Tuberculosis vaccine, preparation method therefor, and use thereof
Inventors
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11426454-B2
Publication Date
2022-08-30
Expiration Date
Abstract
The present invention relates to the field of tuberculosis vaccines, and specifically relates to a tuberculosis vaccine, a preparation method thereof, and a use thereof. To address the problem of existing vaccines being unsuitable for patients having weak immunity, the present invention provides a preparation method for a tuberculosis vaccine: first obtaining Mycobacterium single cell bacteria, and using low dosage radiation to irradiate periodically the Mycobacterium single cell bacteria, so as to obtain the tuberculosis vaccine. The present invention completely retains all of the antigen characteristics of the bacteria, and can more rapidly stimulate stronger specific immune responses, thereby achieving effective and long-lasting immunity. The vaccine prepared using the present invention has low toxicity, is rapid-acting and safer, and can be used for the prevention and treatment of tuberculosis for people having immunodeficiency.
Core Innovation
The disclosed invention relates to a tuberculosis vaccine prepared by obtaining Mycobacterium single cell bacteria and irradiating the Mycobacterium single cell bacteria uniformly with radiation to prepare the tuberculosis vaccine. In the described embodiment, BCG bacteria are used as the Mycobacterium single cell bacteria, and the irradiation uses X-ray, γ-ray, or radiation generated by an isotope radiation source Co60. The irradiation is performed in a uniform and periodic, cyclical manner to inactivate proliferation while retaining antigen structures, including emissive filament-like outer-membrane structures.
The preparation method includes irradiation conditions defined by dosage rate and cycling parameters, including a dosage rate of 10-20 Gy/min, irradiation performed multiple times with a time interval between irradiations, and each irradiation having a duration of 20 min with a time interval of 5 to 10 min. The irradiation is performed 8 to 10 times. Before irradiation, the method further comprises obtaining Mycobacterium strains, inoculating and culturing to logarithmic growth phase, adding resuspension medium, homogenizing, and sieving to obtain the Mycobacterium single cell bacteria.
The resulting vaccine is an inactivated mycobacterial whole-cell product and can be administered for preventing and treating tuberculosis, including extrapulmonary forms. The described immune effects include increased IL-12 and IFN-γ, and experimental assessments include outcomes such as survival and colony-forming unit (CFU) in spleen and lung, along with lymphocyte CD4+/CD8+ responses and cytokine profiles.
Claims Coverage
The provided independent claim defines a tuberculosis vaccine preparation method based on uniformly irradiating Mycobacterium single cell bacteria, specifically BCG bacteria, using specified radiation types and a defined repeated irradiation schedule. The provided claim set contains 5 inventive features.
Uniform irradiation of Mycobacterium single cell bacteria to prepare tuberculosis vaccine
The method includes obtaining Mycobacterium single cell bacteria and irradiating the Mycobacterium single cell bacteria uniformly using radiation to prepare the tuberculosis vaccine.
Radiation source selection for uniform irradiation
The radiation is X-ray, γ-ray, or radiation generated by isotope radiation source Co60, and the Mycobacterium single cell bacteria are BCG bacteria.
Cyclical irradiation schedule with specified dosage rate and timing
The irradiation dosage rate is 10-20 Gy/min, the irradiation is performed multiple times with a time interval between every two irradiations, each irradiation duration is 20 min with the time interval of 5 to 10 min, and the irradiation is performed 8 to 10 times.
Pre-irradiation preparation to obtain Mycobacterium single cell bacteria
Before irradiation, the method further comprises obtaining Mycobacterium strains, inoculating and culturing to logarithmic growth phase, adding resuspension medium, homogenizing, and sieving, and obtaining the Mycobacterium single cell bacteria.
Emissive filament-like structures on outer membrane after irradiation
After irradiation, the BCG bacteria have emissive filament-like structures on the outer membrane that surround the bacteria.
Within the provided claim set, the independent claim centers on uniformly irradiating Mycobacterium single cell bacteria (BCG) with specified radiation types and a cyclical irradiation schedule, with defined pre-irradiation steps to obtain the single cell bacteria. The provided dependent claim extracts further specify a post-irradiation outer-membrane feature of emissive filament-like structures.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Preventing and treating tuberculosis, including pulmonary, meningeal, female pelvic, bone, and intestinal forms.
Possible synergy with first-line chemotherapeutics including isoniazid, rifampicin, and streptomycin.
Evaluation of immune effects including IL-12 and IFN-γ increases and cellular responses including CD4+/CD8+ and splenocyte proliferation.
Safety assessment in SCID mice versus BCG.
Interested in licensing this patent?