Immunogenicity and safety levels of inactivated quadrivalent influenza vaccine in healthy adults via meta-analysis.

Objective: The aim of the current study was to evaluate immunogenicity and safety levels of human inactivated quadrivalent influenza vaccine (QIV) which includes two A strains (A/H1N1, A/H3N2) and two B lineages (B/Victoria, B/Yamagata) in healthy adults via meta-analysis. Methods: Searches were conducted in PubMed, Cochrane Library, ClinicalTrials.gov, and EMBASE databases published in 2011-2020 according to inclusion and exclusion criteria. The purpose was to collect and perform meta-analysis of related randomized clinical trial (RCT) data concerning safety and immunogenicity levels of human QIV compared with inactivated trivalent influenza vaccine (TIV). Results: A total of 9 literatures were included. There was no significant difference in the seroconversion(SCR) and seroprotection(SPR) between QIV and TIV for influenza A strains (A/H1N1, A/H3N2) and the B lineage included in the TIV. QIV showed superior efficacy for the B lineage not included in the TIV: SCR RR of 2.20 (95%CI: 1.44-3.37, p = .0003) and SPR RR of 1.34 (95%CI: 1.10-1.63, p = .004) for B/Victoria, and SCR RR of 1.88 (95%CI: 1.53-2.31, p < .00001) and SPR RR of 1.11 (95%CI: 1.03-1.19, p = .006) for B/Yamagata, respectively. There were no significant differences between QIV and TIV for local and systemic adverse events(AE) post-vaccination. Conclusion: In adults 18-64 years old, QIV not only produced similar immunogenicity and safety levels to TIV, but also had better immunogenicity against influenza B vaccine strains not included in TIV.

A simple and safe antibody neutralization assay based on polio pseudoviruses.

The evaluation of the immunogenicity of Sabin strain based Inactivated Poliovirus Vaccines (sIPV) necessitates the use of wild strains in neutralization assays to assess the potential cross-reactivity of antibodies. The live virus strains including wild and Sabin strains must be handled in level 3 biocontainment laboratories. To develop an alternative assay without the use of a live virus, we constructed Mahoney, MEF-1, and Saukett pseudovirions by inserting luciferase reporter genes into intact capsid proteins. Afterward, we developed a pseudovirus-based neutralization test (pNT) and evaluated for the specificity and reproducibility. We tested serum samples from a clinical trial on sIPV vaccines by pNT and compared the results with those obtained from conventional neutralization tests (cNT). A strong correlation was observed between two methods, with the correlation coefficients of all three types of IPV vaccines being greater than 0.82 (p < 0.0001). The Geometric Mean Titer (GMT) values obtained by pNT were approximately four times higher than that by cNT, revealing the better sensitivity of pNT. In conclusion, pNT is a safe, rapid and sensitive quantitative assay with the potential of being an alternative for the evaluation of the potency of polio vaccines.

Safety and effectiveness assessment of 2011-2012 seasonal influenza vaccine produced in China: a randomized trial.

OBJECTIVE: This study evaluated the effectiveness and safety of the egg-based, trivalent, inactivated split influenza vaccine produced by the Institute of Medical Biology, Chinese Academy of Medical Sciences, Peking Union Medical College, China. METHODS: From March 2012 through May 2012, we enrolled a total of 1390 healthy volunteers between the ages of 3 and 80 years in a randomized clinical trial at the Hebei Disease Control Center Vaccine Clinical Evaluation Center. For all subjects, body part adverse reactions and whole-body adverse reactions were observed 30 min, 6 h, and 1-7 days' post-inoculation. If no severe adverse effects were observed 7 days' post-vaccination, the local and systemic reactions of preliminary test participants were recorded until day 28. There was no placebo group in this study. Blood samples were taken for serological testing before vaccination and 28 days' post-vaccination. RESULTS: Twenty-eight days after vaccination, the seroconversion rates of experimental and control groups were H1N1 75.3% and 75.7%, H3N2 75.8% and 71.8%, B 70.7% vs. 69.4%, (P > 0.05). The antibody Geometric Mean Titer（GMT）of experimental and control groups were H1N1 (179.7, 182.4), H3N2 (584.0, 445.7), B (201.4,191.6). The protection rate of experimental and control groups was not statistically significant (H1N1: 86% vs. 87%, H3N2: 99% vs. 98%, B: 98% vs. 98%). Also, 95% confidence intervals of the protection rate difference between the experimental and the control group were H1N1: -0.1% (-4.1,3.8) %, H3N2: 0.3% (-1.0,1.7) % and B: 0.2% (-1.5,1.9) %; confidence intervals exceeded the limit of -5%. The rates of adverse reactions between experimental and control groups were 6.3% and 7.7% in local response reactions, and 19.5% and 18.0% in systemic reactions. Three hundred and twenty-seven adverse events (AEs) in 1200 (27.76%) subjects were reported within 28 d after vaccination. No serious adverse events occurred during the study. CONCLUSIONS: The experimental vaccine three-antibody protection rate was non-inferior to the control vaccine. Our results demonstrated that the experimental vaccine achieved the primary immunogenic end point of the intended clinical protocol, as well as a secondary immunogenic end-point, with an acceptable level of safety. IRB approval for this study was issued under #2012Y0005 and registered as Clinical Trial No. NCT01551810.