ABSTRACT
The anthrax vaccine candidate AV7909 is being developed as a next-generation vaccine for a post-exposure prophylaxis (PEP) indication against anthrax. AV7909 consists of the anthrax vaccine adsorbed (AVA) (Emergent BioSolutions Inc., Lansing, MI) bulk drug substance adjuvanted with the immunostimulatory oligodeoxynucleotide (ODN) compound, CPG 7909. The addition of CPG 7909 to AVA enhances both the magnitude and the kinetics of antibody responses in animals and human subjects, making AV7909 a suitable next-generation vaccine for use in a PEP setting. Emergent has produced a thermostable (lyophilized) formulation of AV7909 vaccine utilizing drying technology. The purpose of the study described here was to assess the immunogenicity and efficacy of the lyophilized formulation of the AV7909 vaccine candidate as compared with the liquid formulation in the guinea pig general-use prophylaxis (GUP) model. The study also provides initial information on the relationship between the immune response induced by the thermostable formulation of the vaccine, as measured by the toxin neutralization assay (TNA), and animal survival following lethal anthrax aerosol challenge. Results demonstrated that there were no significant differences in the immunogenicity or efficacy of lyophilized AV7909 against lethal anthrax spore aerosol challenge in the guinea pig model as compared to liquid AV7909. For both vaccine formulations, logistic regression modeling showed that the probability of survival increased as the pre-challenge antibody levels increased.
Subject(s)
Anthrax Vaccines/chemistry , Anthrax Vaccines/immunology , Antibodies, Bacterial/blood , Immunogenicity, Vaccine , Temperature , Adjuvants, Immunologic , Animals , Anthrax/prevention & control , Antibodies, Neutralizing/blood , Antigens, Bacterial/immunology , Female , Freeze Drying , Guinea Pigs , Male , Oligodeoxyribonucleotides/immunology , Post-Exposure Prophylaxis , Vaccination , Vaccine PotencyABSTRACT
BACKGROUND: The attentional blink (AB) phenomenon was used to assess the effect of emotional information on early visual attention in typically developing (TD) children and children with autism spectrum disorders (ASD). The AB effect is the momentary perceptual unawareness that follows target identification in a rapid serial visual processing stream. It is abolished or reduced for emotional stimuli, indicating that emotional information has privileged access to early visual attention processes. METHODS: We examined the AB effect for faces with neutral and angry facial expressions in 8- to 14-year-old children with and without an ASD diagnosis. RESULTS: Children with ASD exhibited the same magnitude AB effect as TD children for both neutral and angry faces. CONCLUSIONS: Early visual attention to emotional facial expressions was preserved in children with ASD.
