Safety and Immunogenicity of Pneumococcal Conjugate Vaccines in a High-risk Population: A Randomized Controlled Trial of 10-Valent and 13-Valent Pneumococcal Conjugate Vaccine in Papua New Guinean Infants

被引:29
作者
Pomat, William S. [1 ]
van den Biggelaar, Anita H. J. [2 ,3 ]
Wana, Sandra [1 ]
Francis, Jacinta P. [1 ]
Solomon, Vela [1 ]
Greenhill, Andrew R. [1 ,4 ]
Ford, Rebecca [1 ]
Orami, Tilda [1 ]
Passey, Megan [5 ]
Jacoby, Peter [3 ,6 ]
Kirkham, Lea-Ann [2 ,3 ,7 ]
Lehmann, Deborah [2 ,3 ]
Richmond, Peter C. [2 ,3 ,8 ]
Bele, L.
Dreyam, M.
Elizah, A.
Ford, R.
Francis, J.
Gihigupa, A.
Greenhill, A.
Javati, S.
Kave, J.
Kirarock, W.
Lai, M.
Martin, B.
Masiria, G.
Michael, A.
Moliki, L.
Nagepu, B.
Nenikuro, M.
Nivio, B.
Opa, C.
Orami, T.
Pomat, W. S.
Saleu, G.
Siba, P.
Solomon, V.
Wana, S.
Wawae, L.
Yoannes, M.
Korowi, T.
Mond, C.
Wari, P.
Jacoby, P.
Lehmann, D.
van den Biggelaar, A.
Corscadden, K.
de Gier, C.
Kirkham, L.
Rahman, T.
机构
[1] Papua New Guinea Inst Med Res, Goroka, Papua N Guinea
[2] Univ Western Australia, Telethon Kids Inst, Wesfarmers Ctr Vaccines & Infect Dis, 15 Hosp Ave, Perth, WA 6009, Australia
[3] Univ Western Australia, Ctr Child Hlth Res, 15 Hosp Ave, Perth, WA 6009, Australia
[4] Federat Univ, Sch Hlth & Life Sci, Churchill, Vic, Australia
[5] Univ Sydney, Univ Ctr Rural Hlth, Sch Publ Hlth, Lismore, NSW, Australia
[6] Univ Western Australia, Telethon Kids Inst, Dept Biostat, Perth, WA, Australia
[7] Univ Western Australia, Sch Biomed Sci, Perth, WA, Australia
[8] Univ Western Australia, Sch Med, Div Paediat & Child Hlth, Perth, WA, Australia
基金
英国医学研究理事会;
关键词
pneumococcal conjugate vaccine; S; pneumonia; antibodies; carriage; Papua New Guinea; NONTYPABLE HAEMOPHILUS-INFLUENZAE; STREPTOCOCCUS-PNEUMONIAE; NASOPHARYNGEAL CARRIAGE; PROTEIN-D; HYPORESPONSIVENESS; CHILDREN;
D O I
10.1093/cid/ciy743
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Background. There are little data on the immunogenicity of PCV10 and PCV13 in the same high-risk population. Methods. PCV10 and PCV13 were studied head-to-head in a randomized controlled trial in Papua New Guinea in which 262 infants received 3 doses of PCV10 or PCV13 at 1, 2, and 3 months of age. Serotype-specific immunoglobulin G (IgG) concentrations, and pneumococcal and nontypeable Haemophilus influenzae (NTHi) carriage were assessed prevaccination and at 4 and 9 months of age. Infants were followed up for safety until 9 months of age. Results. One month after the third dose of PCV10 or PCV13, >80% of infants had IgG concentrations >= 0.35 mu g/mL for vaccine serotypes, and 6 months postvaccination IgG concentrations >= 0.35 mu g/mL were maintained for 8/10 shared PCV serotypes in >75% of children vaccinated with either PCV10 or PCV13. Children carried a total of 65 different pneumococcal serotypes (plus nonserotypeable). At 4 months of age, 92% (95% confidence interval [CI] 85-96) of children vaccinated with PCV10 and 81% (95% CI 72-88) vaccinated with PCV13 were pneumococcal carriers (P = .023), whereas no differences were seen at 9 months of age, or for NTHi carriage. Both vaccines were well tolerated and not associated with serious adverse events. Conclusions. Infant vaccination with 3 doses of PCV10 or PCV13 is safe and immunogenic in a highly endemic setting; however, to significantly reduce pneumococcal disease in these settings, PCVs with broader serotype coverage and potency to reduce pneumococcal carriage are needed.
引用
收藏
页码:1472 / 1481
页数:10
相关论文
共 50 条
[31]   Cost-effectiveness analysis of replacing the 10-valent pneumococcal conjugate vaccine (PCV10) with the 13-valent pneumococcal conjugate vaccine (PCV13) in Brazil infants [J].
Perdrizet, Johnna ;
Santana, Carlos Felipe S. ;
Senna, Thais ;
Alexandre, Rodrigo Fernandes ;
de Almeida, Rodrigo Sini ;
Spinardi, Julia ;
Wasserman, Matt .
HUMAN VACCINES & IMMUNOTHERAPEUTICS, 2021, 17 (04) :1162-1172
[32]   Pharmacoeconomic evaluation of 10-and 13-valent pneumococcal conjugate vaccines [J].
Chuck, Anderson W. ;
Jacobs, Philip ;
Tyrrell, Gregory ;
Kellner, James D. .
VACCINE, 2010, 28 (33) :5485-5490
[33]   Immunogenicity and Safety of a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers Given With Routine Vaccines in India [J].
Amdekar, Yeshwant K. ;
Lalwani, Sanjay K. ;
Bavdekar, Ashish ;
Balasubramanian, S. ;
Chhatwal, Jugesh ;
Bhat, Swarna Rekha ;
Verghese, Valsan Philip ;
Tansey, Susan P. ;
Gadgil, Durga ;
Jiang, Qin ;
Pride, Michael ;
Emini, Emilio A. ;
Gruber, William C. ;
Scott, Daniel A. .
PEDIATRIC INFECTIOUS DISEASE JOURNAL, 2013, 32 (05) :509-516
[34]   Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine administered to older infants and children naive to pneumococcal vaccination [J].
Wysocki, Jacek ;
Brzostek, Jerzy ;
Szymanski, Henryk ;
Tetiurka, Boguslaw ;
Toporowska-Kowalska, Ewa ;
Wasowska-Krolikowska, Krystyna ;
Sarkozy, Denise A. ;
Giardina, Peter C. ;
Gruber, William C. ;
Emini, Emilio A. ;
Scott, Daniel A. .
VACCINE, 2015, 33 (14) :1719-1725
[35]   Immunogenicity and Safety of the Higher-Valent Pneumococcal Conjugate Vaccine vs the 13-Valent Pneumococcal Conjugate Vaccine in Older Adults: A Systematic Review and Meta-analysis of Randomized Controlled Trials [J].
Ngamprasertchai, Thundon ;
Ruenroengbun, Narisa ;
Kajeekul, Rattagan .
OPEN FORUM INFECTIOUS DISEASES, 2025, 12 (02)
[36]   Effectiveness of the new serotypes in the 13-valent pneumococcal conjugate vaccine [J].
Miller, Elizabeth ;
Andrews, Nicholas J. ;
Waight, Pauline A. ;
Slack, Mary P. E. ;
George, Robert C. .
VACCINE, 2011, 29 (49) :9127-9131
[37]   Safety and immunogenicity of a new 13-valent pneumococcal conjugate vaccine versus a licensed 7-valent pneumococcal conjugate vaccine: a study protocol of a randomised non-inferiority trial in China [J].
Chen, Jing Jing ;
Yuan, Lin ;
Huang, Zhen ;
Shi, Nian Min ;
Zhao, Yu Liang ;
Xia, Sheng Li ;
Li, Guo Hua ;
Li, Rong Cheng ;
Li, Yan Ping ;
Yang, Shu Yuan ;
Xia, Jie Lai .
BMJ OPEN, 2016, 6 (10)
[38]   Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults ≥65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine [J].
Peterson, James T. ;
Stacey, Helen L. ;
MacNair, John E. ;
Li, Jianing ;
Hartzel, Jonathan S. ;
Sterling, Tina M. ;
Benner, Patrice ;
Tamms, Gretchen M. ;
Musey, Luwy K. .
HUMAN VACCINES & IMMUNOTHERAPEUTICS, 2019, 15 (03) :540-548
[39]   Use of the 13-valent pneumococcal conjugate vaccine in infants and young children [J].
Principi, Nicola ;
Esposito, Susanna .
EXPERT OPINION ON BIOLOGICAL THERAPY, 2012, 12 (05) :641-648
[40]   Serotype Replacement after Introduction of 10-Valent and 13-Valent Pneumococcal Conjugate Vaccines in 10 Countries, Europe [J].
Hanquet, Germaine ;
Krizova, Pavla ;
Dalby, Tina ;
Ladhani, Shamez N. ;
Nuorti, J. Pekka ;
Danis, Kostas ;
Mereckiene, Jolita ;
Knol, Mirjam J. ;
Winje, Brita A. ;
Ciruela, Pilar ;
de Miguel, Sara ;
Eugenia Portillo, Maria ;
MacDonald, Laura ;
Morfeldt, Eva ;
Kozakova, Jana ;
Valentiner-Branth, Palle ;
Fry, Norman K. ;
Rinta-Kokko, Hanna ;
Varon, Emmanuelle ;
Corcoran, Mary ;
van der Ende, Arie ;
Vestrheim, Didrik F. ;
Munoz-Almagro, Carmen ;
Sanz, Juan-Carlos ;
Castilla, Jesus ;
Smith, Andrew ;
Henriques-Normark, Birgitta ;
Colzani, Edoardo ;
Pastore-Celentano, Lucia ;
Savulescu, Camelia .
EMERGING INFECTIOUS DISEASES, 2022, 28 (01) :127-138