Valera Rodrigo, García Hilda María, Jidy Manuel Díaz, Mirabal Mayelin, Armesto Marlene Isabel, Fando Rafael, García Luis, Fernández Roberto, Año Gemma, Cedré Bárbara, Ramírez Margarita, Bravo Laura, Serrano Teresita, Palma Sara, González Daniel, Miralles Fernando, Medina Vilma, Nuñez Felicita, Plasencia Yilian, Martínez Juan Carlos, Mandarioti Aleyda, Lugones Juan, Rodríguez Boris Luis, Moreno Arlenis, González Domingo, Baro Morelia, Solis Rosa Lidia, Sierra Gustavo, Barbera Ramón, Domínguez Francisco, Gutiérrez Carlos, Kouri Gustavo, Campa Concepción, Menéndez Jorge
Instituto Finlay, Centro de Investigación, Desarrollo y Producción de Vacunas, P.O. Box 16017, La Lisa, Ciudad de La Habana 11600, Cuba.
Vaccine. 2009 Nov 5;27(47):6564-9. doi: 10.1016/j.vaccine.2009.08.042. Epub 2009 Aug 29.
A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the safety, reactogenicity and the immunogenicity of a 2 x 10(9)CFU dose of the 638 lyophilized live attenuated cholera vaccine for oral administration, formulated and produced at Finlay Institute, City of Havana, Cuba. Thirty-six healthy female and male adult volunteers from 18 to 40 years old were involved, clinically examined and laboratory tested after the informed consent signature. Adverse events were monitored and seroconversion rates and geometrical mean titer (GMT) of vibriocidal antibodies were tested in volunteer's sera samples. Neither serious adverse events nor other damages to the volunteers due to vaccine or placebo feeding were reported during the clinical follow-up period of this study; none of the adverse events registered within the first 72 h after inoculation were life-threatening for volunteers. Neither severe nor moderate adverse events were reported. Sixty-one percent of subjects showed mild expected adverse events in an interval lower than 24h up to the first 72 h, 75% of these in the vaccinated group and 18% in the placebo group. Fourteen days after inoculation the GMT of vibriocidal antibodies in the vaccine group significantly increased in comparison to the placebo group. All subjects in the vaccine group (24) seroconverted (100%). Results show that this vaccine is safe, well tolerated and immunogenic in healthy female and male volunteers.
开展了一项随机、双盲、安慰剂对照临床试验，以评估古巴哈瓦那市芬莱研究所配制和生产的2×10⁹CFU剂量口服638冻干活霍乱疫苗的安全性、反应原性和免疫原性。研究纳入了36名年龄在18至40岁之间的健康成年男女志愿者，在他们签署知情同意书后进行了临床检查和实验室检测。对不良事件进行了监测，并检测了志愿者血清样本中的杀弧菌抗体的血清转化率和几何平均滴度（GMT）。在本研究的临床随访期间，未报告因疫苗或安慰剂接种导致的严重不良事件或对志愿者的其他损害；接种后最初72小时内记录的不良事件均未对志愿者构成生命威胁。未报告严重或中度不良事件。61%的受试者在接种后最初72小时内低于24小时的时间段内出现了轻度预期不良事件，其中75%出现在疫苗接种组，18%出现在安慰剂组。接种后14天，疫苗组的杀弧菌抗体GMT与安慰剂组相比显著升高。疫苗组的所有受试者（24人）均发生了血清转化（100%）。结果表明，该疫苗在健康成年男女志愿者中是安全的、耐受性良好且具有免疫原性。
