Versatility of the adenovirus-vectored foot-and-mouth disease vaccine platform across multiple foot-and-mouth disease virus serotypes and topotypes using a vaccine dose representative of the AdtA24 conditionally licensed vaccine.

We investigated the serotype- and topotype versatility of a replication-deficient human adenovirus serotype 5 vectored foot-and-mouth disease (FMD) vaccine platform (AdtFMD). Sixteen AdtFMD recombinant subunit monovalent vaccines targeting twelve distinct FMD virus (FMDV) serotype/topotypes in FMD Regional Pools I-VII were constructed. The AdtA24 serotype conditionally licensed vaccine served as the basis for vaccine design and target dose for cattle clinical trials. Several vaccines contained an additional RGD motif genetic insertion in the adenovector fiber knob, and/or a full-length 2B gene insertion in the FMDV P1 gene cassette. In 13 of the 22 efficacy studies conducted, naïve control and AdtFMD vaccinated cattle were challenged intradermolingually at 2 weeks post-vaccination using a FMDV strain homologous to the AdtFMD vaccine strain. Each of the 16 AdtFMD vaccines were immunogenic based on the presence of homologous neutralizing antibodies in the serum of approximately 90% of total vaccinates (n = 375) on the day of challenge. Importantly, for 75% of vaccines tested, the effective dose that conferred 100% protection against clinical FMD was identical to or in some cases lower than, the minimum protective dose for the conditionally licensed AdtA24 vaccine formulated with ENABL® adjuvant. Results also confirmed the capability of the AdtFMD vaccine platform to differentiate infected from vaccinated animals (DIVA) across the five FMDV serotypes evaluated. Collectively, this comprehensive set of FMD cattle vaccine dose ranging studies highlights the serotype- and topotype versatility of the AdtFMD vaccine platform for further development, licensure, and application in FMD outbreak control and disease eradication efforts.

Standard Practice for Bulk Sample Collection and Swab Sample Collection of Visible Powders Suspected of Being Biological Agents from Nonporous Surfaces: collaborative study.

The draft ASTM Standard, "Standard Practice for Bulk Sample Collection and Swab Sample Collection of Visible Powders Suspected of Being Biological Agents from Nonporous Surfaces," was validated in a collaborative study consisting of 6 teams comprised of Civil Support personnel and First Responders, 2 levels of Bacillus anthracis Sterne and Bacillus thuringiensis Kurstaki spores, and 7 nonporous surfaces. The sample collection standard includes collection of the bulk sample (Method A) using a dry swab to push the sample onto a collection card and collection of residual sample (Method B) using an onsite test kit followed by a wet swab intended for additional onsite testing. Method A is to be performed prior to Method B in order to preserve unadulterated sample as potential criminal evidence. While statistical differences were observed between surfaces, between teams, and the interaction of surfaces and teams for the various sample types collected, these differences are due to the very low variability of the data and a much more narrow distribution than an ideal normal distribution, rather than to any practical differences. The data demonstrate that from both the 1.0 and 0.01 g powder samples, high levels of spores (mean >10(6) CFU) are recovered from the 7 surfaces by both the dry swab used in bulk sample collection (Method A) and the wet swab (Method B) sampling of the residual powder after bulk sample collection. Thus, after bulk sample collection, there is a high level of residual spores remaining for onsite biological testing and both Methods A and B should be performed in the field.

Method modification (2004.08) to field testing of visible powders on a variety of nonporous environmental surfaces: field study.

The RAMP Anthrax Test Cartridge for detecting Bacillus anthracis was validated for use in the field for detection of B. anthracis spores in visible powder residues on 7 nonporous environmental surfaces. Six teams of trained first responders and civil support personnel in Class C personal protective equipment sampled visible powder residues on plastic, stainless steel, ceramic tile, wood, rubber, sealed concrete, and food-grade painted wood and analyzed the samples on the RAMP Anthrax Test System. The accuracy for each surface was at least 97% and the overall average was 98.8%. The overall average false-positive rate was 1.79% and false-negative rate was 1.07% for all surfaces. There were no significant differences between surfaces or between spore levels.