This is a randomized, parallel-group, double-blind, Phase 1 study designed to assess safety, tolerability and immunogenicity 2 formulations of adjuvanted anthrax vaccine (AV7909), lyophilized and liquid. Forty healthy young adults, 18 to 45 years old, inclusive, who meet all eligibility criteria, will be randomly allocated to one of two study groups in a 1:1 ratio: 20 will receive AV7909 as the thermostable lyophilized product and 20 will receive AV7909 as the liquid product. The vaccines will be given intramuscularly in a 2-dose schedule, 2 weeks apart. Safety will be assessed by evaluation of non-serious unsolicited Adverse Events, Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs) \[the AESIs collected in this study are Potentially Immune-Mediated Medical Conditions (PIMMCs)\], and by laboratory evaluations. Reactogenicity will be measured by the occurrence of solicited injection site and systemic reactions in the week after each study vaccination. Immunogenicity testing will include performing serological assays to assess for toxin neutralizing antibodies (reported as ED50 and NF50), the gold standard assay for assessing response and protection following anthrax vaccines, prior to vaccination and on approximately Days 8, 15, 22, 29, 64, 195, and 380. In addition, anti-PA IgG antibodies will be measured by ELISA from the serum of participants, on those same days. The primary safety objective of this study is to assess the safety of lyophilized and liquid formulations of AV7909. The primary tolerability objective is to assess the tolerability of lyophilized and liquid formulations of AV7909.
Age range
18 Years – 45 Years
Sex
ALL
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Number of Participants With Serious Adverse Events (SAEs).
Timeframe: Day 1 through Day 380
Number of Participants With Abnormal Clinical Safety Laboratory Adverse Events (AEs).
Timeframe: Day 29
Number of Participants With Protocol-specified Adverse Events of Special Interest (AESIs)
Timeframe: Day 1 through Day 380
Number of Participants With Medically Attended Adverse Events (MAAEs).
Timeframe: Day 1 through Day 380
Number of Participants With Unsolicited, Non-serious Adverse Events (AEs).
Timeframe: Day 1 through Day 64
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following First Study Vaccination.
Timeframe: Day 1 through Day 8
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following Second Study Vaccination.
Timeframe: Day 15 through Day 22