Immunogenicity of adjuvanted versus high-dose inactivated influenza vaccines in older adults: a randomized clinical trial
Abstract Background Adjuvanted inactivated influenza vaccine (aIIV) and high-dose inactivated influenza vaccine (HD-IIV) are U.S.-licensed for adults aged ≥ 65 years. This study compared serum hemagglutination inhibition (HAI) antibody titers for the A(H3N2) and A(H1N1)pdm09 and B strains after triv...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-07-01
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| Series: | Immunity & Ageing |
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| Online Access: | https://doi.org/10.1186/s12979-023-00355-7 |
| _version_ | 1797789548204261376 |
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| author | Kenneth E. Schmader Christine K. Liu Brendan Flannery Wes Rountree Heidi Auerbach Elizabeth D. Barnett Elizabeth P. Schlaudecker Christopher A. Todd Marek Poniewierski Mary A. Staat Theresa Harrington Rongxia Li Karen R. Broder Emmanuel B. Walter |
| author_facet | Kenneth E. Schmader Christine K. Liu Brendan Flannery Wes Rountree Heidi Auerbach Elizabeth D. Barnett Elizabeth P. Schlaudecker Christopher A. Todd Marek Poniewierski Mary A. Staat Theresa Harrington Rongxia Li Karen R. Broder Emmanuel B. Walter |
| author_sort | Kenneth E. Schmader |
| collection | DOAJ |
| description | Abstract Background Adjuvanted inactivated influenza vaccine (aIIV) and high-dose inactivated influenza vaccine (HD-IIV) are U.S.-licensed for adults aged ≥ 65 years. This study compared serum hemagglutination inhibition (HAI) antibody titers for the A(H3N2) and A(H1N1)pdm09 and B strains after trivalent aIIV3 and trivalent HD-IIV3 in an older adult population. Results The immunogenicity population included 342 participants who received aIIV3 and 338 participants who received HD-IIV3. The proportion of participants that seroconverted to A(H3N2) vaccine strains after allV3 (112 participants [32.8%]) was inferior to the proportion of participants that seroconverted after HD-IIV3 (130 participants [38.5%]) at day 29 after vaccination (difference, − 5.8%; 95%CI, − 12.9% to 1.4%). There were no significant differences between the vaccine groups in percent seroconversion to A(H1N1)pdm09 or B vaccine strains, in percent seropositivity for any of the strains, or in post-vaccination GMT for the A(H1N1)pdm09 strain. The GMTs for the post-vaccination A(H3N2) and B strains were higher after HD-IIV than after aIIV3. Conclusions Overall immune responses were similar after aIIV3 and HD-IIV3. For the primary outcome, the aIIV3 seroconversion rate for H3N2 did not meet noninferiority criteria compared with HD-IIV3, but the HD-IIV3 seroconversion rate was not statistically superior to the aIIV3 seroconversion rate. Trial registration ClinicalTrials.gov Identifier: NCT03183908. |
| first_indexed | 2024-03-13T01:52:15Z |
| format | Article |
| id | doaj.art-275af69609234cc6b4651fc11dd8d745 |
| institution | Directory Open Access Journal |
| issn | 1742-4933 |
| language | English |
| last_indexed | 2024-03-13T01:52:15Z |
| publishDate | 2023-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Immunity & Ageing |
| spelling | doaj.art-275af69609234cc6b4651fc11dd8d7452023-07-02T11:26:54ZengBMCImmunity & Ageing1742-49332023-07-0120111110.1186/s12979-023-00355-7Immunogenicity of adjuvanted versus high-dose inactivated influenza vaccines in older adults: a randomized clinical trialKenneth E. Schmader0Christine K. Liu1Brendan Flannery2Wes Rountree3Heidi Auerbach4Elizabeth D. Barnett5Elizabeth P. Schlaudecker6Christopher A. Todd7Marek Poniewierski8Mary A. Staat9Theresa Harrington10Rongxia Li11Karen R. Broder12Emmanuel B. Walter13Division of Geriatrics, Department of Medicine and Center for the Study of Aging, Duke University School of MedicineSection of Geriatrics, Division of Primary Care and Population Health, Stanford UniversityInfuenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC)Duke Human Vaccine Institute, Duke University School of MedicineGeriatrics Section, Department of Medicine, School of Medicine and Boston Medical Center, Boston UniversityDepartment of Pediatrics, Section of Pediatric Infectious Diseases, School of Medicine and Boston Medical Center, Boston UniversityDepartment of Pediatrics Division of Infectious Diseases, University of Cincinnati College of Medicine and Cincinnati Children’s Hospital and Medical CenterDuke Human Vaccine Institute, Duke University School of MedicineDuke Human Vaccine Institute, Duke University School of MedicineDepartment of Pediatrics Division of Infectious Diseases, University of Cincinnati College of Medicine and Cincinnati Children’s Hospital and Medical CenterImmunization Safety Office, Centers for Disease Control and Prevention (CDC)Immunization Safety Office, Centers for Disease Control and Prevention (CDC)Immunization Safety Office, Centers for Disease Control and Prevention (CDC)Duke Human Vaccine Institute, Duke University School of MedicineAbstract Background Adjuvanted inactivated influenza vaccine (aIIV) and high-dose inactivated influenza vaccine (HD-IIV) are U.S.-licensed for adults aged ≥ 65 years. This study compared serum hemagglutination inhibition (HAI) antibody titers for the A(H3N2) and A(H1N1)pdm09 and B strains after trivalent aIIV3 and trivalent HD-IIV3 in an older adult population. Results The immunogenicity population included 342 participants who received aIIV3 and 338 participants who received HD-IIV3. The proportion of participants that seroconverted to A(H3N2) vaccine strains after allV3 (112 participants [32.8%]) was inferior to the proportion of participants that seroconverted after HD-IIV3 (130 participants [38.5%]) at day 29 after vaccination (difference, − 5.8%; 95%CI, − 12.9% to 1.4%). There were no significant differences between the vaccine groups in percent seroconversion to A(H1N1)pdm09 or B vaccine strains, in percent seropositivity for any of the strains, or in post-vaccination GMT for the A(H1N1)pdm09 strain. The GMTs for the post-vaccination A(H3N2) and B strains were higher after HD-IIV than after aIIV3. Conclusions Overall immune responses were similar after aIIV3 and HD-IIV3. For the primary outcome, the aIIV3 seroconversion rate for H3N2 did not meet noninferiority criteria compared with HD-IIV3, but the HD-IIV3 seroconversion rate was not statistically superior to the aIIV3 seroconversion rate. Trial registration ClinicalTrials.gov Identifier: NCT03183908.https://doi.org/10.1186/s12979-023-00355-7Influenza vaccineImmunogenicityAgedAdjuvanted influenza vaccineHigh dose influenza vaccine |
| spellingShingle | Kenneth E. Schmader Christine K. Liu Brendan Flannery Wes Rountree Heidi Auerbach Elizabeth D. Barnett Elizabeth P. Schlaudecker Christopher A. Todd Marek Poniewierski Mary A. Staat Theresa Harrington Rongxia Li Karen R. Broder Emmanuel B. Walter Immunogenicity of adjuvanted versus high-dose inactivated influenza vaccines in older adults: a randomized clinical trial Immunity & Ageing Influenza vaccine Immunogenicity Aged Adjuvanted influenza vaccine High dose influenza vaccine |
| title | Immunogenicity of adjuvanted versus high-dose inactivated influenza vaccines in older adults: a randomized clinical trial |
| title_full | Immunogenicity of adjuvanted versus high-dose inactivated influenza vaccines in older adults: a randomized clinical trial |
| title_fullStr | Immunogenicity of adjuvanted versus high-dose inactivated influenza vaccines in older adults: a randomized clinical trial |
| title_full_unstemmed | Immunogenicity of adjuvanted versus high-dose inactivated influenza vaccines in older adults: a randomized clinical trial |
| title_short | Immunogenicity of adjuvanted versus high-dose inactivated influenza vaccines in older adults: a randomized clinical trial |
| title_sort | immunogenicity of adjuvanted versus high dose inactivated influenza vaccines in older adults a randomized clinical trial |
| topic | Influenza vaccine Immunogenicity Aged Adjuvanted influenza vaccine High dose influenza vaccine |
| url | https://doi.org/10.1186/s12979-023-00355-7 |
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