Abstract：
:As a step in the development of an oral vaccine against ETEC, we evaluated the safety and immunogenicity of CS6, a polymeric protein commonly found on the surface of ETEC. Formulations included 1 and 5mg doses of CS6, either encapsulated in biodegradable polymer poly(D, L)-lactide-co-glycolide (PLG), or as free protein, administered orally in a solution of either normal saline or a rice-based buffer. Three doses of CS6 were given at 2-week intervals. Blood was collected immediately before and 7 days after each dose. All formulations were well tolerated. Four of five volunteers who received 1mg CS6 in PLG microspheres with buffer had significant IgA ASC responses (median=30 ASC per 10(6) PBMC) and significant serum IgG responses (median=3.5-fold increase). Oral administration of these prototype ETEC vaccine formulations are safe and can elicit immune responses. The ASC, serum IgA, and serum IgG responses to CS6 are similar in magnitude to the responses after challenge with wild-type ETEC [Coster et al., unpublished data]. Further studies are underway to determine whether these immune responses are sufficient for protection.
journal_name
Vaccinejournal_title
Vaccineauthors
Katz DE,DeLorimier AJ,Wolf MK,Hall ER,Cassels FJ,van Hamont JE,Newcomer RL,Davachi MA,Taylor DN,McQueen CEdoi
10.1016/s0264-410x(02)00613-8subject
Has Abstractpub_date
2003-01-17 00:00:00pages
341-6issue
5-6eissn
0264-410Xissn
1873-2518pii
S0264410X02006138journal_volume
21pub_type
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