Safety and immunogenicity of one and two doses of the live, attenuated oral ETEC candidate vaccine BB01 in healthy adults - a phase I, randomized, double-blind study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN05087777

Enrollment

Registered

2005-10-19

Start date

2005-05-13

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ETEC disease. Infections and Infestations Enterotoxigenic E. coli infection

Interventions

1. Single dose of ETEC candidate vaccine 2. Two doses of ETEC candidate vaccine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy adults between 18 and 45 years of age.

Exclusion criteria

Exclusion criteria: Any confirmed or suspected immunosuppressive or immunodeficient condition or prior exposure to ETEC.

Design outcomes

Primary

Measure	Time frame
Safety as measured by the incidence of adverse events reported post-vaccination.	—

Secondary

Measure	Time frame
1. Seroconversion rates as determined by antibody titers pre- and post-vaccination against ETEC candidate vaccine antigens 2. Responder rates as determined by the number of antibody secreting cells pre- and post-vaccination against ETEC candidate vaccine antigens 3. Shedding of ETEC candidate vaccine strain post-vaccination as measured by duration and number of bacteria shedded	—

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026