CIMAvax-EGF® therapeutic vaccine for treatment of the worsening non-small-cell lung cancer
Therapeutic vaccine, immunostimulating agent. CIMAvax-EGF® is a combination of molecule of human recombinant epidermal growth factor (hrEGF) and P64k recombinant protein which forms a therapeutic-oriented drug together with a montanide adjuvant (Montanide ISA 51). The drug stimulates immune system with reduction of antibodies, which interact with abnormally expressed EGF of patients with some sort of pulmonary cancer.
Cuban medicin - CIMAvax-EGF® vaccine is developed for patients with large cell carcinoma of lungs in advanced stages (IIIb/IV), who finished with the main stage of specific oncotherapy at the least 4 weeks prior to drug administration.
Completion of a treatment course with CIMAvax-EGF® vaccine is available on the basis of La Pradera International Health Center.
CIMAvax-EGF® is a transparent colorless liquid, which becomes a white emulsion under mixture with Montanide ISA 51.
Vaccine consists of two vials.
One vial includes:
- sterile conjugate hrEGF-p64k - 0,9 mL
- physiological salt solution - 0,9 mL
Human recombinant epidermal growth factor (hrEGF) comes from yeast (Saccharomyces cerevesiae) and it presents a polypeptide molecule of 6.054 kDa molecular mass.
P64K protein is Neisseria membrane protein, obtained by recombinant method from E.coli. this protein acts as a carrier.
Two vial includes:
- Montanide ISA 51 (Seppic, France).
Mode of administration
0, 8 mL of conjugate is to be added into a vial with adjuvant (Montanide ISA 51) and mixed for obtaining of an emulsion. 1,2mL of emulsion is to be syringed into injection sites of a patient (two deltoid muscles and two gluteus muscles).
- Induction phase, dose is applied in each 14 days ( 4 injections/1,2 mL);
- Consolidation phase, dose is applied in each 28 days (4 injections/1,2 mL).
Schemes of aplications:
Contraindications on vaccine application
- Hypersensitivity to certain components;
- fever, but patients with respiratory upper respiratory tract infection and not high temperature can obtain therapeutic vaccination;
- not prescribed for the period of pregnancy and breast feeding.
Drug-to-drug interactions are not revealed.
- redness and pain feelings when injection sites;
- shiver, headache, sickness, vomiting, fever, dyspnea, flushings, arterial hypertension or hypotension. All symptoms can be classified by mild and medium form (class1 or 2) in accordance with NCI classification. Synptoms can be removed with the help of ordinary antihistaminic analgetic remedies and drugs regulating pressure;
- hematological data (concentration of hemoglobulin, leucocytes and thrombocytes) and chemical blood data remained within normal limits during immunization and further period.
Important! Recommendations on storage: At the temperature of 2-8 ° С, use cool bag during transportation.
Clinical testing conclusions
- vaccine is safe and immunogenic;
- increase lifetime;
- improve quality of life.