Application of Transthoracic Echocardiography for Cardiac Safety Evaluation in the Clinical Development Process of Vaccines Against Streptococcus pyogenes.
Journal
Drugs in R&D
ISSN: 1179-6901
Titre abrégé: Drugs R D
Pays: New Zealand
ID NLM: 100883647
Informations de publication
Date de publication:
18 Mar 2024
18 Mar 2024
Historique:
accepted:
07
01
2024
medline:
18
3
2024
pubmed:
18
3
2024
entrez:
18
3
2024
Statut:
aheadofprint
Résumé
Superficial infections with Streptococcus pyogenes (Strep A), pharyngitis and impetigo can induce acute rheumatic fever, an autoimmune sequela manifesting mostly with arthritis and rheumatic carditis. Valvular heart damage can persist or advance following repeated episodes of acute rheumatic fever, causing rheumatic heart disease. Acute rheumatic fever and rheumatic heart disease disproportionately affect children and young adults in developing countries and disadvantaged communities in developed countries. People living with rheumatic heart disease are at risk of experiencing potentially fatal complications such as heart failure, bacterial endocarditis or stroke. Transthoracic echocardiography plays a central role in diagnosing both rheumatic carditis and rheumatic heart disease. Despite the obvious medical need, no licensed Strep A vaccines are currently available, as their clinical development process faces several challenges, including concerns for cardiac safety. However, the development of Strep A vaccines has been recently relaunched by many vaccine developers. In this context, a reliable and consistent safety evaluation of Strep A vaccine candidates, including the use of transthoracic echocardiography for detecting cardiac adverse events, could greatly contribute to developing a safe and efficacious product in the near future. Here, we propose a framework for the consistent use of transthoracic echocardiography to proactively detect cardiac safety events in clinical trials of Strep A vaccine candidates. Throat and skin infections caused by certain types of bacteria, named Streptococcus pyogenes, are frequent worldwide; however, in many children from less developed countries and disadvantaged communities, infections with S. pyogenes lead to a condition called acute rheumatic fever, which usually affects the joints and the heart. Damage to the heart valves may evolve to rheumatic heart disease, a permanent condition with often life-threatening complications. Rheumatic heart disease is an important health problem in places and communities where S. pyogenes infections occur frequently. A vaccine against these bacteria would help lower the number of people with valvular heart disease; however, no such vaccine exists yet. Research on vaccines against S. pyogenes was on hold for almost 30 years because of initial concerns that vaccinated children might develop acute rheumatic fever more frequently. Recently, researchers started working again on vaccines against S. pyogenes, but concerns about the safety of such vaccines persist. Doctors can reliably use echocardiography to diagnose cases of rheumatic carditis (as a sign of acute rheumatic fever) and rheumatic heart disease. Here, we propose a simple approach for the consistent use of echocardiography in clinical research of vaccines against S. pyogenes that will allow the detection of any potential heart-related side effects of the vaccine.
Autres résumés
Type: plain-language-summary
(eng)
Throat and skin infections caused by certain types of bacteria, named Streptococcus pyogenes, are frequent worldwide; however, in many children from less developed countries and disadvantaged communities, infections with S. pyogenes lead to a condition called acute rheumatic fever, which usually affects the joints and the heart. Damage to the heart valves may evolve to rheumatic heart disease, a permanent condition with often life-threatening complications. Rheumatic heart disease is an important health problem in places and communities where S. pyogenes infections occur frequently. A vaccine against these bacteria would help lower the number of people with valvular heart disease; however, no such vaccine exists yet. Research on vaccines against S. pyogenes was on hold for almost 30 years because of initial concerns that vaccinated children might develop acute rheumatic fever more frequently. Recently, researchers started working again on vaccines against S. pyogenes, but concerns about the safety of such vaccines persist. Doctors can reliably use echocardiography to diagnose cases of rheumatic carditis (as a sign of acute rheumatic fever) and rheumatic heart disease. Here, we propose a simple approach for the consistent use of echocardiography in clinical research of vaccines against S. pyogenes that will allow the detection of any potential heart-related side effects of the vaccine.
Identifiants
pubmed: 38494581
doi: 10.1007/s40268-024-00452-y
pii: 10.1007/s40268-024-00452-y
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. GlaxoSmithKline Biologicals S.A.
Références
Ferretti JJ, Köhler W. History of streptococcal research. In: Ferretti JJ, Stevens DL, Fischetti VA, editors. Streptococcus pyogenes: basic biology to clinical manifestations. Oklahoma City (OK): University of Oklahoma Health Sciences Center; 2016. https://www.ncbi.nlm.nih.gov/books/NBK333430/ . Accessed 4 May 2022.
Marshall HS, Richmond P, Nissen M, et al. Group A streptococcal carriage and seroepidemiology in children up to 10 years of age in Australia. Pediatr Infect Dis J. 2015;34(8):831–8. https://doi.org/10.1097/INF.0000000000000745 .
doi: 10.1097/INF.0000000000000745
pubmed: 25961895
May PJ, Bowen AC, Carapetis JR. The inequitable burden of Group A streptococcal diseases in indigenous Australians. Med J Aust. 2016;205(5):201–3. https://doi.org/10.5694/mja16.00400 .
doi: 10.5694/mja16.00400
pubmed: 27581260
Efstratiou A, Lamagni T. Epidemiology of Streptococcus pyogenes. In: Ferretti JJ, Stevens DL, Fischetti VA, editors. Streptococcus pyogenes: basic biology to clinical manifestations. Oklahoma City (OK): University of Oklahoma Health Sciences Center; 2016. https://www.ncbi.nlm.nih.gov/books/NBK343616/ . Accessed 18 May 2022.
Avire NJ, Whiley H, Ross K. A review of Streptococcus pyogenes: public health risk factors, prevention and control. Pathogens. 2021;10(2):248. https://doi.org/10.3390/pathogens10020248 .
doi: 10.3390/pathogens10020248
pubmed: 33671684
pmcid: 7926438
Sika-Paotonu D, Beaton A, Raghu A, et al. Acute rheumatic fever and rheumatic heart disease. In: Ferretti JJ, Stevens DL, Fischetti VA, editors. Streptococcus pyogenes: basic biology to clinical manifestations. Oklahoma City (OK): University of Oklahoma Health Sciences Center; 2016. https://www.ncbi.nlm.nih.gov/books/NBK425394/ . Accessed 18 May 2022.
Bowen AC, Mahé A, Hay RJ, et al. The global epidemiology of impetigo: a systematic review of the population prevalence of impetigo and pyoderma. PLoS One. 2015;10(8): e0136789. https://doi.org/10.1371/journal.pone.0136789 .
doi: 10.1371/journal.pone.0136789
pubmed: 26317533
pmcid: 4552802
Carapetis JR, Beaton A, Cunningham MW, et al. Acute rheumatic fever and rheumatic heart disease. Nat Rev Dis Primers. 2016;2:15084. https://doi.org/10.1038/nrdp.2015.84 .
doi: 10.1038/nrdp.2015.84
pubmed: 27188830
pmcid: 5810582
Watkins DA, Johnson CO, Colquhoun SM, et al. Global, regional, and national burden of rheumatic heart disease, 1990–2015. N Engl J Med. 2017;377(8):713–22. https://doi.org/10.1056/NEJMoa1603693 .
doi: 10.1056/NEJMoa1603693
pubmed: 28834488
Rwebembera J, Beaton AZ, de Loizaga SR, et al. The global impact of rheumatic heart disease. Curr Cardiol Rep. 2021;23(11):160. https://doi.org/10.1007/s11886-021-01592-2 .
doi: 10.1007/s11886-021-01592-2
pubmed: 34599389
Dale JB, Walker MJ. Update on Group A streptococcal vaccine development. Curr Opin Infect Dis. 2020;33(3):244–50. https://doi.org/10.1097/qco.0000000000000644 .
doi: 10.1097/qco.0000000000000644
pubmed: 32304470
pmcid: 7326309
Vekemans J, Gouvea-Reis F, Kim JH, et al. The path to Group A Streptococcus vaccines: World Health Organization research and development technology roadmap and preferred product characteristics. Clin Infect Dis. 2019;69(5):877–83. https://doi.org/10.1093/cid/ciy1143 .
doi: 10.1093/cid/ciy1143
pubmed: 30624673
pmcid: 6695511
Dick GF, Dick GH. Scarlet fever. Am J Public Health (NY). 1924;14(12):1022–8. https://doi.org/10.2105/ajph.14.12.1022 .
doi: 10.2105/ajph.14.12.1022
Peterman MG. Immunization against scarlet fever. Am J Dis Child. 1937;54(1):89–95. https://doi.org/10.1001/archpedi.1937.01980010098009 .
doi: 10.1001/archpedi.1937.01980010098009
Rejholec V, Wagner V. Response by antibodies to tissue antigens in the course of rheumatic fever. Ann Rheum Dis. 1956;15(4):364–72. https://doi.org/10.1136/ard.15.4.364 .
doi: 10.1136/ard.15.4.364
pubmed: 13395271
pmcid: 1006910
Sharma A, Nitsche-Schmitz D. Challenges to developing effective streptococcal vaccines to prevent rheumatic fever and rheumatic heart disease. Vaccine Dev Ther. 2014;4:39–54. https://doi.org/10.2147/VDT.S45037 .
doi: 10.2147/VDT.S45037
Asturias EJ, Excler JL, Ackland J, et al. Safety of Streptococcus pyogenes vaccines: anticipating and overcoming challenges for clinical trials and post-marketing monitoring. Clin Infect Dis. 2023;77(6):917–24. https://doi.org/10.1093/cid/ciad311 .
doi: 10.1093/cid/ciad311
pubmed: 37232372
pmcid: 10506775
Massell BF, Honikman LH, Amezcua J. Rheumatic fever following streptococcal vaccination: report of three cases. JAMA. 1969;207(6):1115–9.
doi: 10.1001/jama.1969.03150190037007
pubmed: 5818242
Food and Drug Administration, HHS. Revocation of status of specific products; Group A Streptococcus. Direct final rule. Fed Regist. 2005;70(231):72197–9.
Reményi B, Wilson N, Steer A, et al. World Heart Federation criteria for echocardiographic diagnosis of rheumatic heart disease-an evidence-based guideline. Nat Rev Cardiol. 2012;9(5):297–309. https://doi.org/10.1038/nrcardio.2012.7 .
doi: 10.1038/nrcardio.2012.7
pubmed: 22371105
pmcid: 5523449
Centers for Disease Control and Prevention. Group A streptococcal (GAS) disease. Pharyngitis (Strep throat). https://www.cdc.gov/groupastrep/diseases-hcp/strep-throat.html . Accessed 24 Apr 2022.
Bryant AE, Stevens DL. Streptococcus pyogenes. In: Bennett JE, Dolin R, Blaser MJ, editors. Mandell, Douglas, and Bennett’s principles and practice of infectious diseases, vol. 2. 8th ed. Philadelphia: Elsevier Saunders; 2015. p. 2285- 99.e4.
doi: 10.1016/B978-1-4557-4801-3.00199-5
Wessels MR. Pharyngitis and scarlet fever. In: Ferretti JJ, Stevens DL, Fischetti VA, editors. Streptococcus pyogenes: basic biology to clinical manifestations. Oklahoma City (OK): University of Oklahoma Health Sciences Center; 2016. https://www.ncbi.nlm.nih.gov/books/NBK333418/ . Accessed 5 May 2022.
Stevens DL, Bryant AE. Impetigo, erysipelas and cellulitis. In: Ferretti JJ, Stevens DL, Fischetti VA, editors. Streptococcus pyogenes: basic biology to clinical manifestations. Oklahoma City (OK): University of Oklahoma Health Sciences Center; 2016. https://www.ncbi.nlm.nih.gov/books/NBK333408/ . Accessed 4 Apr 2022.
Centers for Disease Control and Prevention. Group A streptococcal (GAS) disease. Acute rheumatic fever. https://www.cdc.gov/groupastrep/diseases-hcp/acute-rheumatic-fever.html . Accessed 8 Apr 2022.
Shulman ST, Bisno AL. Nonsuppurative poststreptococcal sequelae: rheumatic fever and glomerulonephritis. In: Bennett J, Dolin R, Blaser M, editors. Mandell, Douglas and Bennett’s principles and practice of infectious diseases, vol. 2. 8th ed. Philadelphia: Elsevier; 2015. p. 2300–9.
doi: 10.1016/B978-1-4557-4801-3.00200-9
McDonald MI, Towers RJ, Andrews RM, et al. Low rates of streptococcal pharyngitis and high rates of pyoderma in Australian aboriginal communities where acute rheumatic fever is hyperendemic. Clin Infect Dis. 2006;43(6):683–9. https://doi.org/10.1086/506938 .
doi: 10.1086/506938
pubmed: 16912939
McDonald M, Currie BJ, Carapetis JR. Acute rheumatic fever: a chink in the chain that links the heart to the throat? Lancet Infect Dis. 2004;4(4):240–5. https://doi.org/10.1016/s1473-3099(04)00975-2 .
doi: 10.1016/s1473-3099(04)00975-2
pubmed: 15050943
Raynes JM, Frost HRC, Williamson DA, et al. Serological evidence of immune priming by Group A streptococci in patients with acute rheumatic fever. Front Microbiol. 2016;7:1119. https://doi.org/10.3389/fmicb.2016.01119 .
doi: 10.3389/fmicb.2016.01119
pubmed: 27499748
pmcid: 4957554
Lorenz N, Ho TKC, McGregor R, et al. Serological profiling of Group A Streptococcus infections in acute rheumatic fever. Clin Infect Dis. 2021;73(12):2322–5. https://doi.org/10.1093/cid/ciab180 .
doi: 10.1093/cid/ciab180
pubmed: 33639619
Zühlke LJ, Beaton A, Engel ME, et al. Group A Streptococcus, acute rheumatic fever and rheumatic heart disease: epidemiology and clinical considerations. Curr Treat Options Cardiovasc Med. 2017;19(2):15. https://doi.org/10.1007/s11936-017-0513-y .
doi: 10.1007/s11936-017-0513-y
pubmed: 28285457
pmcid: 5346434
Tubridy-Clark M, Carapetis JR. Subclinical carditis in rheumatic fever: a systematic review. Int J Cardiol. 2007;119(1):54–8. https://doi.org/10.1016/j.ijcard.2006.07.046 .
doi: 10.1016/j.ijcard.2006.07.046
pubmed: 17034886
Essop MR, Wisenbaugh T, Sareli P. Evidence against a myocardial factor as the cause of left ventricular dilation in active rheumatic carditis. J Am Coll Cardiol. 1993;22(3):826–9. https://doi.org/10.1016/0735-1097(93)90197-9 .
doi: 10.1016/0735-1097(93)90197-9
pubmed: 8354818
RHDAustralia (ARF/RHD writing group) The 2020 Australian guideline for prevention, diagnosis and management of acute rheumatic fever and rheumatic heart disease (3.2 edition, March 2022). https://www.rhdaustralia.org.au/system/files/fileuploads/arf_rhd_guidelines_3.2_edition_march_2022.pdf . Accessed 4 Apr 2022.
Tandon R, Sharma M, Chandrashekhar Y, et al. Revisiting the pathogenesis of rheumatic fever and carditis. Nat Rev Cardiol. 2013;10(3):171–7. https://doi.org/10.1038/nrcardio.2012.197 .
doi: 10.1038/nrcardio.2012.197
pubmed: 23319102
World Health Organization. Rheumatic heart disease. 2020. https://www.who.int/news-room/fact-sheets/detail/rheumatic-heart-disease . Accessed 5 May 2022.
Dass C, Kanmanthareddy A. Rheumatic heart disease. Treasure Island (FL): StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK538286/ . Accessed 4 Apr 2022.
Remenyi B, ElGuindy A, Smith SC Jr, et al. Valvular aspects of rheumatic heart disease. Lancet. 2016;387(10025):1335–46. https://doi.org/10.1016/s0140-6736(16)00547-x .
doi: 10.1016/s0140-6736(16)00547-x
pubmed: 27025439
Manyemba J, Mayosi BM. Penicillin for secondary prevention of rheumatic fever. Cochrane Database Syst Rev. 2002;2002(3):CD002227. https://doi.org/10.1002/14651858.CD002227 .
doi: 10.1002/14651858.CD002227
pubmed: 12137650
pmcid: 7017848
Carapetis JR, Steer AC, Mulholland EK, et al. The global burden of Group A streptococcal diseases. Lancet Infect Dis. 2005;5(11):685–94. https://doi.org/10.1016/S1473-3099(05)70267-x .
doi: 10.1016/S1473-3099(05)70267-x
pubmed: 16253886
Sims Sanyahumbi A, Colquhoun S, Wyber R, et al. Global disease burden of group A Streptococcus. In: Ferretti JJ, Stevens DL, Fischetti VA, editors. Streptococcus pyogenes: basic biology to clinical manifestations. Oklahoma City (OK): University of Oklahoma Health Sciences Center; 2016. https://www.ncbi.nlm.nih.gov/books/NBK333415/ . Accessed 4 Apr 2022.
Jackson SJ, Steer AC, Campbell H. Systematic review: estimation of global burden of non-suppurative sequelae of upper respiratory tract infection: rheumatic fever and post-streptococcal glomerulonephritis. Trop Med Int Health. 2011;16(1):2–11. https://doi.org/10.1111/j.1365-3156.2010.02670.x .
doi: 10.1111/j.1365-3156.2010.02670.x
pubmed: 21371205
Kang K, Chau KWT, Howell E, et al. The temporospatial epidemiology of rheumatic heart disease in Far North Queensland, tropical Australia 1997–2017; impact of socioeconomic status on disease burden, severity and access to care. PLoS Negl Trop Dis. 2021;15(1): e0008990. https://doi.org/10.1371/journal.pntd.0008990 .
doi: 10.1371/journal.pntd.0008990
pubmed: 33444355
pmcid: 7840049
Okello E, Ndagire E, Atala J, et al. Active case finding for rheumatic fever in an endemic country. J Am Heart Assoc. 2020;9(15): e016053. https://doi.org/10.1161/jaha.120.016053 .
doi: 10.1161/jaha.120.016053
pubmed: 32750303
pmcid: 7792248
Watkins D, Daskalakis A. The economic impact of rheumatic heart disease in developing countries. Lancet Glob Health. 2015;3:S37. https://doi.org/10.1016/S2214-109X(15)70156-7 .
doi: 10.1016/S2214-109X(15)70156-7
Gewitz MH, Baltimore RS, Tani LY, et al. Revision of the Jones Criteria for the diagnosis of acute rheumatic fever in the era of Doppler echocardiography: a scientific statement from the American Heart Association. Circulation. 2015;131(20):1806–18. https://doi.org/10.1161/cir.0000000000000205 .
doi: 10.1161/cir.0000000000000205
pubmed: 25908771
Dajani AS, Ayoub E, Bierman FZ, et al. Guidelines for the diagnosis of rheumatic fever: Jones criteria, 1992 update. JAMA. 1992;268(15):2069–73. https://doi.org/10.1001/jama.1992.03490150121036 .
doi: 10.1001/jama.1992.03490150121036
Ramakrishnan S. Echocardiography in acute rheumatic fever. Ann Pediatr Cardiol. 2009;2(1):61–4. https://doi.org/10.4103/0974-2069.52812 .
doi: 10.4103/0974-2069.52812
pubmed: 20300272
pmcid: 2840767
Wilson N. Echocardiography and subclinical carditis: guidelines that increase sensitivity for acute rheumatic fever. Cardiol Young. 2008;18(6):565–8. https://doi.org/10.1017/S1047951108003211 .
doi: 10.1017/S1047951108003211
pubmed: 18950543
Pekpak E, Atalay S, Karadeniz C, et al. Rheumatic silent carditis: echocardiographic diagnosis and prognosis of long-term follow up. Pediatr Int. 2013;55(6):685–9. https://doi.org/10.1111/ped.12163 .
doi: 10.1111/ped.12163
pubmed: 23789715
Agarwal PK, Misra M, Sarkari NB, et al. Usefulness of echocardiography in detection of subclinical carditis in acute rheumatic polyarthritis and rheumatic chorea. J Assoc Physicians India. 1998;46(11):937–8.
pubmed: 11229218
Beaton A, Okello E, Rwebembera J, et al. Secondary antibiotic prophylaxis for latent rheumatic heart disease. N Engl J Med. 2022;386(3):230–40. https://doi.org/10.1056/NEJMoa2102074 .
doi: 10.1056/NEJMoa2102074
pubmed: 34767321
Ansa VO, Odigwe CO, Agbulu RO, et al. The clinical utility of echocardiography as a cardiological diagnostic tool in poor resource settings. Niger J Clin Pract. 2013;16(1):82–5. https://doi.org/10.4103/1119-3077.106772 .
doi: 10.4103/1119-3077.106772
pubmed: 23377477
Zahari N, Yeoh SL, Muniandy SR, et al. Pediatric rheumatic heart disease in a middle-income country: a population-based study. J Trop Pediatr. 2022;68(1):fmac05. https://doi.org/10.1093/tropej/fmac005 .
doi: 10.1093/tropej/fmac005
Bhaya M, Panwar S, Beniwal R, et al. High prevalence of rheumatic heart disease detected by echocardiography in school children. Echocardiography. 2010;27(4):448–53. https://doi.org/10.1111/j.1540-8175.2009.01055.x .
doi: 10.1111/j.1540-8175.2009.01055.x
pubmed: 20345448
Saxena A. Echocardiographic diagnosis of chronic rheumatic valvular lesions. Glob Heart. 2013;8(3):203–12. https://doi.org/10.1016/j.gheart.2013.08.007 .
doi: 10.1016/j.gheart.2013.08.007
pubmed: 25690497
Reményi B, Wilson N, Steer A, et al. World Heart Federation criteria for echocardiographic diagnosis of rheumatic heart disease: an evidence-based guideline. Nat Rev Cardiol. 2012;9(5):297–309. https://doi.org/10.1038/nrcardio.2012.7 .
doi: 10.1038/nrcardio.2012.7
pubmed: 22371105
pmcid: 5523449
Clark BC, Krishnan A, McCarter R, et al. Using a low-risk population to estimate the specificity of the World Heart Federation criteria for the diagnosis of rheumatic heart disease. J Am Soc Echocardiogr. 2016;29(3):253–8. https://doi.org/10.1016/j.echo.2015.11.013 .
doi: 10.1016/j.echo.2015.11.013
pubmed: 26725186
Roberts K, Maguire G, Brown A, et al. Echocardiographic screening for rheumatic heart disease in high and low risk Australian children. Circulation. 2014;129(19):1953–61. https://doi.org/10.1161/CIRCULATIONAHA.113.003495 .
doi: 10.1161/CIRCULATIONAHA.113.003495
pubmed: 24622384
Culliford-Semmens N, Nicholson R, Tilton E, et al. The World Heart Federation criteria raise the threshold of diagnosis for mild rheumatic heart disease: three reviewers are better than one. Int J Cardiol. 2019;291:112–8. https://doi.org/10.1016/j.ijcard.2019.02.058 .
doi: 10.1016/j.ijcard.2019.02.058
pubmed: 30851993
Scheel A, Mirabel M, Nunes MCP, et al. The inter-rater reliability and individual reviewer performance of the 2012 World Heart Federation guidelines for the echocardiographic diagnosis of latent rheumatic heart disease. Int J Cardiol. 2021;328:146–51. https://doi.org/10.1016/j.ijcard.2020.11.013 .
doi: 10.1016/j.ijcard.2020.11.013
pubmed: 33186665
Rwebembera J, Marangou J, Mwita JC, et al. World Heart Federation guidelines for the echocardiographic diagnosis of rheumatic heart disease. Nat Rev Cardiol. 2023. https://doi.org/10.1038/s41569-023-00940-9 .
doi: 10.1038/s41569-023-00940-9
pubmed: 37914787
Atatoa-Carr P, Lennon D, Wilson N, et al. Rheumatic fever diagnosis, management, and secondary prevention: a New Zealand guideline. N Z Med J. 2008;121(1271):59–69.
pubmed: 18392063
Working Group on Pediatric Acute Rheumatic Fever and Cardiology Chapter of Indian Academy of Pediatrics, Saxena A, Kumar RK, et al. Consensus guidelines on pediatric acute rheumatic fever and rheumatic heart disease. Indian Pediatr. 2008;45(7):565–73.
Azuar A, Jin W, Mukaida S, et al. Recent advances in the development of peptide vaccines and their delivery systems against Group A Streptococcus. Vaccines (Basel). 2019;7(3):58. https://doi.org/10.3390/vaccines7030058 .
doi: 10.3390/vaccines7030058
pubmed: 31266253
pmcid: 6789462
World Health Organization. Group A streptococcal vaccine development: current status and issues of relevance to less developed countries. 2005. http://apps.who.int/iris/bitstream/handle/10665/69065/WHO_IVB_05.14_eng.pdf?sequence=1 . Accessed 28 Mar 2022.
Schödel F, Moreland NJ, Wittes JT, et al. Clinical development strategy for a candidate Group A streptococcal vaccine. Vaccine. 2017;35(16):2007–14. https://doi.org/10.1016/j.vaccine.2017.02.060 .
doi: 10.1016/j.vaccine.2017.02.060
pubmed: 28318768
Kotloff KL, Corretti M, Palmer K, et al. Safety and immunogenicity of a recombinant multivalent group a streptococcal vaccine in healthy adults: phase 1 trial. JAMA. 2004;292(6):709–15. https://doi.org/10.1001/jama.292.6.709 .
doi: 10.1001/jama.292.6.709
pubmed: 15304468
McNeil SA, Halperin SA, Langley JM, et al. Safety and immunogenicity of 26-valent Group A Streptococcus vaccine in healthy adult volunteers. Clin Infect Dis. 2005;41(8):1114–22. https://doi.org/10.1086/444458 .
doi: 10.1086/444458
pubmed: 16163629
McNeil S, Halperin S, Langley J, et al. A double-blind, randomized phase II trial of the safety and immunogenicity of 26-valent group A streptococcus vaccine in healthy adults. Int Congr Ser. 2006;1289:303–6. https://doi.org/10.1016/j.ics.2005.12.002 .
doi: 10.1016/j.ics.2005.12.002
Sekuloski S, Batzloff MR, Griffin P, et al. Evaluation of safety and immunogenicity of a Group A Streptococcus vaccine candidate (MJ8VAX) in a randomized clinical trial. PLoS One. 2018;13(7): e0198658. https://doi.org/10.1371/journal.pone.0198658 .
doi: 10.1371/journal.pone.0198658
pubmed: 29965967
pmcid: 6028081
Pastural É, McNeil SA, MacKinnon-Cameron D, et al. Safety and immunogenicity of a 30-valent M protein-based Group A streptococcal vaccine in healthy adult volunteers: a randomized, controlled phase I study. Vaccine. 2020;38(6):1384–92. https://doi.org/10.1016/j.vaccine.2019.12.005 .
doi: 10.1016/j.vaccine.2019.12.005
pubmed: 31843270
Di Benedetto R, Mancini F, Carducci M, et al. Rational design of a glycoconjugate vaccine against Group A Streptococcus. Int J Mol Sci. 2020;21(22):8558. https://doi.org/10.3390/ijms21228558 .
doi: 10.3390/ijms21228558
pubmed: 33202815
pmcid: 7696035
Mc Loughlin MJ, Mc LS. Cardiac auscultation: preliminary findings of a pilot study using continuous Wave Doppler and comparison with classic auscultation. Int J Cardiol. 2013;167(2):590–1. https://doi.org/10.1016/j.ijcard.2012.09.223 .
doi: 10.1016/j.ijcard.2012.09.223
pubmed: 23117017
McIsaac WJ, White D, Tannenbaum D, et al. A clinical score to reduce unnecessary antibiotic use in patients with sore throat. CMAJ. 1998;158(1):75–83.
pubmed: 9475915
pmcid: 1228750
Hanson-Manful P, Whitcombe AL, Young PG, et al. The novel Group A Streptococcus antigen SpnA combined with bead-based immunoassay technology improves streptococcal serology for the diagnosis of acute rheumatic fever. J Infect. 2018;76(4):361–8. https://doi.org/10.1016/j.jinf.2017.12.008 .
doi: 10.1016/j.jinf.2017.12.008
pubmed: 29269013
Whitcombe AL, Hanson-Manful P, Jack S, et al. Development and evaluation of a new triplex immunoassay that detects Group A Streptococcus antibodies for the diagnosis of rheumatic fever. J Clin Microbiol. 2020;58(9):e00300-e320. https://doi.org/10.1128/jcm.00300-20 .
doi: 10.1128/jcm.00300-20
pubmed: 32461283
pmcid: 7448642
Beaton A, Aliku T, Okello E, et al. The utility of handheld echocardiography for early diagnosis of rheumatic heart disease. J Am Soc Echocardiogr. 2014;27(1):42–9. https://doi.org/10.1016/j.echo.2013.09.013 .
doi: 10.1016/j.echo.2013.09.013
pubmed: 24183541
Grayburn PA, Bhella P. Grading severity of mitral regurgitation by echocardiography: science or art? JACC Cardiovasc Imaging. 2010;3(3):244–6. https://doi.org/10.1016/j.jcmg.2009.11.008 .
doi: 10.1016/j.jcmg.2009.11.008
pubmed: 20223420
Scalzi V, Hadi HA, Alessandri C, et al. Anti-endothelial cell antibodies in rheumatic heart disease. Clin Exp Immunol. 2010;161(3):570–5. https://doi.org/10.1111/j.1365-2249.2010.04207.x .
doi: 10.1111/j.1365-2249.2010.04207.x
pubmed: 20646009
pmcid: 2962976
Rastogi M, Sarkar S, Makol A, et al. Anti-endothelial cell antibody rich sera from rheumatic heart disease patients induces proinflammatory phenotype and methylation alteration in endothelial cells. Genes Dis. 2018;5(3):275–89. https://doi.org/10.1016/j.gendis.2018.02.002 .
doi: 10.1016/j.gendis.2018.02.002
pubmed: 30320192
pmcid: 6176156
Delunardo F, Scalzi V, Capozzi A, et al. Streptococcal-vimentin cross-reactive antibodies induce microvascular cardiac endothelial proinflammatory phenotype in rheumatic heart disease. Clin Exp Immunol. 2013;173(3):419–29. https://doi.org/10.1111/cei.12135 .
doi: 10.1111/cei.12135
pubmed: 23663103
pmcid: 3949629
Ralph AP, Webb R, Moreland NJ, et al. Searching for a technology-driven acute rheumatic fever test: the START study protocol. BMJ Open. 2021;11(9): e053720. https://doi.org/10.1136/bmjopen-2021-053720 .
doi: 10.1136/bmjopen-2021-053720
pubmed: 34526345
pmcid: 8444258
News Medical. Collaborative network wins $8 million grant to identify biomarkers for acute rheumatic fever. https://www.news-medical.net/news/20220919/Collaborative-network-wins-248-million-grant-to-identify-biomarkers-for-acute-rheumatic-fever.aspx . Accessed 25 Oct 2023.
Passos LSA, Jha PK, Becker-Greene D, et al. Prothymosin alpha: a novel contributor to estradiol receptor alpha-mediated CD8(+) T-cell pathogenic responses and recognition of type 1 collagen in rheumatic heart valve disease. Circulation. 2022;145(7):531–48. https://doi.org/10.1161/circulationaha.121.057301 .
doi: 10.1161/circulationaha.121.057301
pubmed: 35157519
pmcid: 8869797