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About
The purpose of this study is to evaluate the safety, tolerability and immunogenicity of rAAV1-PG9DP when administered intramuscularly at different dose levels in healthy male adults.
Full description
This study is a phase 1, randomized, blinded, dose-escalation study to evaluate the safety and tolerability of rAAV1-PG9DP when administered intramuscularly at 4x10^12 vg, 4x10^13 vg, 8x10^13 vg and 1.2x10^14 vg in healthy male adults.
Volunteers will be screened up to 42 days before injection and will be followed for 12 months after the single administration. It is anticipated that it will take approximately 13 months to enroll the study.
Volunteers will be randomly assigned investigational product (IP) or placebo within each of the dose groups described in the study design table above depending on which group is enrolling. Study staff and volunteers will be blinded only with respect to the allocation of placebo or IP. Blinding will not apply to the assignment of dosage levels.
Volunteers will be offered enrollment into a follow-up study at the research center when they have finished participating in the trial
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Confirmed HIV-1 or HIV-2 infection.
Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the investigator within the previous 6 months.
Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the investigator makes the volunteer unsuitable for participation in the study.
Any of the following specific risk behaviour for HIV infection within 6 months prior to injection:
Bleeding disorder that was diagnosed by a physician (e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions).
Clinically significant laboratory abnormalities.
Anti-AAV1 antibody level above the cut-off.
Receipt of live attenuated vaccine within the previous 60 days or planned receipt within 60 days after injection with IP; or receipt of other vaccine within the previous 14 days or planned receipt within 14 days after injection with IP (exception is live attenuated influenza vaccine within 14 days).
Receipt of blood transfusion or blood-derived products within the previous 3 months.
Participation in another clinical trial of an IMP currently, within the previous 3 months or expected participation during this study.
Prior receipt of another AAV vector, investigational HIV vaccine candidate, monoclonal antibody or polyclonal immunoglobulin (note: receipt of placebo in a previous HIV vaccine or monoclonal antibody trial will not exclude a volunteer from participation).
History of severe local or systemic reactogenicity to vaccines or infusions (e.g., anaphylaxis, respiratory difficulties, angioedema)
Psychiatric condition that compromises safety of the volunteer and precludes compliance with the protocol.
In the opinion of the Principal Investigator, it is not in the best interest of the volunteer to participate in the trial.
Seizure disorder: a participant who has had a seizure in the last 3 years.
ECG with clinically significant findings or features.
History of, or known active cardiovascular disease.
Have 3 or more of the following risk factors:
Primary purpose
Allocation
Interventional model
Masking
21 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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