Safety and Immunogenicity of a Live Attenuated Tetravalent Dengue Vaccine Candidate in Flavivirus-Naive Adults: A Randomized, Double-Blinded Phase 1 Clinical Trial

The Journal of Infectious Diseases
Sarah L GeorgeDan T Stinchcomb

Abstract

Dengue viruses (DENVs) infect >300 million people annually, causing 96 million cases of dengue disease and 22 000 deaths [1]. A safe vaccine that protects against DENV disease is a global health priority [2]. We enrolled 72 flavivirus-naive healthy adults in a phase 1 double-blinded, randomized, placebo-controlled dose-escalation trial (low and high dose) of a live attenuated recombinant tetravalent dengue vaccine candidate (TDV) given in 2 doses 90 days apart. Volunteers were followed for safety, vaccine component viremia, and development of neutralizing antibodies to the 4 DENV serotypes. The majority of adverse events were mild, with no vaccine-related serious adverse events. Vaccinees reported injection site pain (52% vs 17%) and erythema (73% vs 25%) more frequently than placebo recipients. Low levels of TDV-serotype 2 (TDV-2), TDV-3, and TDV-4 viremia were observed after the first but not second administration of vaccine. Overall seroconversion rates and geometric mean neutralization titers after 2 doses were 84.2% and 54.1, respectively, for DENV serotype 1 (DENV-1); 92.1% and 292.8, respectively, for DENV-2; 86.8% and 32.3, respectively, for DENV-3; and 71.1% and 15.0, respectively, for DENV-4. More than 90.0% of high-d...Continue Reading

Associated Clinical Trials

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Citations

Oct 31, 2015·Annual Review of Medicine·Bruno GuyNicholas Jackson
Sep 21, 2015·Applied Microbiology and Biotechnology·Vania Aparecida MarezeOscar Bruña-Romero
Nov 21, 2015·Vaccine·Jorge E OsorioDan T Stinchcomb
Mar 15, 2016·Vaccine·Kirsten S VanniceJoachim Hombach
Nov 26, 2015·Nature Reviews. Immunology·Gavin ScreatonCatherine Roberts
Apr 4, 2017·The Lancet Infectious Diseases·Annelies Wilder-Smith
Jun 8, 2017·Expert Review of Vaccines·Bruno GuyNicholas Jackson
Dec 17, 2016·Journal of Immunoassay & Immunochemistry·Justina O TamLee Gehrke
Aug 19, 2017·The American Journal of Tropical Medicine and Hygiene·Elizabeth A DietrichClaire Y-H Huang
Aug 5, 2016·Clinical and Experimental Vaccine Research·Sl-Ki LimIn-Kyu Yoon
Apr 30, 2020·The New England Journal of Medicine·Shibadas BiswalHansi Dean
Aug 26, 2020·Expert Opinion on Drug Discovery·Fakhriedzwan IdrisSylvie Alonso
Jul 25, 2019·Frontiers in Cellular and Infection Microbiology·Megan ChesnutDavid Pamies
Jul 14, 2020·Frontiers in Immunology·Josilene Ramos Pinheiro-MichelsenJaime Henrique Amorim
Aug 6, 2020·Viruses·Harapan HarapanAllison Imrie
Mar 11, 2017·Human Vaccines & Immunotherapeutics·J TorresiM Pellegrini
Jul 19, 2017·The American Journal of Tropical Medicine and Hygiene·Alexander C SchmidtStephen J Thomas
May 26, 2018·The Journal of Infectious Diseases·Jesica A SwanstromRalph S Baric
Dec 16, 2020·The Journal of Infectious Diseases·Eduardo López-MedinaUNKNOWN TIDES study group
Jun 17, 2021·Revista Panamericana De Salud Pública = Pan American Journal of Public Health·Shibadas BiswalAstrid Borkowski
Oct 5, 2021·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Luis RiveraUNKNOWN TIDES study group

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