Sabchareon Arunee, Lang Jean, Chanthavanich Pornthep, Yoksan Sutee, Forrat Remi, Attanath Phanorsi, Sirivichayakul Chukiate, Pengsaa Krisana, Pojjaroen-Anant Chanathep, Chambonneau Laurent, Saluzzo Jean-Francois, Bhamarapravati Natth
Vaccine Trial Center, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Pediatr Infect Dis J. 2004 Feb;23(2):99-109. doi: 10.1097/01.inf.0000109289.55856.27.
The safety and immunogenicity of tetravalent live-attenuated dengue vaccines after a three dose vaccination series were evaluated in Thai children.
One hundred three healthy flavivirus-seronegative schoolchildren ages 5 to 12 years were randomized to receive either dengue vaccine containing 3, 2, 1 and 2 log10 of the 50% cell culture infective dose, respectively, of the live-attenuated dengue vaccine serotypes 1, 2, 3 and 4 per dose (F3212; n = 40) or 3, 3, 1 and 3 log10 of the 50% cell culture infective dose (F3313; n = 42) or purified Vero cell rabies vaccine (control group; n = 21) given in a two dose schedule (3 to 5 months apart). A third dose was administered 8 to 12 months after the second dose to 90 subjects. Safety and immunogenicity were evaluated within 28 days after each injection.
No serious adverse event related to the vaccines occurred. Most children experienced mild to moderate fever, rash, headache and myalgia occurring within 12 days after Dose 1 and generally lasting 3 days or less. One subject in Group F3212 had a 1-week dengue-like fever. Reactogenicity was minimal after Doses 2 and 3. Transient mild variations in liver enzymes and hematologic indices were noted mainly after Dose 1. After the third dose 89% of the subjects in Group F3212 seroconverted (neutralizing antibody response, > or =10) to all four serotypes, and all children in Group F3313 seroconverted.
This study demonstrates a moderate although improvable reactogenicity and high seroconversion rates against the four serotypes of dengue after a three dose schedule of tetravalent live-attenuated dengue vaccine in children.
在泰国儿童中评估三剂次四价减毒活登革热疫苗接种后的安全性和免疫原性。
103名年龄在5至12岁的健康黄病毒血清阴性学童被随机分为三组，分别接受每剂含有1型、2型、3型和4型减毒活登革热疫苗50%细胞培养感染剂量的对数分别为3、2、1和2（F3212组，n = 40）或3、3、1和3（F3313组，n = 42）的登革热疫苗，或接受两剂次（间隔3至5个月）的纯化Vero细胞狂犬病疫苗（对照组，n = 21）。90名受试者在第二剂后8至12个月接种第三剂。在每次注射后28天内评估安全性和免疫原性。
未发生与疫苗相关的严重不良事件。大多数儿童在第1剂后12天内出现轻至中度发热、皮疹、头痛和肌痛，通常持续3天或更短时间。F3212组有1名受试者出现了为期1周的登革热样发热。第2剂和第3剂后的反应原性极小。主要在第1剂后观察到肝酶和血液学指标的短暂轻度变化。第三剂后，F3212组89%的受试者对所有四种血清型均发生血清转化（中和抗体反应，≥10），F3313组所有儿童均发生血清转化。
本研究表明，在儿童中进行三剂次四价减毒活登革热疫苗接种后，虽然反应原性有待改善，但针对四种登革热血清型的反应原性适中，血清转化率较高。
