Safety, immunogenicity, and antibody persistence following an investigational streptococcus pneumoniae and haemophilus influenzae triple-protein vaccine in a phase 1 randomized controlled study in healthy adults

Clinical and Vaccine Immunology

Volumn 21, Issue 1, 2014, Pages 56-65

  Berglund, Johan ^a   Vink, Peter ^b   Da Silva, Fernanda Tavares ^c   Lestrate, Pascal ^c   Boutriau, Dominique ^c  

^a BLEKINGE INSTITUTE OF TECHNOLOGY   (Sweden)

^b GLAXOSMITHKLINE   (United States)

^c GSK   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBODY; DETOXIFIED PNEUMOLYSIN; HAEMOPHILUS INFLUENZAE VACCINE; HISTIDINE; IMMUNOLOGICAL ADJUVANT; LIPOPROTEIN; NONTYPEABLE HAEMOPHILUS INFLUENZAE PROTEIN D; PNEUMOCOCCAL HISTIDINE TRIAD D; PNEUMOCOCCUS VACCINE; PNEUMOLYSIN; RECOMBINANT HEPATITIS B VACCINE; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CD4+ T LYMPHOCYTE; CELLULAR IMMUNITY; CHILL; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; DRUG MONITORING; DRUG SAFETY; FATIGUE; FEMALE; FEVER; FLU LIKE SYNDROME; HEADACHE; HUMAN; HUMAN EXPERIMENT; HUMORAL IMMUNITY; IMMUNOGENICITY; INJECTION SITE PAIN; INJECTION SITE REACTION; MALE; MUSCULOSKELETAL PAIN; MYALGIA; NORMAL HUMAN; OROPHARYNX PAIN; OTALGIA; PHASE 1 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SINUSITIS; SKIN REDNESS; SWELLING; SYMPTOM; TONSILLITIS; VACCINATION; VERTIGO; VIRAL PHARYNGITIS; VOMITING;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; ALPHA-TOCOPHEROL; ANTIBODIES, BACTERIAL; CD4-POSITIVE T-LYMPHOCYTES; DRUG COMBINATIONS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HAEMOPHILUS VACCINES; HUMANS; MALE; PNEUMOCOCCAL VACCINES; POLYSORBATES; SQUALENE; VACCINATION; VACCINES, COMBINED; VACCINES, SUBUNIT; VACCINES, SYNTHETIC; YOUNG ADULT;

EID: 84892145644     PISSN: 15566811     EISSN: 1556679X     Source Type: Journal    
DOI: 10.1128/CVI.00430-13     Document Type: Article

References (43)

1. Woodhead M. 2002. Community-acquired pneumonia in Europe: causative pathogens and resistance patterns. Eur. Respir. J. Suppl. 36: 20s-27s. http://dx.doi.org/10.1183/09031936.02.00702002.
2. Murphy TF. 2003. Respiratory infections caused by non-typeable Haemophilus influenzae. Curr. Opin. Infect. Dis. 16: 129-134. http://dx.doi.org/10.1097/01.aco.0000065079.06965.e0.
3. Centers for Disease Control and Prevention. 2012. Licensure of 13-valent pneumococcal conjugate vaccine for adults aged 50 years and older. MMWR Morb. Mortal. Wkly. Rep. 61: 394-395. http://www.cdc.gov/mmwr/preview/mmwrhtml/ mm6121a3.htm.
4. Jackson LA, Neuzil KM, Yu O, Benson P, Barlow WE, Adams AL, Hanson CA, Mahoney LD, Shay DK, Thompson WW. 2003. Effectiveness of pneumococcal polysaccharide vaccine in older adults. N. Engl. J. Med. 348: 1747-1755. http://dx.doi.org/10.1056/NEJMoa022678.
5. Vila-Corcoles A, Ochoa-Gondar O. 2012. Pneumococcal vaccination among adults with chronic respiratory diseases: a historical overview. Expert Rev. Vaccines 11: 221-236. http://dx.doi.org/10.1586/erv.11.176.
6. Borgoño JM, McLean AA, Vella PP, Woodhour AF, Canepa I, Davidson WL, Hilleman MR. 1978. Vaccination and revaccination with polyvalent pneumococcal polysaccharide vaccines in adults and infants. Proc. Soc. Exp. Biol. Med. 157: 148-154.
7. Wyres KL, Lambertsen LM, Croucher NJ, McGee L, von Gottberg A, Liñares J, Jacobs MR, Kristinsson KG, Beall BW, Klugman KP, Parkhill J, Hakenbeck R, Bentley SD, Brueggemann AB. 2013. Pneumococcal capsular switching: a historical perspective. J. Infect. Dis. 207: 439-449. http://dx.doi.org/10. 1093/infdis/jis703.
8. Mera R, Miller LA, Fritsche TR, Jones RN. 2008. Serotype replacement and multiple resistance in Streptococcus pneumoniaeafter the introduction of the conjugate pneumococcal vaccine. Microb. Drug Resist. 14: 101-107. http://dx.doi.org/10.1089/mdr.2008.0782.
9. Weinberger DM, Malley R, Lipsitch M. 2011. Serotype replacement in disease after pneumococcal vaccination. Lancet 378: 1962-1973. http://dx.doi.org/10.1016/S0140-6736(10)62225-8.
10. Adamou JE, Heinrichs JH, Erwin AL, Walsh W, Gayle T, Dormitzer M, Dagan R, Brewah YA, Barren P, Lathigra R, Langermann S, Koenig S, Johnson S. 2001. Identification and characterization of a novel family of pneumococcal proteins that are protective against sepsis. Infect. Immun. 69: 949-958. http://dx.doi.org/10.1128/IAI.69.2.949-958.2001.
11. 2+-dependent repressor AdcR and inhibit complement deposition through the recruitment of complement factor H. FASEB J. 23: 731-738. http://dx.doi.org/10.1096/fj.08-119537.
12. Melin M, Di Paolo E, Tikkanen L, Jarva H, Neyt C, Käyhty H, Meri S, Poolman J, Väkeväinen M. 2010. Interaction of pneumococcal histidine triad proteins with human complement. Infect. Immun. 78: 2089-2098. http://dx.doi.org/10.1128/IAI.00811-09.
13. Rioux S, Neyt C, Di Paolo E, Turpin L, Charland N, Labbé S, Mortier M-C, Mitchell TJ, Feron C, Martin D, Poolman JT. 2011. Transcriptional regulation, occurrence and putative role of the Pht family of Streptococcus pneumoniae. Microbiology 157: 336-348. http://dx.doi.org/10.1099/mic.0.042184-0.
14. Godfroid F, Hermand P, Verlant V, Denoël P, Poolman JT. 2011. Preclinical evaluation of the Pht proteins as potential cross-protective pneumococcal vaccine antigens. Infect. Immun. 79: 238-245. http://dx.doi.org/10. 1128/IAI.00378-10.
15. Holmlund E, Quiambao B, Ollgren J, Jaakkola T, Neyt C, Poolman J, Nohynek H, Käyhty H. 2009. Antibodies to pneumococcal proteins PhtD, CbpA, and LytC in Filipino pregnant women and their infants in relation to pneumococcal carriage. Clin. Vaccine Immunol. 16: 916-923. http://dx.doi.org/10.1128/CVI. 00050-09.
16. Simell B, Ahokas P, Lahdenkari M, Poolman J, Henckaerts I, Kilpi TM, Käyhty H. 2009. Pneumococcal carriage and acute otitis media induce serum antibodies to pneumococcal surface proteins CbpA and PhtD in children. Vaccine 27: 4615-4621. http://dx.doi.org/10.1016/j.vaccine.2009.05.071.
17. Hagerman A, Posfay-Barbe KM, Grillet S, Ochs MM, Brookes RH, Greenberg D, Givon-Lavi N, Dagan R, Siegrist C-A. 2012. Failure to elicit seroresponses to pneumococcal surface proteins (pneumococcal histidine triad D, pneumococcal choline-binding protein A, and serine proteinase precursor A) in children with pneumococcal bacteraemia. Clin. Microbiol. Infect. 18: 756-762. http://dx.doi.org/10.1111/j.1469-0691.2011.03629.x.
18. Tai SS. 2006. Streptococcus pneumoniae protein vaccine candidates: properties, activities and animal studies. Crit. Rev. Microbiol. 32: 139-153. http://dx.doi.org/10.1080/10408410600822942.
19. Hirst RA, Kadioglu A, O'Callaghan C, Andrew PW. 2004. The role of pneumolysin in pneumococcal pneumonia and meningitis. Clin. Exp. Immunol. 138: 195-201. http://dx.doi.org/10.1111/j.1365-2249.2004.02611.x.
20. Alexander JE, Lock RA, Peeters CC, Poolman JT, Andrew PW, Mitchell TJ, Hansman D, Paton JC. 1994. Immunization of mice with pneumolysin toxoid confers a significant degree of protection against at least nine serotypes of Streptococcus pneumoniae. Infect. Immun. 62: 5683-5688.
21. Ogunniyi AD, Woodrow MC, Poolman JT, Paton JC. 2001. Protection against Streptococcus pneumoniae elicited by immunization with pneumolysin and CbpA. Infect. Immun. 69: 5997-6003. http://dx.doi.org/10.1128/IAI.69.10.5997-6003. 2001.
22. Denoël P, Philipp MT, Doyle L, Martin D, Carletti G, Poolman JT. 2011. A protein-based pneumococcal vaccine protects rhesus macaques from pneumonia after experimental infection with Streptococcus pneumoniae. Vaccine 29: 5495-5501. http://dx.doi.org/10.1016/j.vaccine.2011.05.051.
23. Prymula R, Peeters P, Chrobok V, Kriz P, Novakova E, Kaliskova E, Kohl I, Lommel P, Poolman J, Prieels J-P, Schuerman L. 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. http://dx.doi.org/10.1016/S0140-6736(06)68304-9.
24. van den Bergh MR, Spijkerman J, Swinnen KM, François NA, Pascal TG, Borys D, Schuerman L, Ijzerman EPF, Bruin JP, van der Ende A, Veenhoven RH, Sanders EAM. 2013. Effects of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D-conjugate vaccine on nasopharyngeal bacterial colonization in young children: a randomized controlled trial. Clin. Infect. Dis. 56:e30-e39. http://dx.doi.org/10.1093/cid/cis922.
25. Garçon N, Vaughn DW, Didierlaurent AM. 2012. Development and evaluation of AS03, an adjuvant system containing α-tocopherol and squalene in an oil-in-water emulsion. Expert Rev. Vaccines 11: 349-366. http://dx.doi.org/10.1586/erv.11.192.
26. Poolman JT, Bakaletz L, Cripps A, Denoel PA, Forsgren A, Kyd J, Lobet Y. 2000. Developing a nontypeable Haemophilus influenzae (NTHi) vaccine. Vaccine 19(Suppl 1):S108-S115. http://dx.doi.org/10.1016/S0264-410X(00)00288-7.
27. A-adjuvanted prepandemic H5N1 vaccines: a randomized study in European adults. Influenza Other Respir. Viruses 7: 55-65. http://dx.doi.org/10.1111/j.1750-2659.2012.00349.x.
28. A-adjuvanted influenza A (H1N1) 2009 vaccine for adults up to 85 years of age. Clin. Infect. Dis. 51: 668-677. http://dx.doi.org/10.1086/655830.
29. A induces strong cross-reactive and polyfunctional CD4 T-cell responses. J. Clin. Immunol. 31: 443-454. http://dx.doi.org/10.1007/ s10875-010-9490-6.
30. Leroux-Roels I, Devaster J-M, Leroux-Roels G, Verlant V, Henckaerts I, Moris P, Hermand Van Belle P, Poolman JT, Vandepapelière P, Horsmans Y. 2013. Adjuvant system AS02V enhances humoral and cellular immune responses to pneumococcal protein PhtD vaccine in healthy young and older adults: randomised, controlled trials. Vaccine http://dx.doi.org/10.1016/j.vaccine.2013.10.052.
31. Turnbull FM, Heath TC, Jalaludin BB, Burgess MA, Ramalho AC. 2000. A randomized trial of two acellular pertussis vaccines (dTpa and pa) and a licensed diphtheria-tetanus vaccine (Td) in adults. Vaccine 19: 628-636. http://dx.doi.org/10.1016/S0264-410X(00)00252-8.
32. A-adjuvanted H5N1 influenza vaccine in a Taiwanese population. J. Formos. Med. Assoc. 110: 780-786. http://dx.doi.org/10.1016/j.jfma.2011.11.009.
33. Langley JM, Frenette L, Ferguson L, Riff D, Sheldon E, Risi G, Johnson C, Li P, Kenney R, Innis B, Fries L. 2010. Safety and cross-reactive immunogenicity of candidate AS03-adjuvanted prepandemic H5N1 influenza vaccines: a randomized controlled phase 1/2 trial in adults. J. Infect. Dis. 201: 1644-1653. http://dx.doi.org/10.1086/652701.
34. Walker WT, Faust SN. 2010. Monovalent inactivated split-virion AS03-adjuvanted pandemic influenza A (H1N1) vaccine. Expert Rev. Vaccines 9: 1385-1398. http://dx.doi.org/10.1586/erv.10.141.
35. A-adjuvanted prepandemic influenza vaccine: a phase III study in a large population of Asian adults. Vaccine 27: 7428-7435. http://dx.doi.org/10.1016/j.vaccine.2009.07.102.
36. GlaxoSmithKline. 2009. Pandemrix product information. GlaxoSmith-Kline Biologicals SA, Rixensart, Belgium.
37. Leroux-Roels G, Marchant A, Levy J, Van Damme P, Schwarz TF, Horsmans Y, Kremsner P, Gabor J, Esen M, Carletti I, Fissette L, Tavares Da Silva F, Burny W, Janssens M, van den Berg R, Delhaye S, Van Der Most R, Van Mechelen M, Garçon N, Van Belle P, Didierlaurent AM. 2012. Learnings from clinical assessment of innate responses induced by several adjuvants combined with HBsAg model antigen. Keystone Symp. Immunol. Mech. Vaccin., Ottawa, Canada, 13 to 18 December 2012.
38. Khan MN, Pichichero ME. 2012. Vaccine candidates PhtD and PhtE of Streptococcus pneumoniae are adhesins that elicit functional antibodies in humans. Vaccine 30: 2900-2907. http://dx.doi.org/10.1016/j.vaccine.2012.02.023.
39. Lin Y, Slight SR, Khader SA. 2010. Th17 cytokines and vaccine-induced immunity. Semin. Immunopathol. 32: 79-90. http://dx.doi.org/10.1007/s00281-009- 0191-2.
40. + T-cell responses among adults and young children in response to Streptococcus pneumoniae and Haemophilus influenzae vaccine candidate protein antigens. Vaccine 31: 3090-3097. http://dx.doi.org/10.1016/j.vaccine.2013.03. 060.
41. McCully ML, Ladell K, Hakobyan S, Mansel RE, Price DA, Moser B. 2012. Epidermis instructs skin homing receptor expression in human T cells. Blood 120: 4591-4598. http://dx.doi.org/10.1182/blood-2012-05-433037.
42. Pepper M, Linehan JL, Pagán AJ, Zell T, Dileepan T, Cleary PP, Jenkins MK. 2010. Different routes of bacterial infection induce long-lived TH1 memory cells and short-lived TH17 cells. Nat. Immunol. 11: 83-89. http://dx.doi.org/10.1038/ni.1826.
43. Zielinski CE, Mele F, Aschenbrenner D, Jarrossay D, Ronchi F, Gattorno M, Monticelli S, Lanzavecchia A, Sallusto F. 2012. Pathogen-induced human TH17 cells produce IFN-7 or IL10 and are regulated by IL-1β. Nature 484: 514-518. http://dx.doi.org/10.1038/nature10957.