Evidence map›Paper›PMID 12717874›Full record

Trial reportWorld journal of gastroenterology2003

Immunogenicity and reactogenicity of a recombinant hepatitis B vaccine in subjects over age of forty years and response of a booster dose among nonresponders.

Kunal Das, R K Gupta, V Kumar, P Kar

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in World journal of gastroenterology, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01126853 (A Pilot Study Evaluating the Combination Hepatitis A and B Vaccine), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
–field-weighted citation impact
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.

NCT01126853 phase4withdrawnnot on this mapstarted 2010, after this paper: background citation

A Pilot Study Evaluating the Combination Hepatitis A and B Vaccine (Twinrix®) in Healthy Healthcare Workers Who Meet the CDC Definition for Non-responders.

TypeinterventionalSponsorMount Sinai Hospital, CanadaRan2010 to 2011Enrolled0ConditionsHepatitis BArmsTwinrix
3 · Its place in the literature

Who cites it

15 citing papers in PubMed.

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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

4 authors.

Kunal DasProfessor of Medicine, Maulana Azad Medical College & L.N. Hospital, New Delhi-110002, India.
R K Gupta
V Kumar
P Kar

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThe study was initiated to evaluate the reactogenicity and immunogenicity of a recombinant hepatitis B vaccine in age group >40 years and to study the response of a single booster dose in primary non-responders to the hepatitis B vaccination.

methodsA total of 102 volunteers without markers of hepatitis B infection (negative for HBsAg, anti-HBc antibody, HBeAg and anti-HBs antibody) received 20 microg of recombinant HB vaccine intramuscularly at 0, 1, and 6 months. Anti HBs titers were evaluated by a quantitative Elisa kit at 90 and 210 days. A booster dose of 20 microg HB vaccine was given after 6 months of the 3(rd) vaccine dose to the 15 non-responders and anti-HBs titers were measured after 1 month.

resultsSeroprotection (anti-HBs GMT(3) 10 IU/L) was achieved in 85.3 % (87/102) volunteers. The mean GMT titers of the vaccine responders was 136.1 IU/L. Of the seroprotected individuals, there were 32.4 % (33/102) hyporesponders (anti-HBs titers <10-99 mlU/ml) and 52.9 % (54/102) were responders (anti-HBs titers >100 IU/L). All the non-responders (15/15) responded to a single dose of the booster dose of recombinant HB vaccine and their mean anti-HBs antibody titers were more than 100.5 mIU/ml after the booster dose.

conclusionRecombinant hepatitis B vaccine offers good seroprotection in the age group >40 years and has a good safety profile. A single booster dose after 6 months in primary non-responders leads to good seroprotective anti-HBs antibody titers. However, larger population based studies are needed to evaluate the role of a booster dose in selected group of non-responders and whether such an approach will be cost effective.

Indexed as

AdultAgedAge FactorsFemaleHepatitis B AntibodiesHepatitis B VaccinesHumansImmunization, SecondaryMaleMiddle AgedSafetyVaccines, SyntheticHepatitis B AntibodiesHepatitis B VaccinesVaccines, Synthetic

Identifiers

PMID12717874
PMCPMC4611390

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Registered trials

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