Pertussis Acellular Vaccine Adjuvanted With TQL1055

A Phase 1, Randomized, Double Blind, Active-Controlled Dose-Escalation Study to Assess the Safety and Immunogenicity of Pertussis Acellular Vaccine Adjuvanted With TQL1055 (PAVA)

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04793620

Enrollment

Registered

2021-03-11

Start date

2021-04-06

Completion date

2022-02-14

Last updated

2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pertussis

Keywords

vaccine, adjuvant

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 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.

Interventions

OTHERTQL1055

Semisynthetic saponin adjuvant

BIOLOGICALAcellular pertussis vaccine

Acellular pertussis vaccine

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Intervention model description

Sequential-group dose-escalation study.

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Reactogenicity	7 days	Solicited local and systemic adverse events

Secondary

Measure	Time frame	Description
Adverse Events	365 days	Adverse Events/Serious Adverse Events
Incidence of abnormal laboratory test results	28 days	Incidence of abnormal laboratory test results
Immunogenicity	28 days	Anti-Pertussis Toxin antibodies

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026