Evidence map›Paper›PMID 33119068›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021

Efficacy and Safety of a 3-Antigen (Pre-S1/Pre-S2/S) Hepatitis B Vaccine: Results of a Phase 3 Randomized Clinical Trial in the Russian Federation.

Elena V Esaulenko, Aleksey A Yakovlev, Genady A Volkov, Anastasia A Sukhoruk, Kirill G Surkov, Peter V Kruglyakov, Francisco Diaz-Mitoma

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04209400 (A Comparative Randomized Double-Blind Study of Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® in Adult Study Subjects), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 27% 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.

NCT04209400 phase3completednot on this map

A Comparative Randomized Double-Blind Study of Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® in Adult Study Subjects

TypeinterventionalSponsorVBI Vaccines Inc.Ran2014 to 2015Enrolled100ConditionsHepatitis BArmsSci-B-Vac®, Engerix-B®
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
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 2 institutions in 1 country.

Elena V EsaulenkoFederal State Budgetary Educational Institution of Higher Education; Saint Petersburg State Paediatric Medical University of the Ministry of Health of the Russian Federation, Saint Petersburg, Russia.
Aleksey A YakovlevSt Petersburg State Budgetary Healthcare Institution; S.P. Botkin Clinical Infectious Diseases Hospital, Saint Petersburg, Russia.
Genady A VolkovPharmsynthez PAO (Publichnoye Aktsionernoye Obshchestvo), Kuzmolovski, Russia.
Anastasia A SukhorukFederal State Budgetary Educational Institution of Higher Education; Saint Petersburg State Paediatric Medical University of the Ministry of Health of the Russian Federation, Saint Petersburg, Russia.
Kirill G SurkovPharmsynthez PAO (Publichnoye Aktsionernoye Obshchestvo), Kuzmolovski, Russia.
Peter V KruglyakovPharmsynthez PAO (Publichnoye Aktsionernoye Obshchestvo), Kuzmolovski, Russia.
Francisco Diaz-MitomaVBI Vaccines Inc, Cambridge, Massachusetts, USA.ORCID 0000-0003-0292-4859
Rybinsk State Aviation Technological Academy · RUSt. Petersburg State Medical Academy "City Hospital No. 26" · RU

Funding

Pharmsynthez PAOVBI Vaccines Inc
6 · The paper itself

Abstract

backgroundThis study compares the immunogenicity and safety of a 3-antigen (S/pre-S1/pre-S2) hepatitis B (HepB) vaccine (3AV), to a single antigen vaccine (1AV) in adults to support the registration of 3AV in Russia.

methodsWe conducted a randomized, double-blind, comparative study of 3-dose regimens of 3AV (10 μg) and 1AV (20 µg) in adults aged 18-45 years. We evaluated immunogenicity based on hepatitis B surface (HBs) antibody titers at days 1, 28, 90, 180, and 210, adverse and serious adverse events (SAEs) to study day 210. The primary outcome was based on the difference in rates of seroconversion at day 210 (lower bound 95% confidence interval [CI]: > - 4%). Secondary outcomes were seroprotection rates (SPR), defined as anti-HBs ≥10 mIU/mL and anti-HBs geometric mean concentration (GMC).

resultsRate of seroconversion in 3AV (100%) was noninferior to 1AV (97.9%) at study day 210 (difference: 2.1%, 95% CI: -2.0, 6.3%]) but significantly higher at study day 28. SPR at study day 210 was >97% in both arms. Anti-HBs titers were significantly higher at study days 90 (P = .001) and 180 (P = .0001) with 3AV. Sex, age, and body mass index (BMI) had no impact on anti-HBs titers. The rates of local reactions related to vaccination were similar between vaccine arms (3AV vs 1AV) after the first (30% vs 18.8%, P = .15), second (20.0% vs 14.6%, P = .33), and third vaccination (14.9% vs 23.4%, P = .22). No SAEs were reported.

conclusions3AV was noninferior to 1AV. 3AV induced high SPR, and there were no safety concerns. Clinical Trials Registration. NCT04209400.

Indexed as

Hepatitis BHepatitis B VaccinesAdultHepatitis B AntibodiesHepatitis B Surface AntigensHumansImmunization, SecondaryRussiaHepatitis B AntibodiesHepatitis B Surface AntigensHepatitis B Vaccineshepatitis Bseroconversionseroprotectionvaccine

Identifiers

PMID33119068
PMCPMC8563202
OpenAlexW3097440725

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.