Safety and immunogenicity of a single dose 23-valent pneumococcal polysaccharide vaccine in Russian subjects

References

• Pilishvili T, Lexau C, Farley MM, Hadler J, Harrison LH, Bennett NM, Reingold A, Thomas A, Schaffner W, Craig AS, et al. Sustained reductions in invasive pneumococcal disease in the era of conjugate vaccine. J Infect Dis 2010; 201(1):32-41; PMID:19947881; http://dx.doi.org/10.1086/648593
   PubMed Web of Science ®Google Scholar
• Robinson KA, Baughman W, Rothrock G, Barrett NL, Pass M, Lexau C, Damaske B, Stefonek K, Barnes B, Patterson J, et al. Epidemiology of invasive streptococcus pneumoniae infections in the United States, 1995–1998: opportunities for prevention in the conjugate vaccine era. JAMA 2001; 285(13):1729-35; PMID:11277827; http://dx.doi.org/10.1001/jama.285.13.1729
   PubMed Web of Science ®Google Scholar
• Weycker D, Strutton D, Edelsberg J, Sato R, Jackson LA. Clinical and economic burden of pneumococcal disease in older US adults. Vaccine 2010; 28(31):4955-60; PMID:20576535; http://dx.doi.org/10.1016/j.vaccine.2010.05.030
   PubMed Web of Science ®Google Scholar
• O'Brien KL, Wolfson LJ, Watt JP, Henkle E, Deloria- Knoll M, McCall N, Lee E, Mulholland K, Levine OS, Cherian T, et al. Burden of disease caused by Streptococcus pneumoniae in children younger than 5 years: global estimates. Lancet 2009; 374(9693):893-902; PMID:19748398; http://dx.doi.org/10.1016/S0140-6736(09)61204-6
   PubMed Web of Science ®Google Scholar
• Fedson DS, Musher DM. Pneumococcal vaccine. In: Plotkin SA, Mortimer EA, Jr., eds. Vaccines 2 ed. Philadelphia: W.B. Saunders Company, 1994:517-64.
   Google Scholar
• Kyaw MH, Rose CE, Jr., Fry AM, Singleton JA, Moore Z, Zell ER, Whitney CG. Active Bacterial Core Surveillance Program of the Emerging Infections Program Network. The influence of chronic illnesses on the incidence of invasive pneumococcal disease in adults. J Infect Dis 2005; 192(3):377-86; PMID:15995950; http://dx.doi.org/10.1086/431521
   PubMed Web of Science ®Google Scholar
• Vila-Corcoles A, Aguirre-Chavarria C, Ochoa-Gondar O, de Diego C, Rodriguez-Blanco T, Gomez F, Raga X, Barnes L, Magarolas R, Esteban L. Influence of chronic illnesses and underlying risk conditions on the incidence of pneumococcal pneumonia in older adults. Infection 2015; 43:699-706; PMID:26037386.
   PubMed Web of Science ®Google Scholar
• Torres A, Blasi F, Dartois N, Akova M. Which individuals are at increased risk of pneumococcal disease and why? Impact of COPD, asthma, smoking, diabetes, and/or chronic heart disease on community-acquired pneumonia and invasive pneumococcal disease. Thorax 2105; 70:984-9; PMID:26219979.
   PubMedGoogle Scholar
• Harboe ZB, Larsen MV, Ladelund S, Kronborg G, Konradsen HB, Gerstoft J, Larsen CS, Pedersen C, Pedersen G, Obel N, et al. Incidence and risk factors of invasive pneumococcal disease in HIV-infected and non-HIV-infected individuals before and after the introduction of combination antiretroviral therapy: Persistent high risk among HIV-infected injecting drug users. Clin Infect Dis 2014; 59:1168-76; PMID:25038114; http://dx.doi.org/10.1093/cid/ciu558
   PubMed Web of Science ®Google Scholar
• Fletcher MA, Balmer P, Bonnet E, Dartois N. PCVs in individuals at increased risk of pneumococcal disease: a literature review. Expert Rev Vaccines 2015; 14:975-1030; PMID:26083459; http://dx.doi.org/10.1586/14760584.2015.1037743
   PubMed Web of Science ®Google Scholar
• Tatochenko V, Sidorenko S, Namazova-Baranova L, Mayanskiy N, Kulichenko T, Baranov A, Lobzin Y, Kharit S, Kozlov R, Andreeva I, et al. Streptococcus pneumoniae serotype distribution in children in the Russian Federation before the introduction of pneumococcal conjugate vaccines into the National Immunization Program. Expert Rev Vaccines 2014; 13:257-64; PMID:24350587; http://dx.doi.org/10.1586/14760584.2013.871205
   PubMed Web of Science ®Google Scholar
• Beloshickij GV, Koroleva IS, Koshkina NI. (Pneumococcal meningitis in the Russian Federation). Epidemiology and Vaccinoprophylaxis. 2009; 45(2):21-6 (translated Russian).
   Google Scholar
• Baranov AA, Briko NY, Namazova-Baranova LS, Chuchalin AG, Tatochenko VK, et al. (Vaccinal prevention of infection caused by streptococcus pneumoniae. Federal Clinical recommendations) 2015; (4):6-9; Available from: http://www.pediatr-russia.ru/sites/default/files/file/kr_pnev.pdf (translated Russian).
   Google Scholar
• Turkutukov VB, Martinova AV. (Serotype description and pathogenic evidence of pneumococcus strains and pathogenic organisms bringing on community-acquired pneumonia at young people in closed groups). Pacific Med J 2004; 3:49-51 (translated Russian).
   Google Scholar
• Briko NI. The burden of pneumococcal infections and the directions of improving epidemiological surveillance in Russia. Epidemiol Infectious Diseases 2013; 6:4-937.
   Google Scholar
• Koroleva IS, Kharit SM, Ruleva AA, Perova AL, Sidorenko SV. (Pneumococcal infection in Russia: epidemiological situation). Pediatric Pharmacology 2010; 7(4):12-8 (translated Russian).
   Google Scholar
• World Health Organization. Country specific and global health estimates: Russian Federation, 2009.
   Google Scholar
• Bilichenko TN, Argunova AN, Antonova OA, et al. Pneumococcal pneumonia frequency in therapeutic adult inpatients at three Russian Regions. Pulmonology 2013; 4:29-36.
   Google Scholar
• Guchev IA, Yu VL, Sinopalnikov A, Klochkov OL, Kozlov RS, Stratchounski LS. Management of nonsevere pneumonia in military trainees with the urinary antigen test for streptococcus pneumoniae: an innovative approach to targeted therapy. CID 2005; 40(11):1608-16; http://dx.doi.org/10.1086/429919
   PubMed Web of Science ®Google Scholar
• Shapiro ED, Berg AT, Austrian R, Schroeder D, Parcells V, Margolis A, Adair RK, Clemens JD, et al. The protective efficacy of polyvalent pneumococcal polysaccharide vaccine. N Engl J Med 1991; 325(21):1453-60; PMID:1944423; http://dx.doi.org/10.1056/NEJM199111213252101
   PubMed Web of Science ®Google Scholar
• Vila-Corcoles A, Salsench E, Rodriguez-Blanco T, Ochoa-Gondar O, de Diego C, Valdivieso A, Hospital I, Gomez-Bertomeu F, Raga X. Clinical effectiveness of 23-valent pneumococcal polysaccharide vaccine against pneumonia in middle-aged and older adults: a matched case-control study. Vaccine 2009; 27(10):1504-10; PMID:19171174; http://dx.doi.org/10.1016/j.vaccine.2009.01.013
   PubMed Web of Science ®Google Scholar
• Murayama T, Taguchi O, Niederman MS, Morser J, Kobayashi H, Kobayashi T, et al. Efficacy of 23-valent pneumococcal vaccine in preventing pneumonia and improving survival in nursing home residents: double blind, randomised and placebo controlled trial. BMJ 2010; 340:1-7.
   Google Scholar
• Ochoa-Gondar O, Vila-Corcoles A, Rodriguez-Blanco T, Gomez-Bertomeu F, Figuerola-Massana E, Raga-Luria X, Hospital-Guardiola I. Effectiveness of the 23-valent pneumococcal polysaccharide vaccine against community-acquired pneumonia in the general population aged 60 years: 3 years of follow-up in the CAMPAMIS study. Clin Infect Dis 2014; 58:909-17; PMID:24532544; http://dx.doi.org/10.1093/cid/ciu002
   PubMed Web of Science ®Google Scholar
• Örtqvist A, Hedlund J, Burman LA, Elbel E, Höfer M, Leinonen M, Lindblad I, Sundelöf B, Kalin M. Randomised trial of 23-valent pneumococcal capsular polysaccharide vaccine in prevention of pneumonia in middle-aged and elderly people. Swedish Pneumococcal Vaccination Study Group. Lancet 1998; 351(9100):399-403.
   PubMed Web of Science ®Google Scholar
• Jackson LA, Neuzil KM, Yu O, Benson P, Barlow WE, Adams AL, Hanson CA, Mahoney LD, Shay DK, Thompson WW, et al. Effectiveness of pneumococcal polysaccharide vaccine in older adults. N Engl J Med 2003; 348(18):1747-55; PMID:12724480; http://dx.doi.org/10.1056/NEJMoa022678
   PubMed Web of Science ®Google Scholar
• Huss A, Scott P, Stuck AE, Trotter C, Egger M. Efficacy of pneumococcal vaccination in adults: a meta-analysis. CMAJ 2009; 180(1):48-58; PMID:19124790; http://dx.doi.org/10.1503/cmaj.080734
   PubMed Web of Science ®Google Scholar
• Moberley S, Holden J, Tatham DP, Andrews RM. Vaccines for preventing pneumococcal infection in adults (review), 2008.
   Google Scholar
• Robbins JB, Austrian R, Lee CJ, Rastogi SC, Schiffman G, Henrichsen J, Mäkelä PH, Broome CV, Facklam RR, Tiesjema RH, et al. Considerations for formulating the second-generation pneumococcal capsular polysaccharide vaccine with emphasis on the cross-reactive types within groups. J Infect Dis 1983; 148:1136-59; PMID:6361173; http://dx.doi.org/10.1093/infdis/148.6.1136
   PubMed Web of Science ®Google Scholar
• Artz AS, Ershler WB, Longo DL. Pneumococcal vaccination and revaccination of older adults. Clin Microbiol Rev 2003; 16:308-318; PMID:12692100; http://dx.doi.org/10.1128/CMR.16.2.308-318.2003
   PubMed Web of Science ®Google Scholar
• Mair S, Fiquet A, Meghlaoui G, Thomas S, Ledesma E. Immunogenicity and safety of PNEUMOVAX II manufactured by a new process in older adults. Hum Vaccin 2009; 5:608-13; PMID:19617717; http://dx.doi.org/10.4161/hv.9228
   PubMed Web of Science ®Google Scholar
• Musher DM, Manoff SB, McFetridge RD, Liss C, 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. Human Vaccin 2011; 7:919-28; http://dx.doi.org/10.4161/hv.7.9.15996
   PubMed Web of Science ®Google Scholar
• Manoff SB, Liss C, Caulfield MJ, Marchese RD, Silber J, Boslego J, Romero-Steiner S, Rajam G, Glass NE, Whitney CG, et al. Revaccination with a 23-valent pneumococcal polysaccharide vaccine induces elevated and persistent functional antibody responses in adults ≥65 years. J Infect Dis 2010; 201: 525-33; PMID:20088694; http://dx.doi.org/10.1086/651131
   PubMed Web of Science ®Google Scholar
• Smit P, Oberholzer D, Hayden-Smith S, Koornhof HJ, Hilleman MR. Protective efficacy of pneumococcal polysaccharide vaccines. JAMA 1977; 238(24):2613-6; PMID:21973; http://dx.doi.org/10.1001/jama.1977.03280250039019
   PubMed Web of Science ®Google Scholar
• Zhogolev SD, Ogarkov PI, Mel'nichenko PI. (The prophylaxis of nonhospital pneumonia using 23-valent pneumococcus vaccine in the military collectives). Voen Med Zh 2004; 325(12):35-43, 96 (translated Russian); PMID:15690855.
   PubMedGoogle Scholar
• Marchese RD, Jain NT, Antonello J, Mallette L, Butterfield-Gerson KL, Raab J, Burke P, Schulman C, Adgate H, Sikkema DJ, et al. Enzyme-linked immunosorbent assay for measuring antibodies to pneumococcal polysaccharides for the PNEUMOVAX 23 vaccine: Assay operating characteristics and correlation to the WHO International Assay. Clin Vaccine Immunol 2006; 13:905-12; PMID:16893991; http://dx.doi.org/10.1128/CVI.00014-06
   PubMed Web of Science ®Google Scholar
• Clopper CJ, Pearson ES. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 1934; 26(4):404-13; http://dx.doi.org/10.1093/biomet/26.4.404
   Google Scholar