Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04177355 | Evaluating the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Alum Adjuvants in Healthy, HIV-uninfected Adults | PHASE1 | COMPLETED | 127 | — | — | Jan 13, 2020 | Nov 4, 2024 | Sep 2, 2025 | 10 | United States |
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
For each local laboratory measure meeting Grade 1 AE criteria (Mild) or above as specified in the DAIDS AE Grading Table, counts of severity were presented by treatment group and timepoint for the overall population
The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm
The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm
The number (percentage) of participants with early study termination and reason for early study termination was summarized by arm
| Arm | Type | Description |
|---|---|---|
| Part A, Group 1 (T1): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum | EXPERIMENTAL | Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 1 mcg of 3M-052-AF and 500 mcg of Aluminum Hydroxide Suspension (Alum), as one intramuscular (IM) injection at Months 0 and 2, with optional second boost at Month 6. |
| Part A, Group 1 (P1): Placebo | PLACEBO_COMPARATOR | Participants will receive placebo as one IM injection at Months 0 and 2, with optional second boost at Month 6. |
| Part A, Group 2 (T2): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum | EXPERIMENTAL | Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 5 mcg of 3M-052-AF and 500 mcg of Alum, as one IM injection at Months 0 and 2, with optional second boost at Month 6. |
| Part A, Group 2 (P2): Placebo | PLACEBO_COMPARATOR | Participants will receive placebo as one IM injection at Months 0 and 2, with optional second boost at Month 6. |
| Part B, Group 3 (T3): BG505 SOSIP.664 gp140 + CpG 1018 + Alum | EXPERIMENTAL | Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 300 mcg of CpG 1018 and 500 mcg of Alum, as one IM injection at Months 0, 2, and 6. |
| Part B, Group 3 (P3): Placebo | PLACEBO_COMPARATOR | Participants will receive placebo as one IM injection at Months 0, 2, and 6. |
| Part B, Group 4 (T4): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum | EXPERIMENTAL | Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with either 1 mcg or 5 mcg of 3M-052-AF (the highest tolerated dose from Part A), and 500 mcg of Alum, as one IM injection at Months 0, 2, and 6. |
| Group 4 (P4): Placebo | PLACEBO_COMPARATOR | Participants will receive placebo as one IM injection at Months 0, 2, and 6. |
| Part B, Group 5 (T5): BG505 SOSIP.664 gp140 + GLA-LSQ | EXPERIMENTAL | Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with GLA-LSQ (GLA 5 mcg, and QS-21 2 mcg), as one IM injection at Months 0, 2, and 6. |
| Part B, Group 5 (P5): Placebo | PLACEBO_COMPARATOR | Participants will receive placebo as one IM injection at Months 0, 2, and 6. |
| Part B, Group 6 (T6): BG505 SOSIP.664 gp140 + Alum | EXPERIMENTAL | Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 500 mcg of Alum, administered as one IM injection at Months 0, 2, and 6. |
| Part B, Group 6 (P6): Placebo | PLACEBO_COMPARATOR | Participants will receive placebo as one IM injection at Months 0, 2, and 6. |
| Part C, Group 7 (T7): BG505 SOSIP.664 gp140 + Alum | EXPERIMENTAL | Participants will receive BG505 SOSIP.664 gp140, 100 mcg admixed with 3M-052-AF, 3 mcg and Alum, 500 mcg to be administered as one 0.5-mL dose intramuscularly (IM) at months 0, 2, and 6. |
| Part C, Group 7 (P7): Placebo | PLACEBO_COMPARATOR | Participants will receive placebo as one IM injection at Months 0, 2, and 6. |
| Part C, Group 8 (T8): Trimer 4571 + Alum | EXPERIMENTAL | Participants will receive Trimer 4571, 100 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as one 0.5-mL dose IM at months 0, 2, and 6. |
| Part C, Group 8 (P8): Placebo | PLACEBO_COMPARATOR | Participants will receive placebo as one IM injection at Months 0, 2, and 6. |
| Name | Type | Description |
|---|---|---|
| BG505 SOSIP.664 gp140 | BIOLOGICAL | Administered by IM injection |
| Placebo | BIOLOGICAL | Administered by IM injection |
| 3M-052-AF | BIOLOGICAL | Administered by IM injection |
| CpG 1018 | BIOLOGICAL | Administered by IM injection |
| GLA-LSQ | BIOLOGICAL | Administered by IM injection |
| Alum (Aluminum Hydroxide Suspension) | BIOLOGICAL | Administered by IM injection |
| Trimer 4571 | BIOLOGICAL | Administered by IM injection |
Inclusion Criteria: General and Demographic Criteria * Age of 18 through 50 years, inclusive * Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study * Ability and willingness to provide informed...