Evaluating the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Alum Adjuvants in Healthy, HIV-uninfected Adults
NCT04177355 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 127
Last updated 2025-09-02
Summary
The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults.
Conditions
- HIV Infections
Interventions
- BIOLOGICAL
-
BG505 SOSIP.664 gp140
Administered by IM injection
- BIOLOGICAL
-
Administered by IM injection
- BIOLOGICAL
-
3M-052-AF
Administered by IM injection
- BIOLOGICAL
-
CpG 1018
Administered by IM injection
- BIOLOGICAL
-
GLA-LSQ
Administered by IM injection
- BIOLOGICAL
-
Alum (Aluminum Hydroxide Suspension)
Administered by IM injection
- BIOLOGICAL
-
Trimer 4571
Administered by IM injection
Sponsors & Collaborators
-
HIV Vaccine Trials Network
collaborator NETWORK -
International AIDS Vaccine Initiative
collaborator NETWORK -
Access to Advanced Health Institute (AAHI)
collaborator OTHER -
Dynavax Technologies Corporation
collaborator INDUSTRY -
Fred Hutchinson Cancer Center
collaborator OTHER -
National Institute of Allergy and Infectious Diseases (NIAID)
lead NIH
Principal Investigators
-
M. Juliana McElrath · Seattle Vaccine Trials Unit
-
Nadine Rouphael · Emory University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-01-13
- Primary Completion
- 2024-11-04
- Completion
- 2024-11-04
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein BG505 SOSIP.GT1.1 Gp140 Vaccine, Adjuvanted in Healthy, HIV-uninfected Adults
NCT04224701 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3
NCT00000779 ·Status: COMPLETED ·Phase: PHASE1
-
A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV Envelope Protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in Healthy, HIV-1 Uninfected Adults
NCT03699241 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Trial to Evaluate the Safety and Immunogenicity of BG505 MD39.3, BG505 MD39.3 gp151, and BG505 MD39.3 gp151 CD4KO HIV Trimer mRNA Vaccines in Healthy, HIV-uninfected Adult Participants
NCT05217641 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Evaluating the Safety and Immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs Adjuvanted With GLA-SE in Healthy, HIV-Uninfected Adults
NCT03220724 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 16055 NFL Delta Gly4 Env Protein Trimer and Trimer 4571 Combined With 3M-052-AF + Alum Adjuvant and Ad4-Env145NFL Viral Particles as Heterologous Prime-boost Regimens in Adult Participants Without HIV.
NCT06332339 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
The Study of Immunization in People Living With HIV Undergoing an ATI for Elicitation of VRC01-lineage Antibodies
NCT06006546 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of rgp120/HIV-1MN (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults.
NCT00001044 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of MN Recombinant Soluble gp120/HIV-1 (rsgp120/HIV-1) (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults
NCT00001052 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding NP-GT8 and IL-12, With or Without a TLR-agonist-Adjuvanted HIV Env Trimer 4571 Boost, in Adults Without HIV
NCT05781542 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Trial to Evaluate the Safety and Immunogenicity of Glycan-trimmed HIV-1 Nanoparticle Vaccine (UVAX-1107), Followed by Homologous or Wild-type HIV-1 Nanoparticle Vaccine (UVAX-1197) Boost, Each Adjuvanted With 3M-052-AF + Alum in Adult Participants Without HIV
NCT06905275 ·Status: SUSPENDED ·Phase: PHASE1
-
Study of an HIV Preventive Vaccine Given With or Without an Adjuvant in HIV Uninfected Adults
NCT00111605 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59®- or AS01B-adjuvanted Bivalent Subtype C gp120 in Healthy, HIV-uninfected Adult Participants
NCT03122223 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Evaluating the Safety and Immunogenicity of an HIV Vaccine (gp145 C.6980) in Healthy, HIV-Uninfected Adults in the United States
NCT03382418 ·Status: COMPLETED ·Phase: PHASE1
-
Safety & Immunogenicity of 426c.Mod.Core-C4b Vaccine With 3M-052-AF+Alum in Infants Perinatally Exposed to HIV But Uninfected
NCT06613789 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
A Phase I Clinical Trial To Evaluate the Toxicity, Antiviral and Immunomodulatory Effects of a Range of Doses of Ampligen in HIV-Infected Subjects
NCT00000713 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity of Adjuvanted HIV-1 Fusion Peptide Conjugate Vaccine Alone or in Prime-Boost Regimens With Adjuvanted HIV-1 Envelope Trimer 4571 and HIV-1 Trimer 6931 Vaccines in Healthy Adults
NCT05470400 ·Status: TERMINATED ·Phase: PHASE1
-
Evaluation of Safety and Immunogenicity of Ad26.Mos4.HIV and CH505 TF chTrimer Combination in Healthy Adults
NCT06205056 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Evaluate the Safety and Immunogenicity of 2 Doses of 100µg BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, Given to a Population of Adults Who Have Received 3 Doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted
NCT05983874 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE1
-
A Clinical Trial to Evaluate the Safety and Immunogenicity of CH505M5 N197D mRNA-gp160 Followed by CH505 TF mRNA-gp160 in Adults in Overall Good Health Without HIV
NCT06557785 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Phase I Safety and Immunogenicity Study of HIV p17/p24:Ty-VLP in HIV-1 Seronegative Subjects
NCT00001053 ·Status: COMPLETED ·Phase: PHASE1
-
Immune Response to an HIV DNA Plasmid Vaccine Prime Followed by Adenovirus Boost in HIV-uninfected Individuals
NCT00955006 ·Status: COMPLETED ·Phase: PHASE1
-
Safety of and Immune Response to an HIV Preventive Vaccine (HIV-1 Gag DNA Alone or With IL-15 DNA) Given With or Without 2 Different Booster Vaccinations in HIV Uninfected Adults
NCT00115960 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Trial in Healthy, HIV-1-Uninfected Adult Participants to Compare the Safety, Tolerability and Immunogenicity of CH505TF gp120 Produced From Stably Transfected Cells to CH505TF gp120 Produced From Transiently Transfected Cells
NCT03856996 ·Status: COMPLETED ·Phase: PHASE1
-
Study Evaluating Vaccine in Adults With HIV
NCT00195312 ·Status: TERMINATED ·Phase: PHASE1