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In this large-scale cluster-randomized controlled trial (cRCT) we sought to assess the effectiveness of facemasks against viral respiratory infections. Over three consecutive Hajj seasons (2013, 2014, 2015) pilgrims' tents in Makkah were allocated to 'facemask' or 'no facemask' group. Fifty facemasks were offered to participants in intervention tents, to be worn over four days, and none were offered to participants in control tents. All participants recorded facemask use and respiratory symptoms in health diaries. Nasal swabs were collected from the symptomatic for virus detection by reverse transcription polymerase chain reaction. Clinical symptoms and laboratory results were analyzed by 'intention- to-treat' and 'per-protocol'. A total of 7687 adult participants from 318 tents were randomized: 3864 from 149 tents to the intervention group, and 3823 from 169 tents to the control group. Participants were aged 18 to 95 (median 34, mean 37) years, with a male to female ratio of 1:1.2. Overall, respiratory viruses were detected in 277 of 650 (43%) nasal/pharyngeal swabs collected from symptomatic pilgrims. Common viruses were rhinovirus (35.1%), influenza (4.5%) and parainfluenza (1.7%). In the intervention arm, respectively 954 (24.7%) and 1842 (47.7%) participants used facemasks daily and intermittently, while in the control arm, respectively 546 (14.3%) and 1334 (34.9%) used facemasks daily and intermittently. By intention-to-treat analysis, facemask use did not seem to be effective against laboratory-confirmed viral respiratory infections (odds ratio [OR], 1.4; 95% confidence interval [CI], 0.9 to 2.1, p = 0.18) nor against clinical respiratory infection (OR, 1.1; 95% CI, 0.9 to 1.4, p = 0.40). Similarly, in a per-protocol analysis, facemask use did not seem to be effective against laboratory-confirmed viral respiratory infections (OR 1.2, 95% CI 0.9-1.7, p = 0.26) nor against clinical respiratory infection (OR 1.3, 95% CI 1.0-1.8, p = 0.06). This trial was unable to provide conclusive evidence on facemask efficacy against viral respiratory infections most likely due to poor adherence to protocol.

Background The risk of transmission of viral respiratory tract infections (RTIs) is high in mass gatherings including Hajj. This cohort study estimated the incidence of symptomatic RTIs and hand hygiene compliance with its impact among Hajj pilgrims during the COVID-19 pandemic. Methods During the week of Hajj rituals in 2021, domestic pilgrims were recruited by phone and asked to complete a baseline questionnaire. Pilgrims were followed up after seven days using a questionnaire about the development of symptoms, and practices of hand hygiene. Syndromic definitions were used to clinically diagnose ‘possible’ influenza-like illnesses (ILI) and COVID-19 infection. Results A total of 510 pilgrims aged between 18 and 69 (median of 50) years completed the questionnaire, 280 (54.9%) of whom were female, and all of them (except for one) were vaccinated against COVID-19 with at least one dose. The mean (± SD) of pilgrims’ hand hygiene knowledge score (on a scale of 0 to 6) was 4.15 (± 1.22), and a higher level of knowledge was correlated with a higher frequency of handwashing using soap and water. Among those 445 pilgrims who completed the follow-up form, 21 (4.7%) developed one or more respiratory symptoms, of which sore throat and cough were the commonest (respectively 76.2% and 42.8%); ‘possible ILI’ and ‘possible COVID-19’ were present in 1.1% and 0.9% of pilgrims. Obesity was found to be a significant factor associated with the risk of developing RTIs (odds ratio = 4.45, 95% confidence interval 1.15–17.13). Conclusions Hajj pilgrims are still at risk of respiratory infections. Further larger and controlled investigations are needed to assess the efficacy of hand hygiene during Hajj.

Recombinant vaccines against invasive meningococcal disease due to Neisseria meningitidis serogroup B (MenB) have shown substantial impact in reducing MenB disease in targeted populations. 4CMenB targets four key N. meningitidis protein antigens; human factor H binding protein (fHbp), Neisserial heparin binding antigen (NHBA), Neisseria adhesin A (NadA) and the porin A protein (PorA P1.4), with one or more of these expressed by most pathogenic MenB strains, while MenB-FHbp targets two distinct fHbp variants. While many countries recommend MenB immunisation in adults considered at high risk due to underlying medical conditions or immunosuppression, there are no recommendations for routine use in the general adult population. We reviewed the burden of MenB in adults, where, while incidence rates remain low (and far lower than in young children < 5 years of age at greatest risk), a substantial proportion of MenB cases (20% or more) is now observed in the adult population; evident in Europe, Australia, and in the United States. We also reviewed immunogenicity data in adults from clinical studies conducted during MenB vaccine development and subsequent post-licensure studies. A 2-dose schedule of 4CMenB generates hSBA titres ≥ 1:4 towards all four key vaccine target antigens in up to 98–100% of subjects. For MenB-FHbp, a ≥ fourfold rise in hSBA titres against the four primary representative test strains was observed in 70–95% of recipients following a 3-dose schedule. While this suggests potential benefits for MenB immunisation if used in adult populations, data are limited (especially for adults > 50 years) and key aspects relating to duration of protection remain unclear. Although a broader adult MenB immunisation policy could provide greater protection of the adult population, additional data are required to support policy decision-making. Graphical Abstract

This protocol presents a comprehensive proposal for the establishment of the Saudi Cerebral Palsy Register (SCPR), a crucial project for investigating and addressing the prevalence, etiology, and management of cerebral palsy (CP) in Saudi Arabia. The SCPR will not only provide a robust database for ongoing research and analysis but will also serve as a platform for investigating the causes of CP, implementing preventative strategies, and improving the quality of care and outcomes for people with CP and their families in Saudi Arabia. Detailed case definitions, inclusion/exclusion criteria, and data collection protocols are discussed to ensure the integrity and comparability of the data. The plan also outlines strategic funding, institutional and government endorsement, sustainability considerations, potential challenges and proposed solutions, and expected outcomes and impact. These include creating research and educational opportunities, fostering regional and international collaborations, and significantly contributing to CP prevention strategies. Overcoming anticipated obstacles, such as stigma, institutional policies, and collaborations, and securing both necessary funding and endorsements are highlighted as critical for the success of the SCPR. The project is not only aligned with promote prevention of health risks, a target of Vision 2030 in Saudi Arabia, but is also expected to have a substantial impact on the health and quality of life of people with CP and their families in Saudi Arabia, serving as inspiration for similar efforts worldwide.

This research evaluated the most visible symptoms associated with coronavirus (COVID-19) vaccines among residents in Makkah of Saudi Arabia. A cross-sectional study was conducted in 2021 among a representative sample of residents receiving COVID-19 vaccination at King Abdullah Medical City, ‏Al Ukayshiyyah, and Umm Al-Qura University vaccination centers. A total of 805 participants selected by a census sampling method were included. Data regarding characteristics, medical history, and post-vaccination symptoms were obtained with an interview-based questionnaire. The participants' mean age was 25.20 ± 15.5 years. Of them, 61.7% and 38.3% received one and two doses of the COVID-19 vaccine, respectively. 2.2% have an allergic reaction to the COVID-19 vaccine. 25.3% were infected with COVID-19, 23% were infected before the first dose, and only 1.6% were infected after the first dose. Significant statistical associations were found between males and females in smoking status, age, body mass index, history of diabetes mellitus, and types of COVID-19 vaccines (P-value < 0.05). After adjustment for confounding variables, male participants had lower odds of having swelling, redness, or pain at the injection site, muscle or joint pain, headache, dizziness, and nausea compared to female participants [OR = 0.596, 95% CI = (0.388-0.916)], [OR = 0.272, 95% CI = (0.149-0.495)], [OR = 0.529, 95% CI = (0.338-0.828)], [OR = 0.263, 95% CI = (0.125-0.554)], and [OR = 0.145, 95% CI = (0.31-0.679), P < 0.05 for all], respectively. The female participants may have a higher risk of post-COVID-19 vaccination symptoms than males among Makkah residents of Saudi Arabia.

Cost-effective interventions are needed to control the transmission of viral respiratory tract infections (RTIs) in mass gatherings. Facemasks are a promising preventive measure, however, previous studies on the efficacy of facemasks have been inconclusive. This study proposes a large-scale facemask trial during the Hajj pilgrimage in Saudi Arabia and presents this protocol to illustrate its feasibility and to promote both collaboration with other research groups and additional relevant studies. A cluster-randomised controlled trial is being conducted to test the efficacy of standard facemasks in preventing symptomatic and proven viral RTIs among pilgrims during the Hajj season in Mina, Mecca, Saudi Arabia. The trial will compare the ‘supervised use of facemasks’ versus ‘standard measures’ among pilgrims over several Hajj seasons. Cluster-randomisation will be done by accommodation tents with a 1:1 ratio. For the intervention tents, free facemasks will be provided to be worn consistently for 7days. Data on flu-like symptoms and mask use will be recorded in diaries. Nasal samples will be collected from symptomatic recruits and tested for nucleic acid of respiratory viruses. Data obtained from questionnaires, diaries and laboratory tests will be analysed to examine whether mask use significantly reduces the frequency of laboratory-confirmed respiratory viral infection and syndromic RTI as primary outcomes. This trial will provide valuable evidence on the efficacy of standard facemask use in preventing viral respiratory tract infections at mass gatherings. This study is registered at the Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN: ACTRN12613001018707 (http://www.anzctr.org.au).

[...]to overcome the issue of unavailability due to seasonal shift, the Saudi Thoracic Society suggested that the southern hemisphere vaccine be used for pilgrims arriving from the northern hemisphere (evidence D, the committee's expert opinion), but the logistics of such a policy are not outlined.4 It is unclear how a tailormade vaccine for a specific season and hemisphere could be made available for the population of the other hemisphere; since influenza is an RNA virus that mutates rapidly, the vaccine might be ineffective, and whether the strategy is going to be beneficial or sustainable should be formally explored.

Hajj is the world’s largest annual mass gathering that attracts two to three million Muslims from around the globe to a religious assemblage in Makkah, Saudi Arabia. The risk of acquisition and transmission of influenza among Hajj pilgrims is high. Therefore, influenza vaccination is recommended, and was monitored frequently among pilgrims from different countries. However, the vaccination uptake among Saudi pilgrims has not been assessed in recent years. This analysis aims to evaluate influenza vaccine uptake among Saudi Hajj pilgrims, and identify the key barriers to vaccination. Data on influenza vaccination were obtained from Saudi pilgrims who took part in a large trial during the Hajj of 2013, 2014 and 2015. Pilgrims were met and recruited in Mina, Makkah during the peak period of Hajj and were asked to complete a baseline questionnaire that recorded their influenza vaccination history, including reason(s) for non-receipt of vaccine. A total of 6974 Saudi pilgrims aged between 18 and 95 (median 34) years were recruited; male to female ratio was 1:1.2. Of the total, 90.8% declared their influenza vaccination history, 51.3% of them reported receiving influenza vaccine before travel to Hajj. The vaccination rates for the years 2013, 2014 and 2015 were 21.4%, 48.2% and 58.1%, respectively (P < 0.001). Of 1,269 pilgrims who were at higher risk of severe disease, 54.5% received the vaccine. Lack of awareness (47.5%), reliance on natural immunity (15.8%) and being busy (15.5%) were the main reasons for non-receipt. These data from a convenience sample indicate that influenza vaccine uptake among Saudi Hajj pilgrims is increasing over years but still needs further improvement. Lack of awareness and misperceptions are the main barriers. Education of Saudi pilgrims and health professionals is required to raise awareness about influenza vaccination. Further studies are needed to understand pilgrims’ misperceptions.

Introduction Diabetes mellitus (DM) was reported as one of the most common non-communicable diseases during Hajj. However, few studies evaluated acute complications of DM during Hajj. Therefore, this study aims to explore the most common acute complications among pilgrims with DM during Hajj 2017 and its clinical presentations. Methods This is a descriptive cross-sectional study. Data were collected using an anonymous questionnaire from the database of pilgrims with DM, who sought medical care in mobile clinics in Mina during the peak period of Hajj from 31 August to 4 September 2017. Data were entered afterwards into an Excel sheet and analyzed using SPSS. Results In this study, a total of 281 pilgrims were recruited, male to female ratio 3:1. Out of 281 pilgrims, 199 (70.8%) had foot injuries, 77 (27.4%) had hyperglycemia, and 37 (13.2%) had hypoglycemia, noting that some of them presented with more than one complication. Most of the participants who developed foot injuries, presented with redness (28.8%) and bullous (20.6%). The most reported symptoms among hyperglycemic pilgrims were polydipsia (17.1%) and dry mouth (16.4%). Also, the most reported symptoms of hypoglycemia were fatigue (14.9%) and headache (12.5%). In addition, pilgrims with type 2 DM reported a higher rate of acute complications compared to type 1 DM (81.8% versus 18.2%, p  = 0.33). Conclusion The most common acute complication of diabetes during Hajj is foot injury. Pilgrims who suffered from hyperglycemia presented mainly with polydipsia, while those who developed hypoglycemia presented mainly with fatigue. There was no statistically significant difference according to the association between the type of diabetes and the occurrence of acute complications.