The clinical and immunological safety of inactivated immunologic adjuvant influenza subunit vaccine for pregnant women
Objective. To study the clinical and immunological safety of influenza vaccines in pregnant women, as well as pregnancy outcome. Material and methods. A blind placebo-controlled study was conducted in 137 women in the second and third trimesters of physiological pregnancy who had received single vaccination against influenza in the season of 2010-2011. Group 1 comprised 43 women vaccinated with the Russian monovalent subunit adjuvant vaccine monogrippol plus (A/H1N1v strain 5 μg, Polyoxidonium 500 μg); Group 2 included 50 pregnant women vaccinated with the trivalent subunit adjuvant vaccine grippol plus (5 μg of each strain: A/H1N1v, H3N2, and B, 500 μg of polyoxydonium (Petrovax, Russia); Group 3 consisted of 44 pregnant women vaccinated with the commercial triple subunit vaccine agrippal containing 15 μg in each of the above 3 strains of antigens (Novartis Vaccines and Diagnostics, Italy). A control group included 41 pregnant women who had placebo (phosphate salt buffer). Clinical, biochemical, immunological, and statistical studies were used. Results. Assessment of the clinical course of the postvaccinal period showed that the asymptomatic course was recorded in 58.1% of the pregnant women in Group 1, 60.0% in Group 2, 54.5% in Group 3, and 60.9% in Group 4 (p > 0.05), which were not different from Group 5 (30 (61.3%) vaccinated nonpregnant women). Local systemic reactions were slightly marked, comparable in all the groups, and unaccompanied by deterioration in the status of pregnant women. On days 7 and 30, there were no pronounced changes in the results of biochemical blood tests in each examined group (p > 0.05), lipidograms, hormonal profile, and serum immunoglobulins. There was a difference in the short-term increase in INF-γ in the pregnant women in the second trimester of pregnancy in the use of immunologic adjuvant subunit vaccines, which was presumably associated with the involvement of Th1-mediated mechanisms in a postvaccinal immune response. As for an adjuvant-free analogue, there was an elevation of IL-4 (a sign of Th2-dependent activation), especially in the vaccinated in the third trimester of pregnancy. All the found shifts in the values recorded in different groups of the vaccinated persons were within the allowable limits. Pregnancy resulted in physiological birth in 85.4-90.7% of cases in all the groups. Conclusion. The injection of the Russian immunologic adjuvant influenza vaccine is immunologically safe and does not affect the course of pregnancy.