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Pertussis Acellular Vaccine Adjuvanted With TQL1055

Sponsor
Adjuvance Technologies, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04793620
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
16.9
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: TQL1055
  • Biological: Acellular pertussis vaccine
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Sequential-group dose-escalation study.Sequential-group dose-escalation study.
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
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)
Actual Study Start Date :
Apr 6, 2021
Actual Primary Completion Date :
Aug 23, 2021
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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

Acellular pertussis vaccine

Biological: Acellular pertussis vaccine
Acellular pertussis vaccine

Outcome Measures

Primary Outcome Measures

  1. Reactogenicity [7 days]

    Solicited local and systemic adverse events

Secondary Outcome Measures

  1. Adverse Events [365 days]

    Adverse Events/Serious Adverse Events

  2. Incidence of abnormal laboratory test results [28 days]

    Incidence of abnormal laboratory test results

  3. Immunogenicity [28 days]

    Anti-Pertussis Toxin antibodies

  4. Immunogenicity [365 days]

    Anti-Pertussis Toxin antibodies

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Q-Pharm Brisbane Australia

Sponsors and Collaborators

  • Adjuvance Technologies, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Adjuvance Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT04793620
Other Study ID Numbers:
  • V1.1-101
First Posted:
Mar 11, 2021
Last Update Posted:
Aug 26, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Adjuvance Technologies, Inc.
vaccine
adjuvant
Additional relevant MeSH terms:
Whooping Cough

Study Results

No Results Posted as of Aug 26, 2021