Hospital Clinic-IDIBAPS, Barcelona, Spain.
Vaccine. 2011 Oct 26;29(46):8309-16. doi: 10.1016/j.vaccine.2011.08.098. Epub 2011 Sep 9.
To investigate the safety and immunogenicity of a modified vaccinia virus Ankara vector expressing HIV-1 antigens from clade B (MVA-B), a phase-I, doubled-blind placebo-controlled trial was performed.
30 HIV-uninfected volunteers at low risk of HIV-1 infection were randomly allocated to receive 3 intramuscular injections (1×10(8)pfu/dose) of MVA-B (n=24) or placebo (n=6) at weeks 0, 4 and 16. All volunteers were followed 48 weeks. Primary end-points were adverse events and immunogenicity.
A total of 169 adverse events were reported, 164 of grade 1-2, and 5 of grade 3 (none related to vaccination). Overall 75% of the volunteers showed positive ELISPOT responses at any time point. The magnitude (median) of the total responses induced was 288SFC/10(6)PBMC at week 18. Antibody responses against Env were observed in 95% and 72% of vaccinees at week 18 and 48, respectively. HIV-1 neutralizing antibodies were detected in 33% of volunteers.
MVA-B was safe, well tolerated and elicited strong and durable T-cell and antibody responses in 75% and 95% of volunteers, respectively. These data support further exploration of MVA-B as an HIV-1 vaccine candidate. Clinical Trials.gov identifier: NCT00679497.
为了研究表达 HIV-1 抗原的改良安卡拉牛痘病毒（MVA-B）的安全性和免疫原性，进行了一项 I 期、双盲、安慰剂对照试验。
30 名 HIV 未感染、感染 HIV-1 风险低的志愿者被随机分配接受 3 次肌肉注射（1×10(8)pfu/剂量）MVA-B（n=24）或安慰剂（n=6），分别在 0、4 和 16 周。所有志愿者随访 48 周。主要终点为不良事件和免疫原性。
共报告了 169 例不良事件，其中 164 例为 1-2 级，5 例为 3 级（均与疫苗接种无关）。总体而言，75%的志愿者在任何时间点均出现阳性 ELISPOT 反应。18 周时总反应的幅度（中位数）为 288SFC/10(6)PBMC。18 周和 48 周时，分别有 95%和 72%的疫苗接种者出现针对 Env 的抗体反应。33%的志愿者检测到 HIV-1 中和抗体。
MVA-B 安全、耐受良好，分别在 75%和 95%的志愿者中诱导出强烈和持久的 T 细胞和抗体反应。这些数据支持进一步探索 MVA-B 作为 HIV-1 疫苗候选物。临床试验注册号：NCT00679497。
