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

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;...

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Bibliographic Details
Published in:The Journal of infectious diseases 2010-02, Vol.201 (3), p.370-377
Main Authors: Morrison, Dennis, Legg, Thomas J., Billings, Christopher W., Forrat, Remi, Yoksan, Sutee, Lang, Jean
Format: Article
Language:English
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
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Summary: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.
ISSN:0022-1899
1537-6613
DOI:10.1086/649916