NCT04056117

A Study to Determine If a New Shigella Vaccine is Safe, Induces Immunity and The Best Dose Among Kenyan Infants

Safety and Immunogenicity of a Shigella-Tetravalent Bioconjugate Vaccine: A Phase 1/2 Randomized Controlled and Age Descending Study Including Dose Finding in 9 Month Old Infants

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 596 (actual)
• Sponsor: LimmaTech Biologics AG · Industry
• Sex: All
• Age: 8 Months – 50 Years
• Healthy volunteers: Accepted

Summary

In this study, the tetravalent bioconjugate candidate vaccine Shigella4V will be tested to obtain first-in-human data on its safety and immunogenicity in infants and to identify the preferred dose of Shigella4V in 9 month old infants.

Detailed description

Shigella4V is a tetravalent bioconjugate vaccine including O antigen-polysaccharides of the most predominant Shigella serotypes. The study will be conducted in two steps. In Step1: safety and reactogenicity of the vaccine will be evaluated first in adults and subsequently in children and infants through an age-descending and dose escalation approach. In Step 2: in order to further evaluate safety and to identify the optimum immunogenic dose, infants will be randomised to receive 1 of 4 different vaccine doses or control vaccine. Adults will receive a 2 dose schedule, children and infants will receive a 3 dose schedule. For each vaccine dose, formulation with and without Aluminium adjuvant will be tested.

Conditions

• Shigellosis

Interventions

Type	Name	Description
BIOLOGICAL	Shigella 4V	Non-adjuvanted and adjuvanted Shigella 4V administrated at 4 different doses: very low, low, medium and high.
BIOLOGICAL	MenACWY	Control vaccine administrated to adults and infants
BIOLOGICAL	Rabies	Control vaccine administrated to children
BIOLOGICAL	Diphtheria, Tetanus and Pertussis (DTaP)	Control vaccine administrated to infants
BIOLOGICAL	Placebo	Control administrated to adults

Timeline

• Start date: 2019-09-02
• Primary completion: 2022-09-01
• Completion: 2022-11-14
• First posted: 2019-08-14
• Last updated: 2024-07-30

Locations

2 sites across 1 country: Kenya