A phase 3, multicenter, single-arm, open-label study to assess the safety, tolerability, and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine in Japanese participants aged 6-64 years who are considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal vaccines
Copyright © 2021 Elsevier Ltd. All rights reserved..
BACKGROUND: This open-label, single-arm, phase 3 study evaluated safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (PCV13) in pneumococcal vaccine-naive Japanese individuals aged 6-64 years at increased risk of pneumococcal disease (PD).
METHODS: Participants received 1 PCV13 dose. Reactogenicity events were recorded for 7 days (individuals aged 6- to 17-year-old) or 14 days (individuals aged 18 to 64 years old) postvaccination. Adverse events (AEs) were collected for 1 month postvaccination. Opsonophagocytic activity (OPA) and anticapsular immunoglobulin G (IgG) geometric mean concentrations (GMCs) were measured for vaccine serotypes before and 1 month postvaccination. Post hoc analyses compared immunogenicity in participants categorized as at-risk (immunocompetent but having chronic medical conditions associated with increased PD risk) or high-risk (immunocompromised due to diseases/conditions and/or medications).
RESULTS: 206 participants aged 6- to 17-year-old (n = 53) and 18 to 64 years old (n = 153) completed the study. Reactogenicity events were generally mild to moderate in severity. AEs were reported in 16% (33/206) of participants; 1.0% (2/206) were severe. Six AEs were vaccine-related; most were associated with local reactions. No serious AEs occurred. Circulating antibody levels for all 13 serotypes increased postvaccination. OPA geometric mean fold rises (GMFRs) from prevaccination to 1 month postvaccination were 5.5-61.7; lower limits of the 2-sided, 95% CI were > 1 for all serotypes. IgG GMFRs were consistent with OPA analyses. In post hoc analyses, 55.8% (115/206) and 44.2% (91/206) of participants were categorized as at risk and at high risk of PD, respectively; OPA GMFRs from prevaccination to 1 month postvaccination were 3.9-635.1, with lower limits of the 2-sided 95% CIs > 1 for all 13 serotypes across these risk groups; IgG GMFRs were consistent with OPA analyses.
CONCLUSIONS: PCV13 was well tolerated and immunogenic in Japanese individuals aged 6-64 years considered at increased risk of PD. Results were broadly comparable with past PCV13 studies in other Japanese and non-Japanese populations. Registration number: NCT03571607; JapicCTI-184024.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:39 |
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| Enthalten in: |
Vaccine - 39(2021), 43 vom: 15. Okt., Seite 6414-6421 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Yamazaki, Yoshitaka [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 25.10.2021 Date Revised 31.05.2022 published: Print-Electronic ClinicalTrials.gov: NCT03571607 Citation Status MEDLINE |
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| doi: |
10.1016/j.vaccine.2021.08.106 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM331050501 |
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| 100 | 1 | |a Yamazaki, Yoshitaka |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A phase 3, multicenter, single-arm, open-label study to assess the safety, tolerability, and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine in Japanese participants aged 6-64 years who are considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal vaccines |
| 264 | 1 | |c 2021 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 25.10.2021 | ||
| 500 | |a Date Revised 31.05.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03571607 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2021 Elsevier Ltd. All rights reserved. | ||
| 520 | |a BACKGROUND: This open-label, single-arm, phase 3 study evaluated safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (PCV13) in pneumococcal vaccine-naive Japanese individuals aged 6-64 years at increased risk of pneumococcal disease (PD) | ||
| 520 | |a METHODS: Participants received 1 PCV13 dose. Reactogenicity events were recorded for 7 days (individuals aged 6- to 17-year-old) or 14 days (individuals aged 18 to 64 years old) postvaccination. Adverse events (AEs) were collected for 1 month postvaccination. Opsonophagocytic activity (OPA) and anticapsular immunoglobulin G (IgG) geometric mean concentrations (GMCs) were measured for vaccine serotypes before and 1 month postvaccination. Post hoc analyses compared immunogenicity in participants categorized as at-risk (immunocompetent but having chronic medical conditions associated with increased PD risk) or high-risk (immunocompromised due to diseases/conditions and/or medications) | ||
| 520 | |a RESULTS: 206 participants aged 6- to 17-year-old (n = 53) and 18 to 64 years old (n = 153) completed the study. Reactogenicity events were generally mild to moderate in severity. AEs were reported in 16% (33/206) of participants; 1.0% (2/206) were severe. Six AEs were vaccine-related; most were associated with local reactions. No serious AEs occurred. Circulating antibody levels for all 13 serotypes increased postvaccination. OPA geometric mean fold rises (GMFRs) from prevaccination to 1 month postvaccination were 5.5-61.7; lower limits of the 2-sided, 95% CI were > 1 for all serotypes. IgG GMFRs were consistent with OPA analyses. In post hoc analyses, 55.8% (115/206) and 44.2% (91/206) of participants were categorized as at risk and at high risk of PD, respectively; OPA GMFRs from prevaccination to 1 month postvaccination were 3.9-635.1, with lower limits of the 2-sided 95% CIs > 1 for all 13 serotypes across these risk groups; IgG GMFRs were consistent with OPA analyses | ||
| 520 | |a CONCLUSIONS: PCV13 was well tolerated and immunogenic in Japanese individuals aged 6-64 years considered at increased risk of PD. Results were broadly comparable with past PCV13 studies in other Japanese and non-Japanese populations. Registration number: NCT03571607; JapicCTI-184024 | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Immunocompetent | |
| 650 | 4 | |a Immunocompromised | |
| 650 | 4 | |a Immunogenicity | |
| 650 | 4 | |a Japan | |
| 650 | 4 | |a Pneumococcal vaccine | |
| 650 | 4 | |a Safety | |
| 650 | 7 | |a Antibodies, Bacterial |2 NLM | |
| 650 | 7 | |a Pneumococcal Vaccines |2 NLM | |
| 650 | 7 | |a Vaccines, Conjugate |2 NLM | |
| 700 | 1 | |a Ikeda, Masanori |e verfasserin |4 aut | |
| 700 | 1 | |a Imada, Takayuki |e verfasserin |4 aut | |
| 700 | 1 | |a Furuno, Kenji |e verfasserin |4 aut | |
| 700 | 1 | |a Mizukami, Tomoyuki |e verfasserin |4 aut | |
| 700 | 1 | |a de Solom, Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Shoji, Yasuko |e verfasserin |4 aut | |
| 700 | 1 | |a Oe, Motoki |e verfasserin |4 aut | |
| 700 | 1 | |a Aizawa, Masakazu |e verfasserin |4 aut | |
| 700 | 1 | |a Giardina, Peter C |e verfasserin |4 aut | |
| 700 | 1 | |a Schmoele-Thoma, Beate |e verfasserin |4 aut | |
| 700 | 1 | |a Scott, Daniel A |e verfasserin |4 aut | |
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