CLINICAL TRIAL OF THE PANDEMIC INFLUENZA MONOVALENT VACCINE PANDEFLU

Abstract

Abstract. Evaluation of reactogenicity, safety and immunogenicity of the inactivated subunit influenza vaccine adsorbed monovalent (Pandeflu) on the base of strain A/California/7/2009 (H1N1v) was conducted in 70 volunteers aged 18–60 years immunized by one or two doses. A clinical trial of the vaccine Pandeflu was conducted in the St.Petersburg Institute of Influenza. The study group included 38 women (54,3%) and 32 men (45,7%). The average age of women was 38.2 years, men — 26.9 years, mean age of all volunteers was equal to 31.7 years. This group of volunteers was randomized in 2 subgroups. The first subgroup of 50 volunteers was vaccinated with Pandeflu, but the second one of 20 volunteers was given a placebo. The strong and moderate local and systemic reactions were not observed. All local (6 volunteers) and systemic (6 volunteers) reactions were recorded after ithout any medical care. It proves the good tolerability and low reactogenicity of vaccine Pandeflu. Indicators of clinical and biochemical blood tests, a general analysis of urine during the study period were within normal limits. In the study of the immunogenicity it has been shown that after a single injection of vaccine the first vaccination. All these reactions were mild and transient and disappeared wPandeflu the seroconversion rate reached 68%, but the level of seroprotection was 52%. The multiplication factor of the geometric mean antibody titer increase in serum reached a value of 5.8. Conducting of immunization with two doses of vaccine with the interval of 28 days increases the immunogenicity: the level of seroconversion rate increases up to 96%, but the level of seroprotection – up to 74%, seroconversion factor – up to 10.8. These data confirm high immunogenic potential vaccine in case of single dose as well as double doses administration.

Keywords

• clinical trials
• pandemia
• influenza
• vaccine
• pandeflu