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• W2409283608 abstract "•The impact of changing vaccine policy on infectious disease transmission during the Hajj is reviewed.•The role of preventive measures during the Hajj is discussed.•The status of Hajj vaccination studies highlights the knowledge gaps. Vaccination is an effective preventive measure that has been used in the unique Hajj pilgrimage setting to control the transmission of infectious diseases. The current vaccination policy applied during Hajj is reviewed herein, highlighting the effectiveness of the approaches applied and identifying research gaps that need to be filled in order to improve the development and dissemination of Hajj vaccination strategies. Vaccination is an effective preventive measure that has been used in the unique Hajj pilgrimage setting to control the transmission of infectious diseases. The current vaccination policy applied during Hajj is reviewed herein, highlighting the effectiveness of the approaches applied and identifying research gaps that need to be filled in order to improve the development and dissemination of Hajj vaccination strategies. Hajj is a unique mass gathering event associated with increased risks to public health within the host country (Kingdom of Saudi Arabia, KSA) and globally. The associated infectious disease hazards include the dissemination of airborne infections, food-borne disease, blood-borne diseases, and zoonotic infections.1Ahmed Q.A. Arabi Y.M. Memish Z.A. Health risks at the Hajj.Lancet. 2006; 367: 1008-1015Abstract Full Text Full Text PDF PubMed Scopus (157) Google Scholar Vaccination is one of the major preventive measures used to prevent infections and control the transmission of infectious diseases. Vaccination has reduced the overall global morbidity and mortality associated with many infectious diseases, with the World Health Organization (WHO) estimating that 2.5 million lives a year are protected from infections.2World Health Organization World Bank. State of the world's vaccines and immunization.3rd ed. WHO, Geneva2009Google Scholar Moreover, some vaccines confer protection not only to the vaccinated individuals but also to unvaccinated contacts, contributing to the development of community protection or herd immunity.3Andre F.E. Booy R. Bock H.L. Clemens J. Datta S.K. John T.J. et al.Vaccination greatly reduces disease, disability, death and inequity worldwide.Bull World Health Organ. 2008; 86: 140-146Crossref PubMed Scopus (111) Google Scholar In addition, there is increasing evidence that bacterial and viral vaccines may have an impact on controlling the emergence and dissemination of antimicrobial resistance.4Dagan R. Klugman K.P. Impact of conjugate pneumococcal vaccines on antibiotic resistance.Lancet Infect Dis. 2008; 8: 785-795Abstract Full Text Full Text PDF PubMed Scopus (125) Google Scholar, 5Cohen R. Approaches to reduce antibiotic resistance in the community.Pediatr Infect Dis J. 2006; 25: 977-980Crossref PubMed Scopus (20) Google Scholar, 6Kwong J.C. Maaten S. Upshur R.E. Patrick D.M. Marra F. The effect of universal influenza immunization on antibiotic prescriptions: an ecological study.Clin Infect Dis. 2009; 49: 750-756Crossref PubMed Scopus (28) Google Scholar Currently, licensed vaccines can be categorized into five main types: inactivated, live attenuated, subunit, toxoid, and conjugate vaccines (Table 1). The type of vaccine determines its mode of action, including the prevention of pathogen transmission, inhibition of pathogen persistence and multiplication, or a reduction in disease progression and severity.7Siegrist C.A. Vaccine immunology.Vaccines. Sixth. Elsevier, 2013: 14-32Crossref Scopus (0) Google ScholarTable 1Vaccine availability for Hajj-associated diseases (FDA-approved only)Health hazards at HajjInfectious agentVaccineManufacturerVaccine typeAdministrationApproved for persons aged:1. AirborneNeisseria meningitidisMenomuneSanofiInactivated (A/C/Y/W135, polysaccharide)SC≥2 yearsMenactraSanofiInactivated (A/C/Y/W135, conjugate diphtheria toxoid)IM9 months–55 yearsMenveoGlaxoSmithKlineInactivated (A/C/Y/W135) conjugate (diphtheria CRM197)IM2 months–55 yearsBexseroGlaxoSmithKlineRecombinantIM10–25 yearsTrumenbaPfizerRecombinantIM10–25 yearsStreptococcus pneumoniaePneumovax 23MerckInactivated (23-valent polysaccharide)IM or SC2 years at high risk and adults >50 yearsPrevnar 13PfizerInactivated (13-valent) conjugate (diphtheria CRM197)IM6–17 years and adults >50 yearsInfluenza virusFluarixGlaxoSmithKlineInactivated (A and B serotypes)IM≥3 yearsFluLavalGlaxoSmithKlineInactivated (A and B serotypes)IM≥3 yearsFluvirinNovartisInactivated (A and B serotypes)IM≥4 yearsAgrifluNovartisInactivated (A and B serotypes)IM≥18 yearsFlucelvaxNovartisInactivated (A and B serotypes)IM≥18 yearsFluzoneSanofiInactivated (A and B serotypes)IM≥6 monthsFluzone (intradermal)SanofiInactivated (A and B serotypes)ID18–64 yearsFluzone (high-dose)SanofiInactivated (A and B serotypes)IM≥65 yearsAfluriabioCSLInactivated (A and B serotypes)IM≥5 yearsFlublokProtein Science CorporationRecombinantIM≥18 yearsFluMistMedimmuneLive attenuatedIN (spray)2–49 years2. Food-borne and entericPoliovirusSabin OPVaNot currently FDA-approved, but included for completeness.Live attenuatedOralIPOLSanofiInactivatedSC or IM≥6 weeksHepatitis A virusHavrixGlaxoSmithKlineInactivatedIM≥1 yearVaqtaMerckInactivatedIM≥1 yearRotavirusRotateqMerckLive (pentavalent)Oral6–12 weeksRotarixGlaxoSmithKlineLive (pentavalent)Oral6–24 weeksVibrio choleraeaNot currently FDA-approved, but included for completeness.DukoralValnevaInactivated with recombinant CTBOral≥2 yearsShancholShanthaInactivated bivalent O1/O139Oral≥1 yearSalmonella TyphiVivotifCrucellLive attenuated Ty2Oral≥6 yearsTyphim ViSanofiInactivatedIM≥2 yearsDiarrhoeagenic Escherichia coliNAShigella sppNA3. Blood-borneHepatitis B virusEngerix-BGlaxoSmithKlineRecombinant (all HepB serotypes)IMAll agesRecombivax-HBMerckRecombinant (all HepB serotypes)IMAll agesTwinrixGlaxoSmithKlineInactivated/recombinant (HepA–HepB)IM≥18 yearsHepatitis C virusNAHIVNA4. Vector-borneYellow fever virusYF-VaxSanofiLive attenuatedSC≥9 monthsFDA, US Food and Drug Administration; NA, no commercial vaccine is available; SC, subcutaneous; IM, intramuscular; ID, intradermal; IN, intranasal; CTB, Cholera Toxin B subunit.a Not currently FDA-approved, but included for completeness. Open table in a new tab FDA, US Food and Drug Administration; NA, no commercial vaccine is available; SC, subcutaneous; IM, intramuscular; ID, intradermal; IN, intranasal; CTB, Cholera Toxin B subunit. The current Hajj vaccination policy includes mandatory vaccination for all pilgrims against meningococcal disease.8Memish Z.A. Al Rabeeah A.A. Health conditions for travellers to Saudi Arabia for the Umra and pilgrimage to Mecca (Hajj)—2014.J Epidemiol Glob Health. 2014; 4: 73-75Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar, 9WHO Health conditions for travellers to Saudi Arabia for the pilgrimage to Mecca (Hajj), 2015.Wkly Epidemiol Rec. 2015; 90: 381-392Google Scholar This is in addition to mandatory vaccination against yellow fever and polio for pilgrims coming from endemic regions.10International Travel and Health WHO ITH International travel and health. WHO, Geneva2015Google Scholar The Saudi Ministry of Health strongly recommends seasonal influenza vaccination for all pilgrims, particularly those at high risk of infection complications.8Memish Z.A. Al Rabeeah A.A. Health conditions for travellers to Saudi Arabia for the Umra and pilgrimage to Mecca (Hajj)—2014.J Epidemiol Glob Health. 2014; 4: 73-75Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar, 9WHO Health conditions for travellers to Saudi Arabia for the pilgrimage to Mecca (Hajj), 2015.Wkly Epidemiol Rec. 2015; 90: 381-392Google Scholar The impact of the current vaccination policy on the control of infectious disease transmission in this unique setting of the Hajj pilgrimage is reviewed herein. Furthermore, how research can determine the elements of future Hajj vaccination strategies is discussed, and the research gaps in current knowledge required to improve the development and dissemination of vaccine strategies are identified. A number of issues need to be addressed carefully before the introduction of a new vaccine for use during Hajj. Key aspects include the type of immune response induced by the vaccine, the efficacy of the vaccine among extremely varied populations (including different age groups, prior exposure to infectious agents, and ethnic origin), the ability of the vaccine to block the transmission of disease, the impact of vaccine types on circulating microbial genomes (risk of emergence of vaccine escape variants), and any indirect effects on the circulation of antimicrobial-resistant elements. Vaccination strategies in the Hajj setting should carefully address these aspects and emphasize the potential impacts from the immunological (e.g., efficacy and safety among different age groups), epidemiological (e.g., changes in transmission patterns), and evolutionary (e.g., changes in pathogen population structure) perspectives. Importantly, the innate and acquired immune responses are weaker at younger ages and also decline with age, leading to the impaired persistence of antibody responses and the development of lower levels of serum antibodies to both protein and polysaccharide vaccines.7Siegrist C.A. Vaccine immunology.Vaccines. Sixth. Elsevier, 2013: 14-32Crossref Scopus (0) Google Scholar Therefore, age-associated changes in the immune response impact the efficacy of these particular types of vaccine. In addition to their broad age range, Hajj pilgrims are also characterized by significant diversity in ethnic origin, which may also impact their susceptibility/resistance (e.g., influenza virus-specific severity alleles) to particular pathogens and to vaccine-induced immune responses. In addition, vaccines can induce the emergence of novel variants of particular pathogens through Darwinian selection pressures. Pathogens that this has been seen with include viruses (influenza) and bacteria (Neisseria meningitidis,11Maiden M.C. The impact of protein-conjugate polysaccharide vaccines: an endgame for meningitis?.Philos Trans R Soc Lond B Biol Sci. 2013; 368: 20120147Crossref PubMed Scopus (0) Google Scholar, 12Funk A. Uadiale K. Kamau C. Caugant D.A. Ango U. Greig J. Sequential outbreaks due to a new strain of Neisseria meningitidis serogroup C in northern Nigeria, 2013–14.PLoS Curr. 2014; 6PubMed Google Scholar, 13Delrieu I. Yaro S. Tamekloe T.A. Njanpop-Lafourcade B.M. Tall H. Jaillard P. et al.Emergence of epidemic Neisseria meningitidis serogroup X meningitis in Togo and Burkina Faso.PLoS One. 2011; 6: e19513Crossref PubMed Scopus (54) Google Scholar, 14Xie O. Pollard A.J. Mueller J.E. Norheim G. Emergence of serogroup X meningococcal disease in Africa: need for a vaccine.Vaccine. 2013; 31: 2852-2861Crossref PubMed Scopus (29) Google Scholar, 15Swartley J.S. Marfin A.A. Edupuganti S. Liu L.J. Cieslak P. Perkins B. et al.Capsule switching of Neisseria meningitidis.Proc Natl Acad Sci U S A. 1997; 94: 271-276Crossref PubMed Scopus (278) Google Scholar, 16Beddek A.J. Li M.S. Kroll J.S. Jordan T.W. Martin D.R. Evidence for capsule switching between carried and disease-causing Neisseria meningitidis strains.Infect Immun. 2009; 77: 2989-2994Crossref PubMed Scopus (27) Google Scholar Streptococcus pneumoniae,17Golubchik T. Brueggemann A.B. Street T. Gertz Jr., R.E. Spencer C.C. Ho T. et al.Pneumococcal genome sequencing tracks a vaccine escape variant formed through a multi-fragment recombination event.Nat Genet. 2012; 44: 352-355Crossref PubMed Scopus (42) Google Scholar and Bordetella pertussis18Xu Y. Liu B. Grondahl-Yli-Hannuksila K. Tan Y. Feng L. Kallonen T. et al.Whole-genome sequencing reveals the effect of vaccination on the evolution of Bordetella pertussis.Sci Rep. 2015; 5: 12888Crossref PubMed Google Scholar). These changes within the pathogen population due to vaccine-induced selection can occur at both the host level and the community level.19Day T. Galvani A. Struchiner C. Gumel A. The evolutionary consequences of vaccination.Vaccine. 2008; 26: C1-C3Crossref Scopus (5) Google Scholar Large-scale studies are needed to examine the evolutionary consequences of different vaccine introductions into the Hajj setting, with a particular model in the near-future being the introduction of pneumococcal conjugate vaccines with limited valences. These evolutionary studies will need to address not only the vaccine escape variants but also the structural changes in virulence factors that lead to the emergence of variants of novel virulence potential. It is important to highlight that many vaccines protect vaccinees from the disease but do not necessarily prevent the vaccinee from becoming infected by the pathogen (leading to pathogen colonization/carriage) and therefore acting as a transmitter. The ideal vaccine profile to be used in the Hajj setting would be one that impacts the transmission of the pathogen itself through a reduction in the amount and/or duration of carriage by vaccinees. The Hajj pilgrimage has been associated with two major outbreaks of bacterial meningitis caused by N. meningitidis serogroups A and W135, resulting in the global dissemination of meningococcal disease in 198720Wilder-Smith A. Memish Z. Meningococcal disease and travel.Int J Antimicrob Agents. 2003; 21: 102-106Abstract Full Text Full Text PDF PubMed Scopus (30) Google Scholar, 21Moore P.S. Reeves M.W. Schwartz B. Gellin B.G. Broome C.V. Intercontinental spread of an epidemic group A Neisseria meningitidis strain.Lancet. 1989; 2: 260-263Abstract PubMed Scopus (136) Google Scholar and 2000,22Wilder-Smith A. Goh K.T. Barkham T. Paton N.I. Hajj-associated outbreak strain of Neisseria meningitidis serogroup W135: estimates of the attack rate in a defined population and the risk of invasive disease developing in carriers.Clin Infect Dis. 2003; 36: 679-683Crossref PubMed Scopus (71) Google Scholar, 23Aguilera J.F. Perrocheau A. Meffre C. Hahne S. Group WWOutbreak of serogroup W135 meningococcal disease after the Hajj pilgrimage, Europe, 2000.Emerg Infect Dis. 2002; 8: 761-767Crossref PubMed Google Scholar respectively. In response to the first outbreak, the Saudi Ministry of Health introduced the first mandated vaccination policy, with all pilgrims being required to receive the polysaccharide bivalent (A, C) meningococcal vaccine from 1988 onwards.20Wilder-Smith A. Memish Z. Meningococcal disease and travel.Int J Antimicrob Agents. 2003; 21: 102-106Abstract Full Text Full Text PDF PubMed Scopus (30) Google Scholar However, this bivalent vaccine lacked the capability to prevent the nasopharyngeal carriage of N. meningitidis and therefore a subsequent outbreak of serotype A was seen in the UK and was associated with returning pilgrims and their contacts, particularly children.24Jones D.M. Sutcliffe E.M. Group A meningococcal disease in England associated with the Haj.J Infect. 1990; 21: 21-25Abstract Full Text PDF PubMed Scopus (31) Google Scholar This, combined with the outbreak of serotype W135 in 2000,25Klaber R. Booy R. El Bashir H. Mifsud A. Taylor S. Sustained outbreak of W135 meningococcal disease in east London, UK.Lancet. 2002; 360: 644Abstract Full Text Full Text PDF PubMed Google Scholar led to the introduction of a new vaccination policy in 2001 that mandated quadrivalent meningococcal vaccine (ACYW135) at least 10 days prior to travelling for the pilgrimage as a requirement for granting a Hajj visa.22Wilder-Smith A. Goh K.T. Barkham T. Paton N.I. Hajj-associated outbreak strain of Neisseria meningitidis serogroup W135: estimates of the attack rate in a defined population and the risk of invasive disease developing in carriers.Clin Infect Dis. 2003; 36: 679-683Crossref PubMed Scopus (71) Google Scholar Recently, studies have suggested that the newly licensed conjugate vaccines have significant advantages over the previous polysaccharide ones. These include longer lasting immunity26Balmer P. Borrow R. Miller E. Impact of meningococcal C conjugate vaccine in the UK.J Med Microbiol. 2002; 51: 717-722Crossref PubMed Google Scholar, 27Trotter C.L. Andrews N.J. Kaczmarski E.B. Miller E. Ramsay M.E. Effectiveness of meningococcal serogroup C conjugate vaccine 4 years after introduction.Lancet. 2004; 364: 365-367Abstract Full Text Full Text PDF PubMed Scopus (400) Google Scholar and, more importantly, the ability to reduce the asymptomatic carriage of N. meningitidis.28Trotter C.L. Maiden M.C. Meningococcal vaccines and herd immunity: lessons learned from serogroup C conjugate vaccination programs.Expert Rev Vaccines. 2009; 8: 851-861Crossref PubMed Scopus (91) Google Scholar, 29Read R.C. Baxter D. Chadwick D.R. Faust S.N. Finn A. Gordon S.B. et al.Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage: an observer-blind, phase 3 randomised clinical trial.Lancet. 2014; 384: 2123-2131Abstract Full Text Full Text PDF PubMed Scopus (48) Google Scholar The introduction of such vaccines into the Hajj setting would have a significant impact on the risk of meningococcal disease dissemination by interrupting the transmission of N. meningitidis from pilgrims returning to their home countries colonized with the bacteria. However, before the quadrivalent conjugate vaccine becomes the mandated vaccine for Hajj, more comprehensive studies are required to answer questions such as the efficacy of the vaccine among groups of different ages and ethnic origins, and the time required for vaccinees to become fully protected against both invasion and colonization. Data so far suggest that the conjugate vaccine efficiently reduces N. meningitidis carriage.29Read R.C. Baxter D. Chadwick D.R. Faust S.N. Finn A. Gordon S.B. et al.Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage: an observer-blind, phase 3 randomised clinical trial.Lancet. 2014; 384: 2123-2131Abstract Full Text Full Text PDF PubMed Scopus (48) Google Scholar Carriage was found to be reduced in UK university students only 2 months after the vaccine had been administered, and this probably represents the time required for the immune response to eliminate meningococcal carriage.29Read R.C. Baxter D. Chadwick D.R. Faust S.N. Finn A. Gordon S.B. et al.Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage: an observer-blind, phase 3 randomised clinical trial.Lancet. 2014; 384: 2123-2131Abstract Full Text Full Text PDF PubMed Scopus (48) Google Scholar For the meningococcal vaccines, as with all vaccines used at the Hajj, the important outstanding question of the potential impact of vaccine escape mutants also needs further investigation. Pneumonia is one of the major causes of hospital admission during Hajj.30Ridda I. King C. Rashid H. Pneumococcal infections at Hajj: current knowledge gaps.Infect Disord Drug Targets. 2014; 14: 177-184Crossref Google Scholar Many studies have identified S. pneumoniae as the main etiological agent of lower respiratory tract infections during the pilgrimage.31El-Sheikh S.M. El-Assouli S.M. Mohammed K.A. Albar M. Bacteria and viruses that cause respiratory tract infections during the pilgrimage (Haj) season in Makkah, Saudi Arabia.Trop Med Int Health. 1998; 3: 205-209PubMed Google Scholar, 32Baharoon S. Al-Jahdali H. Al Hashmi J. Memish Z.A. Ahmed Q.A. Severe sepsis and septic shock at the Hajj: etiologies and outcomes.Travel Med Infect Dis. 2009; 7: 247-252Abstract Full Text Full Text PDF PubMed Scopus (18) Google Scholar, 33Asghar A.H. Ashshi A.M. Azhar E.I. Bukhari S.Z. Zafar T.A. Momenah A.M. Profile of bacterial pneumonia during Hajj.Indian J Med Res. 2011; 133: 510-513PubMed Google Scholar, 34Memish Z.A. Almasri M. Turkestani A. Al-Shangiti A.M. Yezli S. 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Viboud C. et al.The role of influenza in the epidemiology of pneumonia.Sci Rep. 2015; 5: 15314Crossref Google Scholar The currently available commercial pneumococcal vaccine types include a 23-valent polysaccharide vaccine (PPV23) and 7-valent (PCV7) and 13-valent (PCV13) conjugate vaccines. The United States Advisory Committee on Immunization Practices (ACIP) recommends PPV23 for adults over age 65 years and adults aged 19–64 years with immunocompromising or chronic medical conditions, including smokers. ACIP also recommends further vaccination with PCV13 for all immunocompromised adults and immunocompetent adults with cerebrospinal fluid leaks and/or cochlear implants. PCV13 is approved for use in children aged 6 weeks and over and ACIP recommends its use in all children aged 2 months and over.40World Health Organization. 23-valent pneumococcal polysaccharide vaccine. WHO position paper. 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• W2409283608 date "2016-06-01" @default.
• W2409283608 modified "2023-10-18" @default.
• W2409283608 title "Hajj vaccinations—facts, challenges, and hope" @default.
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