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 journalArticleResearchpeer-review

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

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Anthrax Vaccines
placebos
clinical trials
Placebos
immune response
vaccines
Safety
Antigens
Vaccines
Enzyme-Linked Immunosorbent Assay
Bioterrorism
seroconversion
neutralization
toxins
enzyme-linked immunosorbent assay
Healthy Volunteers
bioterrorism
anthrax
assays
dosage

Keywords

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

Cite this

@article{e6c1cebcb8744539be15bcc5a29b1691,
title = "Immunogenicity and safety of a novel recombinant protective antigen anthrax vaccine (GC1109), a randomized, single-blind, placebo controlled phase II clinical study",
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.",
keywords = "Bacillus anthracis, Immunogenicity, Recombinant protective antigen anthrax vaccine, Safety",
author = "Kang, {Chang Kyung} and Kim, {Nak Hyun} and Kim, {Chung Jong} and Rhie, {Gi eun} and Jo, {Su Kyoung} and Misun Ahn and Jieun Kang and Choe, {Pyoeng Gyun} and Park, {Wan Beom} and Kim, {Nam Joong} and Myoung-Don Oh",
year = "2019",
month = "6",
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language = "English",
volume = "37",
pages = "3820--3824",
journal = "Vaccine",
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Immunogenicity and safety of a novel recombinant protective antigen anthrax vaccine (GC1109), a randomized, single-blind, placebo controlled phase II clinical study. / Kang, Chang Kyung; Kim, Nak Hyun; Kim, Chung Jong; Rhie, Gi eun; Jo, Su Kyoung; Ahn, Misun; Kang, Jieun; Choe, Pyoeng Gyun; Park, Wan Beom; Kim, Nam Joong; Oh, Myoung-Don.

In: Vaccine, Vol. 37, No. 29, 27.06.2019, p. 3820-3824.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Immunogenicity and safety of a novel recombinant protective antigen anthrax vaccine (GC1109), a randomized, single-blind, placebo controlled phase II clinical study

AU - Kang, Chang Kyung

AU - Kim, Nak Hyun

AU - Kim, Chung Jong

AU - Rhie, Gi eun

AU - Jo, Su Kyoung

AU - Ahn, Misun

AU - Kang, Jieun

AU - Choe, Pyoeng Gyun

AU - Park, Wan Beom

AU - Kim, Nam Joong

AU - Oh, Myoung-Don

PY - 2019/6/27

Y1 - 2019/6/27

N2 - 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.

AB - 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.

KW - Bacillus anthracis

KW - Immunogenicity

KW - Recombinant protective antigen anthrax vaccine

KW - Safety

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