Estratégias de campo em ensaios clínicos com novas vacinas produzidas no Brasil

Abstract

Objective: To report field strategies applied to clinical trials with vaccines developed by Instituto Butantan in Campinas, Brazil, in 2004 and 2006. Methods: This report describes the planning and the operational issues of two clinical trials conducted to evaluate immunogenicity and safety of recombinant Hepatitis B vaccine combined with BCG vaccine (BCG/VrHB-IB) and quadrivalent diphteria-tetanus-Haemophilus influenzae type b-cellular pertussis vaccine with low lipopolysaccharide (DTPm/Hib). Results: The main field strategies applied were: a) Partnership between the researchers and managers from Municipal Health Department and b) Research procedures at home or in Health Centers attended by participants. In the first study, BCG vaccine and VrHB-IB (combined or separated) were given to 552 newborns in the maternity, followed by two subsequent doses of VrHB-IB vaccine in households. The second study included 241 infants at Health Centers, which were vaccinated with DTPm/Hib vaccines concomitantly to the others recommended by the National Immunization Program. In both studies, blood samples were taken at home. No adverse events occurred during the experimental period. The field strategies used in those clinical trials allowed adherence by 90.2 and 93.8% of the participants of the first and second study, respectively. The vaccines were given according to the recommendation of National Immunization Program and blood samples were obtained according to the protocol schedules. Conclusions: The field strategies were important to guarantee enrollment and protocol compliance, causing little interference in families' daily routine, pediatrics appointments and children's vaccine.