SAFETY AND IMMUNOGENICITY OF CANARYPOX CMV (VCP260) IN HEALTHY ADULTS

金丝雀痘 CMV (VCP260) 对健康成年人的安全性和免疫原性

• 批准号: 6219840
• 负责人: Stuart E Starr
• 金额: $ 0.06万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6219840
• 关键词: Poxviridae; adult human (21+); clinical research; cytomegalovirus; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; humoral immunity; outcomes research; recombinant virus; viral vaccines

Thirty-eight (38) patients were screened for eligibility. Screening was completed on March 31, 1998. Twenty-seven (27) patients have been enrolled and have received all 4 doses of vaccine. Fifteen(15) patients have completed the study. Five (5) patients will have their final visit in April, 1999. Four (4) patients will have their final visit in June, 1999. One (1) patient dropped out after dose #1. One (1) patient was dropped from the study due to a severe local reaction after dose #2. One (1) patient was dropped from the study for not meeting entrance criteria. There have been no serious adverse events related to study vaccine. Preliminary results indicate that the vaccine were immunogenic.

对38例患者进行了资格筛选。放映于1998年3月31日完成。已有27名患者入组并接种了全部4剂疫苗。15名患者已经完成了这项研究。5例患者将于1999年4月进行最后一次复诊。4例患者将于1999年6月进行最后一次复诊。1例患者在第1次用药后退出。1名患者因在第2次剂量后出现严重的局部反应而退出研究。1名患者因不符合入组标准而退出研究。未发生与研究疫苗相关的严重不良事件。初步结果表明，该疫苗具有免疫原性。