Ability of SPI2 mutant of S. typhi to effectively induce antibody responses to the mucosal antigen enterotoxigenic E. coli heat labile toxin B subunit after oral delivery to humans
2007

Oral Vaccine Based on Salmonella Typhi Induces Immune Response to E. coli Toxin

Sample size: 36 publication 10 minutes Evidence: moderate

Author Information

Author(s): Khan S., Chatfield S., Stratford R., Bedwell J., Bentley M., Sulsh S., Giemza R., Smith S., Bongard E., Cosgrove C.A., Johnson J., Dougan G., Griffin G.E., Makin J., Lewis D.J.M.

Primary Institution: St. George's Vaccine Institute

Hypothesis

Can a Salmonella typhi-based oral vaccine effectively induce immune responses to the enterotoxigenic E. coli heat labile toxin in humans?

Conclusion

The study found that the oral vaccine was well tolerated and induced significant immune responses in a majority of participants.

Supporting Evidence

  • 97% of subjects showed immune responses to S. typhi lipopolysaccharide.
  • 67% of subjects demonstrated immune responses to ETEC LT.
  • The vaccine was well tolerated with no serious adverse events.
  • Transient stool shedding was observed in most subjects.
  • Responses were measured using both ELISA and ELISPOT assays.

Takeaway

Researchers tested a new vaccine made from a type of Salmonella that helps the body fight off a common cause of diarrhea, and it worked well in most people.

Methodology

The study was an open-label, dose-escalating trial with 36 volunteers receiving two doses of the vaccine, and immune responses were measured using ELISA and ELISPOT assays.

Potential Biases

Potential bias due to the open-label design and lack of randomization.

Limitations

The study was not placebo-controlled and had a small sample size.

Participant Demographics

Volunteers aged 18-50 years were recruited.

Statistical Information

P-Value

<0.05

Confidence Interval

95%

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1016/j.vaccine.2007.03.007

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