Status:

TERMINATED

Pertussis Acellular Vaccine Adjuvanted With TQL1055

Lead Sponsor:

Adjuvance Technologies, Inc.

Conditions:

Pertussis

Eligibility:

All Genders

18-50 years

Phase:

PHASE1

Brief Summary

This is a phase 1 study to evaluate the safety and immunogenicity of the semisynthetic saponin adjuvant TQL1055 administered in combination with an acellular pertussis vaccine.

Detailed Description

The recent increase in the incidence of pertussis has prompted the need for improvements to current acellular pertussis vaccines. Use of novel adjuvants is one approach to such improvement. TQL1055 is...

Eligibility Criteria

Inclusion

  • Key
  • 18 to 50 years of age
  • General good health
  • BMI between 17 and 35 kg/m2
  • Not of childbearing potential OR using adequate contraception
  • Key

Exclusion

  • Pregnant or lactating
  • Prior medical condition that could adversely affect subject safety
  • Clinically significant abnormal laboratory parameter
  • Current acute febrile illness
  • Contraindication to intramuscular injection
  • Contraindication to pertussis vaccination
  • Received pertussis vaccine within 3 years

Key Trial Info

Start Date :

April 6 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 14 2022

Estimated Enrollment :

72 Patients enrolled

Trial Details

Trial ID

NCT04793620

Start Date

April 6 2021

End Date

February 14 2022

Last Update

November 1 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

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Q-Pharm

Brisbane, Australia