3-抗原制剂乙型肝炎疫苗接种 3 剂后在健康成人中观察到高免

StephenW

3-抗原制剂乙型肝炎疫苗接种 3 剂后在健康成人中观察到高免疫原性
杰西卡·奈博士
一项 3 期临床试验发现，乙型肝炎病毒 (HBV) 疫苗的 3-抗原 (3A) 制剂比单抗原 (1A) 制剂更有效。这些发现发表在 JAMA Network Open 上。

这项随机、双盲试验招募了 18 至 45 岁的健康成年人 (N=2838)。 2017 年至 2019 年间，在欧洲和北美 6 个国家的 37 个中心，参与者以 1:1:1:1 的比例随机分配，分别在第 0、28 和 168 天接受 3 剂 1A-HBV 疫苗或3 个连续批次中的 1 个（A、B 和 C）的 3A-HBV 疫苗。评估免疫原性直至第 336 天。

研究人群包括 57.8% 的女性。参与者的平均年龄为 33.5 (SD, 8.0) 岁，91.5% 为白人，中位体重指数为 25.4 (IQR, 13.9-34.9) kg/m2。

对于从所有批次中接受 3A-HBV 疫苗的人来说，抗乙型肝炎表面抗原的几何平均浓度 (GMC) 比率在预先指定的 0.67 到 1.50 范围内（A 对 B：0.82；A 对 C：0.95；B 对 C： 1.16）。

合并的 3A 制剂的血清保护率为 99.3%（95% CI，98.8%-99.6%），而 1A 的血清保护率为 94.8%（95% CI，92.7%-96.4%）。在第 168 天（55.3% 对 16.6%）、196 人（95.8% 对 86.3%）和 336 人（92.7% 对 74.0%）时，达到 ³100 mlU/mL 的抗乙型肝炎表面抗原浓度的个体比例在 3A 受者中更高。

0.5% 的合并 3A 受者和 0.3% 的 1A 受者因不良事件停药。疫苗相关事件包括注射部位疼痛、骨关节炎、头晕和口咽疼痛。 68.0% 的 3A 接受者和 60.1% 的 1A 接受者报告了任何不良事件。接种3A-HBV疫苗后7天发生心源性猝死1例。

这项研究的局限性在于将针对乙型肝炎感染的保护定义为血清保护率。

这些数据表明，3 剂 3A-HBV 疫苗制剂可能对健康成人的乙型肝炎感染具有更强的保护作用。

披露：多位作者声明与行业有联系。有关披露的完整列表，请参阅原始文章。
参考

Vesikari T、Finn A、van Damme P 等。三抗原乙型肝炎疫苗与单抗原乙型肝炎疫苗的免疫原性和安全性。 3期随机临床试验。 JAMA 网络公开赛。 2021;4(10):e2128652。 doi:10.1001/jamanetworkopen.2021.28652

StephenW

High Immunogenicity Observed Among Healthy Adults After 3 Doses of the 3-Antigen Formulation Hepatitis B Vaccine
Jessica Nye, PhD
A phase 3 clinical trial found the 3-antigen (3A) formulation of the hepatitis B virus (HBV) vaccine was more effective than the single-antigen (1A) formulation. These findings were published in JAMA Network Open.

Healthy adults (N=2838) aged 18 to 45 years were recruited for this randomized, double-blind trial. Between 2017 and 2019 at 37 centers in 6 countries across Europe and North America, participants were randomly assigned in a 1:1:1:1 ratio to receive 3 doses on days 0, 28, and 168 of the 1A-HBV vaccine or the 3A-HBV vaccine from 1 of 3 consecutive lots (A, B, and C). Immunogenicity was assessed up to day 336.

The study population consisted of 57.8% women. Participants were aged mean 33.5 (SD, 8.0) years, 91.5% were White, and median body mass index was 25.4 (IQR, 13.9-34.9) kg/m2.

Geometric mean concentration (GMC) ratios of antihepatitis B surface antigens were within the prespecified range of 0.67 to 1.50 for those who received the 3A-HBV vaccine from all lots (A vs B: 0.82; A vs C: 0.95; B vs C: 1.16).

The seroprotection rate of the pooled 3A formulation was 99.3% (95% CI, 98.8%-99.6%) compared with 94.8% (95% CI, 92.7%-96.4%) for 1A. The proportion of individuals achieving antihepatitis B surface antigen concentrations of ³100 mlU/mL was higher among 3A recipients at days 168 (55.3% vs 16.6%), 196 (95.8% vs 86.3%), and 336 (92.7% vs 74.0%).

Vaccine discontinuation for adverse events occurred among 0.5% of the pooled 3A recipients and 0.3% for the 1A recipients. Vaccine-related events included injection site pain, osteoarthritis, dizziness, and oropharyngeal pain. Any adverse events were reported by 68.0% of the 3A and 60.1% of the 1A recipients. There was 1 case of sudden cardiac death 7 days after receiving the 3A-HBV vaccine.

This study was limited by defining protection against hepatitis B infection as the seroprotection rate.

These data indicate that 3 doses of the 3A-HBV vaccine formulation is likely more protective against hepatitis B infection among heathy adults.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Reference

Vesikari T, Finn A, van Damme P, et al. Immunogenicity and safety of a 3-antigen hepatitis B vaccine vs a single-antigen hepatitis B vaccine. a phase 3 randomized clinical trial. JAMA Netw Open. 2021;4(10):e2128652. doi:10.1001/jamanetworkopen.2021.28652