PertussisPhase 1NCT04793620
Pertussis Acellular Vaccine Adjuvanted With TQL1055
A Phase 1 study testing TQL1055 and Acellular pertussis vaccine in people with Pertussis, run by Adjuvance Technologies, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pertussis
- What is being tested?
- TQL1055 and Acellular pertussis vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteAustralia
- Study dates
- 6 Apr 2021to 14 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 50 years of age
- General good health
- BMI between 17 and 35 kg/m2
- Not of childbearing potential OR using adequate contraception
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Pertussis
- Being tested
- TQL1055, Acellular pertussis vaccine
- Keywords
- vaccine, adjuvant
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQL1055Other
Semisynthetic saponin adjuvant
Acellular pertussis vaccineBiological
Acellular pertussis vaccine
| Study group | Role | What they receive |
|---|---|---|
| TQL1055 | Experimental | TQL1055 + acellular pertussis vaccine Receives: Other: TQL1055; Biological: Acellular pertussis vaccine |
| Acellular pertussis vaccine | Active comparator | Acellular pertussis vaccine Receives: Biological: Acellular pertussis vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactogenicity
Solicited local and systemic adverse events
Measured: 7 days
Secondary outcomes (4)
Adverse Events
Adverse Events/Serious Adverse Events
Measured: 365 days
Incidence of abnormal laboratory test results
Incidence of abnormal laboratory test results
Measured: 28 days
Immunogenicity
Anti-Pertussis Toxin antibodies
Measured: 28 days
Immunogenicity
Anti-Pertussis Toxin antibodies
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start6 Apr 2021
- Primary completion23 Aug 2021
- Study completion14 Feb 2022
Why it stopped: financial constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PertussisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential-group dose-escalation study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adjuvance Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean R Bennett, MD PhD, Study director, Adjuvance Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793620
- Sponsor's protocol ID
- V1.1-101
- Status last verified
- Oct 2022
- First submitted
- 4 Mar 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04793620
- Acronym / sponsor ID
- V1.1-101
- Conditions
- Pertussis
- Keywords
- vaccine, adjuvant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: financial constraints
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Adjuvance Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 23 Aug 2021 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Sequential-group dose-escalation study.
| Arm | Type | Receives |
|---|---|---|
| TQL1055 | Experimental | Other: TQL1055, Biological: Acellular pertussis vaccineTQL1055 + acellular pertussis vaccine |
| Acellular pertussis vaccine | Active comparator | Biological: Acellular pertussis vaccineAcellular pertussis vaccine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQL1055Semisynthetic saponin adjuvant | Other | TQL1055 |
| Acellular pertussis vaccineAcellular pertussis vaccine | Biological | Acellular pertussis vaccine, TQL1055 |
Primary outcome
Reactogenicity
Time frame: 7 days
Solicited local and systemic adverse events
4 secondary outcomes
Adverse Events
Time frame: 365 days
Incidence of abnormal laboratory test results
Time frame: 28 days
Immunogenicity
Time frame: 28 days
Immunogenicity
Time frame: 365 days
Results and safety
The study was stopped early (reason given: financial constraints). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Pertussis
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A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
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RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
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Not yet recruitingObservational study
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Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean R Bennett, MD PhD study director
Adjuvance Technologies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQL1055 and Acellular pertussis vaccine in people with Pertussis, run by Adjuvance Technologies, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: financial constraints). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reactogenicity (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.