Merck Research Laboratories , West Point, Pennsylvania.
Office of the Chief Medical Officer, Merck , Upper Gwynedd, Pennsylvania.
Open Forum Infect Dis. 2014 May 17;1(1):ofu016. doi: 10.1093/ofid/ofu016. eCollection 2014 Mar.
The immunogenicity results from 3 phase I trials of the Merck DNA human immunodeficiency virus (HIV) vaccine have previously been reported. Because preventive DNA vaccine strategies continue to be leveraged for diverse infections, the safety and tolerability results from these studies can inform the field moving forward, particularly regarding adverse reactions and adjuvants. No serious vaccine-related adverse events were reported during the 3-dose priming phase. Pain at the injection site was more common with adjuvanted formulations than with the phosphate-buffered saline diluent alone. Febrile reactions were usually low grade. Although the AlPO4 or CRL1005 adjuvants used in these studies did not significantly enhance the immunogenicity of the DNA vaccine, adverse events were numerically more common with adjuvanted formulations than without adjuvants.
此前已经报道了默克公司 DNA 人类免疫缺陷病毒（HIV）疫苗的 3 期 I 期临床试验的免疫原性结果。由于预防性 DNA 疫苗策略继续被用于多种感染，因此这些研究的安全性和耐受性结果可以为未来的研究提供信息，特别是关于不良反应和佐剂。在 3 剂初免阶段没有报告严重的疫苗相关不良事件。与单独使用磷酸盐缓冲盐水稀释剂相比，佐剂制剂更常见注射部位疼痛。发热反应通常为低度。虽然这些研究中使用的 AlPO4 或 CRL1005 佐剂并未显著增强 DNA 疫苗的免疫原性，但与无佐剂制剂相比，佐剂制剂的不良事件更为常见。
