FLU-v, developed by PepTcell (SEEK), is a peptide vaccine aiming to provide a broadly protective cellular immune response against influenza A and B. A randomized, double-blind, placebo-controlled, single-center, phase IIb efficacy and safety trial was conducted. One hundred and fifty-three healthy individuals 18–55 years of age were randomized to receive one or two doses of adjuvanted FLU-v or adjuvanted placebo subcutaneously on days −43 and −22, prior to intranasal challenge on day 0 with the A/California/04/2009/H1N1 human influenza A challenge virus. The primary objective of the study was to identify a reduction in mild to moderate influenza disease (MMID) defined as the presence of viral shedding and clinical influenza symptoms. Single-dose adjuvanted FLU-v recipients (n = 40) were significantly less likely to develop MMID after challenge vs placebo (n = 42) (32.5% vs 54.8% p = 0.035). FLU-v should continue to be evaluated and cellular immunity explored further as a possible important correlate of protection against influenza.

FLU-v 由 PepTcell (SEEK) 开发，是一种肽疫苗，旨在针对甲型和乙型流感提供广泛的保护性细胞免疫反应。随机、双盲、安慰剂对照、单中心、IIb 期疗效和安全性进行了审判。 153 名 18-55 岁的健康个体被随机分组​​，在第 0 天用 A/ 进行鼻内攻击之前，在第 -43 和 -22 天皮下接受一剂或两剂含佐剂的 FLU-v 或含佐剂的安慰剂。加利福尼亚州/04/2009/H1N1 人类甲型流感攻击病毒。该研究的主要目的是确定轻度至中度流感疾病（MMID）的减少，MMID（MMID）定义为病毒脱落和临床流感症状的存在。与安慰剂组 ( n = 42) 相比，单剂辅助 FLU-v 接受者 ( n = 40) 在攻击后发生 MMID 的可能性显着降低 (32.5% vs 54.8% p = 0.035)。应继续评估 FLU-v 并进一步探索细胞免疫作为预防流感的可能重要相关因素。