Pertussis Acellular Vaccine Adjuvanted With TQL1055

Adjuvance Technologies

Status and phase: Terminated; Phase 1

Conditions: Pertussis

Treatments: Biological: Acellular pertussis vaccine; Other: TQL1055

Study type: Interventional

Funder types: Industry

Identifiers

NCT04793620

V1.1-101

Details and patient eligibility

About

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.

Full 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 a rationally designed, semisynthetic analog of the licensed Quillaja saponin (QS)-21. It has been designed to maintain adjuvant activity with improved tolerability and greater ease of manufacture.

This is a Phase 1, randomized, double blind, active-controlled sequential-group study, designed to evaluate the safety, tolerability, and immunogenicity of the combination of TQL1055 and acellular pertussis vaccine. The dose of TQL1055 will increase by group.

Enrollment: 72 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 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 Criteria:

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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72 participants in 2 patient groups

TQL1055

Experimental group

Description:

TQL1055 + acellular pertussis vaccine

Treatment:

Biological: Acellular pertussis vaccine

Other: TQL1055

Acellular pertussis vaccine

Active Comparator group

Description:

Acellular pertussis vaccine

Treatment:

Biological: Acellular pertussis vaccine