Antigenic activity and the reactogenicity of UV ray-inactivated antirabies vaccine from the brain of sheep]

Tests in volunteers showed that the reactogenicity of rabies vaccine prepared from sheep brain and inactivated with ultraviolet rays was not greater than the reactogenicity of Fermi vaccine. At the same time it was found to have a higher activity when injected both in the form of 5% suspension (in full and decreased doses) and with brain tissue content as low as 2.5%.     

A new rabies vaccine in public health practice in the USSR

A new antirabies vaccine prepared on the basis of virus grown in the ovine brain, purified from 85-90% of brain-tissue ballast substances and inactivated with beta-propilactone has been developed at the Moscow Research Institute of Viral preparations (USSR Acad. Med. Sci.). The preparation produces no neuro-allergenic effect in tests on guinea pigs. When injected to humans, the vaccine shows much lower reactogenicity than Fermi vaccine. High antigenic and immunogenic activity of the new vaccine has made it possible to work out a less intensive immunization schedule in comparison with that used for immunization with Fermi vaccine and nonconcentrated tissue-culture vaccine, viz. doses of 3 ml for 12 days or doses of 3 ml for 20 days with two booster immunizations. The preparation has been introduced into medical practice.     

Comparative evaluation of the reactogenicity and antigenic activity of Soviet inactivated influenza vaccines

The reactogenicity and antigenic potency of existing inactivated influenza vaccines were tested on 750 practically healthy adults. In all the preparations under test the levels of reactogenicity were found to correspond to the Technical Specifications TY--KBC, but the subunit type vaccine, "Gripovac", proved to possess the lowest reactogenicity and was, therefore, recommended for further trials in young children. Taking into account the characteristics of antigenic potency, the work gives grounds for the necessity of increasing the content of hemagglutinin in the vaccine prepared by the centrifugal method and for the practical use of the same volumetric dose (0.2 ml) for both virion vaccines (prepared by the centrifugal and chromatographic methods).     

The evaluation of the reactogenicity and immunological activity of an inactivated 3-component influenza vaccine with an elevated hemagglutinin concentration in the inoculation dosage

In this work the reactogenic properties and antigenic potency of inactivated trivalent influenza vaccine, obtained by elution and centrifugation and containing up to 9-11 micrograms of hemagglutinin for influenza viruses A(H1N1) and A(H3N2) and up to 14 micrograms for influenza virus B, were studied. The reactogenicity of the preparation was found to correspond to the regulations. The immunogenic potency characteristics of individual batches of this trivaccine were higher than the immunogenicity of divaccines, but did not meet the requirements of technical specifications.     

Specific prophylaxis of influenza with inactivated split vaccine Vaxigrip

Influenza remains a serious health problem, annually causing epidemics embracing up to 10% of the population of the world, and at the periods of pandemics this number may rise 4- to 6-fold. In the overwhelming majority of the countries the prophylaxis of influenza is carried out at present out with the use of inactivated vaccines. One of such vaccines is the highly purified split vaccine Vaxigrip (Aventis-Pasteur, France), permitted for use in Russia since 1992. The article contains the review of the data of literature, as well as the materials provided by the authors, which indicate that the preparation has low reactogenicity (also for children starting from the age of 6 months) and high reactogenic properties, leading to antibody formation at protective levels with respect to all three components of the vaccine. The vaccine has been found to ensure pronounced prophylactic efficacy for 70-90% of vaccinees and a decrease in influenza morbidity even in case of using the preparation a week before the onset of the epidemic. This shows the advantage of Vaxigrip in comparison with other inactivated vaccines.     

Comparative study of the reactogenicity and immunogenicity of various doses of a chemical polysaccharide meningococcal vaccine administered by syringe and jet injector

The article presents the results obtained in the comparative study of the reactogenicity and immunogenic potency of different doses of chemical polysaccharide meningococcal vaccine, type A, introduced with a syringe and a jet-injector. The preparation has been shown to possess low reactogenicity, high immunogenic potency and to produce a sufficiently pronounced intensity of postvaccinal immunity. The preparation is recommended for wide use in immunization of adults in a dose of 75 micrograms.     

A cultured concentrated inactivated vaccine against tick-borne encephalitis studied during the immunization of children and adolescents

The word deals with the results obtained in the study of the reactogenicity and immunological activity of concentrated and inactivated tissue-culture tick-borne encephalitis vaccine, manufactured by the Chumakov Institute of Poliomyelitis and Viral Encephalitides, in the immunization of children and adolescents. The vaccine proved to be moderately reactogenic and exhibited pronounced immunological activity. In 91.5% of the immunized children the fourfold increase of the antibody level was observed. On the basis of the data obtained in this study the tick-borne encephalitis vaccine was recommended for use in medical practice for the prophylaxis of tick-borne encephalitis among children and adolescents.     

The evaluation of the reactogenicity and immunogenic activity of a new concentrated inactivated leptospirosis vaccine

In the controlled field trial the reactogenicity, safety and antigenic activity of a new concentrated inactivated leptospirosis vaccine after its administration in one and two injections of 0.5 ml were studied in comparison with those of the existing commercial vaccine, introduced in two injections in doses of 2.0 and 2.5 ml. The new experimental vaccine exhibited low reactogenicity and was found to be safe and highly immunogenic when introduced in a single injection of 0.5 ml. As shown in this trial, the immunogenic characteristics of immunization made in a single injection were not inferior than those obtained as the result of immunization made in two injections, yielding high percentage of seroconversions (89.8% to 98.3%) with respect to 4 Leptospira serogroups and leading to the production of the protective titers of corresponding antibodies. The existing commercial vaccine was inferior to the experimental one in antigenic activity (the frequency of seroconversions, antibody titers). The results of the trial make it possible to recommend the experimental concentrated leptospirosis vaccine for use in medical practice in a dose of 0.5 ml introduced in a single injection.     

Covaxin: An overview of its immunogenicity and safety trials in India

The spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to a global coronavirus disease-19 (COVID-19) pandemic. Several vaccine types, such as inactivated, viral vector-, or mRNA-based, have received approval against SARS-CoV-2. The ability to induceT-helper-1 cell (Th1) responses is desirable from an effective vaccine against this virus. Covaxin (BBV152) is a wholevirion inactivated SARS-CoV-2 vaccine adjuvanted with Algel-Imidazoquinoline (IMDG) molecule, a toll-like receptor (TLR) 7/8 agonist. The mRNA-based vaccine use is hindered because of cold storage requirement, whereas covaxin is stored between 2°C and 8°C, making it suitable for countries with limited resources. The Drug Controller General of India (DCGI) has approved the BBV152 vaccine. Therefore, it is of interest to document known data on BBV152 vaccine phase I, phase II and phase III human clinical trials to evaluate the safety, reactogenicity, tolerance, and immunogenicity of the whole-virion inactivated SARS-CoV-2 vaccine (BBV152).     

Comparative evaluation of the reactogenicity and immunogenicity of inactivated influenza vaccines in the elderly

A comparative study was carried out to assess reactogenicity and immunogenicity of inactivated influenza vaccines (Begrivac, Vaxigrip, Grippol, Influvac, and Fluarix), licensed in Russia. Immunization of the elderly demonstrated low reactogenicity and high immunogenicity for all vaccines. Concomitant chronic diseases had no influence on the vaccine immunogenicity levels, which testifies to the benefit of vaccination in this age group. In the group of vaccinated the highest seroconversion to all vaccine strains was found for Vaxigrip (82-89% for group A viruses and 86% for group B virus); the vaccine demonstrated the highest level of diagnostic increase of antibody titers to all 3 viruses, i.e. 69.0% (p < .05), with 22.0% of vaccinees gained antibodies to 2 vaccine viruses (91.0% in total). The number of positive responses to 3 and 2 strains in subjects immunized with Fluarix, Begrivac and Influvac reached 85.0%, 85.0% and 83.0% respectively. It is noteworthy that the combination of surface antigens of A and B flu viruses in low concentration with polyoxidonium immune modulator in Grippol induced intensive immune response.     

Assessment of the prophylactic effectiveness of an inactivated influenza vaccine by immunizing schoolchildren in the springtime

To evaluate the prophylactic effectiveness of influenza inactivated chromatographic vaccine, limited epidemiological observations were made on school children aged 11-14 years in Leningrad, in the autumn of 1981 and the spring of 1982. For immunization, made in a single administration, the vaccine composed of A (H3N2) + +A (H1N1) and containing 3.0-3.4 micrograms of hemagglutinin of each component per 0.2 ml of the preparation was used. Altogether 6928 schoolchildren were under observation; of these, 3686 children were immunized and 3242 children received placebo. The results of questioning and the analysis of morbidity rate among the schoolchildren, both immunized and receiving placebo, showed the safety and low reactogenicity of the vaccine irrespective of the time of the immunization campaign. The immunogenic potency of the preparation, as indicated by all observation results, proved to be higher in spring, than in autumn. The data thus obtained indicate that children immunized in spring were better protected and retained a higher level of protection within 12 months after immunization. The shift of the time of the immunization campaign from autumn to spring increased the immune layer in the groups of children by 16.5%. In 10 months after spring immunization the morbidity rate in influenza and acute respiratory diseases among the vaccinees was found to decrease 1.7 times.     

Comparative study of the safety and reactogenicity of different doses of brucellosis chemical vaccine in human revaccination

The period of 11-12 months has been found to be the optimal interval, among other experimentally tested periods of time, between primary immunization and booster immunization with chemical brucellosis vaccine. The safety and low reactogenicity of different doses (1 mg, 0.75 mg and 0.5 mg) of the vaccine have been established. The occurrence and intensity of local and systemic reactions to this vaccine depend neither on the dose of the preparation, nor on previous immunization.     

Optimal inoculation doses of meningococcal chemical polyvalent ABC vaccine for immunizing children of various ages and adolescents. I. Safety and reactogenicity of different dosages of the preparation

The investigation was carried out to study the safety and reactogenicity of meningococcal chemical polyvalent (ABC) vaccine with the aim of finding the optimum vaccination doses of this vaccine for the immunization of children of different age groups. The investigation, carried out in accordance with the methodological principles of a strictly controlled epidemiological field trial, showed the preparation to be safe, nonreactogenic and to produce no pronounced sensitizing effect.     

Comparative clinical trial of vaccines against avian influenza

Scientic-production association "Microgen" has finished 1st phase of clinical trials of candidate vaccines against avian influenza in order to assess their reactogenicity, safety, and immunogenicity. Two vaccines constructed from NIBRG-14 vaccine strain [A/Vietnam/1 194/2004 (H5N1)], obtained from World Health Organization, were studied: "OrniFlu" (inactivated subunit influenza vaccine adsorbed on aluminium hydroxide) and inactivated polymer-subunit influenza vaccine with polyoxydonium (IPSIV). Clinical trial of the vaccines with different quantity of antigen (15, 30, and 45 mcg of H5N1 virus hemagglutinin) was carried out in Influenza Research Institute (St. Petersburg) and in Mechnikov Research Institute of Vaccines and Sera (Moscow). Analysis of results allowed to conclude that both vaccines were safe, well tolerated and characterized by low reactogenicity. Two-doses vaccination schedule was needed to meet required seroconversion and seroprotection rates (> or =1:40 in > or =70% of vaccinated volunteers). "Orni-Flu" vaccine containing 15 mcg of hemagglutinin and optimal quantity of aluminium hydroxide (0.5 mg) in one dose as well as IPSIV containing 45 mcg of hemagglutinin and 0.75 mg of polyoxydonium in one dose were most immunogenic after 2 doses - seroprotection rates in microneutralization assay were 72.2% and 77.0% respectively. Marked influence of aluminium hydroxide content on immunogenicity of the "OrniFlu" vaccine was confirmed in the study. Optimal quantity of adjuvant was 0.5 mg per dose. According to basic concept of vaccine development, preference is given to vaccine that under minimal quantity of antigen induces sufficient specific immune response and is safe in volunteers. "OrniFlu" vaccine containing 15 mcg of H5N1 virus hemagglutinin and optimal quantity of aluminium hydroxide (0.5 mg) corresponded to these requirements that allowed researchers to recommend it for clinical trials of 2nd phase.     

Results of a study of new preparations of inactivated whole-virion influenza vaccines for the protection of children in the USSR

The safety, reactogenic properties and antigenic potency of inactivated whole-virion influenza vaccines produced in the USSR were studied on 1,117 schoolchildren in limited coded clinico-immunological observations. Inactivated chromatographic influenza vaccine obtained from strain A/Texas/1/77 (H3N2) and a variant of this vaccine, developed specially for children and obtained from strains A/Texas/1/77 and B/Leningrad/76, were used for immunization. Both preparations were introduced intradermally in a single injection in a volume of 0.1-0.2 ml by means of bi-3 jet injector. The content of hemagglutinin in this volume varied from 3.0 to 8.0 micrograms. Clinico-laboratory investigations demonstrated the safety of mono- and bivalent inactivated whole-virion influenza vaccine administered intradermally in a single injection to children of school age. The vaccines showed low reactogenicity and high antigenic potency in children aged 7-10 and 11-14 years, and the optimal doses of the preparations were selected for children of different age groups. The distinct prophylactic effectiveness of inactivated chemical chromatographic influenza vaccines in children aged 11-14 years was revealed 11 months after immunization, the index of immunological effectiveness being 1.7.     

A field trial with the liquid multicomponent meningococcal vaccine ABC

The morbidity rates of generalized forms of meningococcal infection in persons immunized with different doses of liquid meningococcal vaccine ABC were compared. The vaccine was introduced subcutaneously by means of a jet injector. Altogether 3,920 males aged 18 years and older were immunized. 1,966 vaccinees received this vaccine in a dose of 200 micrograms and 1,954 vaccinees, in a dose of 400 micrograms. Meningococcal multicomponent vaccine ABC used in these doses showed moderate reactogenicity and did not prevent the development of generalized forms of meningococcal infection.     

Basic results of a committee trial of the new vaccine Grippovac SE-AZh

In the trial of the trivalent subunit influenza vaccine Grippovac CE-AK observations on children aged 3-6 years were made. The preparation showed insignificant reactogenicity and moderate antigenic potency. The trial established that at the period of the epidemic rise of influenza B morbidity the vaccine showed, according to the data of the clinical diagnosis of influenza, insignificant effectiveness, its index of effectiveness (IE) being 1.08; according to the data of the serological diagnosis of influenza, only the A (H1N1) component of the vaccine was found to have IE equal to 1.58.     

The evaluation of the reactogenicity, harmlessness and prophylactic efficacy of Grippol trivalent polymer-subunit influenza vaccine administered to schoolchildren

Vaccine "Grippol"--has been developed at the State Research Center--Institute of Immunology. The preparation belongs to new generation vaccines and is a trivalent polymer-subunit vaccine containing the sterile conjugate of influenza virus surface proteins, types A and B, bound with copolymer polyoxidonium. The administration of "Grippol" to children of school age (6-18 years) demonstrated low reactogenicity of the vaccine, its safety and sufficient prophylactic effectiveness. During observations on total morbidity (with the exception of influenza and acute respiratory diseases) no side effects produced by "Grippol" were registered. At the same time the fact that the morbidity rate of upper respiratory tract disease in the group of children immunized with the vaccine decreased in comparison with the control group (by 2.4 times) cannot be disregarded.     

Possible use of a concentrated vaccine against tick-borne encephalitis for immunizing donors to obtain specific immunoglobulin

The immunization of donors with dried, purified, inactivated and concentrated cell-culture tick-borne encephalitis vaccine, produced at the Institute of Poliomyelitis and Viral Encephalitides in Moscow, has been carried out with the aim of obtaining immune raw material for the production of specific donor immunoglobulin. The high immunogenic potency and low reactogenicity of the vaccine, introduced in 2 injections at an interval of 6 months, have been confirmed. Immunization in 2 injections has proved to be as effective as that achieved by 3 injections. The expediency of the immunization of regularly bled donors has been established: hemagglutinin titers in these donors have been found to be significantly higher than in a group of persons never bled before. The optimum time for taking blood has been determined: 3 weeks for regularly bled donors and 2 weeks for donors bled for the first time. Blood may be taken again 2 months after the first bleeding without booster immunization and 2 weeks after the third injection of the vaccine.     

The effects of different inactivating agents on the potency, toxicity and stability of pertussis vaccine

The effect of heat (56 degrees C for 10 min), formaldehyde (0.1% at 37 degrees for 24h), glutaraldehyde (0.05% at room temperature for 10 min), thimerosal (0.02% at 37 degrees C for 24h), acetone-I (three treatments at room temperature) and acetone-II (three treatments at room temperature and fourth treatment at 37 degrees C), when used as inactivating agents in the preparation of pertussis suspension, was studied with regard to potency, toxicity and stability. Five batches each of Bordetella pertussis strains 134 and 509 were used for the study. The thimerosal inactivated pertussis (TIP) preparation was 1.5-2 times more potent than the heat inactivated pertussis (HIP) preparation. The potency values of the formaldehyde inactivated pertussis (TIP) and glutaraldehyde inactivated pertussis (GIP) preparations were similar to those of the HIP preparation, while the potencies of the acetone-I treated pertussis (A(I)TP) and acetone-II treated pertussis (A(II)TP) preparations were about half those of the HIP preparation. The FIP preparation was the least toxic showing maximum weight gain in the mouse weight-gain test (MGWT), while the TIP preparation did not pass the MWGT. The weight gains shown the GIP, A(I)TP and A(II)TP preparations were greater than those shown by the HIP preparation. The potency of pertussis component in the adsorbed diphtheria-pertussis-tetanus (DPT) vaccine was stable at 4-8 degrees C and 25 degrees C for three months for all types of pertussis vaccine. There was about 54-65% loss in the potency of the samples after three months at 35 degrees C. The inactivating agents used in the manufacture of pertussis preparations had no effect on the stability of the vaccine.