Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BG505 SOSIP.664 gp140 · 1 trial · 1 indication
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...
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BG505 SOSIP.664 gp140 is an investigational monoclonal antibody being studied for the prevention of HIV infections. It is currently in Phase 1 clinical development, meaning it has not been approved and is still being evaluated for safety and immunogenicity in healthy, HIV-uninfected adults.
BG505 SOSIP.664 gp140 is being developed by Dynavax Technologies Corporation, a biopharmaceutical company traded on NASDAQ under the ticker symbol DVAX. The company is conducting clinical research to evaluate the safety and immune response of this investigational product.
BG505 SOSIP.664 gp140 is in Phase 1 clinical development. It is an investigational product, not yet approved by regulatory authorities. The Phase 1 trial has been completed, and the product remains under study for its potential use in preventing HIV infections.
BG505 SOSIP.664 gp140 has been studied in one completed Phase 1 clinical trial, identified as NCT04177355. This trial evaluated the safety and immunogenicity of the product with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults in the United States, enrolling 127 participants.
BG505 SOSIP.664 gp140 is a specific formulation of the BG505 SOSIP.664 immunogen. The clinical trial NCT04177355 evaluates this gp140 version, which is designed to elicit immune responses against HIV. It is distinct from other BG505 constructs and is being tested as a potential vaccine component.