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

Aging Antibody Cellular immunity Hepatitis B Immunesenescence Vaccine

Journal

Immunity & ageing : I & A
ISSN: 1742-4933
Titre abrégé: Immun Ageing
Pays: England
ID NLM: 101235427

Informations de publication

Date de publication:
2020
Historique:
received: 14 11 2019
accepted: 31 03 2020
entrez: 2 5 2020
pubmed: 2 5 2020
medline: 2 5 2020
Statut: epublish

Résumé

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. 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%, 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- and T-CMI responses to primary alum adjuvanted protein antigens persisted even in strictly healthy elderly populations with verified IM placement compared to younger populations. ClinicalTrials.gov, NCT04162223. Registered 14 November 2019. Retrospectively registered.

Sections du résumé

BACKGROUND 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 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%,
CONCLUSIONS 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- and 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 BACKGROUND
ClinicalTrials.gov, NCT04162223. Registered 14 November 2019. Retrospectively registered.

Identifiants

pubmed: 32355503
doi: 10.1186/s12979-020-00179-9
pii: 179
pmc: PMC7187507
doi:

Banques de données

ClinicalTrials.gov
['NCT04162223']

Types de publication

Journal Article

Langues

eng

Pagination

9

Subventions

Organisme : NIA NIH HHS
ID : P30 AG028747
Pays : United States
Organisme : NIAID NIH HHS
ID : T32 AI007524
Pays : United States

Informations de copyright

© The Author(s) 2020.

Déclaration de conflit d'intérêts

Competing interestsThe authors declare that they have no competing interests.

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Auteurs

Robert Edelman (R)

1Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA.
2Department of Medicine, University of Maryland School of Medicine, Baltimore, USA.

Meagan E Deming (ME)

1Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA.
2Department of Medicine, University of Maryland School of Medicine, Baltimore, USA.
3Institute of Human Virology, University of Maryland School of Medicine, Baltimore, USA.

Franklin R Toapanta (FR)

1Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA.
2Department of Medicine, University of Maryland School of Medicine, Baltimore, USA.

Mark D Heuser (MD)

2Department of Medicine, University of Maryland School of Medicine, Baltimore, USA.
Present Adress: Department of Veterans Affairs, Salisbury VA Health Care System, Salisbury, NC USA.

Lisa Chrisley (L)

1Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA.

Robin S Barnes (RS)

1Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA.

Steven S Wasserman (SS)

1Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA.
2Department of Medicine, University of Maryland School of Medicine, Baltimore, USA.
5Present Adress: Office of Research, University of Virginia, Charlottesville, USA.

William C Blackwelder (WC)

6Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, USA.

Barry S Handwerger (BS)

7Rheumatology and Clinical Immunology, Dept of Medicine, University of Maryland School of Medicine, Baltimore, USA.

Marcela Pasetti (M)

1Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA.
8Department of Pediatrics, University of Maryland School of Medicine, Baltimore, USA.
9Department of Microbiology and Immunology, Dept of Medicine, University of Maryland School of Medicine, Baltimore, USA.

Khan M Siddiqui (KM)

10Imaging Informatics and Body Magnetic Resonance Imaging unit, Veterans Affairs Maryland Health Care System Baltimore, Baltimore, MD USA.
11Present Adress: Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, USA.

Marcelo B Sztein (MB)

1Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA.
2Department of Medicine, University of Maryland School of Medicine, Baltimore, USA.
8Department of Pediatrics, University of Maryland School of Medicine, Baltimore, USA.
9Department of Microbiology and Immunology, Dept of Medicine, University of Maryland School of Medicine, Baltimore, USA.

Classifications MeSH