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Stabilizing formulations for inhalable powders of an adenovirus 35-vectored tuberculosis (TB) vaccine (AERAS-402).
Vaccine. 2010 Jun 17; 28(27):4369-75.V

Abstract

A powder vaccine intended for aerosol delivery was formulated by spray drying the Ad35-vectored tuberculosis (TB) AERAS-402 vaccine with mannitol-based stabilizers. Thermodynamic properties, water absorption, particle size distribution and morphology of the powders were evaluated. Virus survival during spray drying and storage was determined by medium Tissue Culture Infectious Dose (TCID(50)). A mannitol-based powder (mannitol-cyclodextrin-trehalose-dextran, MCTD) had a narrow size distribution with a median volume diameter around 3.2-3.5microm (suitable for pulmonary vaccination of humans) and good aerosolization characteristics. The spray dry powders generated from mannitol-based formulations were hydrophobic, which benefits virus survival during both production and storage at 4 degrees C, 25 degrees C and 37 degrees C as compared to the hygroscopic formulations (trehalose, sucrose, dextran, PVP, leucine). In conclusion, this study demonstrates that it is possible to produce in a one-step spray drying process a stable dry powder formulation of a TB vaccine suitable for mass vaccination.

Authors+Show Affiliations

Aeras Global TB Vaccine Foundation, Rockville, MD 20850, USA. zjin@aeras.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20444437

Citation

Jin, Tom H., et al. "Stabilizing Formulations for Inhalable Powders of an Adenovirus 35-vectored Tuberculosis (TB) Vaccine (AERAS-402)." Vaccine, vol. 28, no. 27, 2010, pp. 4369-75.
Jin TH, Tsao E, Goudsmit J, et al. Stabilizing formulations for inhalable powders of an adenovirus 35-vectored tuberculosis (TB) vaccine (AERAS-402). Vaccine. 2010;28(27):4369-75.
Jin, T. H., Tsao, E., Goudsmit, J., Dheenadhayalan, V., & Sadoff, J. (2010). Stabilizing formulations for inhalable powders of an adenovirus 35-vectored tuberculosis (TB) vaccine (AERAS-402). Vaccine, 28(27), 4369-75. https://doi.org/10.1016/j.vaccine.2010.04.059
Jin TH, et al. Stabilizing Formulations for Inhalable Powders of an Adenovirus 35-vectored Tuberculosis (TB) Vaccine (AERAS-402). Vaccine. 2010 Jun 17;28(27):4369-75. PubMed PMID: 20444437.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Stabilizing formulations for inhalable powders of an adenovirus 35-vectored tuberculosis (TB) vaccine (AERAS-402). AU - Jin,Tom H, AU - Tsao,Eric, AU - Goudsmit,Jaap, AU - Dheenadhayalan,Veerabadran, AU - Sadoff,Jerald, Y1 - 2010/05/02/ PY - 2010/01/04/received PY - 2010/03/29/revised PY - 2010/04/19/accepted PY - 2010/5/7/entrez PY - 2010/5/7/pubmed PY - 2010/9/2/medline SP - 4369 EP - 75 JF - Vaccine JO - Vaccine VL - 28 IS - 27 N2 - A powder vaccine intended for aerosol delivery was formulated by spray drying the Ad35-vectored tuberculosis (TB) AERAS-402 vaccine with mannitol-based stabilizers. Thermodynamic properties, water absorption, particle size distribution and morphology of the powders were evaluated. Virus survival during spray drying and storage was determined by medium Tissue Culture Infectious Dose (TCID(50)). A mannitol-based powder (mannitol-cyclodextrin-trehalose-dextran, MCTD) had a narrow size distribution with a median volume diameter around 3.2-3.5microm (suitable for pulmonary vaccination of humans) and good aerosolization characteristics. The spray dry powders generated from mannitol-based formulations were hydrophobic, which benefits virus survival during both production and storage at 4 degrees C, 25 degrees C and 37 degrees C as compared to the hygroscopic formulations (trehalose, sucrose, dextran, PVP, leucine). In conclusion, this study demonstrates that it is possible to produce in a one-step spray drying process a stable dry powder formulation of a TB vaccine suitable for mass vaccination. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/20444437/Stabilizing_formulations_for_inhalable_powders_of_an_adenovirus_35_vectored_tuberculosis__TB__vaccine__AERAS_402__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(10)00583-9 DB - PRIME DP - Unbound Medicine ER -