Background: To evaluate the effectiveness and safety of pseudomonas aeruginosa MSHA vaccine (PA-MSHA vaccine) used as immune modulator.
Methods: The study was carried out by non-blinded randomized control trial. The lung cancer patients were divided into experimental group (44 cases) and control group (45 cases) . Both groups were given same chemotherapy , and the experimental group was injected PA-MSHA vaccine subdermally. After finishing the treatment , tumor response and infection rate were evaluated. Immune function was measured before , during and after the treatment respectively.
Results: Clinical effective rate (CR + PR) was 59. 09 % in the experimental group , and 42. 23 % in the control group ( P < 0. 01) . Infection rate was 15. 91 % in the experimental group and 40 % in the control group ( P < 0. 05) . After the treatment , C3 and C4 , the ratio of CD4 to CD8 , NKcell activity and IL-2 level in the experimental group were significantly higher than those in the control group ( P < 0. 05) . Three cases in the experimental group had adverse reactions. One case had fever and was treated with antibiotics , while the other two with swelling in the injection site recovered automatically.
Conclusions: As a new kind of immune modulator , PA-MSHA vaccine can enhance immune function of lung cancer patient and prevent infection. It may improve chemotherapeutic effectiveness in adjuvant therapy of lung cancer with low adverse reaction rate.