Efficacy of Pneumococcal Nontypable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) in Young Latin American Children: A Double-Blind Randomized Controlled Trial

PLoS Medicine

Volumn 11, Issue 6, 2014, Pages 1-18

  Tregnaghi, Miguel W ^a   Sáez Llorens, Xavier ^b   López, Pio ^c   Abate, Hector ^d   Smith, Enrique ^e   Pósleman, Adriana ^f   Calvo, Arlene ^g   Wong, Digna ^h   Cortes Barbosa, Carlos ^c   Ceballos, Ana ^a   Tregnaghi, Marcelo ^a   Sierra, Alexandra ^c   Rodriguez, Mirna ^h   Troitiño, Marisol ^g   Carabajal, Carlos ^e   Falaschi, Andrea ^d   Leandro, Ana ^b   Castrejón, Maria Mercedes ⁱ   Lepetic, Alejandro ^j   Lommel, Patricia ^k   Hausdorff, William P ^k   Borys, Dorota ^k   Guiñazú, Javier Ruiz ^k   Ortega Barría, Eduardo ⁱ   Yarzábal, Juan P ^k   Schuerman, Lode ^k   more..

^a Centro de Desarrollo del Proyectos Avanzados en Pediatría   (Argentina)

^b Hospital del Niño   (Panama)

^c Centro de Estudios en Infectologia Pediatrica   (Colombia)

^d Hospital H Notti   (Argentina)

^e Centro de Desarrollo del Proyectos Avanzados en Pediatría   (Argentina)

^f Centro de Desarrollo del Proyectos Avanzados en Pediatría   (Argentina)

^g Health Research International   (Panama)

^h INSTITUTO DE INVESTIGACIONES CIENTÍFICAS Y SERVICIOS DE ALTA TECNOLOGÍA   (Panama)

ⁱ GLAXOSMITHKLINE   (United Kingdom)

^j GlaxoSmithKline   (Argentina)

^k GSK   (Belgium)

more..

Author keywords

[No Author keywords available]

Indexed keywords

C REACTIVE PROTEIN; DIPHTHERIA PERTUSSIS POLIOMYELITIS TETANUS HAEMOPHILUS INFLUENZAE TYPE B HEPATITIS B VACCINE; DIPHTHERIA PERTUSSIS TETANUS HAEMOPHILUS INFLUENZAE TYPE B VACCINE; HEPATITIS A VACCINE; HEPATITIS B CORE ANTIGEN; HEPATITIS B SURFACE ANTIGEN; PNEUMOCOCCAL NONTYPABLE HAEMOPHILUS INFLUENZAE PROTEIN D CONJUGATE VACCINE; PNEUMOCOCCUS VACCINE; RECOMBINANT HEPATITIS B VACCINE; UNCLASSIFIED DRUG; BACTERIAL PROTEIN; BACTERIUM ANTIBODY; CARRIER PROTEIN; GLPQ PROTEIN, HAEMOPHILUS INFLUENZAE; IMMUNOGLOBULIN D; LIPOPROTEIN; VACCINE;

ACUTE OTITIS MEDIA; ARTICLE; BRONCHIOLITIS; BRONCHITIS; BRONCHUS OBSTRUCTION; CHILDHOOD MORTALITY; COMMUNITY ACQUIRED PNEUMONIA; CONTROLLED STUDY; DEHYDRATION; DISEASE SURVEILLANCE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; FOLLOW UP; GASTROENTERITIS; HEARING IMPAIRMENT; HEPATITIS A; HEPATITIS B; HUMAN; IMMUNOGENICITY; INFANT; MALE; NEWBORN; NONTYPEABLE HAEMOPHILUS INFLUENZAE; OTALGIA; OTOSCOPY; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL; PLEURA EFFUSION; PNEUMOCOCCAL INFECTION; PNEUMONIA; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; THORAX RADIOGRAPHY; VACCINATION; BLOOD; CLINICAL TRIAL; HAEMOPHILUS INFECTION; HAEMOPHILUS INFLUENZAE; IMMUNIZATION; IMMUNOLOGY; INTENTION TO TREAT ANALYSIS; MICROBIOLOGY; OTITIS MEDIA; PNEUMOCOCCAL INFECTIONS; PRESCHOOL CHILD; SOUTH AND CENTRAL AMERICA; STREPTOCOCCUS PNEUMONIAE; TREATMENT OUTCOME;

ANTIBODIES, BACTERIAL; BACTERIAL PROTEINS; CARRIER PROTEINS; CHILD, PRESCHOOL; DOUBLE-BLIND METHOD; HAEMOPHILUS INFECTIONS; HAEMOPHILUS INFLUENZAE; HUMANS; IMMUNIZATION, SECONDARY; IMMUNOGLOBULIN D; INFANT; INTENTION TO TREAT ANALYSIS; LATIN AMERICA; LIPOPROTEINS; OTITIS MEDIA; PNEUMOCOCCAL INFECTIONS; PNEUMOCOCCAL VACCINES; STREPTOCOCCUS PNEUMONIAE; TREATMENT OUTCOME; VACCINATION; VACCINES, CONJUGATE;

EID: 84903304920     PISSN: 15491277     EISSN: 15491676     Source Type: Journal    
DOI: 10.1371/journal.pmed.1001657     Document Type: Article

References (58)

1. Black RE, Cousens S, Johnson HL, Lawn JE, Rudan I, et al. (2010) Global, regional, and national causes of child mortality in 2008: a systematic analysis. Lancet 375: 1969-1987 doi:10.1016/S0140-6736(10)60549-1.
2. World Health Organization (2012) Pneumococcal vaccines WHO position paper-2012. Wkly Epidemiol Rec 87: 129-144.
3. O'Brien KL, Wolfson LJ, Watt JP, Henkle E, Deloria-Knoll M, et al. (2009) Burden of disease caused by Streptococcus pneumoniae in children younger than 5 years: global estimates. Lancet 374: 893-902 doi:10.1016/S0140-6736(09)61204-6.
4. Johnson HL, Deloria-Knoll M, Levine OS, Stoszek SK, Freimanis HL, et al. (2010) Systematic evaluation of serotypes causing invasive pneumococcal disease among children under five: the pneumococcal global serotype project. PLoS Med 7: e1000348 doi:10.1371/journal.pmed.1000348.
5. Bardach A, Ciapponi A, Garcia-Marti S, Glujovsky D, Mazzoni A, et al. (2011) Epidemiology of acute otitis media in children of Latin America and the Caribbean: a systematic review and meta-analysis. Int J Pediatr Otorhinolaryngol 75: 1062-1070 doi:10.1016/j.ijporl.2011.05.014.
6. Prymula R, Schuerman L, (2009) 10-valent pneumococcal nontypeable Haemophilus influenzae PD conjugate vaccine: Synflorix. Expert Rev Vaccines 8: 1479-1500 doi:10.1586/erv.09.113.
7. World Health Organization (2005) Pneumococcal conjugate vaccines. Recommendations for production and control of pneumococcal conjugate vaccines. WHO Tech Rep Ser 927 (Annex 2): 64-98.
8. Loens K, Van HL, Malhotra-Kumar S, Goossens H, Ieven M, (2009) Optimal sampling sites and methods for detection of pathogens possibly causing community-acquired lower respiratory tract infections. J Clin Microbiol 47: 21-31 doi:10.1128/JCM.02037-08.
9. Gentile A, Bardach A, Ciapponi A, Garcia-Marti S, Aruj P, et al. (2012) Epidemiology of community-acquired pneumonia in children of Latin America and the Caribbean: a systematic review and meta-analysis. Int J Infect Dis 16: e5-e15 doi:10.1016/j.ijid.2011.09.013.
10. Gentile A, Bazan V, (2011) Prevention of pneumococcal disease through vaccination. Vaccine 29(Suppl 3): C15-C25 doi:10.1016/j.vaccine.2011.07.121.
11. Lagos R, Munoz A, San MO, Maldonado A, Hormazabal JC, et al. (2008) Age- and serotype-specific pediatric invasive pneumococcal disease: insights from systematic surveillance in Santiago, Chile, 1994-2007. J Infect Dis 198: 1809-1817 doi:10.1086/593334.
12. Pirez MC, Algorta G, Cedres A, Sobrero H, Varela A, et al. (2011) Impact of universal pneumococcal vaccination on hospitalizations for pneumonia and meningitis in children in Montevideo, Uruguay. Pediatr Infect Dis J 30: 669-674 doi:10.1097/INF.0b013e3182152bf1.
13. O'Brien KL, (2013) PCV13 impact evaluations: the obvious and the unpredicted. Pediatr Infect Dis J 32: 264-265 doi:10.1097/INF.0b013e3182787f89.
14. Taylor S, Marchisio P, Vergison A, Harriague J, Hausdorff WP, et al. (2012) Impact of pneumococcal conjugate vaccination on otitis media: a systematic review. Clin Infect Dis 54: 1765-1773 doi:10.1093/cid/cis292.
15. Castañeda E, Agudelo CI, Regueira M, Corso A, Brandileone MC, et al. (2009) Laboratory-based surveillance of Streptococcus pneumoniae invasive disease in children in 10 Latin American countries: a SIREVA II project, 2000-2005. Pediatr Infect Dis J 28: e265-e270 doi:10.1097/INF.0b013e3181a74b22.
16. Tregnaghi M, Ceballos A, Ruttimann R, Ussher J, Tregnaghi P, et al. (2006) Active epidemiologic surveillance of pneumonia and invasive pneumococcal disease in ambulatory and hospitalized infants in Cordoba, Argentina. Pediatr Infect Dis J 25: 370-372 doi:10.1097/01.inf.0000208368.67448.51.
17. Arguedas A, Sher L, Lopez E, Sáez-Llorens X, Hamed K, et al. (2003) Open label, multicenter study of gatifloxacin treatment of recurrent otitis media and acute otitis media treatment failure. Pediatr Infect Dis J 22: 949-956 doi:10.1097/01.inf.0000095193.42502.d1.
18. Sáez-Llorens X, Rodriguez A, Arguedas A, Hamed KA, Yang J, et al. (2005) Randomized, investigator-blinded, multicenter study of gatifloxacin versus amoxicillin/clavulanate treatment of recurrent and nonresponsive otitis media in children. Pediatr Infect Dis J 24: 293-300.
19. Pichichero ME, Arguedas A, Dagan R, Sher L, Sáez-Llorens X, et al. (2005) Safety and efficacy of gatifloxacin therapy for children with recurrent acute otitis media (AOM) and/or AOM treatment failure. Clin Infect Dis 41: 470-478 doi:10.1086/431584.
20. Rubino CM, Ambrose P, Cirincione B, Arguedas A, Sher L, et al. (2007) Pharmacokinetics and pharmacodynamics of gatifloxacin in children with recurrent otitis media: application of sparse sampling in clinical development. Diagn Microbiol Infect Dis 59: 67-74 doi:10.1016/j.diagmicrobio.2007.04.015.
21. World Health Organization (2013) WHO vaccine-preventable diseases: monitoring system. 2013 global summary [database]. Available: http://apps.who.int/immunization_monitoring/globalsummary. Accessed 14 April 2013.
22. Ropero-Alvarez AM, Kurtis HJ, Danovaro-Holliday MC, Ruiz-Matus C, Andrus JK, (2009) Expansion of seasonal influenza vaccination in the Americas. BMC Public Health 9: 361 doi:10.1186/1471-2458-9-361.
23. Giglio N, Gentile A, Lees L, Micone P, Armoni J, et al. (2012) Public health and economic benefits of new pediatric influenza vaccination programs in Argentina. Hum Vaccin Immunother 8: 312-322 doi:10.4161/hv.18569.
24. The World Bank (2013) Data: countries and economies [database]. Available: http://data.worldbank.org/country. Accessed 16 April 2013.
25. World Health Organization (2013) Global health observatory data repository [database]. Available: http://apps.who.int/gho/data/node.main. Accessed 16 April 2013.
26. World Health Organization (2013) Global Health Observatory: infant mortality-situation and trends [database]. Available: http://www.who.int/gho/child_health/mortality/neonatal_infant_text/en/index.html. Accessed 16 April 2013.
27. Eurostat (2012 October) Mortality and life expectancy statistics. Available: http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/Mortality_and_life_expectancy_statistics. Accessed 16 April 2013.
28. Mulholland K (2004) Ethical considerations arising from vaccine trials conducted in paediatric populations with high disease burden in developing countries. WHO/V&B/04.04. Geneva: World Health Organization.
29. World Health Organization Pneumonia Vaccine Trial Investigators' Group (2001) Standardization of interpretation of chest radiographs for the diagnosis of pneumonia in children. WHO/V&B/01.35. Geneva: World Health Organization.
30. Madhi SA, Klugman KP, (2007) World Health Organisation definition of "radiologically-confirmed pneumonia" may under-estimate the true public health value of conjugate pneumococcal vaccines. Vaccine 25: 2413-2419 doi:10.1016/j.vaccine.2006.09.010.
31. Friedman NR, McCormick DP, Pittman C, Chonmaitree T, Teichgraeber DC, et al. (2006) Development of a practical tool for assessing the severity of acute otitis media. Pediatr Infect Dis J 25: 101-107 doi:10.1097/01.inf.0000199290.73333.89.
32. Dagan R, Leibovitz E, Greenberg D, Yagupsky P, Fliss DM, et al. (1998) Early eradication of pathogens from middle ear fluid during antibiotic treatment of acute otitis media is associated with improved clinical outcome. Pediatr Infect Dis J 17: 776-782.
33. Goldstein B, Giroir B, Randolph A, (2005) International pediatric sepsis consensus conference: definitions for sepsis and organ dysfunction in pediatrics. Pediatr Crit Care Med 6: 2-8.
34. Concepcion NF, Frasch CE, (2001) Pneumococcal type 22F polysaccharide absorption improves the specificity of a pneumococcal-polysaccharide enzyme-linked immunosorbent assay. Clin Diagn Lab Immunol 8: 266-272.
35. Henckaerts I, Goldblatt D, Ashton L, Poolman J, (2006) Critical differences between pneumococcal polysaccharide enzyme-linked immunosorbent assays with and without 22F inhibition at low antibody concentrations in pediatric sera. Clin Vaccine Immunol 13: 356-360.
36. Poolman JT, Frasch CE, Kayhty H, Lestrate P, Madhi SA, et al. (2010) Evaluation of pneumococcal polysaccharide immunoassays using a 22F adsorption step with serum samples from infants vaccinated with conjugate vaccines. Clin Vaccine Immunol 17: 134-142 doi:10.1128/CVI.00289-09.
37. Romero-Steiner S, Libutti D, Pais LB, Dykes J, Anderson P, et al. (1997) Standardization of an opsonophagocytic assay for the measurement of functional antibody activity against Streptococcus pneumoniae using differentiated HL-60 cells. Clin Diagn Lab Immunol 4: 415-422.
38. Henckaerts I, Durant N, De Grave D, Schuerman L, Poolman J, (2007) Validation of a routine opsonophagocytosis assay to predict invasive pneumococcal disease efficacy of conjugate vaccine in children. Vaccine 25: 2518-2527.
39. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (1998) ICH Topic E9. Statistical principles for clinical trials. CPMP/ICH/363/96. London: European Medicines Agency.
40. European Medicines Agency (2008) Ethical considerations for clinical trials on medicinal products conducted with the paediatric population. London: European Medicines Agency.
41. Black SB, Shinefield HR, Ling S, Hansen J, Fireman B, et al. (2002) Effectiveness of heptavalent pneumococcal conjugate vaccine in children younger than five years of age for prevention of pneumonia. Pediatr Infect Dis J 21: 810-815 doi:10.1097/01.inf.0000027926.99356.4c.
42. Cutts FT, Zaman SM, Enwere G, Jaffar S, Levine OS, et al. (2005) Efficacy of nine-valent pneumococcal conjugate vaccine against pneumonia and invasive pneumococcal disease in The Gambia: randomised, double-blind, placebo-controlled trial. Lancet 365: 1139-1146 doi:10.1016/S0140-6736(05)71876-6.
43. Klugman KP, Madhi SA, Huebner RE, Kohberger R, Mbelle N, et al. (2003) A trial of a 9-valent pneumococcal conjugate vaccine in children with and those without HIV infection. N Engl J Med 349: 1341-1348.
44. Lucero MG, Nohynek H, Williams G, Tallo V, Simoes EA, et al. (2009) Efficacy of an 11-valent pneumococcal conjugate vaccine against radiologically confirmed pneumonia among children less than 2 years of age in the Philippines: a randomized, double-blind, placebo-controlled trial. Pediatr Infect Dis J 28: 455-462 doi:10.1097/INF.0b013e31819637af.
45. Hansen J, Black S, Shinefield H, Cherian T, Benson J, et al. (2006) Effectiveness of heptavalent pneumococcal conjugate vaccine in children younger than 5 years of age for prevention of pneumonia: updated analysis using World Health Organization standardized interpretation of chest radiographs. Pediatr Infect Dis J 25: 779-781 doi:10.1097/01.inf.0000232706.35674.2f.
46. Guiñazù JR, Moreira M, Tregnaghi MW, Madhi SA, Hausdorff WP,et al. (2014) Effect of infant immunization on pneumonia with alveolar consolidation by age: comparison of double-blind randomized controlled trials [abstract]. 9th Biennial International Symposium on Pneumococci & Pneumococcal Diseases; 9-13 March 2014; Hyderabad, India.
47. Monasta L, Ronfani L, Marchetti F, Montico M, Vecchi BL, et al. (2012) Burden of disease caused by otitis media: systematic review and global estimates. PLoS ONE 7: e36226 doi:10.1371/journal.pone.0036226.
48. Palmu A, Jokinen J, Kilpi T, (2008) Impact of different case definitions for acute otitis media on the efficacy estimates of a pneumococcal conjugate vaccine. Vaccine 26: 2466-2470 doi:10.1016/j.vaccine.2008.03.013.
49. Fletcher MA, Fritzell B, (2012) Pneumococcal conjugate vaccines and otitis media: an appraisal of the clinical trials. Int J Otolaryngol 2012: 312935 doi:10.1155/2012/312935.
50. Prymula R, Peeters P, Chrobok V, Kriz P, Novakova E, et al. (2006) Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by both Streptococcus pneumoniae and non-typable Haemophilus influenzae: a randomised double-blind efficacy study. Lancet 367: 740-748.
51. Rodgers GL, Arguedas A, Cohen R, Dagan R, (2009) Global serotype distribution among Streptococcus pneumoniae isolates causing otitis media in children: potential implications for pneumococcal conjugate vaccines. Vaccine 27: 3802-3810 doi:10.1016/j.vaccine.2009.04.021.
52. Jokinen J, Palmu AA, Kilpi T, (2012) Acute otitis media replacement and recurrence in the Finnish otitis media vaccine trial. Clin Infect Dis 55: 1673-1676 doi:10.1093/cid/cis799.
53. Jansen AG, Hak E, Veenhoven RH, Damoiseaux RA, Schilder AG, et al. (2009) Pneumococcal conjugate vaccines for preventing otitis media. Cochrane Database Syst Rev 2009: CD001480 doi:10.1002/14651858.CD001480.pub3.
54. Fireman B, Black SB, Shinefield HR, Lee J, Lewis E, et al. (2003) Impact of the pneumococcal conjugate vaccine on otitis media. Pediatr Infect Dis J 22: 10-16 doi:10.1097/01.inf.0000045221.96634.7c.
55. Palmu AA, Jokinen J, Borys D, Nieminen H, Ruokokoski E, et al. (2013) Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. Lancet 382: 214-222 doi:10.1016/S0140-6736(12)61854-6.
56. Black S, Shinefield H, Fireman B, Lewis E, Ray P, et al. (2000) Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Northern California Kaiser Permanente Vaccine Study Center Group. Pediatr Infect Dis J 19: 187-195.
57. Fitzwater SP, Chandran A, Santosham M, Johnson HL, (2012) The worldwide impact of the seven-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J 31: 501-508 doi:10.1097/INF.0b013e31824de9f6.
58. Sociedad Argentina de Pediatría (2012) Investigación en pediatría: posición de la Sociedad Argentina de Pediatría. Available: http://www.sap.org.ar/prof-comunicaciones12_investigacion.php. Accessed 29 April 2014.