A phase 1, randomized, double-blind, placebo-controlled dosage escalation trial to evaluate the safety and immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted in HIV-uninfected, healthy adult volunteers (G001)
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This is a phase 1 first-in-human clinical trial to assess the safety, tolerability, and immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted, in up to 48 healthy adult HIV-negative volunteers. The study is a randomized, double-blind, placebo-controlled dosage-escalation Phase 1 study intended to evaluate the safety and immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted in a prime-boost regimen.
Investigational Product/Placebo administered on study day 0 & 56
The eOD-GT8 60mer Vaccine, Adjuvanted vaccinations escalate by dosage as shown below in the Study Design table below. Safety and tolerability of the eOD-GT8 60mer Vaccine, Adjuvanted will be evaluated by the SMC for, at minimum, the first 14 days after the first vaccination for all volunteers of the 20 μg dosage level (Group 1) before escalating to the 100 μg dosage level (Group 2).
| Group | N | Dose | Week 0 | Week 8/ Month 2 |
| 1 | 18/ 6 | 20 μg eOD-GT8 60mer + AS01B/ DPBS sucrose/IM | X | X |
SMC review following first dose | ||||
| 2 | 18/ 6 | 100 μg eOD-GT8 60mer + AS01B/ DPBS sucrose/IM | X | X |
| Total | 48 36/ 12 | |||
Safety
1. To evaluate the safety and tolerability of the study regimens
Immunogenicity
1. To assess the frequency of VRC01-class memory B cells
2. To assess the frequency and magnitude of binding antibody responses to eOD-GT8 60mer and eOD-GT8 monomer
3. To assess the proportion of volunteers with epitope-specific antibody responses against eOD-GT8
Primary Outcome Measures
Safety and Tolerability: frequency of local and systemic reactogenicity events
To evaluate the safety and tolerability of the study regimens based on the frequency of local and systemic reactogenicity events as assessed using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (v2.1). [Time Frame: 7 days]
Safety and Tolerability: proportion of volunteers with moderate or greater unsolicited adverse events
To evaluate the safety and tolerability of the study regimens based on the proportion of volunteers with moderate or greater unsolicited adverse events including safety laboratory as assessed using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (v2.1). [Time Frame: 16 months]
Safety and Tolerability: proportion of volunteers in each group with potential immune-mediated diseases (pIMDs)
To evaluate the proportion of volunteers in each group with potential immune mediated diseases (pIMDs) based on a defined list of pIMDs in the study protocol. [Time Frame: 16 months]
Secondary Outcome Measures
Immunogenicity: Frequency of responses
To evaluate the frequency of eOD-GT8 60mer-specific, eOD-GT8 monomer-specific, and epitope-specific serum antibody responses after 1st and/or 2nd immunization compared to baseline and placebo [Time Frame: 16 months]
Immunogenicity: Magnitude of responses
To evaluate the magnitude of eOD-GT8 60mer-specific, eOD-GT8 monomer-specific, and epitope-specific serum antibody responses after 1st and/or 2nd immunization compared to baseline and placebo [Time Frame: 16 months]
District of Columbia Locations
Washington, District of Columbia, United States, 20037
Washington Locations
Seattle, Washington, United States, 98109
Fred Hutchinson Cancer Research Center
NCT03547245
June 15, 2018
Jan. 17, 2020