Antonio Nieto1, Angel Mazón2, María Nieto3, Rafael Calderón4, Susana Calaforra5, Blanca Selva5, Sonia Uixera6, Maria José Palao7, Paola Brandi8, Laura Conejero9, Paula Saz-Leal9, Cristina Fernández-Pérez10, David Sancho8, José Luis Subiza9, Miguel Casanovas9. 1. La Fe University and Polytechnic Hospital, 16273, Unit of Pediatric Allergy and Pneumology., Valencia, Spain; antonio.nieto@me.com. 2. La Fe University and Polytechnic Hospital, 16273, Pediatric Allergy Unit, Valencia, Spain. 3. La Fe University and Polytechnic Hospital, 16273, Unit of Pediatrci Allergy and Pneumology, Valencia, Spain. 4. Hospital de Manises, 200131, Department of pediatrics, Manises, Spain. 5. La Fe University and Polytechnic Hospital, 16273, Unit of Pediatric Allergy and Pneumology, Valencia, Spain. 6. La Fe University and Polytechnic Hospital, 16273, Unit of Pediatric Allergy and Pneumology., Valencia, Spain. 7. Hospital de Manises, 200131, Department of Pediatrics, Manises, Spain. 8. Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III, 38799, Madrid, Spain. 9. Inmunotek SL, 511986, Alcala de Henares, Spain. 10. Complutense University of Madrid, 16734, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos, Madrid, Spain.
Abstract
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 a 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 positive skin test to common aeroallergens in the area where the clinical trial was carried out were excluded from the trial. Subjects received MV130 or placebo daily for 6 months. The primary endpoint was the number of WA within one year after the first dose comparing MV130 and placebo. MEASUREMENTS AND MAIN RESULTS: There was a significant lower number of WA in MV130 vs placebo group, 3.0 [IQR, 2.0 - 4.0] vs 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 MV130 vs 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 registration available at www.clinicaltrials.gov, ID: NCT01734811.
RCT Entities:
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 a 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 positive skin test to common aeroallergens in the area where the clinical trial was carried out were excluded from the trial. Subjects received MV130 or placebo daily for 6 months. The primary endpoint was the number of WA within one year after the first dose comparing MV130 and placebo. MEASUREMENTS AND MAIN RESULTS: There was a significant lower number of WA in MV130 vs placebo group, 3.0 [IQR, 2.0 - 4.0] vs 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 MV130 vs 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 registration available at www.clinicaltrials.gov, ID: NCT01734811.
Authors: Matt S Zinter; A Birgitta Versluys; Caroline A Lindemans; Madeline Y Mayday; Gustavo Reyes; Sara Sunshine; Marilynn Chan; Elizabeth K Fiorino; Maria Cancio; Sabine Prevaes; Marina Sirota; Michael A Matthay; Sandhya Kharbanda; Christopher C Dvorak; Jaap J Boelens; Joseph L DeRisi Journal: Sci Transl Med Date: 2022-03-09 Impact factor: 19.319
Authors: Paola Brandi; Laura Conejero; Francisco J Cueto; Sarai Martínez-Cano; Gillian Dunphy; Manuel J Gómez; Carlos Relaño; Paula Saz-Leal; Michel Enamorado; Ana Quintas; Ana Dopazo; Joaquín Amores-Iniesta; Carlos Del Fresno; Estanislao Nistal-Villán; Carlos Ardavín; Antonio Nieto; Miguel Casanovas; José Luis Subiza; David Sancho Journal: Cell Rep Date: 2022-01-04 Impact factor: 9.995
Authors: Silvia Sánchez-Ramón; Lidia Fernández-Paredes; Paula Saz-Leal; Carmen M Diez-Rivero; Juliana Ochoa-Grullón; Concepción Morado; Pilar Macarrón; Cristina Martínez; Virginia Villaverde; Antonia Rodríguez de la Peña; Laura Conejero; Keyla Hernández-Llano; Gustavo Cordero; Miguel Fernández-Arquero; Benjamin Fernández- Gutierrez; Gloria Candelas Journal: Front Immunol Date: 2021-06-04 Impact factor: 7.561