Safety and immunogenicity of an inactivated cell culture-derived H7N9 influenza vaccine in healthy adults: A phase I/II, prospective, randomized, open-label trial

Un In Wu, Szu Min Hsieh, Wen Sen Lee, Ning Chi Wang, Hsiang Chi Kung, Tsong Yih Ou, Fu Lun Chen, Te Yu Lin, Yee Chun Chen, Shan Chwen Chang

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Background: We conducted a phase I/II clinical trial to evaluate the safety and immunogenicity of a Madin-Darby canine kidney (MDCK) cell-grown inactivated H7N9 influenza vaccine for pandemic preparedness purposes. Methods: Between April 7, 2015 and May 27, 2016, healthy adults aged 20-60. years were enrolled sequentially in phase I (n = 40) and phase II (n = 160) from three hospitals in Taiwan and randomized to receive 2 doses of whole-virus H7N9 vaccine (15 or 30. μg hemagglutinin antigen (HA) with or without an aluminum hydroxide adjuvant) at 21-day intervals. Safety up to 180. days and changes in hemagglutinin inhibition (HI) titers at 21. days after each vaccination were determined. Results: Of the 200 randomized subjects, 193 (96.5%) received 2 doses of the study vaccine and were included in the intention-to-treat analysis for safety, and 190 (95%) were included in the per-protocol analysis for immunogenicity. Most adverse events were mild and transient; no death or vaccine-related serious adverse events were reported. Overall, higher immune responses were observed in the groups administered with 30. μg. HA formulation than in the other two groups administered with 15. μg. HA formulation. The highest immune response was observed in subjects who received 2 doses of the adjuvanted vaccine containing 30. μg. HA with HI titer, seroprotection rate, seroconversion rate, and seroconversion factor of 36.2, 64.6%, 64.6% and 5.7, respectively. Conclusions: Our study demonstrated that the H7N9 influenza vaccine containing 30. μg. HA with aluminum hydroxide adjuvant was immunogenic and safe in adults aged 20-60. years.CLINICALTRIALS.GOV identifier: NCT02436928.

Original languageEnglish
JournalVaccine
DOIs
Publication statusAccepted/In press - 2017

Fingerprint

Influenza Vaccines
Hemagglutinins
hemagglutinins
influenza
cell culture
Cell Culture Techniques
immune response
vaccines
Safety
antigens
Antigens
Vaccines
Aluminum Hydroxide
aluminum hydroxide
seroconversion
adjuvants
H7N9 Subtype Influenza A Virus
dosage
Phase II Clinical Trials
Clinical Trials, Phase I

Keywords

  • H7N9 influenza
  • Immunogenicity
  • Safety
  • Vaccine

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

Cite this

Safety and immunogenicity of an inactivated cell culture-derived H7N9 influenza vaccine in healthy adults : A phase I/II, prospective, randomized, open-label trial. / Wu, Un In; Hsieh, Szu Min; Lee, Wen Sen; Wang, Ning Chi; Kung, Hsiang Chi; Ou, Tsong Yih; Chen, Fu Lun; Lin, Te Yu; Chen, Yee Chun; Chang, Shan Chwen.

In: Vaccine, 2017.

Research output: Contribution to journalArticle

Wu, Un In ; Hsieh, Szu Min ; Lee, Wen Sen ; Wang, Ning Chi ; Kung, Hsiang Chi ; Ou, Tsong Yih ; Chen, Fu Lun ; Lin, Te Yu ; Chen, Yee Chun ; Chang, Shan Chwen. / Safety and immunogenicity of an inactivated cell culture-derived H7N9 influenza vaccine in healthy adults : A phase I/II, prospective, randomized, open-label trial. In: Vaccine. 2017.
@article{51a7c6f1e9824756ae2aadb30567a47a,
title = "Safety and immunogenicity of an inactivated cell culture-derived H7N9 influenza vaccine in healthy adults: A phase I/II, prospective, randomized, open-label trial",
abstract = "Background: We conducted a phase I/II clinical trial to evaluate the safety and immunogenicity of a Madin-Darby canine kidney (MDCK) cell-grown inactivated H7N9 influenza vaccine for pandemic preparedness purposes. Methods: Between April 7, 2015 and May 27, 2016, healthy adults aged 20-60. years were enrolled sequentially in phase I (n = 40) and phase II (n = 160) from three hospitals in Taiwan and randomized to receive 2 doses of whole-virus H7N9 vaccine (15 or 30. μg hemagglutinin antigen (HA) with or without an aluminum hydroxide adjuvant) at 21-day intervals. Safety up to 180. days and changes in hemagglutinin inhibition (HI) titers at 21. days after each vaccination were determined. Results: Of the 200 randomized subjects, 193 (96.5{\%}) received 2 doses of the study vaccine and were included in the intention-to-treat analysis for safety, and 190 (95{\%}) were included in the per-protocol analysis for immunogenicity. Most adverse events were mild and transient; no death or vaccine-related serious adverse events were reported. Overall, higher immune responses were observed in the groups administered with 30. μg. HA formulation than in the other two groups administered with 15. μg. HA formulation. The highest immune response was observed in subjects who received 2 doses of the adjuvanted vaccine containing 30. μg. HA with HI titer, seroprotection rate, seroconversion rate, and seroconversion factor of 36.2, 64.6{\%}, 64.6{\%} and 5.7, respectively. Conclusions: Our study demonstrated that the H7N9 influenza vaccine containing 30. μg. HA with aluminum hydroxide adjuvant was immunogenic and safe in adults aged 20-60. years.CLINICALTRIALS.GOV identifier: NCT02436928.",
keywords = "H7N9 influenza, Immunogenicity, Safety, Vaccine",
author = "Wu, {Un In} and Hsieh, {Szu Min} and Lee, {Wen Sen} and Wang, {Ning Chi} and Kung, {Hsiang Chi} and Ou, {Tsong Yih} and Chen, {Fu Lun} and Lin, {Te Yu} and Chen, {Yee Chun} and Chang, {Shan Chwen}",
year = "2017",
doi = "10.1016/j.vaccine.2017.06.044",
language = "English",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier BV",

}

TY - JOUR

T1 - Safety and immunogenicity of an inactivated cell culture-derived H7N9 influenza vaccine in healthy adults

T2 - A phase I/II, prospective, randomized, open-label trial

AU - Wu, Un In

AU - Hsieh, Szu Min

AU - Lee, Wen Sen

AU - Wang, Ning Chi

AU - Kung, Hsiang Chi

AU - Ou, Tsong Yih

AU - Chen, Fu Lun

AU - Lin, Te Yu

AU - Chen, Yee Chun

AU - Chang, Shan Chwen

PY - 2017

Y1 - 2017

N2 - Background: We conducted a phase I/II clinical trial to evaluate the safety and immunogenicity of a Madin-Darby canine kidney (MDCK) cell-grown inactivated H7N9 influenza vaccine for pandemic preparedness purposes. Methods: Between April 7, 2015 and May 27, 2016, healthy adults aged 20-60. years were enrolled sequentially in phase I (n = 40) and phase II (n = 160) from three hospitals in Taiwan and randomized to receive 2 doses of whole-virus H7N9 vaccine (15 or 30. μg hemagglutinin antigen (HA) with or without an aluminum hydroxide adjuvant) at 21-day intervals. Safety up to 180. days and changes in hemagglutinin inhibition (HI) titers at 21. days after each vaccination were determined. Results: Of the 200 randomized subjects, 193 (96.5%) received 2 doses of the study vaccine and were included in the intention-to-treat analysis for safety, and 190 (95%) were included in the per-protocol analysis for immunogenicity. Most adverse events were mild and transient; no death or vaccine-related serious adverse events were reported. Overall, higher immune responses were observed in the groups administered with 30. μg. HA formulation than in the other two groups administered with 15. μg. HA formulation. The highest immune response was observed in subjects who received 2 doses of the adjuvanted vaccine containing 30. μg. HA with HI titer, seroprotection rate, seroconversion rate, and seroconversion factor of 36.2, 64.6%, 64.6% and 5.7, respectively. Conclusions: Our study demonstrated that the H7N9 influenza vaccine containing 30. μg. HA with aluminum hydroxide adjuvant was immunogenic and safe in adults aged 20-60. years.CLINICALTRIALS.GOV identifier: NCT02436928.

AB - Background: We conducted a phase I/II clinical trial to evaluate the safety and immunogenicity of a Madin-Darby canine kidney (MDCK) cell-grown inactivated H7N9 influenza vaccine for pandemic preparedness purposes. Methods: Between April 7, 2015 and May 27, 2016, healthy adults aged 20-60. years were enrolled sequentially in phase I (n = 40) and phase II (n = 160) from three hospitals in Taiwan and randomized to receive 2 doses of whole-virus H7N9 vaccine (15 or 30. μg hemagglutinin antigen (HA) with or without an aluminum hydroxide adjuvant) at 21-day intervals. Safety up to 180. days and changes in hemagglutinin inhibition (HI) titers at 21. days after each vaccination were determined. Results: Of the 200 randomized subjects, 193 (96.5%) received 2 doses of the study vaccine and were included in the intention-to-treat analysis for safety, and 190 (95%) were included in the per-protocol analysis for immunogenicity. Most adverse events were mild and transient; no death or vaccine-related serious adverse events were reported. Overall, higher immune responses were observed in the groups administered with 30. μg. HA formulation than in the other two groups administered with 15. μg. HA formulation. The highest immune response was observed in subjects who received 2 doses of the adjuvanted vaccine containing 30. μg. HA with HI titer, seroprotection rate, seroconversion rate, and seroconversion factor of 36.2, 64.6%, 64.6% and 5.7, respectively. Conclusions: Our study demonstrated that the H7N9 influenza vaccine containing 30. μg. HA with aluminum hydroxide adjuvant was immunogenic and safe in adults aged 20-60. years.CLINICALTRIALS.GOV identifier: NCT02436928.

KW - H7N9 influenza

KW - Immunogenicity

KW - Safety

KW - Vaccine

UR - http://www.scopus.com/inward/record.url?scp=85021388685&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85021388685&partnerID=8YFLogxK

U2 - 10.1016/j.vaccine.2017.06.044

DO - 10.1016/j.vaccine.2017.06.044

M3 - Article

C2 - 28668573

AN - SCOPUS:85021388685

JO - Vaccine

JF - Vaccine

SN - 0264-410X

ER -