Denis Crevat1, Job D Brion, Sophia Gailhardou, Thelma M Laot, Maria Rosario Capeding. 1. From the *Clinical Department, Sanofi Pasteur, Marcy l'Etoile, France; †San Pablo City Health Office, San Pablo, Philippines; ‡Pharmacovigilance Department, Sanofi Pasteur, Lyon, France; §Clinical Department, Sanofi Pasteur, Makati, Philippines; and ¶Research Institute for Tropical Medicine, Muntinlupa City, Philippines.
Abstract
BACKGROUND: Dengue is a major public health concern in pediatric populations in endemic regions. A recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV) is under development for the control of dengue with a 3-dose (0-6-12 month) vaccination schedule. METHODS: In this controlled phase II trial conducted in the Philippines, 210 toddlers aged 12-15 months were randomized to 4 groups: 3 groups received the CYD-TDV vaccination schedule and a measles, mumps and rubella (MMR) vaccine given either concomitantly with the first CYD-TDV dose or 1 month earlier; 1 group received 3 active control vaccines. Safety and reactogenicity were assessed after each dose. Immunogenicity was assessed 30 days after vaccinations using the plaque reduction neutralization test against dengue and enzyme-linked immunosorbent assay methods against MMR antigens. RESULTS:Injection site and systemic reactions occurred at similar rates across CYD-TDV groups, except for fever, which was more frequent after CYD-TDV and MMR coadministration (28.8%) compared with other groups (12-20%). Reactogenicity did not increase with subsequent CYD-TDV injections. There were no safety issues with the study vaccine. CYD-TDV achieved a balanced antibody response to all 4 dengue serotypes across the study groups, with geometric mean titers in the range of 105-124, 147-213, 311-387 and 127-160 for serotypes 1, 2, 3 and 4, respectively. CYD-TDV coadministration did not affect MMR immunogenicity (≥95% seroprotection against MMR) and vice versa. CONCLUSIONS: The CYD-TDV has an acceptable safety and immunogenicity profile in toddlers and when coadministered with MMR.
RCT Entities:
BACKGROUND: Dengue is a major public health concern in pediatric populations in endemic regions. A recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV) is under development for the control of dengue with a 3-dose (0-6-12 month) vaccination schedule. METHODS: In this controlled phase II trial conducted in the Philippines, 210 toddlers aged 12-15 months were randomized to 4 groups: 3 groups received the CYD-TDV vaccination schedule and a measles, mumps and rubella (MMR) vaccine given either concomitantly with the first CYD-TDV dose or 1 month earlier; 1 group received 3 active control vaccines. Safety and reactogenicity were assessed after each dose. Immunogenicity was assessed 30 days after vaccinations using the plaque reduction neutralization test against dengue and enzyme-linked immunosorbent assay methods against MMR antigens. RESULTS: Injection site and systemic reactions occurred at similar rates across CYD-TDV groups, except for fever, which was more frequent after CYD-TDV and MMR coadministration (28.8%) compared with other groups (12-20%). Reactogenicity did not increase with subsequent CYD-TDV injections. There were no safety issues with the study vaccine. CYD-TDV achieved a balanced antibody response to all 4 dengue serotypes across the study groups, with geometric mean titers in the range of 105-124, 147-213, 311-387 and 127-160 for serotypes 1, 2, 3 and 4, respectively. CYD-TDV coadministration did not affect MMR immunogenicity (≥95% seroprotection against MMR) and vice versa. CONCLUSIONS: The CYD-TDV has an acceptable safety and immunogenicity profile in toddlers and when coadministered with MMR.
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