A phase III clinical trial to evaluate the safety and immunogenicity of 23-valent pneumococcal polysaccharide vaccine (PPV23) in healthy children, adults, and elderly

References

• Robinson KA, Baughman W, Rothrock G, Barrett NL, Pass M, Lexau C, Damaske B, Stefonek K, Barnes B, Patterson J. Epidemiology of invasive streptococcus pneumoniae infections in the United States, 1995-1998: opportunities for prevention in the conjugate vaccine era. Jama. 2001;285(13):1729–1735. doi:10.1001/jama.285.13.1729.
   PubMed Web of Science ®Google Scholar
• Yao KH, Yang YH. Streptococcus pneumoniae diseases in Chinese children: past, present and future. Vaccine. 2008;26(35):4425–4433. doi:10.1016/j.vaccine.2008.06.052.
   PubMed Web of Science ®Google Scholar
• Huang S, Liu X, Lao W, Zeng S, Liang H, Zhong R, Dai X, Wu X, Li H, Yao Y. Serotype distribution and antibiotic resistance of Streptococcus pneumoniae isolates collected at a Chinese hospital from 2011 to 2013. Bmc Infect Dis. 2015;15(1):312–321. doi:10.1186/s12879-015-1042-5.
   PubMedGoogle Scholar
• Nuorti JP, Whitney CG. Prevention of pneumococcal disease among infants and children - use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine - recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recommendations Rep. MMWR-Morbid Mortal W. 2010;59(RR–11):1–18. PMID:21150868.
   PubMedGoogle Scholar
• Mo X, Tobe RG, Liu X, Mori R. Cost-effectiveness and health benefits of pediatric 23-valent pneumococcal polysaccharide vaccine, 7-valent and forecasting 13-valent pneumococcal conjugate vaccines in China. Pediatr Infect Dis J. 2016;35(11):e353–e361. doi:10.1097/INF.0000000000001288.
   PubMed Web of Science ®Google Scholar
• CDC. Pneumococcal polysaccharide vaccine, what you need to know. US Department of Health and Human Services, CDC. 2015 http://www.immunize.org/vis/ppsv.pdf.
   Google Scholar
• CDC. Updated recommendations for prevention of invasive pneumococcal disease among adults using the 23-valent pneumococcal polysaccharide vaccine (PPSV23)-Advisory Committee on Immunization Practices (ACIP). MMWR-Morbid Mortal W. 2010;59:1102–1106. PMID:20814406.
   PubMedGoogle Scholar
• Chinese Prevention Medicine Association. Technical guidline on application of pneumococcal vaccine in China (2012). Chin J Epidemiol. 2012;33(11):1101–1110. PMID: 23290891.
   Google Scholar
• O’Brien KL, Hochman M, Goldblatt D. Combined schedules of pneumococcal conjugate and polysaccharide vaccines: is hyporesponsiveness an issue? Lancet Infect Dis. 2007;7(9):597–606. doi:10.1016/S1473-3099(07)70210-4.
   PubMed Web of Science ®Google Scholar
• Aliberti S, Mantero M, Mirsaeidi M, Blasi F. The role of vaccination in preventing pneumococcal disease in adults. Clin Microbiol Infec. 2014;20(Supplement s5):52–58. doi:10.1111/1469-0691.12518.
   PubMedGoogle Scholar
• Liang Q, Li GF, Zhu FC. Vaccine profile of PPV23: beijing Minhai Biotech 23-valent pneumococcal vaccine. Expert Rev Vaccines. 2016;15(11):1351–1359. doi:10.1080/14760584.2016.1239536.
   PubMed Web of Science ®Google Scholar
• Zhang GH, Zheng DY, Shi NM, Ai X, Bai YH. Pneumonia vaccination coverage and influencing factors among part of community elderly in Chaoyang District, Beijing City, China. Chin J Biol Prod. 2013;26(1):93–95. (In Chinese). doi:10.13200/j.cjb.2013.01.98.zhanggh.009.
   Google Scholar
• You ZJ, Lin B, Gao Z. Pneumonia vaccination coverage and influencing factors among elderly in Qingpu Distric, Shanghai City, China. Med Heal Care. 2015;3:89. (In Chinese).
   Google Scholar
• Martinelli D, Tafuri S, Caputi G, Fortunato F, Reggio P, Germinario C, Prato R. Eight years of active proposal of pneumococcal 23-valent polysaccharide vaccine: survey on coverage rate among elderly and chronic patients. Ajic Am J Infec Contr. 2010;38(4):e8–e15. doi:10.1016/j.ajic.2009.09.019.
   PubMed Web of Science ®Google Scholar
• Zhou Z, Deceuninck G, Lefebvre B, De WP. Forecasting trends in invasive pneumococcal disease among elderly adults in Quebec. Can J Infect Dis Med Microbiol. 2017;2017(37):4347206. doi:10.1155/2017/4347206.
   PubMedGoogle Scholar
• Wen YW, Wu H, Chang CJ. Using dynamic transmission modeling to determine vaccination coverage rate based on 5-year economic burden of infectious disease: an example of pneumococcal vaccine. Value Heal Reg Issues. 2015;6(7):46–52. doi:10.1016/j.vhri.2015.03.014.
   PubMedGoogle Scholar
• Kong Y, Zhang W, Jiang Z, Wang L, Li C, Li Y, Xia J. Immunogenicity and safety of a 23-valent pneumococcal polysaccharide vaccine in Chinese healthy population aged >2 years: A randomized, double-blinded, active control, phase III trial. Hum Vacc Immunother. 2015;11(10):2425–2433. doi:10.1080/21645515.2015.1055429.
   PubMed Web of Science ®Google Scholar
• Guifan L, Qi L, Jichun S, Yuemei H, Hong L, Wenjin W, Fengcai Z, Qiang Y. Safety and immunogenicity of 23-valent pneumococcal polysaccharide vaccine in 2 to 70 year old healthy people in China: A phase III double blind, randomized clinical trial. Hum Vacc Immunother. 2015;11(3):699–703. doi:10.1080/21645515.2015.1011015.
   PubMed Web of Science ®Google Scholar
• Yang Y, Su KX, Song SZ, Zhang Y, Jiang S, Xie QH, Lan F, Huang J, Li YD, Li FX, et al. Clinical Effect of 23-valent Pneumococcal Polysaccharide Vaccine. J Prev Med Infor. 2007;4:390–391.
   Google Scholar
• World Health Organization. 23-valent pneumococcal polysaccharide vaccine. WHO Position Pap. 2008;83(42):373–384. http://www.who.int/iris/handle/10665/241221.
   Google Scholar
• Jackson LA, Gurtman A, Van CM, Frenck RW, Treanor J, Jansen KU, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Influence of initial vaccination with 13-valent pneumococcal conjugate vaccine or 23-valent pneumococcal polysaccharide vaccine on anti-pneumococcal responses following subsequent pneumococcal vaccination in adults 50 years and older. Vaccine. 2013;31(35):3594–3602. doi:10.1016/j.vaccine.2013.04.084.
   PubMed Web of Science ®Google Scholar
• Sankilampi U, Honkanen PO, Bloigu A, Leinonen M. Persistence of antibodies to pneumococcal capsular polysaccharide vaccine in the elderly. J Infect Dis. 1997;176(4):1100–1104. doi:10.1086/516521.
   PubMed Web of Science ®Google Scholar
• Musher DM, Manoff SB, Mcfetridge RD, Liss CL, Marchese RD, Raab J, Rueda AM, Walker ML, Hoover PA. Antibody persistence ten years after first and second doses of 23-valent pneumococcal polysaccharide vaccine, and immunogenicity and safety of second and third doses in older adults. Hum Vacc Immunother. 2011;7(9):919–928. doi:10.4161/hv.7.9.15996.
   PubMed Web of Science ®Google Scholar
• Musher DM, Manoff SB, Liss C, Mcfetridge RD, Marchese RD, Bushnell B, Alvarez F, Painter C, Blum MD, Silber JL. Safety and antibody response, including antibody persistence for 5 years, after primary vaccination or revaccination with pneumococcal polysaccharide vaccine in middle-aged and older adults. J Infect Dis. 2010;201(4):516–524. doi:10.1086/649839.
   PubMed Web of Science ®Google Scholar
• Hammitt LL, Bulkow LR, Singleton RJ, Nuorti JP, Hummel KB, Miernyk KM, Zanis C, Whaley M, Romero-Steiner S, Butler JC. Repeat revaccination with 23-valent pneumococcal polysaccharide vaccine among adults aged 55–74 years living in Alaska: no evidence of hyporesponsiveness. Vaccine. 2011;29(12):2287–2295. doi:10.1016/j.vaccine.2011.01.029.
   PubMed Web of Science ®Google Scholar
• Grabenstein JD, Manoff SB. Pneumococcal polysaccharide 23-valent vaccine: long-term persistence of circulating antibody and immunogenicity and safety after revaccination in adults. Vaccine. 2012;30(30):4435–4444. doi:10.1016/j.vaccine.2012.04.052.
   PubMed Web of Science ®Google Scholar