OBJECTIVEUsing the advantages of Japanese encephalitis live attenuated and inactivated vaccine, to reduce the rate of immunization reaction and to increase the effect, we conducted a study on the strategy of immunization in Japanese encephalitis using live attenuated vaccine combined with inactivated vaccine.

METHODSObserving the safety and immune effects of different groups.

RESULTSData on side effect showed that the rate of moderate and severe systematic reactions of the group who were inoculated with combined vaccine was 0.73%, with local reaction 1.46% while the combined rate of moderate and severe systematic reaction of the group who were inoculated with inactivated vaccine was 2.8%. Under the detection of serum neutralizing antibody, the GMT rose from 1:1.05 - 1:3.35 before vaccination to 1:47.34 - 1:101.30 after vaccination in the different groups. Neutralizing antibody was detected in 97.67% of the combined group. There was a significant difference by comparing neutralizing antibody seroconversion rate of the combined group with the inactivated group (chi(2) = 3.89, P < 0.05), but no significant difference with attenuated group (chi(2) = 0.74, P > 0.05).

CONCLUSIONResults showed that in children who previously had been immunized with two doses of inactivated vaccine, the booster administration of live attenuated vaccine was both effective and safe.

Antibodies, Viral ; blood ; Child, Preschool ; Encephalitis Virus, Japanese ; immunology ; Humans ; Immunization ; Japanese Encephalitis Vaccines ; administration & dosage ; adverse effects ; immunology ; Vaccines, Attenuated ; immunology ; Vaccines, Inactivated ; immunology

Child, Preschool ; China ; Female ; Hepatitis A ; immunology ; prevention & control ; Hepatitis A Antibodies ; blood ; Hepatitis A Vaccines ; adverse effects ; immunology ; Humans ; Infant ; Male ; Safety ; Sampling Studies ; Vaccination ; Vaccines, Inactivated ; adverse effects ; immunology

Although the overall incidence of hepatitis A in Korea has been decreasing, adolescents remain highly vulnerable to its outbreaks. This study was conducted to compare the immunogenicity and safety of three hepatitis A vaccines in Korean adolescents. Healthy anti-hepatitis A virus seronegative subjects aged 13 to 19 yr were randomized in three equal groups to receive two doses of Avaxim(TM), Epaxal(R), or Havrix(R), 6 to 12 months apart. Seroconversion rates one month after the first dose were 98%, 95%, and 93% for Avaxim(TM), Epaxal(R), and Havrix(R), respectively. Seroconversion rates reached 100% for all vaccine groups one month after the second dose. Anti-HAV geometric mean concentrations (GMCs) were 7,207.7 mIU/mL (95% CI, 6023.1-8684.7), 1,750.5 mIU/mL (95% CI, 1362.9-2248.3), and 1,953.5 mIU/mL (95% CI, 1459.4-2614.7) after two doses of Avaxim(TM), Epaxal(R), and Havrix(R) respectively. Avaxim(TM) was significantly more immunogenic than Epaxal(R) and Havrix(R), whereas there were no significant differences in antibody responses between Epaxal(R) and Havrix(R). Local and systemic solicited adverse events (AEs) were mostly of mild-to-moderate intensity and resolved within 5 days. No serious AEs were reported. In conclusion, all three vaccines are highly immunogenic and well-tolerated in Korean adolescents. (Clinical Trial Registry NCT00483470)
Adolescent ; Antibody Formation ; Female ; Hepatitis A/immunology/*prevention & control ; Hepatitis A Antibodies/blood ; Hepatitis A Vaccines/adverse effects/*immunology ; Humans ; Male ; Republic of Korea ; Vaccines, Inactivated/adverse effects/immunology ; Young Adult

Influenza vaccines are the primary method for controlling influenza and its complications. This study was conducted as a phase 3, randomized, double-blind, controlled, multi-center trial at seven university hospitals to evaluate the immunogenicity and safety of an inactivated, split, trivalent influenza vaccine (GC501, Green Cross Corporation, Yongin, Korea), which was newly manufactured in Korea in 2008. Between September 21 and 26, a total of 329 healthy subjects were recruited for the immunogenicity analysis, while 976 subjects were enrolled for the safety analysis. The GC501 vaccine met both FDA and EMEA criteria with > or = 80% of subjects achieving post-vaccination titers > or = 40 for all three subtypes, even in the elderly. The vaccine was well tolerated with only mild systemic and local adverse events. In summary, GC501 showed excellent immunogenicity and a good safety profile in both young adults and the elderly. The licensure of GC501 might be an important basis in preparation for the future influenza pandemic.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Double-Blind Method ; Humans ; Influenza Vaccines/administration & dosage/*adverse effects/*immunology ; Influenza, Human/*prevention & control ; Male ; Middle Aged ; Republic of Korea ; Vaccination ; Vaccines, Inactivated/administration & dosage/adverse effects/immunology ; Young Adult

Objective: To evaluate the immunogenicity of inactivated quadrivalent influenza vaccine (QIV) in adults aged 18-64 years, through a Meta-analysis. Methods: Literature was retrieved by searching the Medline, Cochrane Library, Science Direct in the past decade. All the studies were under random control trial (RCT) and including data related to immunogenicity which involving sero-protection rate (SPR) and sero-conversion rate (SCR) of the QIV, versus inactivated trivalent influenza vaccine (TIV) in the population aged 18 to 64. Revman 5.3 software was employed to manipulate the pooled date of the included literature. Result: A total of 8 studies for the SPR and SCR of the shared strains (two A lineage and one B lineage) were included. There appeared no significant differences in the response rates between the two vaccines. As for QIV versus TIV (B/Yamagata), the pooled RR of the SPR for B/Victoria was 1.28 (95%CI: 1.08-1.51, P<0.05), with the pooled RR of the SCR for B/Victoria as 1.94 (95%CI: 1.50-2.50, P<0.05). For QIV versus TIV (B/Victoria), the pooled RR of the SPR for B/Yamagata as 1.10 (95%CI: 1.02-1.18, P<0.05), and the pooled RR of SCR for B/Yamagata as 1.99 (95%CI: 1.34-2.97, P<0.05). Conclusion: In the population aged 18-64 years, inactivated QIV was equivalently immunogenic against the shared three strains included in the activated TIV while a superior immunogenic effect was noticed in the vaccine strain which did not include the inactivated QIV.
Adolescent ; Adult ; Antibodies, Viral/blood* ; Drug-Related Side Effects and Adverse Reactions ; Hemagglutination Inhibition Tests ; Humans ; Influenza A virus/immunology* ; Influenza B virus/immunology* ; Influenza Vaccines/immunology* ; Influenza, Human/prevention & control* ; Middle Aged ; Vaccines, Inactivated/immunology* ; Young Adult

OBJECTIVETo compare the reactogenicity and serology between influenza subunit vaccine and split vaccine.

METHODSA randomized, double-blind study was carried out among children (age 6 - 12 years) in order to compare the safety and immunogenicity of an influenza inactivated subunit vaccine (Agrippal, Chiron Vaccines) with that of a split vaccine (Flurix, GSK).

RESULTSA total of 499 subjects were vaccinated and included in the safety analysis. A total of 249 subjects received Agrippal and 250 received Flurix. All subjects were kept under medical observation for 30 minutes in order to check the evidence of having any immediate local and systemic reaction. Daily observation records were collected during the 3-day follow-up after vaccination. 6.4% of the cases with fever >or= 37.5 degrees C was reported in the Flurix group, but 2.4% in Agrippal group which was significantly less than the former group (P > 0.05). Blood samples (the D0 pre- and D23 post-vaccination sera) were collected from 224 of Agrippal group and 223 of Flurix group and analysed by the haemagglutination inhibition (HI) assay. Agrippal and Flurix induced similar seroprotection (HI titer >or= 1:40, H1N1 99.6% vs 100.0%; H3N2 99.1% vs 99.1%) and seroconversion (4-fold increase, 95.1% vs 97.8%; H3N2 74.5% vs 79.8%) rates and geometric mean titer (GMT) increase (16.0 vs 21.0; 5.4 vs 6.4) against the two A subtypes. A similar seroprotection rate (94.2% vs 96.4%) and GMT increase (21.2 vs 18.2) against the influenza B strain were also noticed in both vaccines. No significant difference was found in the results of immunological assay between the two vaccines (P < 0.05). A lower seroconversion rate against B strain was observed in Agrippal group than in Flurix group (91.1% vs 97.3%).

CONCLUSIONIn terms of safety, both vaccines were generally well tolerated. The fever reaction was less frequently seen in the Agrippal group. Both vaccines induced an effective immune response in the vaccines.

Antibodies, Viral ; blood ; Child ; Double-Blind Method ; Female ; Fever ; chemically induced ; Hemagglutination Inhibition Tests ; Humans ; Influenza A virus ; immunology ; Influenza B virus ; immunology ; Influenza Vaccines ; adverse effects ; classification ; immunology ; Influenza, Human ; prevention & control ; Male ; Safety ; Vaccination ; Vaccines, Inactivated ; adverse effects ; immunology ; Vaccines, Subunit ; adverse effects ; immunology

We report results of a randomized, double-blinded, active-controlled, phase III study conducted to evaluate the immunogenicity and safety of a new trivalent inactivated split-virus influenza vaccine (GC501) manufactured by the Green Cross Corporation in Korea. A total of 283 healthy children aged 6 months to < 18 yr were randomized to receive either GC501 or control. Of the GC501 recipients, seroconversion occurred in 48.5% for A/H1N1, 67.7% for A/H3N2 and 52% for influenza B. The proportion of subjects who had post-vaccination hemagglutination-inhibition titers of 1:40 or greater was 90.7% for A/H1N1, 86.8% for A/H3N2 and 82.4% for influenza B in the GC501 recipients. No serious adverse events related to vaccination, or withdrawals because of adverse events were reported. The majority of solicited adverse events were mild in intensity. GC501 vaccine has good tolerability and favorable immunogenicity in children aged 6 months to < 18 yr. The addition of one more brand of influenza vaccine may allow for better global accessibility of vaccine for epidemics or future pandemics.
Adolescent ; Antibodies, Viral/*blood ; Child ; Child, Preschool ; Double-Blind Method ; Female ; Humans ; Infant ; Influenza A Virus, H1N1 Subtype/*immunology ; Influenza A Virus, H3N2 Subtype/*immunology ; Influenza B virus/*immunology ; Influenza Vaccines/*adverse effects/*immunology ; Male ; Republic of Korea ; Vaccination ; Vaccines, Inactivated/adverse effects/immunology

OBJECTIVETo evaluate the safety and immunogenicity of influenza split vaccine.

METHODSAccording to the criteria of No.2002SL0043, instruction of application for new drug in clinical trial issued by the State Food and Drug Administration, 876 healthy persons were divided at random into vaccine group and control group. The trial was performed with the double blind method. Local and systemic adverse reactions were observed within 3 days after the vaccine group subjects were vaccinated. The antibody response to vaccines was detected with hemagglutination inhibition (HI) test. Numbers of seroconversions and HI titers greater than or equal to 40, as well as the mean geometric titer increase in HI were analyzed.

RESULTSThere was no significant difference in local and systemic adverse reaction between vaccine and control groups. Meanwhile there was also no significant difference in seroconversions and protective level between two groups. However, there was obvious difference in mean geometric titer increase of antibody against H1N1 virus, while there was no significant difference in that of antibodies to H3N2 and type B viruses.

CONCLUSIONSThe safety and immunogenicity of both vaccines are excellent.

Adolescent ; Adult ; Aged ; Antibodies, Viral ; blood ; Child ; Child, Preschool ; Double-Blind Method ; Fever ; chemically induced ; Hemagglutination Inhibition Tests ; Humans ; Infant ; Influenza A virus ; immunology ; Influenza B virus ; immunology ; Influenza Vaccines ; adverse effects ; classification ; immunology ; Influenza, Human ; prevention & control ; Middle Aged ; Safety ; Vaccines, Inactivated ; adverse effects ; classification ; immunology