Pertussis Clinical Trial
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)
Verified date | October 2022 |
Source | Adjuvance Technologies, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 72 |
Est. completion date | February 14, 2022 |
Est. primary completion date | August 23, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Q-Pharm | Brisbane |
Lead Sponsor | Collaborator |
---|---|
Adjuvance Technologies, Inc. |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reactogenicity | Solicited local and systemic adverse events | 7 days | |
Secondary | Adverse Events | Adverse Events/Serious Adverse Events | 365 days | |
Secondary | Incidence of abnormal laboratory test results | Incidence of abnormal laboratory test results | 28 days | |
Secondary | Immunogenicity | Anti-Pertussis Toxin antibodies | 28 days | |
Secondary | Immunogenicity | Anti-Pertussis Toxin antibodies | 365 days |
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