NCT04602975

A Study to Investigate the Safety and Immunogenicity of the SF2a-TT15 Synthetic Carbohydrate-based Conjugate Vaccine Against Shigella Flexneri 2a

A Phase 2a Age Descending Study to Investigate the Safety and Immunogenicity of the SF2a-TT15 Synthetic Carbohydrate-based Conjugate Vaccine Against Shigella Flexneri 2a in Adults, Children, and Infant Target Population in Endemic Countries.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Institut Pasteur · Industry
• Sex: All
• Age: 8 Months – 50 Years
• Healthy volunteers: Accepted

Summary

A study among adults, children and infants in Kenya to determine if a new type of glycoconjugate vaccine incorporating a synthetic carbohydrate component is safe and induces immunity against Shigella.

Detailed description

The purpose of this study is to examine the safety and immunogenicity of two doses of the parenteral synthetic carbohydrate-based conjugate vaccine against Shigella flexneri 2a (Shigella flexneri 2a-Tetanus Toxoid15 (SF2a-TT15)) adjuvanted or not with Alhydrogel in infants in an endemic country (Kenya), the target population for the vaccine, using an age-descending approach. In total, 232 participants will be enrolled in the study: 16 adults (18-50 years-old), 16 children (2-5 years-old) and 200 infants (9 months-old +/ 1 mo). The vaccine will be tested in adults first, then in children and eventually in infants in Kenya (where Shigella infection is present), based on the safety/tolerability in each group before to moving to the other. Participants will be randomly assigned to receive the study vaccine or a placebo control (same solution but without the vaccine component). The participants will have to go through all the trial procedures including the 14 visits (3 injections and 11 follow-up) during a 16 months period.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Injection SF2A-TT15 10 µg Adjuvanted	Intramuscular injection of experimental vaccine (adjuvanted 10 µg)
BIOLOGICAL	Injection SF2A-TT15 10 µg	Intramuscular injection of experimental vaccine (not adjuvanted 10 µg)
BIOLOGICAL	Injection Adjuvanted Placebo	Intramuscular injection of Placebo with alhydrogel
BIOLOGICAL	Injection Placebo	Intramuscular injection of the not adjuvanted Placebo
BIOLOGICAL	Injection SF2A-TT15 2 µg Adjuvanted	Intramuscular injection of experimental vaccine (adjuvanted 2 µg)
BIOLOGICAL	Injection SF2A-TT15 2 µg	Intramuscular injection of experimental vaccine (not adjuvanted 2 µg)

Timeline

• Start date: 2020-10-06
• Primary completion: 2023-04-12
• Completion: 2023-11-15
• First posted: 2020-10-26
• Last updated: 2024-04-23

Locations

1 site across 1 country: Kenya