BACKGROUND: Phase II and III clinical studies were conducted to evaluate immunogenicity and safety of a novel DTaP-IPV vaccine consisting of Sabin inactivated poliovirus vaccine (sIPV) and diphtheria-tetanus-acellular pertussis vaccine (DTaP). METHODS: A Phase II study was conducted in 104 healthy infants using Formulation H of the DTaP-sIPV vaccine containing high-dose sIPV (3, 100, and 100 D-antigen units for types 1, 2, and 3, respectively), and Formulations M and L, containing half and one-fourth of the sIPV in Formulation H, respectively. Each formulation was administered 3 times for primary immunization and once for booster immunization. A Phase III study was conducted in 342 healthy infants who received eitherFormulation M + oral polio vaccine (OPV) placebo or DTaP + OPV. The OPV or OPV placebo was orally administered twice between primary and booster immunizations. RESULTS: Formulation M was selected as the optimum dose. In the Phase III study, the seropositive rate was 100% for all Sabin strains after primary immunization, and the neutralizing antibody titer after booster immunization was higher than in the control group (DTaP + OPV). All adverse reactions were clinically acceptable. CONCLUSIONS: DTaP-sIPV was shown to be a safe and immunogenic vaccine. CLINICAL TRIALS REGISTRATION: JapicCTI-121902 for Phase II study, JapicCTI-101075 for Phase III study (http://www.clinicaltrials.jp/user/cte_main.jsp).
RCT Entities:
BACKGROUND: Phase II and III clinical studies were conducted to evaluate immunogenicity and safety of a novel DTaP-IPV vaccine consisting of Sabin inactivated poliovirus vaccine (sIPV) and diphtheria-tetanus-acellular pertussis vaccine (DTaP). METHODS: A Phase II study was conducted in 104 healthy infants using Formulation H of the DTaP-sIPV vaccine containing high-dose sIPV (3, 100, and 100 D-antigen units for types 1, 2, and 3, respectively), and Formulations M and L, containing half and one-fourth of the sIPV in Formulation H, respectively. Each formulation was administered 3 times for primary immunization and once for booster immunization. A Phase III study was conducted in 342 healthy infants who received either Formulation M + oral polio vaccine (OPV) placebo or DTaP + OPV. The OPV or OPV placebo was orally administered twice between primary and booster immunizations. RESULTS: Formulation M was selected as the optimum dose. In the Phase III study, the seropositive rate was 100% for all Sabin strains after primary immunization, and the neutralizing antibody titer after booster immunization was higher than in the control group (DTaP + OPV). All adverse reactions were clinically acceptable. CONCLUSIONS:DTaP-sIPV was shown to be a safe and immunogenic vaccine. CLINICAL TRIALS REGISTRATION: JapicCTI-121902 for Phase II study, JapicCTI-101075 for Phase III study (http://www.clinicaltrials.jp/user/cte_main.jsp).
Authors: Yoshiyuki Tanaka; Ruriko Yokokawa; Han Shi Rong; Hiroyuki Kishino; Jon E Stek; Margaret Nelson; Jody Lawrence Journal: Hum Vaccin Immunother Date: 2017-01-31 Impact factor: 3.452
Authors: Viki Bockstal; Machteld M Tiemessen; Rogier Achterberg; Carlo Van Wordragen; Ad M Knaapen; Jan Serroyen; Wilfred E Marissen; Hanneke Schuitemaker; Roland Zahn Journal: Vaccine Date: 2018-10-09 Impact factor: 3.641
Authors: Barbara P Sanders; Isabel de Los Rios Oakes; Vladimir van Hoek; Viki Bockstal; Tobias Kamphuis; Taco G Uil; Yutong Song; Gillian Cooper; Laura E Crawt; Javier Martín; Roland Zahn; John Lewis; Eckard Wimmer; Jerome H H V Custers; Hanneke Schuitemaker; Jeronimo Cello; Diana Edo-Matas Journal: PLoS Pathog Date: 2016-03-31 Impact factor: 6.823