PMID- 33705665
OWN - NLM
STAT- MEDLINE
DCOM- 20210922
LR  - 20240403
IS  - 1535-4970 (Electronic)
IS  - 1073-449X (Print)
IS  - 1073-449X (Linking)
VI  - 204
IP  - 4
DP  - 2021 Aug 15
TI  - Bacterial Mucosal Immunotherapy with MV130 Prevents Recurrent Wheezing in 
      Children: A Randomized, Double-Blind, Placebo-controlled Clinical Trial.
PG  - 462-472
LID - 10.1164/rccm.202003-0520OC [doi]
AB  - Rationale: Recurrent wheezing in children represents a severe public health 
      concern. Wheezing attacks (WA), mainly associated with viral infections, lack 
      effective preventive therapies. Objectives: To evaluate the efficacy and safety 
      of mucosal sublingual immunotherapy based on whole inactivated bacteria (MV130) 
      in preventing WA in children. Methods: A Phase 3 randomized, double-blind, 
      placebo-controlled, parallel-group trial including a cohort of 120 children <3 
      years old with ⩾3 WA during the previous year was conducted. Children with a 
      positive skin test to common aeroallergens in the area where the clinical trial 
      was performed were excluded from the trial. Subjects received MV130 or placebo 
      daily for 6 months. The primary endpoint was the number of WA within 1 year after 
      the first dose comparing MV130 and placebo. Measurements and Main Results: There 
      was a significant lower number of WA in MV130 versus the placebo group, 3.0 
      (interquartile range [IQR], 2.0-4.0) versus 5.0 (IQR, 3.0-7.0) (P < 0.001). As 
      secondary outcomes, a decrease in the duration of WA and a reduction in symptoms 
      and medication scores in the MV130 versus placebo group were found. No adverse 
      events were reported related to the active treatment. Conclusions: Mucosal 
      bacterial immunotherapy with MV130 shows safety and clinical efficacy against 
      recurrent WA in children.Clinical trial registered with www.clinicaltrials.gov 
      (NCT01734811).
FAU - Nieto, Antonio
AU  - Nieto A
AUID- ORCID: 0000-0002-6302-6115
AD  - Unidad de Neumologia y Alergia Pediatrica, Instituto de Investigaciones 
      Sanitarias, Hospital Universitario La Fe, Valencia, Spain.
FAU - Mazon, Angel
AU  - Mazon A
AUID- ORCID: 0000-0001-5639-1037
AD  - Unidad de Neumologia y Alergia Pediatrica, Instituto de Investigaciones 
      Sanitarias, Hospital Universitario La Fe, Valencia, Spain.
FAU - Nieto, Maria
AU  - Nieto M
AD  - Unidad de Neumologia y Alergia Pediatrica, Instituto de Investigaciones 
      Sanitarias, Hospital Universitario La Fe, Valencia, Spain.
FAU - Calderon, Rafael
AU  - Calderon R
AD  - Departmento de Pediatria, Manises Hospital, Valencia, Spain.
FAU - Calaforra, Susana
AU  - Calaforra S
AD  - Unidad de Neumologia y Alergia Pediatrica, Instituto de Investigaciones 
      Sanitarias, Hospital Universitario La Fe, Valencia, Spain.
FAU - Selva, Blanca
AU  - Selva B
AD  - Unidad de Neumologia y Alergia Pediatrica, Instituto de Investigaciones 
      Sanitarias, Hospital Universitario La Fe, Valencia, Spain.
FAU - Uixera, Sonia
AU  - Uixera S
AD  - Unidad de Neumologia y Alergia Pediatrica, Instituto de Investigaciones 
      Sanitarias, Hospital Universitario La Fe, Valencia, Spain.
FAU - Palao, Maria Jose
AU  - Palao MJ
AD  - Departmento de Pediatria, Manises Hospital, Valencia, Spain.
FAU - Brandi, Paola
AU  - Brandi P
AD  - Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain.
FAU - Conejero, Laura
AU  - Conejero L
AUID- ORCID: 0000-0001-6515-9221
AD  - Inmunotek S.L., Alcala de Henares, Spain; and.
FAU - Saz-Leal, Paula
AU  - Saz-Leal P
AUID- ORCID: 0000-0002-6263-4709
AD  - Inmunotek S.L., Alcala de Henares, Spain; and.
FAU - Fernandez-Perez, Cristina
AU  - Fernandez-Perez C
AD  - Instituto de Investigacion Sanitaria del Hospital Clinico San Carlos, Universidad 
      Complutense, Madrid, Spain.
FAU - Sancho, David
AU  - Sancho D
AUID- ORCID: 0000-0003-2890-3984
AD  - Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain.
FAU - Subiza, Jose Luis
AU  - Subiza JL
AUID- ORCID: 0000-0002-0134-5321
AD  - Inmunotek S.L., Alcala de Henares, Spain; and.
FAU - Casanovas, Miguel
AU  - Casanovas M
AUID- ORCID: 0000-0003-2330-3963
AD  - Inmunotek S.L., Alcala de Henares, Spain; and.
LA  - eng
SI  - ClinicalTrials.gov/NCT01734811
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Am J Respir Crit Care Med
JT  - American journal of respiratory and critical care medicine
JID - 9421642
SB  - IM
CIN - Am J Respir Crit Care Med. 2021 Aug 15;204(4):392-394. doi: 
      10.1164/rccm.202103-0698ED. PMID: 33844949
MH  - *Bacteria/immunology
MH  - Child, Preschool
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Infant
MH  - Male
MH  - Recurrence
MH  - *Respiratory Sounds/immunology
MH  - Secondary Prevention/*methods
MH  - Sublingual Immunotherapy/*methods
MH  - Treatment Outcome
PMC - PMC8480240
OTO - NOTNLM
OT  - MV130
OT  - clinical trial
OT  - mucosal vaccination
OT  - wheezing attacks
EDAT- 2021/03/12 06:00
MHDA- 2021/09/23 06:00
PMCR- 2021/03/30
CRDT- 2021/03/11 20:12
PHST- 2021/03/12 06:00 [pubmed]
PHST- 2021/09/23 06:00 [medline]
PHST- 2021/03/11 20:12 [entrez]
PHST- 2021/03/30 00:00 [pmc-release]
AID - 10.1164/rccm.202003-0520OC [doi]
PST - ppublish
SO  - Am J Respir Crit Care Med. 2021 Aug 15;204(4):462-472. doi: 
      10.1164/rccm.202003-0520OC.