Pertussis Acellular Vaccine Adjuvanted With TQL1055

October 28, 2022 updated by: Adjuvance Technologies, Inc.

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQL1055
TQL1055 + acellular pertussis vaccine
Other: TQL1055
Semisynthetic saponin adjuvant
Biological: Acellular pertussis vaccine
Acellular pertussis vaccine
Active Comparator: Acellular pertussis vaccine
Biological: Acellular pertussis vaccine
Acellular pertussis vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reactogenicity
Time Frame: 7 days
Solicited local and systemic adverse events
7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adjuvance Technologies, Inc.

Investigators

  • Study Director: Sean R Bennett, MD PhD, Adjuvance Technologies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2021

Primary Completion (Actual)

August 23, 2021

Study Completion (Actual)

February 14, 2022

Study Registration Dates

First Submitted

March 4, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 11, 2021

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V1.1-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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