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目的评价家蚕生物反应器生产的重组禽流感血凝素疫苗的安全性和免疫原性。方法将SD大鼠随机分为5组,分别经皮下注射9.4、1.88和0.375mg/kg剂量的重组禽流感血凝素疫苗(含氢氧化铝佐剂)、A(lOH)3和生理盐水,每10d注射1次,连续注射3次,分别于第1次给药后第2、22和42天进行血液学、血液生化学、病理学和免疫原性检测。结果3个剂量组疫苗第1次给药后第42天,检测抗体滴度(P/N)在8～11之间,CD4+、CD8+T淋巴细胞含量及IFNγ和IL-2的含量与两对照组相比,未见明显升高;连续3次给药后,大鼠的血液学和生化学指标均无明显改变;给药期间注射部位皮下出现肉芽肿样结节,经20d恢复后有所改善;9.4和1.88mg/kg剂量组动物出现可逆性的脾肿大症状;整个实验期间,动物未出现任何其他明显不良反应。结论重组禽流感血凝素疫苗对大鼠具有良好的安全性,但免疫原性较低。
Objective To evaluate the safety and immunogenicity of recombinant avian influenza hemagglutinin vaccine produced by silkworm bioreactor. Methods The SD rats were randomly divided into 5 groups. The recombinant plasmids were injected subcutaneously with the recombinant HA vaccine (AHA), A (lOH) 3 and saline at doses of 9.4, 1.88 and 0.375 mg / The rats were injected once every 10 days and injected three times in a row. The hematology, blood biochemistry, pathology and immunogenicity were detected on the 2nd, 22nd and 42nd days after the first administration respectively. Results The antibody titer (P / N) was between 8 and 11 on the 42nd day after the first dose of the three doses of the vaccine. The contents of CD4 +, CD8 + T lymphocytes and the contents of IFNγ and IL-2 Compared with the control group, there was no obvious increase. After 3 consecutive administrations, the hematological and biochemical indexes of rats did not change significantly. Granuloma-like nodules occurred subcutaneously in the injection site during the administration, and after 20 days of recovery Improved; 9.4 and 1.88mg / kg dose animals showed reversible symptoms of splenomegaly; throughout the experiment, the animals did not show any other significant adverse reactions. Conclusion The recombinant avian influenza hemagglutinin vaccine has good safety, but immunogenicity is low.