Immunogenicity and safety of a novel recombinant protective antigen anthrax vaccine (GC1109), a randomized, single-blind, placebo controlled phase II clinical study

Chang Kyung Kang, Nak Hyun Kim, Chung Jong Kim, Gi eun Rhie, Su Kyoung Jo, Misun Ahn, Jieun Kang, Pyoeng Gyun Choe, Wan Beom Park, Nam Joong Kim, Myoung don Oh

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

Abstract

Background: The demand on effective and safe anthrax vaccine is increasing as a part of the preparedness for possible bioterrorism in the future. We performed a randomized, single-blind, placebo controlled phase II clinical study to evaluate the immunogenicity and safety of a novel recombinant protective antigen (rPA) anthrax vaccine, GC1109, in healthy adult volunteers. Methods: Participants were randomized to experiment groups (0.3 mL, 0.5 mL, and 1.0 mL of GC1109) or placebo group (normal saline 0.5 mL) in 2:2:2:1 ratio. They received respective vaccines intramuscularly at 0, 4 and 8 weeks. Immunogenicity was evaluated by seroconversion rate and geometric mean titer (GMT) of lethal toxin neutralizing assay (TNA) and anti-PA IgG by ELISA. Safety was assessed by laboratory tests, and solicited and unsolicited adverse events on diary cards. Results: 30, 29, 30 participants were randomized to 0.3, 0.5, and 1.0 mL of GC1109 groups, respectively, while 15 to placebo group. 92 participants received all three doses. In per-protocol analysis, TNA GMTs at week 12 were 296.5, 285.2, and 433.2 in the three groups, respectively. Seroconversion rates measured by ELISA were 100% at week 12 in the three groups. Local and systemic vaccine-related adverse events were frequent; however, most of them were mild, and no serious events were observed. Conclusions: A new rPA anthrax vaccine GC1109 was immunogenic after three doses of intramuscular administration, and was well-tolerated.

Original languageEnglish
Pages (from-to)3820-3824
Number of pages5
JournalVaccine
Volume37
Issue number29
DOIs
StatePublished - 27 Jun 2019

Keywords

  • Bacillus anthracis
  • Immunogenicity
  • Recombinant protective antigen anthrax vaccine
  • Safety

Fingerprint

Dive into the research topics of 'Immunogenicity and safety of a novel recombinant protective antigen anthrax vaccine (GC1109), a randomized, single-blind, placebo controlled phase II clinical study'. Together they form a unique fingerprint.

Cite this