A randomized, double-blind trial to evaluate immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given concomitantly with trivalent influenza vaccine in adults aged ≥65 years

Schwarz, Tino F.; Flamaing, Johan; Rümke, H. C.; Penzes, J; Juergens, Christine; Wenz, A; Jayawardene, Deepthi; Giardina, Peter C.; Emini, Emilio A.; Gruber, William C.; Schmöele-Thoma, Beate

doi:10.1016/j.vaccine.2011.05.031

Cited by 89 publications

(89 citation statements)

References 16 publications

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“…Although there is no correlate of protection for the LLOQ defined in adults, the proportion of subjects achieving an OPA titer of ՆLLOQ after concomitant PCV13 and TIV was similar to or lower than that with PCV13 given alone, with two serotypes being statistically significantly lower after concomitant PCV13 and TIV. Lower IgG responses after concomitant PCV13 and TIV were also reported in a similarly designed study in Germany in adults of Ն65 years of age (20).…”

Section: Discussionsupporting

confidence: 72%

Randomized, Controlled Trial of a 13-Valent Pneumococcal Conjugate Vaccine Administered Concomitantly with an Influenza Vaccine in Healthy Adults

Frenck

Gurtman

Rubino³

et al. 2012

Clin. Vaccine Immunol.

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ABSTRACTA randomized, double-blind, phase 3 trial evaluated the immunogenicity, safety, and tolerability of a 13-valent pneumococcal conjugate vaccine (PCV13) coadministered with trivalent inactivated influenza vaccine (TIV) in pneumococcal vaccine-naive adults. Participants ages 50 to 59 years (n= 1,116) received TIV with PCV13 (group 1) or placebo (group 2) (1:1 randomization); 1 month later, group 1 received placebo and group 2 received PCV13. A hemagglutination inhibition (HAI) assay for TIV and a standardized enzyme-linked immunosorbent assay for pneumococcal serotype-specific immunoglobulin G (IgG) were performed and opsonophagocytic activity (OPA) titers (assessedpost hoc) were measured at baseline and 1 and 2 months postvaccination. The rises in HAI assay geometric mean titer (GMT) and percentage of participants in groups 1 and 2 with ≥4-fold increases in HAI responses (A/H1N1, 84.0% and 81.2%, respectively; A/H3N2, 71.1% and 69.5%, respectively; and B, 60.6% and 60.3%, respectively) were similar. In group 1, all serotypes met the predefined IgG geometric mean concentration (GMC) ratio noninferiority criterion relative to group 2, but GMCs were lower in group 1 than group 2. When comparing group 1 with group 2, 5 serotypes did not meet the OPA GMT ratio noninferiority criterion, and OPA GMTs were significantly lower for 10 serotypes. PCV13 injection site reactions were similar and mostly mild in both groups. Systemic events were more frequent in group 1 (86.2%) than group 2 (76.7%;P< 0.001); no vaccine-related serious adverse events occurred. Coadministration of PCV13 and TIV was well tolerated but associated with lower PCV13 antibody responses and is of unknown clinical significance. Given the positive immunologic attributes of PCV13, concomitant administration with TIV should be dictated by clinical circumstances.

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Section: Discussionsupporting

confidence: 72%

Randomized, Controlled Trial of a 13-Valent Pneumococcal Conjugate Vaccine Administered Concomitantly with an Influenza Vaccine in Healthy Adults

Frenck

Gurtman

Rubino³

et al. 2012

Clin. Vaccine Immunol.

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“…In the three evaluated RCTs [23,82,83], those vaccinated with PCV13 reported muscle pain and local pain significantly more often (GRADE: "moderate" quality of evidence). Fever, malaise, headache, muscle and joint pain occurred more frequently among those vaccinated with PCV13, but the differences were not (or not in all three studies) significant (GRADE: "low" and "moderate" quality of evidence, respectively.…”

Section: Pcv13 (+Iiv) Vs Placebo (+Iiv)mentioning

confidence: 99%

Background paper to the updated pneumococcal vaccination recommendation for older adults in Germany

Falkenhorst

Remschmidt

Harder

et al. 2016

Bundesgesundheitsbl

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are members of the German Standing Committee on Vaccination (STIKO). Bundesgesundheitsblatt -Gesundheitsforschung -Gesundheitsschutz 12 · 2016 1624Tätigkeitsberichte Summary Background and objective The incidence of pneumococcal diseases among adults increases with age. Therefore, Germany's Standing Committee on Vaccination (Ständige Impfkommission, STIKO) has since 1998 recommended vaccination with the 23-valent pneumococcal polysaccharide vaccine (PPSV23) for all people aged ≥60 years. PPSV23 has been the only pneumococcal vaccine licensed for adults until few years ago. Universal pneumococcal vaccination of infants, using a conjugate vaccine, has been recommended by STIKO since 2006. Since then, pneumococcal serotypes contained in conjugate vaccines have declined among cases of pneumococcal disease not only in children, but -through herd protection -also in older adults. The 13-valent pneumococcal conjugate vaccine (PCV13), currently used for most infants in Germany, has now been approved for use in adults as well. Data on the efficacy of PCV13 against clinical endpoints in older adults was published in 2015. For that reason, STIKO investigated whether one of the two vaccines (or the combination of both) should be preferred in order to reduce the burden of pneumococcal diseases in older adults, and at what age the vaccine should be given. Efficacy against invasive pneumococcal diseasesPooled data from 4 randomised controlled trials (RCTs) of PPSV23 in older adults show an efficacy of 73 % against invasive pneumococcal disease (IPD) caused by any serotype (95 % confidence interval [CI], 10-92 %). The IPD cases in these studies were mostly caused by one of the 23 serotypes contained in the vaccine. The efficacy of PCV13 in older adults was investigated in one RCT. Efficacy against IPD by any serotype was 49 % (95 % CI, 21-67 %, modified-intention-to-treat analysis). Efficacy against IPD by the 13 serotypes contained in the vaccine (VT-IPD) was 76 % (95 % CI, 47-90 %). Efficacy against pneumococcal pneumoniaAfter exclusion of 2 RCTs with a high risk of bias, pooled efficacy of PPSV23 against pneumococcal pneumonia (PP) caused by any serotype in the remaining 2 RCTs was 64 % (95 % CI, 35-80 %). In the included observational studies, pooled efficacy ranged from 37 % to 53 %, with broadly overlapping CIs, depending on study type. The efficacy of PCV13 against PP caused by any serotype was 22 % (95 % CI, 2-39 %), and against VT-PP it was 38 % (95 % CI, 14-55 %). Anticipated epidemiological and health economic effectsThe above-mentioned studies do not provide clear evidence of a difference between the two vaccines regarding efficacy against clinical endpoints (IPD, PP) caused by the serotypes contained in the respective vaccine. In the 2015-'16 season, 70 % of IPD cases in people aged ≥60 years were caused by PPSV23 serotypes, but only 30 % by PCV13 serotypes. Because PPSV23 contains all the serotypes in PCV13 (except for serotype 6A), vaccination with PPSV23 confers broader serotype coverage and can thereby prevent ...

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“…13 Studies of antibody responses and duration following HPV vaccination have shown a maximum peak in antibody titers 7 months after beginning the vaccination scheme. 14,15 Subsequently, a gradual decline in antibody levels is observed, and by the 24 th month these levels stabilize and remain constant until at least the 60 th month. 16 To date, the minimum level of antibodies correlated with clinical protection is not yet known, 17 but a correlation has been established between the presence of antibodies and a protective effect.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the immunogenicity of the quadrivalent HPV vaccine using 2 versus 3 doses at month 21: An epidemiological surveillance mechanism for alternate vaccination schemes

Hernández-Ávila

Torres‐Ibarra

Stanley

et al. 2015

Human Vaccines & Immunotherapeutics

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A randomized, double-blind trial to evaluate immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given concomitantly with trivalent influenza vaccine in adults aged ≥65 years

Cited by 89 publications

References 16 publications

Randomized, Controlled Trial of a 13-Valent Pneumococcal Conjugate Vaccine Administered Concomitantly with an Influenza Vaccine in Healthy Adults

Randomized, Controlled Trial of a 13-Valent Pneumococcal Conjugate Vaccine Administered Concomitantly with an Influenza Vaccine in Healthy Adults

Background paper to the updated pneumococcal vaccination recommendation for older adults in Germany

Evaluation of the immunogenicity of the quadrivalent HPV vaccine using 2 versus 3 doses at month 21: An epidemiological surveillance mechanism for alternate vaccination schemes

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