Reactogenicity, safety and immunogenicity of a protein-based pneumococcal vaccine in Gambian children aged 2–4 years: A phase II randomized study

Human Vaccines and Immunotherapeutics

Volumn 12, Issue 2, 2016, Pages 393-402

  Odutola, A ^a   Ota, M O ^a   Ogundare, E O ^a   Antonio, M ^a   Owiafe, P ^a   Worwui, A ^a   Greenwood, B ^b   Alderson, M ^c   Traskine, M ^d   Verlant, V ^d   Dobbelaere, K ^d   Borys, D ^d  

^a MEDICAL RESEARCH COUNCIL LABORATORIES   (Gambia)

^b LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^c PATH   (United States)

^d GSK   (Belgium)

Author keywords

Gambian children; immunogenicity; pneumococcal protein; pneumococcal vaccine; safety

Indexed keywords

BACTERIAL PROTEIN; FRAGILE HISTIDINE TRIAD PROTEIN; PNEUMOCOCCUS VACCINE; PNEUMOLYSIN; POLYSACCHARIDE; 10-VALENT PNEUMOCOCCAL CONJUGATE VACCINE; 13-VALENT PNEUMOCOCCAL VACCINE; BACTERIUM ANTIBODY; HISTIDINE TRIAD PROTEIN; HYDROLASE; PLY PROTEIN, STREPTOCOCCUS PNEUMONIAE; STREPTOLYSIN; VACCINE;

ARTICLE; BLOOD SAMPLING; CHILD; CONTROLLED STUDY; DRUG CROSS REACTIVITY; DRUG SAFETY; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; FEVER; GAMBIAN; HAEMOPHILUS INFLUENZAE; HUMAN; HUMAN CELL; IMMUNE RESPONSE; IMMUNOGENICITY; LOCAL SKIN REACTION; LOSS OF APPETITE; MALE; NORMAL HUMAN; PHASE 2 CLINICAL TRIAL; PNEUMOCOCCAL INFECTION; PRESCHOOL CHILD; RESPIRATORY TRACT INFECTION; SINGLE DRUG DOSE; TINEA CAPITIS; UNSPECIFIED SIDE EFFECT; BLOOD; CLINICAL TRIAL; GAMBIA; IMMUNOLOGY; MICROBIOLOGY; PNEUMOCOCCAL INFECTIONS; RANDOMIZED CONTROLLED TRIAL; STREPTOCOCCUS PNEUMONIAE; VACCINATION;

ANTIBODIES, BACTERIAL; BACTERIAL PROTEINS; CHILD, PRESCHOOL; FEMALE; GAMBIA; HUMANS; HYDROLASES; MALE; PNEUMOCOCCAL INFECTIONS; PNEUMOCOCCAL VACCINES; STREPTOCOCCUS PNEUMONIAE; STREPTOLYSINS; VACCINATION; VACCINES, CONJUGATE;

EID: 84960956314     PISSN: 21645515     EISSN: 2164554X     Source Type: Journal    
DOI: 10.1080/21645515.2015.1111496     Document Type: Article

References (43)

1. K.L.O'Brien, L.J.Wolfson, J.P.Watt, E.Henkle, M.Deloria-Knoll, N.McCall, E.Lee, K.Mulholland, O.S.Levine, T.Cherian. Burden of disease caused by Streptococcus pneumoniae in children younger than 5 years: global estimates. Lancet 2009; 374:893-902; PMID:19748398; http://dx.doi.org/10.1016/S0140-6736(09)61204-6
2. F.T.Cutts, S.M.Zaman, G.Enwere, S.Jaffar, O.S.Levine, J.B.Okoko, C.Oluwalana, A.Vaughan, S.K.Obaro, A.Leach, et al. Efficacy of nine-valent pneumococcal conjugate vaccine against pneumonia and invasive pneumococcal disease in The Gambia: randomised, double-blind, placebo-controlled trial. Lancet 2005; 365:1139-46; PMID:15794968; http://dx.doi.org/10.1016/S0140-6736(05)71876-6
3. C.G.Whitney, T.Pilishvili, M.M.Farley, W.Schaffner, A.S.Craig, R.Lynfield, A.C.Nyquist, K.A.Gershman, M.Vazquez, N.M.Bennett, et al. Effectiveness of seven-valent pneumococcal conjugate vaccine against invasive pneumococcal disease: a matched case-control study. Lancet 2006; 368:1495-502; PMID:17071283; http://dx.doi.org/10.1016/S0140-6736(06)69637-2
4. Direct and indirect effects of routine vaccination of children with 7-valent pneumococcal conjugate vaccine on incidence of invasive pneumococcal disease–United States, 1998-2003. MMWR Morb Mortal Wkly Rep 2005; 54:893-7; PMID:16163262
5. S.S.H.Black, R.Baxter, R.Austrian, L.Bracken, J.Hansen, E.Lewis, B.Fireman. Postlicensure surveillance for pneumococcal invasive disease after use of heptavalent pneumococcal conjugate vaccine in Northern California Kaiser Permanente. Pediat Infect Dis J 2004; 23:485-9; PMID:15194827; http://dx.doi.org/10.1097/01.inf.0000129685.04847.94
6. S.I.Aguiar, I.Serrano, F.R.Pinto, J.Melo-Cristino, M.Ramirez. Changes in Streptococcus pneumoniae serotypes causing invasive disease with non-universal vaccination coverage of the seven-valent conjugate vaccine. Clin Microbiol Infect 2008; 14:835-43; PMID:18844684; http://dx.doi.org/10.1111/j.1469-0691.2008.02031.x
7. Y.B.Z.S.Cheung, E.D.Nsekpong, C.A.Van Beneden, R.A.Adegbola, et al. Nasopharyngeal carriage of Streptococcus pneumoniae in Gambian children who participated in a 9-valent pneumococcal conjugate vaccine trial and in their younger siblings. Pediat Infect Dis J 2009; 28:990-5; PMID:19536041; http://dx.doi.org/10.1097/INF.0b013e3181a78185
8. L.A.Hicks, L.H.Harrison, B.Flannery, J.L.Hadler, W.Schaffner, A.S.Craig, D.Jackson, A.Thomas, B.Beall, R.Lynfield, et al. Incidence of pneumococcal disease due to non-pneumococcal conjugate vaccine (PCV7) serotypes in the United States during the era of widespread PCV7 vaccination, 1998-2004. J Infect Dis 2007; 196:1346-54; PMID:17922399; http://dx.doi.org/10.1086/521626
9. E.M.Panina, A.A.Mironov, M.S.Gelfand. Comparative genomics of bacterial zinc regulons: enhanced ion transport, pathogenesis, and rearrangement of ribosomal proteins. Proc Natl Acad Sci U S A 2003; 100:9912-7; PMID:12904577; http://dx.doi.org/10.1073/pnas.1733691100
10. A.D.Ogunniyi, M.Grabowicz, L.K.Mahdi, J.Cook, D.L.Gordon, T.A.Sadlon, J.C.Paton. Pneumococcal histidine triad proteins are regulated by the Zn2+-dependent repressor AdcR and inhibit complement deposition through the recruitment of complement factor H. FASEB J 2009; 23:731-8; PMID:18971260; http://dx.doi.org/10.1096/fj.08-119537
11. C.D.Plumptre, A.D.Ogunniyi, J.C.Paton. Polyhistidine triad proteins of pathogenic streptococci. Trends Microbiol 2012; 20:485-93; PMID:22819099; http://dx.doi.org/10.1016/j.tim.2012.06.004
12. D.M.Weinberger, R.Malley, M.Lipsitch. Serotype replacement in disease after pneumococcal vaccination. Lancet 2011; 378:1962-73; PMID:21492929; http://dx.doi.org/10.1016/S0140-6736(10)62225-8
13. M.J.Jedrzejas Pneumococcal virulence factors: structure and function. Microbiol Mol Biol Rev 2001; 65:187-207; first page, table of contents; PMID:11381099; http://dx.doi.org/10.1128/MMBR.65.2.187-207.2001
14. F.Godfroid, P.Hermand, V.Verlant, P.Denoel, J.T.Poolman. Preclinical evaluation of the Pht proteins as potential cross-protective pneumococcal vaccine antigens. Infect Immun 2011; 79:238-45; PMID:20956575; http://dx.doi.org/10.1128/IAI.00378-10
15. P.Denoel, M.T.Philipp, L.Doyle, D.Martin, G.Carletti, J.T.Poolman. A protein-based pneumococcal vaccine protects rhesus macaques from pneumonia after experimental infection with Streptococcus pneumoniae. Vaccine 2011; 29:5495-501; PMID:21624422; http://dx.doi.org/10.1016/j.vaccine.2011.05.051
16. M.Garcia-Suarez Mdel, M.D.Cima-Cabal, N.Florez, P.Garcia, R.Cernuda-Cernuda, A.Astudillo, F.Vazquez, J.R.De los Toyos, F.J.Mendez. Protection against pneumococcal pneumonia in mice by monoclonal antibodies to pneumolysin. Infect Immun 2004; 72:4534-40; PMID:15271913; http://dx.doi.org/10.1128/IAI.72.8.4534-4540.2004
17. J.E.H.J.Adamou, A.L.Erwin, W.Walsh, T.Gayle, et al. Identification and characterization of a novel family of pneumococcal proteins that are protective against sepsis. Infect Immunol 2001; 69:949-58; PMID:11159990; http://dx.doi.org/10.1128/IAI.69.2.949-958.2001
18. G.Leroux-Roels, C.Maes, F.De Boever, M.Traskine, J.U.Ruggeberg, D.Borys. Safety, reactogenicity and immunogenicity of a novel pneumococcal protein-based vaccine in adults: a phase I/II randomized clinical study. Vaccine 2014; 32:6838-46; PMID:24607003; http://dx.doi.org/10.1016/j.vaccine.2014.02.052
19. K.Pauksens, A.C.Nilsson, M.Caubet, T.G.Pascal, P.Van Belle, J.T.Poolman, P.G.Vandepapeliere, V.Verlant, P.E.Vink. Randomized controlled study of pneumococcal vaccine formulations containing PhtD and dPly proteins with alum or adjuvant system AS02V in elderly adults: safety and immunogenicity. Clin Vaccine Immunol 2014; 21:651-60; PMID:24599529
20. J.Hoskins, W.E.Alborn, Jr., J.Arnold, L.C.Blaszczak, S.Burgett, B.S.DeHoff, S.T.Estrem, L.Fritz, D.J.Fu, W.Fuller, et al. Genome of the bacterium Streptococcus pneumoniae strain R6. J Bacteriol 2001; 183:5709-17; PMID:11544234; http://dx.doi.org/10.1128/JB.183.19.5709-5717.2001
21. R.Prymula, S.L. Szenborn L, S.Silfverdal, J.Wysocki, P.Albrecht, N.Francois, A.Gardev, D.Borys. Safety and reactogenicity of 2 formulations of an investigational protein-based pneumococcal vaccine in infants in Europe:a phase II trial [Abstract ISPPD - 0167]. The International Symposium on Pneumococci and Pneumococcal Diseases. Hyderabad, India: Pneumonia, 2014.
22. R.Prymula, S.L. Szenborn L, S.Silfverdal, J.Wysocki, P.Albrecht, N.Francois, A.Gardev, D.Borys. Immunogenicity of primary vaccination with an investigational protein-based pneumococcal vaccine in infants in Europe: a phase II randomization trial [Abstract - 0551]. The International Symposium on Pneumococci and Pneumococcal Diseases. Hyderabad, India: Pneumonia, 2014.
23. D.Salha, J.Szeto, L.Myers, C.Claus, A.Sheung, M.Tang, B.Ljutic, D.Hanwell, K.Ogilvie, M.Ming, et al. Neutralizing antibodies elicited by a novel detoxified pneumolysin derivative, PlyD1, provide protection against both pneumococcal infection and lung injury. Infect Immun 2012; 80:2212-20; PMID:22473606; http://dx.doi.org/10.1128/IAI.06348-11
24. P.C.Hill, A.Akisanya, K.Sankareh, Y.B.Cheung, M.Saaka, G.Lahai, B.M.Greenwood, R.A.Adegbola. Nasopharyngeal carriage of Streptococcus pneumoniae in Gambian villagers. Clin Infect Dis 2006; 43:673-9; PMID:16912937; http://dx.doi.org/10.1086/506941
25. S.Rapola, V.Jantti, R.Haikala, R.Syrjanen, G.M.Carlone, J.S.Sampson, D.E.Briles, J.C.Paton, A.K.Takala, T.M.Kilpi, et al. Natural development of antibodies to pneumococcal surface protein A, pneumococcal surface adhesin A, and pneumolysin in relation to pneumococcal carriage and acute otitis media. J Infect Dis 2000; 182:1146-52; PMID:10979911; http://dx.doi.org/10.1086/315822
26. D.M.Musher, H.M.Phan, R.E.Baughn. Protection against bacteremic pneumococcal infection by antibody to pneumolysin. J Infect Dis 2001; 183:827-30; PMID:11181163; http://dx.doi.org/10.1086/318833
27. A.Dicko, O.O.Odusanya, A.I.Diallo, G.Santara, A.Barry, A.Dolo, A.Diallo, Y.A.Kuyinu, O.A.Kehinde, N.Francois, et al. Primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in infants in Mali and Nigeria: a randomized controlled trial. BMC Public Health 2011; 11:882; PMID:22112189; http://dx.doi.org/10.1186/1471-2458-11-882
28. R.Prymula, P.Peeters, V.Chrobok, P.Kriz, E.Novakova, E.Kaliskova, I.Kohl, P.Lommel, J.Poolman, J.P.Prieels, et al. 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 2006; 367:740-8; PMID:16517274; http://dx.doi.org/10.1016/S0140-6736(06)68304-9
29. J.Eskola, T.Kilpi, A.Palmu, J.Jokinen, J.Haapakoski, E.Herva, A.Takala, H.Kayhty, P.Karma, R.Kohberger, et al. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engl J Med 2001; 344:403-9; PMID:11172176; http://dx.doi.org/10.1056/NEJM200102083440602
30. O.O.Odusanya, Y.A.Kuyinu, O.A.Kehinde, F.Shafi, N.Francois, J.P.Yarzabal, K.Dobbelaere, J.U.Ruggeberg, D.Borys, L.Schuerman. Safety and immunogenicity of 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Nigerian children: booster dose and 2-dose catch-up regimens in the second year of life. Hum Vaccines Immunother 2014; 10:757-66; PMID:24356787; http://dx.doi.org/10.4161/hv.27276
31. A.Dicko, G.Santara, A.Mahamar, Y.Sidibe, A.Barry, Y.Dicko, A.Diallo, A.Dolo, O.Doumbo, F.Shafi, et al. Safety, reactogenicity and immunogenicity of a booster dose of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children. Hum Vaccines Immunother 2013; 9:382-8; PMID:23291945; http://dx.doi.org/10.4161/hv.22692
32. A.A.Palmu, J.Jokinen, D.Borys, H.Nieminen, E.Ruokokoski, L.Siira, T.Puumalainen, P.Lommel, M.Hezareh, M.Moreira, et al. Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. Lancet 2013; 381:214-22; PMID:23158882; http://dx.doi.org/10.1016/S0140-6736(12)61854-6
33. M.W.Tregnaghi, X.Saez-Llorens, P.Lopez, H.Abate, E.Smith, A.Posleman, A.Calvo, D.Wong, C.Cortes-Barbosa, A.Ceballos, et al. Efficacy of pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in young Latin American children: a double-blind randomized controlled trial. PLoS Med 2014; 11:e1001657.
34. R.Dagan, N.Givon-Lavi, D.Greenberg, B.Fritzell, C.A.Siegrist. Nasopharyngeal carriage of Streptococcus pneumoniae shortly before vaccination with a pneumococcal conjugate vaccine causes serotype-specific hyporesponsiveness in early infancy. J Infect Dis 2010; 201:1570-9; PMID:20384496; http://dx.doi.org/10.1086/652006
35. T.Vesikari, A.Karvonen, T.Korhonen, T.Karppa, K.Sadeharju, A.Fanic, I.Dieussaert, L.Schuerman. Immunogenicity of 10-valent pneumococcal nontypeable Haemophilus Influenzae Protein D Conjugate Vaccine when administered as catch-up vaccination to children 7 months to 5 years of age. Pediatr Infect Dis J 2011; 30:e130-41; PMID:21540760; http://dx.doi.org/10.1097/INF.0b013e31821d1790
36. J.A.Garcia-Rodriguez, M.J.Fresnadillo Martinez. Dynamics of nasopharyngeal colonization by potential respiratory pathogens. J Antimicrobial Chemother 2002; 50 Suppl S2:59-73; PMID:12556435; http://dx.doi.org/10.1093/jac/dkf506
37. A.A.Odutola, M.O.Afolabi, J.Jafali, I.Baldeh, O.A.Owolabi, P.Owiafe, G.Bah, B.Jaiteh, N.I.Mohammed, S.A.Donkor, et al. Haematological and biochemical reference values of Gambian infants. Trop Med Int Health 2014; 19:275-83; PMID:24393095; http://dx.doi.org/10.1111/tmi.12245
38. N.F.Concepcion, C.E.Frasch. Pneumococcal type 22f polysaccharide absorption improves the specificity of a pneumococcal-polysaccharide enzyme-linked immunosorbent assay. Clin Diagn Lab Immunol 2001; 8:266-72; PMID:11238206
39. I.Henckaerts, D.Goldblatt, L.Ashton, J.Poolman. Critical differences between pneumococcal polysaccharide enzyme-linked immunosorbent assays with and without 22F inhibition at low antibody concentrations in pediatric sera. Clin Vaccine Immunol 2006; 13:356-60; PMID:16522777; http://dx.doi.org/10.1128/CVI.13.3.356-360.2006
40. J.T.Poolman, C.E.Frasch, H.Kayhty, P.Lestrate, S.A.Madhi, I.Henckaerts. Evaluation of pneumococcal polysaccharide immunoassays using a 22F adsorption step with serum samples from infants vaccinated with conjugate vaccines. Clin Vaccine Immunol 2010; 17:134-42; PMID:19889940; http://dx.doi.org/10.1128/CVI.00289-09
41. S.Romero-Steiner, D.Libutti, L.B.Pais, J.Dykes, P.Anderson, J.C.Whitin, H.L.Keyserling, G.M.Carlone. Standardization of an opsonophagocytic assay for the measurement of functional antibody activity against Streptococcus pneumoniae using differentiated HL-60 cells. Clin Diagn Lab Immunol 1997; 4:415-22; PMID:9220157
42. I.Henckaerts, N.Durant, D.De Grave, L.Schuerman, J.Poolman. Validation of a routine opsonophagocytosis assay to predict invasive pneumococcal disease efficacy of conjugate vaccine in children. Vaccine 2007; 25:2518-27; PMID:17034907; http://dx.doi.org/10.1016/j.vaccine.2006.09.029
43. J.W.Findlay, W.C.Smith, J.W.Lee, G.D.Nordblom, I.Das, B.S.DeSilva, M.N.Khan, R.R.Bowsher. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J Pharm Biomed Analysis 2000; 21:1249-73; PMID:10708409; http://dx.doi.org/10.1016/S0731-7085(99)00244-7