title: [Is it ethically acceptable to invite a pregnant woman to enroll in a clinical trial with Tdap if it could entail not being vaccinated with Tdap before delivery?]
abstract: Pertussis incidence has increased in recent years, especially among infants aged <2months. A number of Spanish regions have started a vaccination program with Tdap vaccine to all pregnant women in the third trimester of pregnancy. An observational study has shown that this strategy reduces the number of cases of pertussis by 90% in infants aged <2months. Mathematical models showed that a cocooning strategy (i.e. vaccination of the mother at immediate postpartum, and other adults and adolescents who have close contact with the newborn and caregivers) will reduce the incidence of pertussis by 70% in infants aged <2months. It is intended to conduct a clinical trial in which 340 pregnant women will receive Tdap vaccine, whereas another 340 pregnant woman will be vaccinated soon after delivery. Vaccination with Tdap will be offered to all partners and caregivers of the newborn. After assessing both the ethical and scientific reasons supporting the trial, it is concluded that it is ethically and legally acceptable to invite pregnant women living in communities where Tdap vaccination has been implemented to participate in the trial.
authors.affiliation: Investigación Clínica, Programa BUC (Biociencias UAM+CSIC), Centro de Excelencia Internacional, Universidad Autónoma de Madrid, Madrid, España. Electronic address: Rafael.dalre@fuam.uam.es.
authors.forename: Rafael
authors.initials: R
authors.lastname: Dal-Ré
mesh_terms: D026688:Bioethical Issues; D002986:Clinical Trials as Topic / Q000941:ethics*; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D005260:Female; D006801:Humans; D018579:Patient Selection / Q000941:ethics*; D011247:Pregnancy; D013030:Spain
chemical_list: D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines
keywords: Clinical trial; Cocooning; Doctor-patient relationship; Embarazadas; Ensayo clínico; Estrategia del nido; Ethics; Legal; Legalidad; Pertussis; Pregnant women; Programa de vacunación; Relación médico-enfermo; Tdap; Tos ferina; Vaccination program; dTpa; Ética