Display Settings:

Format

Send to:

Choose Destination
See comment in PubMed Commons below
J Microbiol Immunol Infect. 2013 Dec;46(6):448-55. doi: 10.1016/j.jmii.2012.08.002. Epub 2012 Sep 27.

The Madin-Darby canine kidney cell culture derived influenza A/H5N1 vaccine: a phase I trial in Taiwan.

Author information

  • 1Department of Internal Medicine, National Taiwan University Hospital, Taiwan; College of Medicine, National Taiwan University, Taipei, Taiwan.
  • 2Department of Internal Medicine, National Taiwan University Hospital, Taiwan.
  • 3Vaccine R&D Center, National Institute of Infectious Diseases and Vaccinology, National Health Research Institutes, Zhunan Town, Miaoli County, Taiwan.
  • 4Vaccine R&D Center, National Institute of Infectious Diseases and Vaccinology, National Health Research Institutes, Zhunan Town, Miaoli County, Taiwan; Graduate Institute of Immunology, China Medical University, Taichung, Taiwan.
  • 5Department of Internal Medicine, National Taiwan University Hospital, Taiwan; College of Medicine, National Taiwan University, Taipei, Taiwan. Electronic address: hsmaids@hotmail.com.

Abstract

BACKGROUND:

Avian H5N1 influenza has caused human infections globally and has a high mortality rate. Rapid production of effective vaccines is needed.

METHODS:

A phase 1, randomized, observer-blinded clinical trial was conducted to examine the safety and immunogenicity of an inactivated whole virion vaccine against the influenza A/H5N1 virus produced from the Madin-Darby canine kidney (MDCK) cell line. Participants were randomized to four groups and administered two intramuscular doses of vaccine containing 3 μg hemagglutinin (HA), 3 μg HA with 300 μg aluminum phosphate (AlPO4), 6 μg HA, and 6 μg HA with 300 μg AlPO4, respectively, at two visits, 21 days apart. Serum hemagglutination inhibition (HAI) and neutralizing antibody levels were determined at baseline and on Days 21 and 42.

RESULTS:

Sixty healthy individuals were enrolled. The neutralization assay showed a significant immune response in the 6 μg with ALPO4 group on Day 42 compared to pre-vaccination levels (11.32±9.77 vs. 4.00±0, p=0.02). The adjuvant effect in neutralization assay was also significant on Day 42 in the 6 μg group (4.52±1.94 without adjuvant vs. 11.32±9.77 with adjuvant, p=0.02). HAI assay also showed an aluminum adjuvant-induced increasing trend in HAI geometric mean titer on Day 42 in the 3 μg and 6 μg groups (6.02 versus 8.20, p=0.05 and 5.74 versus 8.21, p=0.14). The most frequent adverse event was local pain (20% to 60%). There were no vaccine-related severe adverse effects.

CONCLUSION:

MDCK cell line-derived H5N1 vaccine was well tolerated. It is necessary to investigate further the immunogenicity of higher antigen doses and the role of aluminum adjuvant in augmenting the effect of the vaccine.

Copyright © 2012. Published by Elsevier B.V.

KEYWORDS:

Adjuvant; Cell culture; Influenza A/H5N1 vaccines

PMID:
23022464
[PubMed - indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Elsevier Science
    Loading ...
    Write to the Help Desk