Current progress towards prevention of Nipah and Hendra disease in humans: A scoping review of vaccine and monoclonal antibody candidates being evaluated in clinical trials.

OBJECTIVES: Nipah and Hendra are deadly zoonotic diseases with pandemic potential. To date, no human vaccine or monoclonal antibody (mAb) has been licensed to prevent disease caused by these pathogens. The aim of this scoping review was to identify and describe all Phase I, II, and III clinical trials of vaccine candidates or mAbs candidates designed to prevent Nipah and Hendra in humans and to compare the characteristics of the vaccine candidates to characteristics outlined in the Target Product Profile drafted by the World Health Organisation as part of the WHO Research & Development Blueprint for Action to Prevent Epidemics. METHODS: We searched 23 clinical trial registries, the Cochrane Central Register of Clinical Trials, and grey literature up to June 2023 to identify vaccine and mAb candidates being evaluated in registered clinical trials. Vaccine candidate and trial characteristics were double-extracted for evaluation and the vaccine candidate characteristics were compared with the preferred and critical criteria of the World Health Organisation's Target Product Profile for Nipah virus vaccine. RESULTS: Three vaccine candidates (Hendra Virus Soluble Glycoprotein Vaccine [HeV-sG-V], PHV02, and mRNA-1215) and one mAb (m102.4) had a registered human clinical trial by June 2023. All trials were phase 1, dose-ranging trials taking place in the United States of America or Australia and enrolling healthy adults. Although all vaccine candidates meet the dose regimen and route of administration criteria of the Target Product Profile, other criteria such as measures of efficacy and reactogenicity will need to be evaluated in the future as evidence becomes available. CONCLUSION: Multiple vaccine candidates and one mAb candidate have reached the stage of human clinical trials and are reviewed here. Monitoring progress during evaluation of these candidates and candidates entering clinical trials in the future can help highlight many of the challenges that remain.

Sex-disaggregated effectiveness data reporting in COVID-19 vaccine research: a systematic review.

BACKGROUND: Sex and gender are believed to influence vaccine response. Yet, the relationship between sex and gender and COVID-19 vaccine efficacy is poorly understood and remains under-investigated. METHODS: We conducted a systematic review to determine whether and to what extent post-approval COVID-19 vaccine effectiveness (VE) studies report sex-disaggregated VE data. We searched four publication and pre-publication databases and additional grey literature sources for relevant published/preprint studies released between 1 January 2020 and 1 October 2021 (i.e., pre-Omicron era). We included observational studies providing VE estimates for one or more licensed/approved COVID-19 vaccines and including both males and females. Two reviewers independently assessed study eligibility, extracted data, and assessed risk-of-bias through a modified version of Cochrane's ROBINS-I tool. A qualitative data synthesis was performed. RESULTS: Here we show that, among 240 eligible publications, 68 (28.3%) do not report the sex distribution among participants. Only 21/240 (8.8%) studies provide sex-disaggregated VE estimates, and high between-study heterogeneity regarding design, target population, outcomes, and vaccine type/timing prevent the assessment of sex in determining COVID-19 VE across studies. CONCLUSIONS: Our findings indicate that few COVID-19 vaccine research publications account for sex. Improved adherence to recommended reporting guidelines will ensure that the evidence generated can be used to better understand the relationship between sex and gender and VE.

The level of protection that vaccines provide against COVID-19 might depend on a person's sex or gender. However, sex and gender are not always reported in studies on the effectiveness of COVID-19 vaccines. Here, we systematically reviewed the literature on COVID-19 vaccine effectiveness and looked at whether the studies we found separated out their data on vaccine effectiveness by participants' sex. Out of the 240 publications we identified, 68 (28.3%) did not report the sex of the participants in their study, and only 21 studies (8.8%) reported vaccine effectiveness data separated by sex. These results show that a substantial proportion of COVID-19 vaccine research publications do not account for sex. Efforts should be made by researchers to study and report the relationship between sex and vaccine effectiveness, to help to optimise vaccination strategies so that all people are adequately protected.

Pneumococcal vaccination uptake and missed opportunities for vaccination among Canadian adults: A cross-sectional analysis of the Canadian Longitudinal Study on Aging (CLSA).

INTRODUCTION: In Canada, pneumococcal vaccination is recommended to all adults aged ≥65 and those <65 who have one or more chronic medical conditions (CMCs). Understanding vaccine uptake and its determinants among eligible groups has important implications for reducing the burden of pneumococcal disease. METHODS: Using data from a large national cohort of Canadian residents aged ≥47 years between 2015-2018, we calculated self-reported pneumococcal vaccine uptake among eligible groups, estimated associations between key factors and non-vaccination, assessed missed opportunities for vaccination (MOV) and examined risk factors for MOV. Adjusted odds ratios (aORs) and 95% confidence intervals (CIs) for relevant associations were estimated through logistic regression. RESULTS: 45.8% (95% CI: 45.2-46.5) of 22,246 participants aged ≥65 and 81.3% (95% CI: 80.5-82.0) of 10,815 individuals aged 47-64 with ≥1 CMC reported never having received a pneumococcal vaccine. Receipt of influenza vaccination in the previous year was associated with the lowest odds of pneumococcal non-vaccination (aOR = 0.14 [95% CI: 0.13-0.15] for older adults and aOR = 0.23 [95% CI: 0.20-0.26] for those aged 47-64 with ≥1 CMC). Pneumococcal vaccine uptake was also more likely in case of contact with a family doctor in the previous year (versus no contact), increased with age and varied widely across provinces. Among individuals recently vaccinated against influenza, 32.6% (95% CI: 31.9-33.4) of those aged ≥65 and 71.1% (95% CI: 69.9-72.3) of those aged 47-64 with ≥1 CMC missed an opportunity to get a pneumococcal vaccine. Among individuals who had contact with a family doctor, 44.8% (95% CI: 44.1-45.5) of those aged ≥65 and 80.4% (95% CI: 79.6-81.2) of those aged 47-64 with ≥1 CMC experienced a MOV. CONCLUSIONS: Pneumococcal vaccine uptake remains suboptimal among at-risk Canadian adults who are eligible for vaccination. Further research is needed to clarify the reasons behind missed opportunities for vaccination and adequately address the main barriers to pneumococcal vaccination.