佐剂重组带状疱疹疫苗的免疫原性：初次接种 10 年后再次接种的持久性和回忆应答。

BACKGROUND

The adjuvanted recombinant zoster vaccine (RZV) is highly immunogenic and efficacious in adults ≥50 years of age. We evaluated (1) long-term immunogenicity of an initial 2-dose RZV schedule, by following up adults vaccinated at ≥60 years of age and by modeling, and (2) immunogenicity of 2 additional doses administered 10 years after initial vaccination.

METHODS

Persistence of humoral and cell-mediated immune (CMI) responses to 2 initial RZV doses was assessed through 10 years after initial vaccination, and modeled through 20 years using a Piecewise, Power law and Fraser model. The immunogenicity and safety of 2 additional RZV doses were also evaluated.

RESULTS

Seventy adults were enrolled. Ten years after initial vaccination, humoral and CMI responses were approximately 6-fold and 3.5-fold, respectively, above those before the initial vaccination levels. Predicted immune persistence through 20 years after initial vaccination was similar across the 3 models. Sixty-two participants (mean age [standard deviation], 82.6 [4.4] years) received ≥1 additional RZV dose. Strong anamnestic humoral and CMI responses were elicited by 1 additional dose, without further increases after a second additional dose.

CONCLUSIONS

Immune responses to an initial 2-dose RZV course persisted for many years in older adults. Strong anamnestic immune responses can be induced by additional dosing 10 years after the initial 2-dose course.

CLINICAL TRIALS REGISTRATION

NCT02735915.

背景

佐剂重组带状疱疹疫苗（RZV）在≥50 岁的成年人中具有高度的免疫原性和疗效。我们评估了（1）通过随访≥60 岁接种疫苗的成年人和建模，评估初始 2 剂 RZV 方案的长期免疫原性，以及（2）初始接种 10 年后接种 2 剂的免疫原性。

方法

通过 10 年的随访，评估初始 2 剂 RZV 接种后 10 年体液和细胞介导免疫（CMI）应答的持久性，并通过分段、幂律和弗雷泽模型预测至 20 年的免疫持久性。还评估了 2 剂额外 RZV 接种的免疫原性和安全性。

结果

共纳入 70 名成年人。初始接种后 10 年，体液和 CMI 应答分别比初始接种前水平高约 6 倍和 3.5 倍。3 种模型预测的初始接种后 20 年的免疫持久性相似。62 名参与者（平均年龄[标准差]，82.6[4.4]岁）接受了≥1 剂额外的 RZV 接种。1 剂额外接种可引起强烈的回忆性体液和 CMI 应答，第 2 剂额外接种后无进一步增加。