TY - JOUR T1 - Live attenuated chimeric yellow fever dengue type 2 (ChimeriVax-DEN2) vaccine: Phase I clinical trial for safety and immunogenicity: effect of yellow fever pre-immunity in induction of cross neutralizing antibody responses to all 4 dengue serotypes. AU - Guirakhoo,Farshad, AU - Kitchener,Scott, AU - Morrison,Dennis, AU - Forrat,Remi, AU - McCarthy,Karen, AU - Nichols,Richard, AU - Yoksan,Sutee, AU - Duan,Xiaochu, AU - Ermak,Thomas H, AU - Kanesa-Thasan,Niranjan, AU - Bedford,Philip, AU - Lang,Jean, AU - Quentin-Millet,Marie-Jose, AU - Monath,Thomas P, Y1 - 2006/03/15/ PY - 2006/10/3/pubmed PY - 2006/10/31/medline PY - 2006/10/3/entrez SP - 60 EP - 7 JF - Human vaccines JO - Hum Vaccin VL - 2 IS - 2 N2 - A randomized double-blind Phase I Trial was conducted to evaluate safety, tolerability, and immunogenicity of a yellow fever (YF)-dengue 2 (DEN2) chimera (ChimeriVax-DEN2) in comparison to that of YF vaccine (YF-VAX). Forty-two healthy YF naïve adults randomly received a single dose of either ChimeriVax-DEN2 (high dose, 5 log plaque forming units [PFU] or low dose, 3 log PFU) or YF-VAX by the subcutaneous route (SC). To determine the effect of YF preimmunity on the ChimeriVax-DEN2 vaccine, 14 subjects previously vaccinated against YF received a high dose of ChimeriVax-DEN2 as an open-label vaccine. Most adverse events were similar to YF-VAX and of mild to moderate intensity, with no serious side-effects. One hundred percent and 92.3% of YF naïve subjects inoculated with 5.0 and 3.0 log10 PFU of ChimeriVax-DEN2, respectively, seroconverted to wt DEN2 (strain 16681); 92% of subjects inoculated with YF-VAX seroconverted to YF 17D virus but none of YF naïve subjects inoculated with ChimeriVax-DEN2 seroconverted to YF 17D virus. Low seroconversion rates to heterologous DEN serotypes 1, 3 and 4 were observed in YF naïve subjects inoculated with either ChimeriVax-DEN2 or YF-VAX. In contrast, 100% of YF immune subjects inoculated with ChimeriVax-DEN2 seroconverted to all 4 DEN serotypes. Surprisingly, levels of neutralizing antibodies to DEN 1, 2 and 3 viruses in YF immune subjects persisted after 1 year. These data demonstrated that (1) the safety and immunogenicity profile of the ChimeriVax-DEN2 vaccine is consistent with that of YF-VAX, and (2) preimmunity to YF virus does not interfere with ChimeriVax-DEN2 immunization, but induces a long lasting and cross neutralizing antibody response to all 4 DEN serotypes. The latter observation can have practical implications toward development of a dengue vaccine. SN - 1554-8600 UR - https://www.unboundmedicine.com/medline/citation/17012873/Live_attenuated_chimeric_yellow_fever_dengue_type_2__ChimeriVax_DEN2__vaccine:_Phase_I_clinical_trial_for_safety_and_immunogenicity:_effect_of_yellow_fever_pre_immunity_in_induction_of_cross_neutralizing_antibody_responses_to_all_4_dengue_serotypes_ L2 - http://www.diseaseinfosearch.org/result/2187 DB - PRIME DP - Unbound Medicine ER -