Evidence map›Paper›PMID 25996838›Full record

Trial reportHuman vaccines & immunotherapeutics2015

Persistence of immunity in healthy adults aged ≥ 50 years primed with a hepatitis B vaccine 3 years previously.

Rajiv Sharma, Clas Ahlm, Lars Ostergaard, Anthony Dowell, Clément Tran, Stéphane Thomas, Cécile Eymin

2 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 41% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01251276 phase3completednot on this map

A Study to Estimate the Immune Response Following a Challenge Dose in Adults (≥50 Years Old) Vaccinated With a Primary Series of an Hepatitis B Vaccine

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2010 to 2011Enrolled204ConditionsHepatitis BArmsModified Process Hepatitis B Vaccine
NCT04540653 phase4unknown statusnot on this mapstarted 2017, after this paper: background citation

Immunogenicity of the Hepatitis B Vaccine in Individuals 50 Years Old or More: Randomized Clinical Trial

TypeinterventionalSponsorUniversidade Federal de GoiasRan2017 to 2022Enrolled240ConditionsVaccine Response Impaired, Hepatitis B, AgingArmsStandard vaccination schedule, Reinforced vaccination schedule
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 5 countries.

Rajiv Sharmaa Sea Road Surgery; Bexhill-on-Sea , East Sussex , UK.
Clas Ahlm
Lars Ostergaard
Anthony Dowell
Clément Tran
Stéphane Thomas
Cécile Eymin
Communauté urbaine de Lyon · FRAarhus University Hospital · DKBexhill Hospital · GBOffice of Infectious Diseases · USSanofi (France) · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Hepatitis B vaccines do not generate protective immune responses in older adults as effectively as they do in children and young adults. Improved formulations of existing vaccines may have the potential to improve this. This study investigated the persistence of serum antibodies against hepatitis B surface antigens (anti-HBs) 3.1-3.5 years following primary vaccination with 3 doses of HBvaxPRO® or Engerix B™ in healthy adults aged ≥ 50 years who were further challenged with 1 dose of recombinant hepatitis B antigen. This was an open-label extension study. Individuals (N = 204) with a mean (standard deviation) age at enrollment of 63.7 (7.0) years receiving HBvaxPRO® or Engerix B™ in a randomized, double-blind primary study were challenged with 1 dose of HBvaxPRO® (10 μg). Anti-HBs were measured pre- and 30 days post-challenge. 45.5% (34.8, 56.4 [95% CI]) of individuals who received HBvaxPRO® in the per protocol set (PPS) had anti-HBs titers ≥ 10 mIU/mL pre-challenge and 85.2% (76.1, 91.9) 1-month post-challenge. In those who received Engerix B™ in the primary vaccination series, the results were 58.8% (48.6, 68.5) and 88.3% (80.5, 93.8), respectively. The challenge dose of HBvaxPRO® was generally well tolerated. Subjects aged ≥ 50 years receiving a challenge dose of HBvaxPRO® demonstrated immune memory against hepatitis B 3 years after a 3-dose primary. The safety profile of this challenge dose of HBvaxPRO® was consistent with the well-established safety profile of the vaccine HBvaxPRO®.

Indexed as

Immunologic MemoryAdultDouble-Blind MethodFemaleHepatitis BHepatitis B AntibodiesHepatitis B Surface AntigensHepatitis B VaccinesHumansImmunization, SecondaryMaleMiddle AgedTime FactorsHepatitis B AntibodiesHepatitis B Surface AntigensHepatitis B VaccinesadultAE, adverse eventanti-HBs, antibody to HBsAgCI, confidence intervalGMT, geometric mean titerHBsAg, hepatitis B surface antigenhepatitis BimmunitypersistencePPS, per protocol setSAE, serious adverse eventSAS, safety analysis setSD, standard deviationSPR, seroprotection ratevaccination

Identifiers

PMID25996838
PMCPMC4514216
OpenAlexW1484923478

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.