• Infection and chemotherapy
• /
• v.50 no.4
• /
• pp.301-310
• /
• 2018

Backgroud: Influenza vaccination is recommended for adults aged ${\geq}65$ years as they are at high risk of significant morbidity and mortality. This open-label, multicenter, post-marketing surveillance study assessed the safety of the MF59-adjuvanted trivalent inactivated subunit influenza vaccine, which is marketed as $FLUAD^{(R)}$ and $VANTAFLU^{(R)}$, in South Korean subjects aged ${\geq}65$ years. Materials and Methods: Solicited local and systemic adverse events (AEs) were collected from day 1 to 4 of the study. All unsolicited AEs and serious AEs (SAEs) were recorded from day 1 until study termination (day 29). Results: Of the 770 subjects enrolled ($FLUAD^{(R)}$, n = 389; $VANTAFLU^{(R)}$, n = 381), 39% overall experienced any solicited AE. Local AEs were reported by 33% of subjects overall; with the most common events being injection-site pain (30%) and tenderness (27%). Systemic AEs were reported by 19% of subjects overall with the most common events being myalgia (11%) and fatigue (8%). Conclusion: These results show that the MF59-adjuvanted influenza vaccine known as $FLUAD^{(R)}$ or $VANTAFLU^{(R)}$ had acceptable safety profiles in older adults (aged ${\geq}65$ years) in South Korea.

• Clinical and Experimental Pediatrics
• /
• v.57 no.4
• /
• pp.164-170
• /
• 2014

Influenza causes acute respiratory infections and various complications. Children in the high-risk group have higher complication and hospitalization rates than high-risk elderly individuals. Influenza prevention in children is important, as they can be a source infection spread in their communities. Influenza vaccination is strongly recommended for high-risk children with chronic underlying circulatory and respiratory disease, immature infants, and children receiving long-term immunosuppressant treatment or aspirin. However, vaccination rates in these children are low because of concerns regarding the exacerbation of underlying diseases and vaccine efficacy. To address these concerns, many clinical studies on children with underlying respiratory diseases have been conducted since the 1970s. Most of these reported no differences in immunogenicity or adverse reactions between healthy children and those with underlying respiratory diseases and no adverse effects of the influenza vaccine on the disease course. Further to these studies, the inactivated split-virus influenza vaccine is recommended for children with underlying respiratory disease, in many countries. However, the live-attenuated influenza vaccine (LAIV) is not recommended for children younger than 5 years with asthma or recurrent wheezing. Influenza vaccination is contraindicated in patients with severe allergies to egg, chicken, or feathers, because egg-cultivated influenza vaccines may contain ovalbumin. There has been no recent report of serious adverse events after influenza vaccination in children with egg allergy. However, many experts recommend the trivalent influenza vaccine for patients with severe egg allergy, with close observation for 30 minutes after vaccination. LAIV is still not recommended for patients with asthma or egg allergy.

• IMMUNE NETWORK
• /
• v.20 no.4
• /
• pp.31.1-31.14
• /
• 2020

The effectiveness of current influenza vaccines is considered suboptimal, and 1 way to improve the vaccines is using adjuvants. However, the current pool of adjuvants used in influenza vaccination is limited due to safety concerns. Aloe vera, or aloe, has been shown to have immunomodulatory functions and to be safe for oral intake. In this study, we explored the potential of orally administered processed Aloe vera gel (PAG) as an adjuvant for influenza vaccines in C57BL/6 mice. We first evaluated its adjuvanticity with a split-type pandemic H1N1 (pH1N1) Ag by subjecting the mice to lethal homologous influenza challenge. Oral PAG administration with the pH1N1 Ag increased survival rates in mice to levels similar to those of alum and MF59, which are currently used as adjuvants in influenza vaccine formulations. Similarly, oral PAG administration improved the survival of mice immunized with a commercial trivalent influenza vaccine against lethal homologous and heterologous virus challenge. PAG also increased hemagglutination inhibition and virus neutralization Ab titers against homologous and heterologous influenza strains following immunization with the split-type pH1N1 Ag or the commercial trivalent vaccine. Therefore, this study demonstrates that PAG may potentially be used as an adjuvant for influenza vaccines.

• Tuberculosis and Respiratory Diseases
• /
• v.79 no.2
• /
• pp.70-73
• /
• 2016

In late March of 2009, an outbreak of influenza in Mexico, was eventually identified as H1N1 influenza A. In June 2009, the World Health Organization raised a pandemic alert to the highest level. More than 214 countries have reported confirmed cases of pandemic H1N1 influenza A. In Korea, the first case of pandemic influenza A/H1N1 infection was reported on May 2, 2009. Between May 2009 and August 2010, 750,000 cases of pandemic influenza A/H1N1 were confirmed by laboratory test. The H1N1-related death toll was estimated to reach 252 individuals. Almost one billion cases of influenza occurs globally every year, resulting in 300,000 to 500,000 deaths. Influenza vaccination induces virus-neutralizing antibodies, mainly against hemagglutinin, which provide protection from invading virus. New quadrivalent inactivated influenza vaccine generates similar immune responses against the three influenza strains contained in two types of trivalent vaccines and superior responses against the additional B strain.

• Korean Journal of Clinical Pharmacy
• /
• v.29 no.3
• /
• pp.173-185
• /
• 2019

Objective: To gather inputs from clinical experts on selecting and prioritizing research topics, to address unmet vaccine safety needs. Methods: A questionnaire containing 15 vaccine safety assessment research proposals was sent to 28 vaccine experts chosen from various domestic medical association boards, and the rationale for each of the proposals was provided by presenting the following information: 1) a brief summary of the clinical safety studies on the vaccine, conducted by the Clinical Immunization Safety Assessment (CISA) project group, supervised by the United States Center for Disease Control (U.S. CDC), and 2) a summary of recently published studies that address vaccine safety issues. The experts were instructed to select and rank 5 topics in the order of preference, and the preference score for each proposed topic was calculated by assigning points on a scale of 1 to 5. Results: All 28 experts responded to the questionnaire, and the following topics were selected according to their calculated preference scores: 1) Human papillomavirus vaccine safety profile in the Korean female adolescents; 2) A signal detection of adverse events following Influenza vaccination: comparison between the US and South Korea; 3) Incidence of anaphylaxis following National Immunization Program vaccines between 2008 and 2017; 4) Safety of quadrivalent influenza vaccines compared to trivalent influenza vaccines; and 5) Pneumococcal vaccine safety profile in the general population. Conclusion: Five research topics addressing vaccine safety were selected, for which well-constructed research protocols need to be promptly developed to address current unmet vaccine safety needs in South Korea.

• Pediatric Infection and Vaccine
• /
• v.18 no.1
• /
• pp.68-79
• /
• 2011

Purpose : This post-marketing surveillance study (NCT00750360) assessed the safety and reactogenicity of an inactivated, trivalent split-virion influenza vaccine licensed for use in the Korea since 2002. Methods : Eight hundred and eighty three subjects aged 6 months received a single dose of the ${\geq}$ vaccine; an additional dose was administered to those aged <9 years and unprimed with an influenza vaccine. Four hundred and eleven subjects used diary cards to record safety information; this report presents data from these subjects. Incidence of solicited local, general and unsolicited adverse events (4-days and 21-days post-vaccination follow-up periods, respectively) were recorded. Serious adverse events (SAEs) were recorded throughout the study period. Results : Injection site pain (subjects aged <6 years: 12.6% of subjects, ${\geq}$6 years: 34.7%), fever (<6 years: 1.3%) and myalgia (${\geq}$6 years: 13.9%) were the most frequently recorded solicited local and general adverse events. Grade 3 solicited adverse events were reported by ${\leq}$4.0% subjects. No vaccine-related SAEs were recorded (KFDA criteria). Conclusion : Considering the vaccine's well-established immunogenicity and its favourable safety and reactogenicity profile across all age groups and its high coverage rate in Korea, it may be recommended as a candidate to facilitate annual seasonal influenza vaccination for all ages as part of the Korean National Immunization Program.

• Pediatric Infection and Vaccine
• /
• v.26 no.3
• /
• pp.161-169
• /
• 2019

Purpose: This study was conducted to compare immunogenicities and reactogenicities of the trivalent inactivated subunit influenza vaccine and split influenza vaccine in Korean children and adolescents. Methods: In total, 202 healthy children aged 36 months to <18 years were enrolled at six hospitals in Korea from October to December 2008. The subjects were vaccinated with either the split or subunit influenza vaccine. The hemagglutinin inhibition antibody titers against the H1N1, H3N2, and B virus strains were measured, and the seroconversion rates, seroprotection rates, and geometric mean titers were calculated. All subjects were observed for local and systemic reactions. Results: Both the split and subunit vaccine groups had similar seroprotection rates against all strains (95.9%, 94.9%, 96.9% vs. 96.0%, 90.9%, and 87.9%). In children aged 36 to <72 months, the seroprotection rates were similar between the two vaccine groups. In children aged 72 months to <18 years, both vaccines showed high seroprotection rates against the H1N1, H3N2, and B strain (98.4%, 98.4%, 98.4% vs. 97.0%, 95.5%, and 91.0%), but showed relatively low seroconversion rates (39.1%, 73.4%, 35.9% vs. 34.3%, 55.2%, and 38.8%). There were more local and systemic reactions in the split vaccine group than in the subunit vaccine group; however, no serious adverse reactions were observed in both groups. Conclusions: Both the split and subunit vaccines showed acceptable immunogenicity in all age groups. There were no serious adverse events with both vaccines.

• Pediatric Infection and Vaccine
• /
• v.25 no.1
• /
• pp.35-44
• /
• 2018

Purpose: This study aimed to evaluate the immunogenicity and safety of a trivalent inactivated influenza vaccine (TIV) among healthy Korean children and adolescents. Methods: From October to December 2008, 65 healthy patients aged 6 months to 18 years who visited Korea University Ansan Hospital for influenza vaccination were enrolled in this study. We measured the hemagglutinin inhibition antibody titers at baseline and 30 days after vaccinating enrollees with split influenza vaccine and calculated the seroprotection rates, geometric mean titers, and seroconversion rates. Local and systemic adverse events were assessed after vaccination. Results: The seroprotection rates against all three viral strains (A/H1N1, A/H3N2, B) were 87.7%, 89.2%, and 89.2% (${\geq}70%$), respectively; seroconversion rates were 44.6%, 73.8%, and 63.1% (${\geq}40%$), respectively; and seroconversion factors were 4.5, 8.4, and 10.5 (>2.5), respectively. The TIV immunogenicity was acceptable according to the CPMP (Committee for Proprietary Medicinal Products) criteria. Although 48 patients (73.8%) reported one or more adverse events, no severe adverse events such as anaphylaxis and convulsion were observed. Forty-two patients (64.6%) reported a local skin reaction, including redness (29.2%), pain (43.1%), or swelling (41.5%) of the injected site, and 26 (40.0%) reported a systemic reaction: fatigue (23.1%), myalgia (20.0%), headache (10.8%), arthralgia (10.8%), chills (9.2%), or fever (7.7%). Conclusions: This study shows that the immunogenicity of the TIV vaccine is acceptable. As there were no serious adverse events aside from local reactions and mild systemic reactions, this vaccine can be safely used among healthy Korean children and adolescents.