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A Perspective on the Strategy for Advancing ETVAX^®, An Anti-ETEC Diarrheal Disease Vaccine, into a Field Efficacy Trial in Gambian Children: Rationale, Challenges, Lessons Learned, and Future Directions.

ABSTRACT: For the first time in over 20 years, an Enterotoxigenic Escherichia coli (ETEC) vaccine candidate, ETVAX^®, has advanced into a phase 2b field efficacy trial for children 6-18 months of age in a low-income country. ETVAX^® is an inactivated whole cell vaccine that has gone through a series of clinical trials to provide a rationale for the design elements of the Phase 2b trial. This trial is now underway in The Gambia and will be a precursor to an upcoming pivotal phase 3 trial. To reach this point, numerous findings were brought together to define factors such as safe and immunogenic doses for children, and the possible benefit of a mucosal adjuvant, double mutant labile toxin (dmLT). Considering the promising but still underexplored potential of inactivated whol

SUBMITTER: Hossain MJ

PROVIDER: S-EPMC10819518 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature

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Dataset Information

A Perspective on the Strategy for Advancing ETVAX^®, An Anti-ETEC Diarrheal Disease Vaccine, into a Field Efficacy Trial in Gambian Children: Rationale, Challenges, Lessons Learned, and Future Directions.

OmicsDI is part of the ELIXIR infrastructure

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Dataset Information

A Perspective on the Strategy for Advancing ETVAX®, An Anti-ETEC Diarrheal Disease Vaccine, into a Field Efficacy Trial in Gambian Children: Rationale, Challenges, Lessons Learned, and Future Directions.

OmicsDI is part of the ELIXIR infrastructure

Tweets

A Perspective on the Strategy for Advancing ETVAX^®, An Anti-ETEC Diarrheal Disease Vaccine, into a Field Efficacy Trial in Gambian Children: Rationale, Challenges, Lessons Learned, and Future Directions.