Yonsei Med J.  2016 Nov;57(6):1354-1360. 10.3349/ymj.2016.57.6.1354.

Immunogenicity and Safety of Trivalent Split Influenza Vaccine in Healthy Korean Adults with Low Pre-Existing Antibody Levels: An Open Phase I Trial

• Kang K
• Han S
• Hong T
• Jeon S
• Paek J
• Kang JH
• Yim DS

• KMID: 2427152
• DOI: http://doi.org/10.3349/ymj.2016.57.6.1354

Abstract

PURPOSE
A phase I clinical trial was conducted to evaluate the immunogenicity and safety of newly developed egg-cultivated trivalent inactivated split influenza vaccine (TIV) in Korea.
MATERIALS AND METHODS
The TIV was administered to 43 healthy male adults. Subjects with high pre-existing titers were excluded in a screening step. Immune response was measured by a hemagglutination inhibition (HI) assay.
RESULTS
The seroprotection rates against A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2009 were 74.42% [95% confidence interval (CI): 61.38-87.46], 72.09% (95% CI: 58.69-85.50), and 86.05% (95% CI: 75.69-96.40), respectively. Calculated seroconversion rates were 74.42% (95% CI: 61.38-87.46), 74.42% (95% CI: 61.38-87.46), and 79.07% (95% CI: 66.91-91.23), respectively. There were 25 episodes of solicited local adverse events in 21 subjects (47.73%), 21 episodes of solicited general adverse events in 16 subjects (36.36%) and 5 episodes of unsolicited adverse events in 5 subjects (11.36%). All adverse events were grade 1 or 2 and disappeared within three days.
CONCLUSION
The immunogenicity and safety of TIV established in this phase I trial are sufficient to plan a larger scale clinical trial.

Keyword

Trivalent influenza split vaccine; safety; immunogenicity; pre-existing HI titer; phase I influenza vaccine study

MeSH Terms

Adult
Antibodies, Viral/*blood
Asian Continental Ancestry Group
Female
Hemagglutination Inhibition Tests
Humans
Influenza A Virus, H1N1 Subtype/*immunology
Influenza A Virus, H3N2 Subtype/*immunology
Influenza Vaccines/administration & dosage/*adverse effects/immunology
Influenza, Human/blood/immunology/prevention & control
Male
Middle Aged
Republic of Korea
Vaccination/*methods
Vaccines, Inactivated/administration & dosage/adverse effects/immunology
Antibodies, Viral
Influenza Vaccines
Vaccines, Inactivated

Figure

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  Fig. 1 Flowchart of subject participation and demographics. SD, standard deviation.

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