Facemask against viral respiratory infections among Hajj pilgrims: A challenging cluster-randomized trial.

BACKGROUND: In this large-scale cluster-randomized controlled trial (cRCT) we sought to assess the effectiveness of facemasks against viral respiratory infections. METHODS AND RESULTS: 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). CONCLUSION: This trial was unable to provide conclusive evidence on facemask efficacy against viral respiratory infections most likely due to poor adherence to protocol.

Surveillance of Australian Hajj pilgrims for carriage of potentially pathogenic bacteria: Data from two pilot studies.

AIM: To estimate the pharyngeal carriage rate of Neisseria meningitidis (N. meningitidis), Streptococcus pneumoniae (S. pneumoniae) and Staphylococcus aureus (S. aureus) among Australian Hajj pilgrims. METHODS: In 2014, surveillance was conducted in two phases among Australian Hajj pilgrims: The first phase during Hajj in Mina, and the second phase soon after returning home to Australia. Nasopharyngeal or oropharyngeal swabs were taken from participants then tested, firstly by nucleic acid testing, and also by standard culture. RESULTS: Of 183 participants recruited in the first phase, 26 (14.2%) tested positive for S. pneumoniae; 4 had received pneumococcal conjugate vaccine (PCV13). Only one tested positive for N. meningitidis (W). Of 93 2nd phase samples cultured, 17 (18.3%) grew S. aureus, all methicillin sensitive, 2 (2.2%) grew N. meningitidis (on subculture; one serotype B, one negative), and 1 (1%), from an unvaccinated pilgrim, grew S. pneumoniae. CONCLUSION: Relatively high carriage of S. pneumoniae and little meningococcal carriage was found. This indicates the importance of a larger study for improved infection surveillance and possible vaccine evaluation.

A cluster-randomised controlled trial to test the efficacy of facemasks in preventing respiratory viral infection among Hajj pilgrims.

BACKGROUND: 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. METHODS/DESIGN: 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. CONCLUSIONS: 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).

Viral respiratory infections among Hajj pilgrims in 2013.

Middle East respiratory syndrome coronavirus (MERS-CoV) has emerged in the Arabian Gulf region, with its epicentre in Saudi Arabia, the host of the 'Hajj' which is the world's the largest mass gathering. Transmission of MERS-CoV at such an event could lead to its rapid worldwide dissemination. Therefore, we studied the frequency of viruses causing influenza-like illnesses (ILI) among participants in a randomised controlled trial at the Hajj 2013. We recruited 1038 pilgrims from Saudi Arabia, Australia and Qatar during the first day of Hajj and followed them closely for four days. A nasal swab was collected from each pilgrim who developed ILI. Respiratory viruses were detected using multiplex RT-PCR. ILI occurred in 112/1038 (11%) pilgrims. Their mean age was 35 years, 49 (44%) were male and 35 (31%) had received the influenza vaccine pre-Hajj. Forty two (38%) pilgrims had laboratory-confirmed viral infections; 28 (25%) rhinovirus, 5 (4%) influenza A, 2 (2%) adenovirus, 2 (2%) human coronavirus OC43/229E, 2 (2%) parainfluenza virus 3, 1 (1%) parainfluenza virus 1, and 2 (2%) dual infections. No MERS-CoV was detected in any sample. Rhinovirus was the commonest cause of ILI among Hajj pilgrims in 2013. Infection control and appropriate vaccination are necessary to prevent transmission of respiratory viruses at Hajj and other mass gatherings.

Pilot Randomised Controlled Trial to Test Effectiveness of Facemasks in Preventing Influenza-like Illness Transmission among Australian Hajj Pilgrims in 2011.

Studies to determine the effectiveness of facemasks in preventing influenza have been inconclusive, largely due to small sample size. The Hajj pilgrimage, where the incidence of influenza and other respiratory infections is high, provides an excellent opportunity to test the effectiveness of facemasks against syndromic and laboratory-confirmed infections. Hence, a pilot study was conducted among Australian pilgrims to assess the feasibility of such a large-scale trial in the coming years. At the 2011 Hajj, tents were randomised to 'supervised mask use' versus 'no supervised mask use'. Pilgrims with ILI symptoms for ≤3 days were recruited as 'cases' and those who slept within 2 meters of them as 'contacts'. Surgical facemasks were provided to cases and contacts in the 'mask' tents, but not in the 'control' tents. Pilgrims in both groups were given diaries to record their respiratory symptoms. Nasal or pharyngeal swabs were collected from the cases and contacts with ILI for point-of-care and nucleic acid tests. A total of 22 tents were randomised to 'mask' (n=12) or 'control' (n=10). There were 164 pilgrims recruited; 75 in 'mask' and 89 in 'control' group. Mask use compliance was 76% in the 'mask' group and 12% in the 'control' group. Based on developing syndromic ILI, less contacts became symptomatic in the 'mask' tents compared to the 'control' tents (31% versus 53%, p= 0.04). However, laboratory results did not show any difference between the two groups. This pilot study shows that a large trial to assess the effectiveness of facemasks use at Hajj is feasible.

Influenza vaccination among Australian Hajj pilgrims: uptake, attitudes, and barriers.

BACKGROUND: Hajj is the largest annual mass gathering where the risk of respiratory infection is high. Although the Saudi Arabian authority recommends influenza vaccination for Hajj pilgrims, the uptake is variable. Influenza vaccine uptake data among Australian Hajj pilgrims is not readily available. Therefore, we aimed to estimate the influenza vaccination uptake rate and identify both attitudes and barriers to vaccine uptake from two consecutives surveys at Hajj in 2011 and 2012. METHODS: Using an anonymous self-administered questionnaire, surveys were conducted in Mecca, Saudi Arabia, among Hajj pilgrims from Australia in 2011 and 2012. Pilgrims staying in "Australian" tents were recruited serially. RESULTS: In 2011, 431 Australian pilgrims completed the survey-median age was 42 (range 7-86) years, 55% were male; 65% reported receiving influenza vaccine. In 2012, 535 pilgrims of median age 43 (range 12-83) years completed the survey, 62% were male; 89% reported receiving the vaccine. Both in 2011 and 2012, common reasons for not receiving the vaccine were the pilgrims' reliance on their "natural immunity" (33 and 26%, respectively, p = 0.4) and believing that they would rarely catch influenza or come in contact with influenza patients (18 and 29%, respectively, p = 0.1). In 2012, when asked why they had received the vaccine, 65% pilgrims responded that it was because of the tour group leaders' recommendation. CONCLUSION: Influenza vaccine uptake among Australian Hajj pilgrims seems satisfactory and increasing but could be better because many pilgrims have misconceptions about vaccines. Tour operators may play a greater role in promoting vaccination.

Knowledge, Attitude and Practice (KAP) Survey Concerning Antimicrobial Use among Australian Hajj Pilgrims.

Resistance to antimicrobial agents has increased for reasons relating to the use and misuse of antimicrobials in human, agriculture and aquaculture. Antimicrobial use is quite high during mass gatherings such as the Hajj pilgrimage. To reduce non-prescription use and inappropriate prescribing of antimicrobials, a more thorough understanding of their use and the motives behind why patients request, even demand, antimicrobials, fail to adhere to the prescription is important. Therefore, we conducted a knowledge, attitude and practice (KAP) survey among Australian Hajj pilgrims in Mecca during Hajj 2013 using an anonymous, self-administered questionnaire concerning antimicrobial use. Our sample consisted of 229 adult Australian subjects. Mean age was 42.4 (SD±12.7) years, 178 (77.9%) were male and 80 (34.9%) used antimicrobials during their stay in Saudi Arabia. Twenty one (26.3%) obtained these in Saudi Arabia without prescription, and about half (38, 47.5%) brought them from Australia. Of the respondents, 55.8% believed that antibiotics are effective against viruses, 53.6% thought that antibiotics are effective against common cold and flu, 78.6 % that humans themselves can become resistant to antibiotics and 75.9% knew that overuse or unnecessary use of antibiotics can cause them to lose effectiveness. This study has revealed that Hajj pilgrims have inappropriate access to antimicrobials in Saudi Arabia as well as in Australia. A large scale education campaign and tighter control on prescribing and dispensing of antimicrobials could improve the appropriate antimicrobial use among Hajj pilgrims.

Pneumococcal Vaccine Uptake Among Australian Hajj Pilgrims in 2011-13.

The uptake of the pneumococcal vaccine is suboptimal in Australia and remains unknown among Australian Hajj pilgrims, many of whom are eligible because of age or underlying disease and at particular risk because of travel and activities at Hajj. Pneumococcal vaccination uptake was examined over three consecutive years (2011 to 2013) through anonymous self-administered cross sectional surveys among Australian pilgrims who assembled in Mina valley, Mecca, Saudi Arabia. Respectively, 158, 513 and 219 pilgrims were recruited in 2011, 2012 and 2013; their mean ages were 43.8 (SD±13), 43 (SD±13.5) and 42.6 (SD±12.3) years; males accounted for 67 (42.4%), 325 (63.4%) and 172 (78.5%). Pneumococcal vaccine uptake rates were 28.5% (45/158), 28.7% (147/513) and 14.2% (31/219); among the pilgrims with 'at risk' conditions the pneumococcal vaccine uptake rates were 15 (30.6%), 43 (45.3%) and 9 (29%) respectively. According to our surveys, the pneumococcal vaccine uptake among Australian pilgrims is low. Further research is needed to explore the reasons through a validated study.

Complications of serogroup B meningococcal disease in survivors: a review.

This systematic review evaluates the prevalence of long-term complications of serogroup B meningococcal disease (MD) in light of the recent licensure of a vaccine against meningococcal B disease. Twelve appropriate studies were identified by searching available databases from 1946 to July 2014. The average prevalence of hearing impairment was 4.2% among serogroup B MD survivors; 2.3% suffered amputation and 2.3% developed seizures. When compared with complications due to non-meningococcal B bacterial meningitis, physical impairment and seizures were more common in survivors of meningococcal B disease but hearing impairment had similar prevalence. Few studies quantified less frequent complications such as visual impairment and cognitive dysfunction. Better comprehensive reporting of the complications and costs of serogroup B MD in survivors and their families is needed to inform vaccination policy.

Prevention of influenza at Hajj: applications for mass gatherings.

Outbreaks of infectious diseases that spread via respiratory route, e.g. influenza, are common amongst Hajj congregation in Mecca, Saudi Arabia. The Saudi Arabian authority successfully organized the Hajj 2009 amidst fear of pandemic influenza. While severe influenza A(H1N1)pdm09 was rare, the true burden of pandemic influenza at Hajj that year remains speculative. In this article we review the latest evidence on influenza control and discuss our experience of influenza and its prevention at Hajj and possible application to other mass gatherings. Depending on study design the attack rate of seasonal influenza at Hajj has ranged from 6% in polymerase chain reaction or culture confirmed studies to 38% in serological surveillance. No significant effect of influenza vaccine or the use of personal protective measures against influenza has been established from observational studies, although the uptake of the vaccine and adherence to face masks and hand hygiene has been low. In all, there is a relatively poor evidence base for control of influenza. Until better evidence is obtained, vaccination coupled with rapid antiviral treatment of symptomatic individuals remains the mainstay of prevention at Hajj and other mass gatherings. Hajj pilgrimage provides a unique opportunity to test the effectiveness of various preventive measures that require a large sample size, such as testing the efficacy of plain surgical masks against laboratory-confirmed influenza. After successful completion of a pilot trial conducted among Australian pilgrims at the 2011 Hajj, a large multinational cluster randomized controlled trial is being planned. This will require effective international collaboration.

Oseltamivir for control of influenza at mass gatherings.

The use of oseltamivir at mass gatherings (MGs) or other crowded settings has not previously been systematically examined to synthesise the evidence of its usefulness. Here we have evaluated its effectiveness by reviewing the published literature. The effectiveness of oseltamivir at MGs is controversial because published clinical trials evaluating this are lacking. Its use, to date, has been predominantly therapeutic, i.e. to treat patients with confirmed or suspected influenza. There are some examples of its use in mass prophylaxis at MGs and other crowded settings like schools and camps, and closed settings such as prisons and aged care facilities. Most of the available studies indicate that oseltamivir use, whether therapeutic or prophylactic, is effective in containing influenza outbreaks in those settings though there are some reports of moderately high side effects, particularly among young children. Targeted prophylaxis of oseltamivir seems to help contain an outbreak of influenza at MG. A combination of 'treatment of cases' and 'ring prophylaxis of contacts' appears to be a feasible and economically sustainable strategy. Further research needs to be directed to uncertainties (e.g. how, when and for whom oseltamivir should be used) over oseltamivir's place in influenza control at mass gatherings.

Hazards of hepatitis at the Hajj.

While an increased risk of hepatitis is associated with travel, the risk of hepatitis associated with the Islamic Hajj pilgrimage to Mecca, Saudi Arabia has not been carefully quantified. Conditions unique to this gathering can pose the risk of both enteral and parenteral viral hepatitis. During this congregation, pilgrims stay in tents shared by 100 or more people often living on foods from street vendors and sharing common toilet facilities that can expose them to both hepatitis A and E. To mark the end of the festival, head shaving or trimming by fellow pilgrims or street barbers, who often re-use their razor may expose them to hepatitis B or C. Pilgrims are also at risk of cuts to the hands and feet while sacrificing cattle and walking barefooted, which may further increase the risk of parenteral viral hepatitis. Emerging diseases such as Alkhumra virus and Rift Valley fever, which may cause hepatitis, are also potentially important for the Hajj pilgrims. Improved health education to increase awareness about the risk of these diseases and appropriate immunisations, particularly hepatitis A and B vaccines, could play an important role.

Influenza and meningococcal disease: lessons for travellers and government from 2 epidemic diseases.

Influenza and meningococcal disease are two serious diseases that are especially linked. Outbreaks of influenza have been frequently associated with secondary outbreaks of meningococcal disease. Travellers such as Hajj pilgrims are at particular risk, the most recent meningococcal outbreaks being in 2000 and 2001, while concern is rising that the annual pilgrimage, centred as it presently is on winter, may even become the epicentre of an avian influenza pandemic. Routine vaccination of pilgrims against meningococcal disease using a 4-valent product has been in place since 2002 with good effect, but influenza vaccine is not yet routinely required for all pilgrims despite the high proportion afflicted. Meningococcal polysaccharide vaccines are effective in older children and adults and this cheaper product can play a role in the short term management of meningococcal outbreaks due to serogroups A, C, W135 or Y. The impressively fast development of a C conjugate vaccine in the late 1990s was a credit to the close collaboration of pharma, academia and the executive. A similar alignment could accelerate the production of an efficacious and cost-effective H5N1 influenza vaccine through direct transparent competition with head-to-head randomised, double-blinded controlled trials. Both organisms have a propensity to mutate and adapt to immune pressure. There are lessons to be learnt from how we manage each for the control of the other.

Influenza vaccine in Hajj pilgrims: policy issues from field studies.

In pilgrims returning to the UK from the Hajj in 2005 and 2006, protection from PCR-confirmed influenza by influenza vaccine was estimated using verified vaccination histories from those with symptoms consistent with influenza. Of 538 patients whose nasal swabs were analysed and immunisation histories confirmed 115 (21%) were in a high-risk group for influenza; half of these (58/115) were immunised against influenza, compared with a fifth (90/423) of those not at high risk. Five percent of vaccinated 'at risk' pilgrims compared with 14% of unvaccinated (RR 0.37, 95% CI 0.1-1.4) had confirmed influenza. Rates of influenza in vaccinated and unvaccinated 'not at risk' pilgrims were similar (10% vs. 11%). Seasonal influenza vaccine was insignificantly protective against influenza in Hajj pilgrims.