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

NCT04959344 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2022-10-04

No results posted yet for this study

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.

Conditions

  • Klebsiella Pneumoniae Infection

Interventions

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

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • LimmaTech Biologics AG

    lead INDUSTRY

Principal Investigators

  • Cristina Alaimo · LimmaTech Biologics AG

  • Steffen Haffner, Dr · Nuvisan GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-05
Primary Completion
2022-09-26
Completion
2022-09-26

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04959344 on ClinicalTrials.gov