Belshe Robert B, Newman Frances K, Cannon Joan, Duane Carol, Treanor John, Van Hoecke Christian, Howe Barbara J, Dubin Gary
Department of Internal Medicine, Division of Infectious Diseases and Immunology, Saint Louis University, St. Louis, MO 63110, USA.
N Engl J Med. 2004 Nov 25;351(22):2286-94. doi: 10.1056/NEJMoa043555. Epub 2004 Nov 3.
If found to be safe and immunogenic, reduced doses of influenza vaccine given by the intradermal route could increase the number of available doses of vaccine.
In an open-label study, we randomly assigned 119 subjects to receive an intradermal injection of trivalent inactivated influenza vaccine, containing 6 mug of hemagglutinin for each antigen (40 percent of the usual dose), and 119 to receive an intramuscular injection of the standard dose of 15 mug of hemagglutinin for each antigen. The two groups were subdivided according to age (18 to 60 years and older than 60 years).
Among subjects who were 18 to 60 years of age, serum antibody responses were vigorous and did not differ significantly between the intradermal and intramuscular groups, and all subjects had hemagglutination-inhibition (HAI) titers of at least 1:40. Although the subjects who were older than 60 years of age also had a vigorous antibody response, there was a trend toward a better response in the intramuscular route, but this finding was significant only for antigen to the H3N2 strain. Nevertheless, 100 percent of older subjects in the intramuscular group and 93 percent of such subjects in the intradermal group had an HAI antibody titer to the H3N2 strain of more than 1:40, and 100 percent in each group had a titer of this level for both the H1N1 and B strains. Local pain was significantly more common in the intramuscular group than in the intradermal group among subjects who were 18 to 60 years of age but not among subjects who were over 60 years old. Signs of local inflammation were significantly more common among subjects in the intradermal group than among those in the intramuscular group, in both age groups.
As compared with an intramuscular injection of full-dose influenza vaccine, an intradermal injection of a reduced dose resulted in similarly vigorous antibody responses among persons 18 to 60 years of age but not among those over the age of 60 years.
如果经证实安全且具有免疫原性,皮内注射较低剂量的流感疫苗可增加可用疫苗剂量的数量。
在一项开放标签研究中,我们将119名受试者随机分配接受皮内注射三价灭活流感疫苗,每种抗原含6微克血凝素(常规剂量的40%),另外119名受试者接受肌肉注射,每种抗原的标准剂量为15微克血凝素。两组根据年龄(18至60岁和60岁以上)进行细分。
在18至60岁的受试者中,血清抗体反应强烈,皮内组和肌肉注射组之间无显著差异,所有受试者的血凝抑制(HAI)效价至少为1:40。虽然60岁以上的受试者也有强烈的抗体反应,但肌肉注射途径有反应更好的趋势,但这一发现仅对H3N2毒株的抗原具有显著性。然而,肌肉注射组中100%的老年受试者和皮内注射组中93%的此类受试者对H3N2毒株的HAI抗体效价超过1:40,每组中100%的受试者对H1N1和B毒株的效价达到这一水平。在18至60岁的受试者中,肌肉注射组局部疼痛明显比皮内注射组更常见,但在60岁以上的受试者中并非如此。在两个年龄组中,皮内注射组受试者局部炎症迹象明显比肌肉注射组更常见。
与肌肉注射全剂量流感疫苗相比,皮内注射较低剂量在18至60岁的人群中产生了同样强烈的抗体反应,但在60岁以上的人群中并非如此。