Anthrax AV7909 Liquid vs Lyophilized
Condition: Anthrax; Anthrax Immunisation
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      This is a randomized, parallel-group, double-blind, Phase 1 study designed to assess safety,
      tolerability and immunogenicity of 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. Stratification by age category and by gender will assure that
      near equal numbers of younger (18-30 years) and older (31-45 years) males and females are
      assigned to each vaccine. 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. The secondary immunogenicity objective of this study is to obtain
      initial estimate of comparative immunogenicity of liquid and lyophilized formulations of
      AV7909.
    

Intervention name(s): AV7909; AV7909
Intervention type(s): Biological; Biological
Intervention description(s): AV7909 (Liquid Formulation) is an investigational vaccine that is a preformulated, sterile, milky-white suspension for IM injection. It consists of the Anthrax Vaccine Adsorbed (AVA) bulk drug substance and CPG 7909 adjuvant; AV7909 (Lyophilized Formulation) is a thermostable, lyophilized version of the liquid AV7909 formulation. Sterile, milky-white suspension for intramuscular injection. It consists of polysorbate 80, CPG7909 adjuvant and AVA bulk drug substance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Anthrax; AV7909 (Liquid); Healthy Adult Volunteers; Immunogenicity; Phase 1; Safety; Thermostable AV7909 (Lyophilized); Vaccine