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Safety and Immunogenicity of a Dengue Virus Serotype-1 Purified-Inactivated Vaccine: Results of a Phase 1 Clinical Trial.
- Source :
-
The American journal of tropical medicine and hygiene [Am J Trop Med Hyg] 2015 Sep; Vol. 93 (3), pp. 454-460. Date of Electronic Publication: 2015 Jul 06. - Publication Year :
- 2015
-
Abstract
- We describe the results from a human clinical trial of a dengue virus serotype-1, purified-inactivated vaccine (DENV-1 PIV) adjuvanted with aluminum hydroxide. This first-in-man, Phase 1, open-label clinical trial consisted of two groups of flavivirus-naïve healthy adult volunteers that received two intramuscular vaccine doses of either 2.5 μg or 5 μg of DENV-1 PIV administered on days 0 and 28. Following vaccination, both vaccine doses exhibited an acceptable safety profile with minimal injection site and systemic reactions. By study day 42, 2 weeks following the second vaccine dose, all volunteers in both vaccine groups developed serum-neutralizing antibodies against DENV-1. Additional testing using an enzyme-linked immunosorbent assay demonstrated induction of a humoral immune response following both vaccine doses. The DENV-1 PIV was safe and immunogenic in a small number of volunteers supporting development and further testing of a tetravalent DENV PIV formulation.<br /> (© The American Society of Tropical Medicine and Hygiene.)
- Subjects :
- Adolescent
Adult
Antibodies, Neutralizing immunology
Antibodies, Viral immunology
Dengue Vaccines administration & dosage
Dengue Vaccines adverse effects
Dengue Vaccines immunology
Dengue Virus immunology
Enzyme-Linked Immunosorbent Assay
Female
Humans
Immunoglobulin G immunology
Immunoglobulin M immunology
Male
Middle Aged
Vaccines, Inactivated adverse effects
Vaccines, Inactivated immunology
Vaccines, Inactivated therapeutic use
Young Adult
Dengue Vaccines therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1476-1645
- Volume :
- 93
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- The American journal of tropical medicine and hygiene
- Publication Type :
- Academic Journal
- Accession number :
- 26149862
- Full Text :
- https://doi.org/10.4269/ajtmh.14-0819