Two Doses of Inactivated Influenza Vaccine Improve Immune Response in Solid Organ Transplant Recipients : Results of TRANSGRIPE 1-2, a Randomized Controlled Clinical Trial
© The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissionsoup.com..
BACKGROUND: Influenza vaccine effectiveness is not optimal in solid organ transplant recipients (SOTR). We hypothesized that a booster dose might increase it.
METHODS: TRANSGRIPE 1-2 is a phase 3, randomized, controlled, multicenter, open-label clinical trial. Patients were randomly assigned (1:1 stratified by study site, type of organ, and time since transplantation) to receive 1 dose (control group) or 2 doses (booster group) of the influenza vaccine 5 weeks apart.
RESULTS: A total of 499 SOTR were enrolled. Although seroconversion at 10 weeks did not meet significance in the modified intention-to-treat population, seroconversion rates were significantly higher in the booster arm for the per-protocol population (53.8% vs 37.6% for influenza A(H1N1)pdm; 48.1% vs 32.3% for influenza A(H3N2); and 90.7% vs 75% for influenza B; P < .05). Furthermore, seroprotection at 10 weeks was higher in the booster group: 54% vs 43.2% for A(H1N1)pdm; 56.9% vs 45.5% for A(H3N2); and 83.4% vs 71.8% for influenza B (P < .05). The number needed to treat to seroprotect 1 patient was <10. The clinical efficacy (99.2% vs 98.8%) and serious adverse events (6.4% vs 7.5%) were similar for both groups.
CONCLUSIONS: In SOTR, a booster strategy 5 weeks after standard influenza vaccination is safe and effective and induces an increased antibody response compared with standard influenza vaccination consisting of a single dose.
CLINICAL TRIALS REGISTRATION: EudraCT (2011-003243-21).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2017 |
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| Erschienen: |
2017 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:64 |
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| Enthalten in: |
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America - 64(2017), 7 vom: 01. Apr., Seite 829-838 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Cordero, Elisa [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 22.12.2017 Date Revised 16.03.2022 published: Print Citation Status MEDLINE |
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| doi: |
10.1093/cid/ciw855 |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 0 | |a Two Doses of Inactivated Influenza Vaccine Improve Immune Response in Solid Organ Transplant Recipients |b Results of TRANSGRIPE 1-2, a Randomized Controlled Clinical Trial |
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| 500 | |a Date Revised 16.03.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissionsoup.com. | ||
| 520 | |a BACKGROUND: Influenza vaccine effectiveness is not optimal in solid organ transplant recipients (SOTR). We hypothesized that a booster dose might increase it | ||
| 520 | |a METHODS: TRANSGRIPE 1-2 is a phase 3, randomized, controlled, multicenter, open-label clinical trial. Patients were randomly assigned (1:1 stratified by study site, type of organ, and time since transplantation) to receive 1 dose (control group) or 2 doses (booster group) of the influenza vaccine 5 weeks apart | ||
| 520 | |a RESULTS: A total of 499 SOTR were enrolled. Although seroconversion at 10 weeks did not meet significance in the modified intention-to-treat population, seroconversion rates were significantly higher in the booster arm for the per-protocol population (53.8% vs 37.6% for influenza A(H1N1)pdm; 48.1% vs 32.3% for influenza A(H3N2); and 90.7% vs 75% for influenza B; P < .05). Furthermore, seroprotection at 10 weeks was higher in the booster group: 54% vs 43.2% for A(H1N1)pdm; 56.9% vs 45.5% for A(H3N2); and 83.4% vs 71.8% for influenza B (P < .05). The number needed to treat to seroprotect 1 patient was <10. The clinical efficacy (99.2% vs 98.8%) and serious adverse events (6.4% vs 7.5%) were similar for both groups | ||
| 520 | |a CONCLUSIONS: In SOTR, a booster strategy 5 weeks after standard influenza vaccination is safe and effective and induces an increased antibody response compared with standard influenza vaccination consisting of a single dose | ||
| 520 | |a CLINICAL TRIALS REGISTRATION: EudraCT (2011-003243-21) | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a booster dose. | |
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| 650 | 4 | |a influenza vaccine | |
| 650 | 4 | |a solid organ transplantation | |
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| 650 | 7 | |a Influenza Vaccines |2 NLM | |
| 650 | 7 | |a Vaccines, Inactivated |2 NLM | |
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| 700 | 1 | |a Fariñas, Maria Carmen |e verfasserin |4 aut | |
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