Stanford University School of Medicine, Stanford, CA, USA.
Emergent BioSolutions Inc, Gaithersburg, MD, USA.
Vaccine. 2023 Oct 6;41(42):6146-6149. doi: 10.1016/j.vaccine.2023.08.086. Epub 2023 Sep 9.
In a phase 2 safety and immunogenicity study of a chikungunya virus virus-like particle (CHIKV VLP) vaccine in an endemic region, of 400 total participants, 78 were found to be focus reduction neutralizing antibody seropositive at vaccination despite being ELISA seronegative at screening, of which 39 received vaccine. This post hoc analysis compared safety and immunogenicity of CHIKV VLP vaccine in seropositive (n = 39) versus seronegative (n = 155) vaccine recipients for 72 weeks post-vaccination. There were no differences in solicited adverse events, except injection site swelling in 10.3% of seropositive versus 0.6% of seronegative recipients (p = 0.006). Baseline seropositive vaccine recipients had stronger post-vaccination luciferase neutralizing antibody responses versus seronegative recipients (peak geometric mean titer of 3594 and 1728, respectively) persisting for 72 weeks, with geometric mean fold increases of 3.1 and 13.2, respectively. In this small study, CHIKV VLP vaccine was well-tolerated and immunogenic in individuals with pre-existing immunity. ClinicalTrials.gov Identifier: NCT02562482.
在一项地方性的基孔肯雅病毒病毒样颗粒(CHIKV VLP)疫苗的 2 期安全性和免疫原性研究中,在总共 400 名参与者中,有 78 人在接种疫苗时被发现尽管在筛查时 ELISA 血清阴性,但仍为焦点减少中和抗体血清阳性,其中 39 人接受了疫苗。这项事后分析比较了血清阳性(n=39)和血清阴性(n=155)疫苗接种者在接种疫苗后 72 周的安全性和免疫原性。除了血清阳性者中有 10.3%出现注射部位肿胀,而血清阴性者中为 0.6%(p=0.006)外,两组的不良反应无差异。基线血清阳性疫苗接种者在接种疫苗后的荧光素酶中和抗体反应比血清阴性者更强(峰值几何平均滴度分别为 3594 和 1728),并持续 72 周,几何平均倍数增加分别为 3.1 和 13.2。在这项小型研究中,CHIKV VLP 疫苗在具有预先存在免疫力的个体中具有良好的耐受性和免疫原性。临床试验.gov 标识符:NCT02562482。