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Robust and Balanced Immune Responses to All 4 Dengue Virus Serotypes Following Administration of a Single Dose of a Live Attenuated Tetravalent Dengue Vaccine to Healthy, Flavivirus-Naive Adults.
- Source :
-
The Journal of infectious diseases [J Infect Dis] 2015 Sep 01; Vol. 212 (5), pp. 702-10. Date of Electronic Publication: 2015 Mar 22. - Publication Year :
- 2015
-
Abstract
- Background: The 4 serotypes of dengue virus, DENV-1-4, are the leading cause of arboviral disease globally. The ideal dengue vaccine would provide protection against all serotypes after a single dose.<br />Methods: Two randomized, placebo-controlled trials were performed with 168 flavivirus-naive adults to demonstrate the safety and immunogenicity of a live attenuated tetravalent dengue vaccine (TV003), compared with those of a second tetravalent vaccine with an enhanced DENV-2 component (TV005), and to evaluate the benefit of a booster dose at 6 months. Safety data, viremia, and neutralizing antibody titers were evaluated.<br />Results: A single dose of TV005 elicited a tetravalent response in 90% of vaccinees by 3 months after vaccination and a trivalent response in 98%. Compared with TV003, the higher-dose DENV-2 component increased the observed frequency of immunogenicity to DENV-2 in the TV005 trial. Both the first and second doses were well tolerated. Neither vaccine viremia, rash, nor a significant antibody boost were observed following a second dose.<br />Conclusions: A single subcutaneous dose of TV005 dengue vaccine is safe and induces a tetravalent antibody response at an unprecedented frequency among vaccinees. A second dose has limited benefit and appears to be unnecessary. Studies to confirm these findings and assess vaccine efficacy will now move to populations in regions where DENV transmission is endemic.<br />Clinical Trials Registration: NCT01072786 and NCT01436422.<br /> (© The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)
- Subjects :
- Adolescent
Adult
Antibodies, Neutralizing blood
Antibodies, Viral blood
Dengue Vaccines administration & dosage
Dengue Vaccines adverse effects
Drug-Related Side Effects and Adverse Reactions
Female
Healthy Volunteers
Humans
Injections, Subcutaneous
Male
Middle Aged
Placebos administration & dosage
Vaccines, Attenuated administration & dosage
Vaccines, Attenuated adverse effects
Vaccines, Attenuated immunology
Viremia
Young Adult
Dengue Vaccines immunology
Dengue Virus immunology
Vaccination methods
Subjects
Details
- Language :
- English
- ISSN :
- 1537-6613
- Volume :
- 212
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- The Journal of infectious diseases
- Publication Type :
- Academic Journal
- Accession number :
- 25801652
- Full Text :
- https://doi.org/10.1093/infdis/jiv082