Immunogenicity and safety of a novel recombinant protective antigen anthrax vaccine (GC1109), a randomized, single-blind, placebo controlled phase II clinical study.
Vaccine
; 37(29): 3820-3824, 2019 06 27.
Article
in En
| MEDLINE
| ID: mdl-31151800
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 (0.3â¯mL, 0.5â¯mL, and 1.0â¯mL of GC1109) or placebo group (normal saline 0.5â¯mL) in 2221 ratio. They received respective vaccines intramuscularly at 0, 4 and 8â¯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 1.0â¯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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Bacterial Toxins
/
Recombinant Proteins
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Anthrax Vaccines
/
Immunogenicity, Vaccine
/
Antigens, Bacterial
Type of study:
Clinical_trials
/
Guideline
Limits:
Adolescent
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Adult
/
Female
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Humans
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Male
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Middle aged
Language:
En
Journal:
Vaccine
Year:
2019
Document type:
Article