Vakzine Projekt Management GmbH, Hannover, Germany.
Vaccine. 2013 Feb 18;31(9):1340-8. doi: 10.1016/j.vaccine.2012.12.053. Epub 2013 Jan 3.
Current vaccination using Mycobacterium bovis bacillus Calmette-Guérin (BCG), fails to prevent pulmonary tuberculosis (TB). New vaccination strategies are essential for reducing the global incidence of TB. We assessed the safety and immunogenicity of VPM1002, a recombinant BCG vaccine candidate. EudraCT (2007-002789-37) and ClinicalTrials.gov (NCT00749034).
Healthy volunteers were enrolled in a phase 1 open-label, dose escalation randomized clinical trial, and received one intradermal dose of VPM1002 (Mycobacterium bovis BCG ΔureC::hly Hm(R)) or BCG. Immunogenicity was assessed by interferon-gamma (IFN-γ) production, cellular immune response markers by flow cytometry and serum antibodies against mycobacterial antigens.
Eighty volunteers were randomized into two groups according to previous BCG vaccination and mycobacterial exposure (BCG-naïve, n=40 and BCG-immune, n=40). In each group, 30 individuals were vaccinated with VPM1002 (randomized to three escalating doses) and 10 with BCG. VPM1002 was safe and stimulated IFN-γ-producing and multifunctional T cells, as well as antibody-producing B cells in BCG-naïve and BCG-immune individuals.
VPM1002 was safe and immunogenic for B-cell and T-cell responses and hence will be brought forward through the clinical trial pipeline.
目前使用牛型分枝杆菌卡介苗（BCG）的疫苗接种未能预防肺结核（TB）。新的疫苗接种策略对于降低全球结核病发病率至关重要。我们评估了 VPM1002，一种重组卡介苗疫苗候选物的安全性和免疫原性。EudraCT（2007-002789-37）和 ClinicalTrials.gov（NCT00749034）。
健康志愿者被纳入一项 1 期开放性、剂量递增随机临床试验，并接受一次 VPM1002（牛型分枝杆菌 BCGΔureC::hly Hm（R））或 BCG 的皮内剂量。通过干扰素-γ（IFN-γ）产生、流式细胞术评估细胞免疫反应标志物和针对分枝杆菌抗原的血清抗体来评估免疫原性。
根据先前的 BCG 接种和分枝杆菌暴露情况（BCG 初免，n=40 和 BCG 免疫，n=40），将 80 名志愿者随机分为两组。每组 30 人接种 VPM1002（随机分为三个递增剂量），10 人接种 BCG。VPM1002 是安全的，并刺激了 BCG 初免和 BCG 免疫个体的 IFN-γ产生和多功能 T 细胞以及抗体产生 B 细胞。
VPM1002对 B 细胞和 T 细胞反应具有安全性和免疫原性，因此将通过临床试验管道推进。
