NCT00277147

Salmonella Typhi Vi O-Acetyl Pectin-rEPA Conjugate Vaccine

Completed Phase 1 Last updated 2 July 2017

What this trial tests

Phase 1 trial testing BB IND 6989 in Typhoid Fever in 25 participants. Completed in 17 September 2008.

Timeline

9 January 2006

17 September 2008

Quick facts

Lead sponsor	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Primary purpose	treatment
Enrollment	25
Start date	9 January 2006
Estimated completion	17 September 2008
Sites	1 location across United States

Drugs / interventions tested

• BB IND 6989 — full drug profile →

Conditions studied

• Typhoid Fever — all drugs for Typhoid Fever →

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Who can join

Adults 18 to 45, any sex, with Typhoid Fever. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will evaluate a new (conjugate) vaccine for typhoid fever, which remains a serious disease especially difficult to treat in developing countries. Salmonella typhi, the bacteria causing typhoid fever, have become resistant to several antibiotics increasing the difficulty of treating the disease. The disease may have serious complications effecting bones, brain, and intestines, with permanent injury or death. Methods to control typhoid fever, such as a sanitary water and food supply, along with effective sewage treatment, are not likely to be available soon in those countries.

NIH scientists developed a vaccine called Vi, made of a polysaccharide (a chain of linked sugars) from the surface of Salmonella typhi, the bacteria that cause typhoid fever. It has been approved by the World Health Organization and is licensed in 94 countries. It is effective in adults but not in young children. Clinical trials have shown that chemically binding the Vi to a protein to form a "conjugate vaccine" has improved and extended its efficacy to children (conjugate vaccines to other bacteria, notably meningitis causing bacteria have been used extensively and successfully). Now NIH scientists have developed another vaccine for typhoid fever - using a polysaccharide from fruit, known as pectin. The pectin has been chemically treated so that it resembles Vi. The treated pectin, O-acetyl pectin, is bound to a protein; exoprotein A, (rEPA). The result is a conjugate, as was formed for Vi. Similarly to the Vi conjugate it induces antibodies against Salmonella typhi in laboratory animals. If the O-acetyl pectin conjugate proves successful, it will be evaluated in children ages 5 to 14 years old and in infants, toward using it with routine vaccines for infants.

Volunteers ages 18 to 45 who do not have an allergy to fruit pectin and who have not been vaccinated against nor had typhoid fever within the last 5 years may be eligible for this study.

Volunteers will undergo several tests at their first visit to the clinic for this study. A blood sample (about 2/3 of an ounce) will be taken to test for HIV, hepatitis B and C, complete blood count, liver functions, blood chemistry and pregnancy in women of childbearing age. The blood sample will also be tested for antibodies to Vi, rEPA (the protein of the conjugate), and pectin. There will also be a urine collection for testing. If the laboratory tests are acceptable, volunteers will be asked to return to the clinic on a...

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Phase I clinical trial of O-acetylated pectin conjugate, a plant polysaccharide based typhoid vaccine.
   Szu SC, Lin KF, Hunt S, Chu C, et al · · 2014 · cited 15× · PMID 24657719 · DOI 10.1016/j.vaccine.2014.03.023
2. Therapeutic Potential of Pectin and Its Derivatives in Chronic Diseases.
   Dambuza A, Rungqu P, Oyedeji AO, Miya G, et al · · 2024 · cited 6× · PMID 38398646 · DOI 10.3390/molecules29040896