NCT04959344

Safety and Immunogenicity of a Klebsiella Pneumoniae Tetravalent Bioconjugate Vaccine (Kleb4V)

Safety and Immunogenicity of a Klebsiella Pneumoniae Tetravalent Bioconjugate Vaccine (Kleb4V) Administered to Healthy Adults: A FTIH Phase I/II Randomized and Controlled Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: LimmaTech Biologics AG · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

In this study, the tetravalent bioconjugate candidate vaccine Kleb4V will be tested to obtain first-time-in-human (FTIH) data on its safety and immunogenicity in healthy adults.

Detailed description

Kleb4V is a tetravalent bioconjugate vaccine including O antigen-polysaccharides of the most predominant Klebsiella pneumoniae serotypes, which will be formulated with or without Adjuvant System, AS03. Study participants will be randomized towards Kleb4V Low dose with or without AS03, Kleb4V Target dose with or without AS03, or placebo. The study will be conducted in two steps. In Step1 (safety cohort): safety and tolerability of Kleb4V without and with Adjuvant AS03 will be evaluated first in adults of 18-40 y, and subsequently in the target population of older adults 55-70 y. Enrolment will be staggered in groups of small numbers to the different doses and formulations. In Step 2 (target cohort): Older adults (55-70y) will be concomitantly randomized to receive 1 of the 4 different vaccine formulations or placebo.

Conditions

• Klebsiella Pneumoniae Infection

Interventions

Type	Name	Description
BIOLOGICAL	Kleb4V target dose	Two doses of the non-adjuvanted Kleb4V target dose will be administered intramuscularly 2 months apart
BIOLOGICAL	Kleb4V target dose + AS03	Two doses of the adjuvanted Kleb4V target dose will be administered intramuscularly 2 months apart
BIOLOGICAL	Kleb4V low dose	Two doses of the non-adjuvanted Kleb4V low dose will be administered intramuscularly 2 months apart
BIOLOGICAL	Kleb4V low dose + AS03	Two doses of the adjuvanted Kleb4V low dose will be administered intramuscularly 2 months apart
BIOLOGICAL	Placebo	Two doses of the Placebo will be administered intramuscularly 2 months apart

Timeline

• Start date: 2021-07-05
• Primary completion: 2022-09-26
• Completion: 2022-09-26
• First posted: 2021-07-13
• Last updated: 2022-10-04

Locations

2 sites across 1 country: Germany