皮内接种流感病毒疫苗在 18-64 岁健康成年人中安全且具有免疫原性。
Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18-64 years of age.
机构信息
Saint Louis University School of Medicine, 1100 South Grand Blvd. (DRC-8th floor), St. Louis, MO 63104, USA.
出版信息
Vaccine. 2013 May 1;31(19):2358-65. doi: 10.1016/j.vaccine.2013.03.008. Epub 2013 Mar 13.
BACKGROUND
To increase vaccine acceptance, intradermal (ID) influenza vaccine (Fluzone(®) Intradermal, Sanofi Pasteur Inc.) may be an attractive alternative to intramuscular (IM) vaccination due to smaller needle and volume injected.
METHODS
A multicenter, randomized (2:1 ID vs IM vaccines) study, blinded for ID vaccine lots, was conducted among 4292 adults 18-64 years of age enrolled in October 2008. Three lots of investigational trivalent influenza vaccine containing 9μg hemagglutinin (HA) per strain in 0.1mL administered ID with a 30 gauge, 1.5mm long needle were compared to standard dose vaccine (0.5mL containing 15μg HA/strain) given IM.
RESULTS
The post-vaccination antibody geometric mean titers (GMT) for the ID vaccine were similar to the IM vaccine (H1N1: 193.2 vs. 178.3, H3N2: 246.7 vs. 230.7, and B: 102.5 vs. 126.9). Non-inferiority was met for the ID vaccine compared to IM vaccine as assessed by antibody GMT ratios (IM/ID) for all three virus strains (H1N1: 0.92, H3N2: 0.94, and B: 1.24). Seroconversion rates were non-inferior for H1N1 and H3N2, but not for B (ID vs. IM: H1N1: 61.2% vs. 60.5%, H3N2: 75.3% vs. 74.8%, and B: 46.2% vs. 54.2%). Seroprotection (HAI titer ≥1:40) rates were similar between groups (ID vs. IM, H1N1: 91.1% vs. 91.7%, H3N2: 90.7% vs. 91.4%, and B: 87.4% vs. 89.3%). Local injection site reactions overall were more common with ID than IM vaccine (ID vs. IM: 89.2% vs. 60.2%), but were usually grade 1 or 2 and transient. The frequencies of local injection site pain and systemic reactions were similar between vaccine groups, except more myalgia with IM vaccine.
CONCLUSIONS
The ID vaccine elicited immune responses comparable to IM vaccine except for the seroconversion rate to B virus. With the exception of pain, local injection site reactions were more common with the ID vaccine, but well-tolerated and of short duration.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT00772109.
背景
为了提高疫苗接种率，皮内（ID）流感疫苗（Fluzone®Intradermal，赛诺菲巴斯德公司）可能是肌肉内（IM）接种的替代选择，因为它使用的针头更小，注射的体积也更小。
方法
这是一项多中心、随机（2:1 ID 与 IM 疫苗）研究，对 ID 疫苗批次进行盲法，纳入了 2008 年 10 月招募的 4292 名 18-64 岁的成年人。三种研究用三价流感疫苗的每个毒株含 9μg 血凝素（HA），用 30 号、1.5 毫米长的针头皮内注射，与标准剂量疫苗（0.5mL 含 15μgHA/株）肌肉内注射进行比较。
结果
ID 疫苗接种后的抗体几何平均滴度（GMT）与 IM 疫苗相似（H1N1：193.2 对 178.3，H3N2：246.7 对 230.7，B：102.5 对 126.9）。通过对所有三种病毒株的抗体 GMT 比值（IM/ID）评估，ID 疫苗与 IM 疫苗相比具有非劣效性（H1N1：0.92，H3N2：0.94，B：1.24）。H1N1 和 H3N2 的血清转化率非劣效，但 B 不劣效（ID 对 IM：H1N1：61.2%对 60.5%，H3N2：75.3%对 74.8%，B：46.2%对 54.2%）。各组间血清保护率（HAI 滴度≥1:40）相似（ID 对 IM，H1N1：91.1%对 91.7%，H3N2：90.7%对 91.4%，B：87.4%对 89.3%）。与 IM 疫苗相比，ID 疫苗的局部注射部位反应更常见（ID 对 IM：89.2%对 60.2%），但通常为 1 级或 2 级，且为一过性。局部注射部位疼痛和全身反应的发生频率在疫苗组之间相似，除了 IM 疫苗组肌痛更常见。
结论
ID 疫苗引起的免疫反应与 IM 疫苗相当，只是 B 型病毒的血清转化率除外。除了疼痛外，ID 疫苗的局部注射部位反应更常见，但耐受性良好，持续时间短。
临床试验注册
ClinicalTrials.gov 标识符：NCT00772109。
Zotero 插件