. PV2 seroprevalence in the younger age group in Guinea and Cote d'Ivoire was <80%. History of <4 polio vaccine doses and acute malnutrition were associated with seronegativity (OR = 2.1 CI95% = 1.5-3.1, OR = 1.8 CI95% = 1.1-3.3 respectively). The risk of poliovirus outbreak following importation is low because of high population immunity to PV1, however, due to large cohort of PV2 seronegative children any future detection of vaccine-derived poliovirus type 2 requires urgent response to arrest rapid spread.

Superiority of 3 over 2 doses of intermittent preventive treatment with sulfadoxine-pyrimethamine for the prevention of malaria during pregnancy in mali: a randomized controlled trial.

BACKGROUND: In 2003, Mali introduced intermittent preventive therapy in pregnancy (ITPp) with sulfadoxine-pyrimethamine (SP) for the control of malaria in pregnancy, consisting of 2 doses of SP given in the 2nd and 3rd trimester. This widely used regimen, although very effective, leaves many women unprotected from malaria during the last 4-to-8 weeks of gestation, which is a pivotal period for fetal weight gain. The aim of the study was to compare the efficacy and safety of 3-dose versus 2-dose IPTp-SP for the prevention of placental malaria and associated low birth weight (LBW). METHODS: We conducted a parallel-group, open-label, individually randomized controlled superiority trial involving 814 women of all gravidity, enrolled from April 2006 through March 2008. All women were seen at least 3 times and received either 2 (n = 401) or 3 (n = 413) doses of IPTp-SP. The primary endpoint measured was placental malaria, LBW, preterm births, and maternal anemia were secondary endpoints, and severe maternal skin reactions and neonatal jaundice were safety endpoints. RESULTS: Among the 96% of study subjects who were followed up until delivery, the prevalence of placental malaria was 2-fold lower in the 3-dose group (8.0%) than in the 2-dose group (16.7%); the adjusted prevalence ratio (APR) was 0.48 (95% confidence interval [CI], 0.32-0.71). LBW and preterm births were also reduced; the prevalence of LBW was 6.6% in the 3-dose group versus 13.3% in the 2-dose group (APR, 0.50; 95% CI, 0.32-0.79), and the prevalence of preterm births was 3.2% versus 8.9% (APR, 0.37; 95% CI, 0.19-0.71). No significant reductions in maternal anemia or differences in safety endpoints were observed. CONCLUSIONS: Adding a third dose of ITPp-SP halved the risk of placental malaria, LBW, and preterm births in all gravidae, compared with the standard 2-dose regimen, in this area of highly seasonal transmission with low levels of SP resistance. CLINICAL TRIALS REGISTRATION: ISRCTN 74189211.