Introduction/Background & Aims Enrichment of breast milk (BM) with immunoglobin (Ig)A and IgG, through maternal vaccination, could help young infants combat targeted pathogens. However, evidence on this effect after preterm delivery is lacking. This study investigated the total and anti-pertussis toxin (anti-PT) specific IgA and IgG production in BM after term or preterm delivery in the presence of maternal Tdap (tetanus, diphtheria, acellular pertussis) vaccination. Methods Serum and BM samples of lactating women, who delivered at term or prematurely and did or did not receive Tdap vaccine (Boostrix®, GSK Biologicals) during pregnancy, were collected as part of a clinical study (N=234, NCT02511327). Anti-PT IgA/IgG (IBL®; MSD®) and Total IgA/IgG (Thermofisher®, on BM samples only) immunosorbent assays were performed on all samples collected at 72 hours, 4, 8, and 12 weeks postpartum. Results BM after preterm delivery contained anti-PT IgA and IgG geometric mean concentrations (GMCs) comparable to those after term delivery (e.g. colostrum anti-PT IgA: 5.39 International Units per milliliter (IU/mL) vs 6.69 IU/mL, respectively). Maternal Tdap vaccination induced significantly higher anti-PT IgG GMC’s in colostrum of vaccinated compared to unvaccinated women delivering at term (0.110 IU/mL vs 0.027 IU/mL, p=0.009). Compliance with postpartum vaccination led to no differences in BM after 4 weeks postpartum. Anti-PT antibodies persisted up to 12 weeks postpartum. Conclusions This study provides evidence that maternal Tdap vaccination induces high Ig levels in BM after both term and preterm delivery and that these antibodies remain abundantly present throughout lactation, possibly offering additional mucosal protection during the most vulnerable period in early life.

IntroductionThis article describes the protocol of an Ebola vaccine clinical trial which investigates the safety and immunogenicity of a two-dose prophylactic Ebola vaccine regimen comprised of two Ebola vaccines (Ad26.ZEBOV and MVA-BN-Filo) administered 56 days apart, followed by a booster vaccination with Ad26.ZEBOV offered at either 1 year or 2 years (randomisation 1:1) after the first dose. This clinical trial is part of the EBOVAC3 project (an Innovative Medicines Initiative 2 Joint Undertaking), and is the first to evaluate the safety and immunogenicity of two different booster vaccination arms in a large cohort of adults.Methods and analysisThis study is an open-label, monocentric, phase 2, randomised vaccine trial. A total of 700 healthcare providers and frontliners are planned to be recruited from the Tshuapa province in the Democratic Republic of the Congo (DRC). The primary and secondary objectives of the study assess the immunogenicity of the first (Ad26.ZEBOV), second (MVA-BN-Filo) and booster (Ad26.ZEBOV) dose. Immunogenicity is assessed through the evaluation of EBOV glycoprotein binding antibody responses after vaccination. Safety is assessed through the collection of serious adverse events from the first dose until 6 months post booster vaccination and the collection of solicited and unsolicited adverse events for 1 week after the booster dose.Ethics and disseminationThe protocol was approved by the National Ethics Committee of the Ministry of Health of the DRC (n°121/CNES/BN/PMMF/2019). The clinical trial was registered on 4 December 2019 on ClinicalTrials.gov. Trial activities are planned to finish in October 2022. All participants are required to provide written informed consent and no study-related procedures will be performed until consent is obtained. The results of the trial will be added on ClinicalTrials.gov, published in peer-reviewed journals and presented at international conferences.Trial registration numberNCT04186000; Pre-results.

Background A partnership between the University of Antwerp and the University of Kinshasa implemented the EBOVAC3 clinical trial with an Ebola vaccine regimen administered to health care provider participants in Tshuapa Province, Democratic Republic of the Congo. This randomized controlled trial was part of an Ebola outbreak preparedness initiative financed through Innovative Medicines Initiative-European Union. The EBOVAC3 clinical trial used iris scan technology to identify all health care provider participants enrolled in the vaccine trial, to ensure that the right participant received the right vaccine at the right visit. Objective We aimed to assess the acceptability, accuracy, and feasibility of iris scan technology as an identification method within a population of health care provider participants in a vaccine trial in a remote setting. Methods We used a mixed methods study. The acceptability was assessed prior to the trial through 12 focus group discussions (FGDs) and was assessed at enrollment. Feasibility and accuracy research was conducted using a longitudinal trial study design, where iris scanning was compared with the unique study ID card to identify health care provider participants at enrollment and at their follow-up visits. Results During the FGDs, health care provider participants were mainly concerned about the iris scan technology causing physical problems to their eyes or exposing them to spiritual problems through sorcery. However, 99% (85/86; 95% CI 97.1-100.0) of health care provider participants in the FGDs agreed to be identified by the iris scan. Also, at enrollment, 99.0% (692/699; 95% CI 98.2-99.7) of health care provider participants accepted to be identified by iris scan. Iris scan technology correctly identified 93.1% (636/683; 95% CI 91.2-95.0) of the participants returning for scheduled follow-up visits. The iris scanning operation lasted 2 minutes or less for 96.0% (656/683; 95% CI 94.6-97.5), and 1 attempt was enough to identify the majority of study participants (475/683, 69.5%; 95% CI 66.1-73.0). Conclusions Iris scans are highly acceptable as an identification tool in a clinical trial for health care provider participants in a remote setting. Its operationalization during the trial demonstrated a high level of accuracy that can reliably identify individuals. Iris scanning is found to be feasible in clinical trials but requires a trained operator to reduce the duration and the number of attempts to identify a participant. Trial Registration ClinicalTrials.gov NCT04186000; https://clinicaltrials.gov/ct2/show/NCT04186000

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Background: Previous studies have associated certain risk factors with hazardous drinking in students. However, big cultur- al and geographical differences exist regarding alcohol use. Objectives: To determine whether or not there was a difference in hazardous drinking between Belgian and South African university students and to establish the risk factors that contribute to hazardous drinking in university students (calculated using the AUDIT-C) from a developing country (South Africa) and a developed country (Belgium). Methods: An online survey assessing hazardous drinking among university students in South Africa (University of KwaZu- lu-Natal, UKZN) and Belgium (University of Antwerp, UoA) was conducted, using the shortened version of the Alcohol Use Disorder Identification Test (AUDIT-C). Risk factors in males and females for hazardous drinking were explored using multivariate logistic regression analysis. Results: In total, 499 students were included in the study (250 UoA and 249 UKZN students). A significant higher amount of male (94.8%) as well as female (92.4%) UoA students drank alcohol in the last year compared to the male (66.2%) and female (67.8%) UKZN students (p<0.001). Additionally, a significant higher amount of UoA students were hazardous drinkers, compared to the UKZN students (p<0.001). Multivaiate analysis showed that male UoA students were almost 6 times more likely to be hazardous drinkers than male UKZN students (OR=5.611, p=0.005). Female UoA students were more than twice as likely to be hazardous drinkers than female UKZN students (OR=2.371, p=0.016). Conclusion: This study found a significant difference in hazardous drinking between Belgian and South African university students. Keywords: Hazardous drinking; university students; South Africa; Belgium.