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Open study of quadrivalent VN-100 in Japanese healthy volunteers

Open study of quadrivalent VN-100 in Japanese healthy volunteers

150

To confirm the safety and immunogenicity of quadrivalent VN-100 in Japanese healthy volunteers 13 years and older

In this study, 150 subjects (13 to 65 years: 100 subjects, 65 years and older: 50 subjects) were enrolled, and all subjects received the 2nd administered vaccines and completed. None of the subjects discontinued in this study.

- During the study, no SAEs or AEs that lead to study discontinuation were observed. - Incidence of injection site AEs was 96.7% (145/150), and the main injection site AEs were injection site erythema, injection site swelling, injection site pruritus, injection site hot feeling, injection site pain, and injection site induration. - Incidence of systemic AEs was 30.0% (45/150), and the main systemic AEs were headache, fatigue, nasopharyngitis, fever, and chills.

1) The subjects 13 to 65 years of age (n=100) - The seroprotection rate in HI antibody titer approximately 3 weeks after 1st vaccination was A/H1N1 98.0%, A/H3N2 98.0%, B/Yamagata 40.0%, B/Victoria 82.0%. The seroconversion rate was A/H1N1 64.0%, A/H3N2 56.0%, B/Yamagata 22.0%, B/Victoria 62.0%. The GMT ratio was A/H1N1 7.608, A/H3N2 5.948, B/Yamagata 2.501, B/Victoria 5.657. - The seroprotection rate in HI antibody titer approximately 3 weeks after 2nd vaccination was A/H1N1 99.0%, A/H3N2 99.0%, B/Yamagata 53.0%, B/Victoria 78.0%. The seroconversion rate was A/H1N1 61.0%, A/H3N2 58.0%, B/Yamagata 45.0%, B/Victoria 61.0%. The GMT ratio was A/H1N1 6.498, A/H3N2 5.647, B/Yamagata 3.068, B/Victoria 4.985. 2) The subjects 65 years and older (n=50) - The seroprotection rate in HI antibody titer approximately 3 weeks after 1st vaccination was A/H1N1 94.0%, A/H3N2 100.0%, B/Yamagata 20.0%, B/Victoria 62.0%. The seroconversion rate was A/H1N1 78.0%, A/H3N2 62.0%, B/Yamagata 14.0%, B/Victoria 48.0%. The GMT ratio was A/H1N1 9.383, A/H3N2 6.589, B/Yamagata 2.420, B/Victoria 4.595. - The seroprotection rate in HI antibody titer approximately 3 weeks after 2nd vaccination was A/H1N1 94.0%, A/H3N2 100.0%, B/Yamagata 44.0%, B/Victoria 56.0%. The seroconversion rate was A/H1N1 76.0%, A/H3N2 64.0%, B/Yamagata 42.0%, B/Victoria 44.0%. The GMT ratio was A/H1N1 8.634, A/H3N2 6.589, B/Yamagata 3.000, B/Victoria 4.469.

1) The subjects 13 to 65 years of age (n=100) - The seroprotection rate in SRH antibody titer approximately 3 weeks after 2nd vaccination was A/H1N1 99.0%, A/H3N2 97.0%, B/Yamagata 100.0%, B/Victoria 100.0%. The seroconversion rate was A/H1N1 63.0%, A/H3N2 62.0%, B/Yamagata 41.0%, B/Victoria 66.0%. The GMT ratio was A/H1N1 2.526, A/H3N2 2.043, B/Yamagata 1.823, B/Victoria 2.262. - The seroprotection rate in neutralizing antibody titer approximately 3 weeks after 2nd vaccination was A/H1N1 70.0%, A/H3N2 100.0%, B/Yamagata 66.0%, B/Victoria 55.0%. The seroconversion rate was A/H1N1 51.0%, A/H3N2 54.0%, B/Yamagata 42.0%, B/Victoria 52.0%. The GMT ratio was A/H1N1 5.589, A/H3N2 4.807, B/Yamagata 3.434, B/Victoria 5.512. 2) The subjects 65 years and older (n=50) - The seroprotection rate in SRH antibody titer approximately 3 weeks after 2nd vaccination was A/H1N1 94.0%, A/H3N2 94.0%, B/Yamagata 100.0%, B/Victoria 98.0%. The seroconversion rate was A/H1N1 80.0%, A/H3N2 62.0%, B/Yamagata 70.0%, B/Victoria 70.0%. The GMT ratio was A/H1N1 4.934, A/H3N2 2.331, B/Yamagata 2.693, B/Victoria 3.449. - The seroprotection rate in neutralizing antibody titer approximately 3 weeks after 2nd vaccination was A/H1N1 42.0%, A/H3N2 100.0%, B/Yamagata 52.0%, B/Victoria 36.0%. The seroconversion rate was A/H1N1 38.0%, A/H3N2 52.0%, B/Yamagata 48.0%, B/Victoria 32.0%. The GMT ratio was A/H1N1 3.986, A/H3N2 4.098, B/Yamagata 4.423, B/Victoria 3.543.

As a result of 2nd intradermal vaccinated of quadrivalent VN-100 in healthy Japanese 13 years and older, no serious AEs or AEs leading to this study discontinuation occurred. Therefore we thought there was no serious issues with safety. In addition, HI antibody titer, SRH antibody titer, and neutralizing antibody titer increased after vaccinated of quadrivalent VN-100, confirming good immunogenicity.

No

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DAIICHISANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

DAIICHISANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

completed

Oct. 29, 2014

Interventional

Single-center, uncontrolled, open-label study

prevention purpose

3

Japanese healthy volunteers

1) Subjects with history of seasonal influenza in the past 6 months
2) Subjects with history of seasonal influenza vaccination in the past 6 months

Both

Prophylaxis of influenza infection

investigational material(s)
Generic name etc : VN-100 (intradermal vaccine for seasonal influenza)
INN of investigational material : -
Therapeutic category code : 631 Vaccines
Dosage and Administration for Investigational material : Intradermal

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

safety
efficacy
1) Safety endpoints: adverse events, laboratory values and body temperature
2) Immunology endpoints: HI antibody titer, SRH antibody titer and neutralizing antibody titer

-

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Oct. 17, 2014