Background Hepatitis B virus (HBV) remains endemic throughout sub-Saharan Africa despite the widespread availability of effective childhood vaccines. In the Democratic Republic of the Congo, HBV treatment and birthdose vaccination programmes are not established. We, therefore, aimed to evaluate the feasibility and acceptability of adding HBV testing and treatment of pregnant women as well as the birth-dose vaccination of HBV-exposed infants to the HIV prevention of mother-to-child transmission programme infrastructure in the Democratic Republic of the Congo. MethodsWe did a feasibility study in two maternity centres in Kinshasa: Binza and Kingasani. Using the already established HIV prevention of mother-to-child transmission programme at these two maternity centres, we screened pregnant women for HBV infection at routine prenatal care registration. Those who tested positive and had a gestational age of 24 weeks or less were included in this study. Eligible pregnant women with a high viral load (≥200 000 IU/mL or HBeAg positivity, or both) were considered as having HBV of high risk of mother-to-child transmission and initiated on oral tenofovir disoproxil fumarate (300 mg/day) between 28 weeks and 32 weeks of gestation and continued through 12 weeks post partum. All HBV-exposed infants received a birth-dose of monovalent HBV vaccine (Euvax-B Pediatric: Sanofi Pasteur, Seoul, South Korea; 0•5 mL) within 24 h of life. All women were followed up for 24 weeks post partum, when they completed an exit questionnaire that assessed the acceptability of study procedures. The primary outcomes were the feasibility of screening pregnant women to identify those at high risk for HBV mother-to-child transmission and to provide them with antiviral prophylaxis, the feasibility of administrating the birth-dose vaccine to exposed infants, and the acceptability of this prevention programme. This study is registered with ClinicalTrials.gov, NCT03567382.

Background The COVID-19 pandemic has led to unprecedented use of telehealth, including by primary care professionals (PCPs) who serve adolescents. Objective To inform future practice and policies, we sought to characterize PCPs’ recent experience using adolescent telehealth as well as their support for it after the COVID-19 pandemic is over. Methods From February to March 2021, we conducted a web-based survey of 1047 PCPs in the United States. Our national sample included physicians (747/1047, 71%), advanced practice providers (177/1047, 17%), and nurses (123/1047, 12%) who provided primary care to adolescents aged 11-17 years. Results Most PCPs reported using telehealth for a low, moderate, or high proportion of their adolescent patients in the three months prior to the survey (424/1047, 40%, 286/1047, 27%, and 219/1047, 21%, respectively); only 11% (118/1047) reported no use. A majority of respondents agreed that adolescent telehealth increases access to care (720/1047, 69%) and enables them to provide high-quality care (560/1047, 53%). Few believed that adolescent telehealth takes too much time (142/1047, 14%) or encourages health care overuse (157/1047, 15%). Most supported giving families the option of adolescent telehealth for primary care after the pandemic is over (683/1047, 65%) and believed that health insurance plans should continue to reimburse for telehealth visits (863/1047, 82%). Approximately two-thirds (702/1047, 67%) wanted to offer adolescent telehealth visits after the pandemic, with intentions being higher among those with recent telehealth experience (P<.001). Conclusions PCPs in our national sample reported widespread use of and predominantly positive attitudes toward adolescent telehealth. Our findings also suggest broad support among PCPs for continuing to offer adolescent telehealth after the COVID-19 pandemic ends.

The novel coronavirus, SARS-CoV-2, can present with a wide range of neurological manifestations, in both adult and pediatric populations. We describe here the case of a previously healthy 8-year-old girl who presented with seizures, encephalopathy, and rapidly progressive, diffuse, and ultimately fatal cerebral edema in the setting of acute COVID-19 infection. CSF analysis, microbiological testing, and neuropathology yielded no evidence of infection or acute inflammation within the central nervous system. Acute fulminant cerebral edema (AFCE) is an often fatal pediatric clinical entity consisting of fever, encephalopathy, and new-onset seizures followed by rapid, diffuse, and medically-refractory cerebral edema. AFCE occurs as a rare complication of a variety of common pediatric infections and a CNS pathogen is identified in only a minority of cases, suggesting a para-infectious mechanism of edema. This report suggests that COVID-19 infection can precipitate AFCE, and highlights the need for high suspicion and early recognition thereof.

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Background Hepatitis B virus (HBV) co-infection in HIV-infected individuals increases the risk of hepatic complications and mortality. Further, the risk of perinatal HBV transmission increases among HBV/HIV co-infected pregnant women. Although HBV is endemic in the Democratic Republic of Congo, there is little data on HBV/HIV co-infection. We aimed to assess the burden and risk factors of HBV surface antigen (HBsAg) positivity among HIV-infected pregnant and post-partum women. Methods This cross-sectional study was conducted as part of an ongoing trial to assess the effect of data-driven continuous quality improvement interventions (CQI) for optimal prevention of mother-to-child transmission (PMTCT) of HIV (CQI-PMTCT study, NCT03048669). In each of the 35 health zones of Kinshasa province, all HIV-infected pregnant or breastfeeding women (≤1 year post-delivery) presenting for care in one of the three busiest maternal and child health clinics of the health zone were tested for HBsAg using Alere Determine, Japan. We used logistic regression with general estimating equation accounting for within-clinic clustering to assess risk factors of HBsAg positivity. Results Between November 2016 and June 2018, a total of 1377 women, all on antiretroviral therapy, were tested for HBsAg. Overall, 4.7% [95% binomial confidence interval (CI): 3.7%-5.7%] tested positive for HBsAg. HBsAg prevalence was 3.3% (95% CI: 2.1%-4.8%) for women tested during pregnancy, 4.5% (2.5%-7.4%) for those tested at delivery, and 8.5% (5.6%-12.2%) for those tested post-partum ( P trend = 0.001). In multivariate models including socio-economic status (SES), type of care facility, duration of antiretroviral therapy, HIV viral load, and self-reported intimate partner violence (IPV), lowest tertile of SES, ≤ 6 months of ART, and IPV were all consistently and positively associated with higher prevalence of HBsAg across pregnancy, delivery, and postpartum period while been tested in a health centre or having a viral load ≥ 1000 copies/mL were consistently associated with lower prevalence. However, only the association with IPV (OR = 2.74, 95% CI: 1.10–6.84) and viral load between 40–1000 copies/ml (OR = 4.28, 95% CI: 1.22–15.01) achieved statistical significance among pregnant women. Conclusion This study revealed an overall high prevalence of HBsAg among HIV-infected pregnant and post-partum women in Kinshasa with the latter showing the highest HBsAg prevalence. Among pregnant women, intimate partner violence was independently and statistically associated with HBsAg positivity, requiring further investigation.

Background: Coronavirus disease 2019 is a pandemic with no specific therapeutic agents or vaccination. Small published case series on critically ill adults suggest improvements in clinical status with minimal adverse events when patients receive coronavirus disease 2019 convalescent plasma, but data on critically ill pediatric patients are lacking. We report a series of four critically ill pediatric patients with acute respiratory failure who received coronavirus disease 2019 convalescent plasma as a treatment strategy for severe disease. Case Summary: Patients ranged in age from 5 to 16 years old. All patients received coronavirus disease 2019 convalescent plasma within the first 26 hours of hospitalization. Additional disease modifying agents were also used. All patients made a full recovery and were discharged home off of oxygen support. No adverse events occurred from the coronavirus disease 2019 convalescent plasma transfusions. Conclusion: Coronavirus disease 2019 convalescent plasma is a feasible therapy for critically ill pediatric patients infected with severe acute respiratory syndrome coronavirus 2. Well-designed clinical trials are necessary to determine overall safety and efficacy of coronavirus disease 2019 convalescent plasma and additional treatment modalities in pediatric patients.

Background National vaccine policies across the world have successfully improved infant vaccine coverage, but birth-dose (BD) vaccine coverage remains low. Countries such as the Democratic Republic of the Congo (DRC) aim to include the hepatitis B birth-dose (HepB-BD) vaccine in their national immunization schedule. HepB-BD’s short window for administration – within 24 hours of delivery to prevent mother-to-child transmission – adds to the complexity of streamlined and timely BD vaccines. This study aims to identify and understand barriers and facilitators to timely delivery of BD vaccine in Kinshasa Province, DRC, through individuals’ accounts with different perspectives on the uptake of the BD vaccine in preparation for its future roll-out. Methods We conducted semi-structured interviews in seven health facilities across Kinshasa Province from June to July 2021. We purposefully sampled health facilities from the provinces’ five most prominent facility types—private, public, Catholic, Protestant, and not-for-profit. We interviewed decision-makers and/or providers from various levels of the health care continuum, including midwives, immunization staff, heads of maternity and immunizations, and vaccine officials at the health zone and the Programme Elargi de Vaccination (PEV) to understand administrative barriers to BD vaccines. We also conducted interviews with expectant mothers to elicit knowledge and perceptions about infant vaccines. Results We interviewed 30 participants (16 informants and 14 expectant mothers). Interviewees were recruited from 7 health facilities, 2 health zones, and PEV. Data analysis was guided by the Consolidated Framework for Implementation Research (CFIR). Our analysis identified 13 constructs (2-3 per domain) related to the success of timely and streamlined BD vaccines. We found significant barriers within and across each domain; most notably, the multi-dose vials of existing BD vaccines determining when facility staff could vaccinate newborns, often resulting in untimely vaccinations; logistical concerns with regular national vaccine stockouts and ability to store vaccines; complex and unsynchronized vaccine fees across facilities; inadequate communication across delivery and vaccination wards; and limited and at times incorrect understanding of vaccines among mothers and other community members. Conclusions Using the CFIR framework, this study integrated perspectives from facility informants and expectant mothers to inform national policy and implementation of the HepB-BD in DRC. These stakeholder-driven findings should guide the streamlining of timely BD vaccinations upon HepB-BD implementation.

ImportanceGreater than 20% of cases and 0.4% of deaths from COVID-19 occur in children. Following demonstration of the safety and efficacy of the adjuvanted, recombinant spike protein vaccine NVX-CoV2373 in adults, the PREVENT-19 trial immediately expanded to adolescents.ObjectiveTo evaluate the safety, immunogenicity, and efficacy of NVX-CoV2373 in adolescents.Design, Setting, and ParticipantsThe NVX-CoV2373 vaccine was evaluated in adolescents aged 12 to 17 years in an expansion of PREVENT-19, a phase 3, randomized, observer-blinded, placebo-controlled multicenter clinical trial in the US. Participants were enrolled from April 26 to June 5, 2021, and the study is ongoing. A blinded crossover was implemented after 2 months of safety follow-up to offer active vaccine to all participants. Key exclusion criteria included known previous laboratory-confirmed SARS-CoV-2 infection or known immunosuppression. Of 2304 participants assessed for eligibility, 57 were excluded and 2247 were randomized.InterventionsParticipants were randomized 2:1 to 2 intramuscular injections of NVX-CoV2373 or placebo, 21 days apart.Main Outcomes and MeasuresSerologic noninferiority of neutralizing antibody responses compared with those in young adults (aged 18-25 years) in PREVENT-19, protective efficacy against laboratory-confirmed COVID-19, and assessment of reactogenicity and safety.ResultsAmong 2232 participants (1487 NVX-CoV2373 and 745 placebo recipients), the mean (SD) age was 13.8 (1.4) years, 1172 (52.5%) were male, 1660 (74.4%) were White individuals, and 359 (16.1%) had had a previous SARS-CoV-2 infection at baseline. After vaccination, the ratio of neutralizing antibody geometric mean titers in adolescents compared with those in young adults was 1.5 (95% CI, 1.3-1.7). Twenty mild COVID-19 cases occurred after a median of 64 (IQR, 57-69) days of follow-up, including 6 among NVX-CoV2373 recipients (incidence, 2.90 [95% CI, 1.31-6.46] cases per 100 person-years) and 14 among placebo recipients (incidence, 14.20 [95% CI, 8.42-23.93] cases per 100 person-years), yielding a vaccine efficacy of 79.5% (95% CI, 46.8%-92.1%). Vaccine efficacy for the Delta variant (the only viral variant identified by sequencing [n = 11]) was 82.0% (95% CI, 32.4%-95.2%). Reactogenicity was largely mild to moderate and transient, with a trend toward greater frequency after the second dose of NVX-CoV2373. Serious adverse events were rare and balanced between treatments. No adverse events led to study discontinuation.Conclusions and RelevanceThe findings of this randomized clinical trial indicate that NVX-CoV2373 is safe, immunogenic, and efficacious in preventing COVID-19, including the predominant Delta variant, in adolescents.Trial RegistrationClinicalTrials.gov Identifier: NCT04611802