Evidence map›Paper›PMID 21391984›Full record

Trial reportClinical and experimental immunology2011

Sublingual therapeutic immunization with a polyvalent bacterial preparation in patients with recurrent respiratory infections: immunomodulatory effect on antigen-specific memory CD4+ T cells and impact on clinical outcome.

D Alecsandru, L Valor, S Sánchez-Ramón, J Gil, J Carbone, J Navarro, J Rodríguez, C Rodríguez-Sainz, E Fernández-Cruz

3 registry-linked trialsOpen access · greenAbstract readClinical Trial
In one paragraph

Trial report in Clinical and experimental immunology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 38 papers.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed
3.3field-weighted citation impact, top 9% 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.

NCT01734811 phase3completednot on this mapstarted 2012, after this paper: background citation

Randomized Double-blind Placebo-controlled, Parallel, Multi Centre Clinical Trial of Sublingual Bacterial Vaccine in Children With Recurrent Bronchospasm (Wheezing Attacks) for the Evaluation of Efficacy, Security and Clinical Impact.

TypeinterventionalSponsorInmunotek S.L.Ran2012 to 2017Enrolled120ConditionsBronchospasm, Bronchiolitis, Bronchospasm, BronchitisArmsBiological vaccine
NCT04363814 phase3unknown statusnot on this mapstarted 2020, after this paper: background citation

A Prospective, Open-label, Randomized Pilot Study (Including a Control Group) of BACTEK-R (MV130), Administered Sublingually to Assess the Clinical Impact in Subjects With Mild Pneumonia Due to COVID-19

TypeinterventionalSponsorInmunotek S.L.Ran2020 to 2022Enrolled100ConditionsCOVID-19ArmsBactek-R
NCT05208060 phase1 / phase2unknown statusnot on this mapstarted 2023, after this paper: background citation

A Phase I/II Randomized, Prospective, Double-blind, Placebo-controlled, Single-center Study to Evaluate the Ability of Sublingual MV130 to Induce the Expression of Trained Immunity in Peripheral Blood Cells

TypeinterventionalSponsorInmunotek S.L.Ran2023 to 2025Enrolled48ConditionsImmune ResponseArmsMV130, Placebo
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 71 citations in OpenAlex.

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  9. Bacterial immunotherapy is highly effective in reducing recurrent upper respiratory tract infections in children: a prospective observational study.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2023
    Observational
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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

9 authors at 2 institutions in 1 country.

D AlecsandruClinical Immunology Unit, Immunology, Department, Hospital General Universitario, Gregorio Marañón, Departamento de Microbiología I, Universidad Complutense de Madrid, Spain. dalecsan.hgugm@salud.madrid.org
L Valor
S Sánchez-Ramón
J Gil
J Carbone
J Navarro
J Rodríguez
C Rodríguez-Sainz
E Fernández-Cruz
Universidad Complutense de Madrid · ESHospital General Universitario Gregorio Marañón · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Recurrent respiratory tract infections (RRTIs) are common clinical conditions in individuals with alterations of the immune function. A prospective open pilot study in a cohort of patients with RRTIs has been performed to assess whether sublingual immunization with a polyvalent bacterial vaccine could exert an immunomodulatory effect on the antigen-specific immunological responses and have an impact on the clinical outcome. Seventeen patients with RRTIs were recruited. An oral polyvalent bacterial preparation (Bactek®) was administered to all patients daily for 6 months. Immunological assessment was performed at baseline and at the end of immunization. Immunological measurements included: T cell-specific proliferations of CD3+CD4+ and CD3+CD8+ to Bactek® antigens, total immunoglobulin levels, antibodies to pneumococcal polysaccharide and tetanus toxoid and B, T and natural killer (NK) cell subsets. There was a significant increase in the proliferative capacity of CD3+CD4+ T cells specific to Bactek® antigens at month 6 in comparison to baseline (P < 0·0001). A significant increase in total CD3+ T cells was also observed (P < 0·05). No significant differences were observed between baseline and month 6 in levels of total immunoglobulins, specific antibodies and B, T or NK cell subsets. A significant reduction in the patient's rate of RRTIs was observed compared with 1 year prior to initiation of therapy (P < 0·0001). The results demonstrate that long-term administration of a sublingual polyvalent bacterial preparation in patients with RRTIs exerts an immune stimulating effect on CD4+ T helper cell responses to bacterial antigens which could be associated with clinical benefit.

Indexed as

Administration, SublingualAdultAgedBacterial InfectionsBacterial VaccinesB-LymphocytesDrug Administration ScheduleFemaleHumansImmunizationImmunoglobulinsKiller Cells, NaturalLymphocyte CountMaleMiddle AgedPilot ProjectsBacterial VaccinesImmunoglobulins

Identifiers

PMID21391984
PMCPMC3074222
OpenAlexW1582493590

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.