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    The SENIEUR protocol and the efficacy of hepatitis B vaccination in healthy elderly persons by age, gender, and vaccine route

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    Author
    Edelman, R.
    Deming, M.E.
    Toapanta, F.R.
    Heuser, M.D.
    Chrisley, L.
    Barnes, R.S.
    Wasserman, S.S.
    Handwerger, B.S.
    Pasetti, M.
    Sztein, M.B.
    Date
    2020
    Journal
    Immunity and Ageing
    Publisher
    BioMed Central Ltd.
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1186/s12979-020-00179-9
    Abstract
    Background: Reduced response to hepatitis B vaccines is associated with aging, confounding and comorbid conditions, as well as inadvertent subcutaneous (SC) inoculation. We hypothesized that the antibody and T cell-mediated immune responses (T-CMI) of elderly adults to a vaccine intended for intramuscular (IM) administration would be attenuated when deposited into SC fat, independent of confounding conditions. Results: Fifty-two healthy, community dwelling elderly adults (65-82 years), seronegative for HBV, were enrolled in the SENIEUR protocol as a strictly healthy population. These seniors were randomized to receive a licensed alum-adjuvanted recombinant HBV vaccine either SC or IM, with the inoculum site verified by imaging. The response rates, defined as hepatitis B surface antibodies (HBsAb) ?10 IU/L, were significantly lower in the elderly than in young adults, a group of 12, healthy, 21-34-year-old volunteers. Moreover, elderly participants who received the vaccine IM were significantly more likely to be responders than those immunized SC (54% versus 16%, p = 0.008). The low seroconversion rate in the IM group progressively declined with increasing age, and responders had significantly lower HBsAb titers and limited isotype responses. Moreover, T-CMI (proliferation and cytokine production) were significantly reduced in both percentage of responders and intensity of the response for both Th1 and Th2 subsets in the elderly. Conclusions: Our data demonstrate the blunted immunogenicity of SC inoculation as measured by peak titers and response rates. Further, the qualitative and quantitative deficits in B- A nd T-CMI responses to primary alum adjuvanted protein antigens persisted even in strictly healthy elderly populations with verified IM placement compared to younger populations. Clinical trial registration: ClinicalTrials.gov, NCT04162223. Registered 14 November 2019. Retrospectively registered. Copyright 2020 The Author(s).
    Keyword
    Aging
    Antibody
    Cellular immunity
    Hepatitis B
    Immunesenescence
    Vaccine
    Identifier to cite or link to this item
    https://www.scopus.com/inward/record.uri?eid=2-s2.0-85084325388&doi=10.1186%2fs12979-020-00179-9&partnerID=40&md5=374ab4219b3ebe7b3529daf684c35007; http://hdl.handle.net/10713/12781
    ae974a485f413a2113503eed53cd6c53
    10.1186/s12979-020-00179-9
    Scopus Count
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    UMB Open Access Articles 2020

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