A Novel Tetravalent Dengue Vaccine Is Well Tolerated and Immunogenic against All 4 Serotypes in Flavivirus-Naive Adults

• Published in: The Journal of infectious diseases Vol. 201; no. 3; pp. 370 - 377
• Main Authors: Morrison, Dennis, Legg, Thomas J., Billings, Christopher W., Forrat, Remi, Yoksan, Sutee, Lang, Jean
• Format: Journal Article
• Language: English
• Published: Oxford The University of Chicago Press 01.02.2010; University of Chicago Press; Oxford University Press
• Subjects: Adult; Antibodies, Viral - blood; Applied microbiology; Arboviroses; Arbovirus; Biological and medical sciences; Dengue; Dengue - immunology; Dengue - prevention & control; Dengue - virology; Dengue fevers; Dengue vaccines; Dengue Vaccines - administration & dosage; Dengue Vaccines - adverse effects; Dengue Vaccines - immunology; Dengue virus; Dengue Virus - classification; Dengue Virus - immunology; Dosage; Drug Administration Schedule; Female; Fundamental and applied biological sciences. Psychology; Human viral diseases; Humans; Immune response; Infectious diseases; Injections; Male; Medical sciences; Microbiology; Middle Aged; Miscellaneous; Placebos; Serotyping; Tropical viral diseases; Vaccination; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Viral diseases; Viremia; Virology; VIRUSES; Yellow fever; Young Adult; Virus; Infection; Immunogenicity; Viral disease; Dengue; Arbovirus disease; Vaccine; Serotype; Flaviviridae; Flavivirus
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1086/649916

Background. Sanofi Pasteur has developed a tetravalent dengue vaccine (TDV) against the world's most common arbovirus infection. Methods. We assessed the safety and immunogenicity of the TDV in healthy adults randomized into 2 groups. Group 1 received 3 TDV injections at months 0, 4, and 12–15; group 2 received saline placebo at month 0 and then 2 TDV injections at months 4 and 12–15. Adverse events were recorded, and biological parameters and viremia levels were measured. Neutralizing antibodies against 4 World Health Organization (WHO) reference strains were measured before and after vaccinations. Results. A total of 33 participants were enrolled in each group. Demographic characteristics were comparable. No vaccine-related serious adverse event was reported. The most common systemic reactions were headache, malaise, and myalgia. Low viremia levels were detected, mainly of serotype 4. Immune response increased with successive vaccine doses. All participants seroconverted against all 4 serotypes after receiving 3 doses at 0, 4, and 12–15-months, and almost all seroconverted after 2 doses given 8–11 months apart. Conclusions. Sanofi Pasteur's TDV was well tolerated and induced full seroconversion against all WHO reference strain serotypes after 3 doses.