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
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. 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. 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. 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. Clinical Trials Registration. NCT01072786. and NCT01436422.
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Publikováno v
- The Journal of infectious diseases
Ročník 212; číslo 5; s. 702 - 710
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Hlavní autoři
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Kirkpatrick, Beth D.,
Durbin, Anna P.,
Pierce, Kristen K.,
Carmolli, Marya P.,
Tibery, Cecilia M.,
Grier, Palmtama L.,
Hynes, Noreen,
Diehl, Sean A.,
Elwood, Dan,
Jarvis, Adrienne P.,
Sabundayo, Beulah P.,
Lyon, Caroline E.,
Larsson, Catherine J.,
Jo, Matthew,
Lovchik, Janece M.,
Luke, Catherine J.,
Walsh, Mary,
Fraser, Ellen A.,
Subbarao, Kanta,
Whitehead, Steven S.
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Typ dokumentu
- Journal Article
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Jazyk
- English
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Vydáno
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United States
Oxford University Press
01. 09. 2015
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Edice
- Editor's choice
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Témata
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Bibliografie
- ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ObjectType-Undefined-3
B. D. K. and A. P. D. are co–first authors.
Presented in part: 62nd Annual Meeting of the American Society of Tropical Medicine and Hygiene, Washington, D.C., November 2013.
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ISSN
- 0022-1899
1537-6613
1537-6613
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DOI
- 10.1093/infdis/jiv082
