A Phase 1 Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core)
NCT05001373 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2024-05-01
Summary
A Phase 1, Randomized, First-in-human, Open-label Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core) in HIV-1 Uninfected Adults in Good General Health
Conditions
Interventions
- BIOLOGICAL
-
Core-g28v2 60mer mRNA Vaccine
100µg, Intramuscularly
- BIOLOGICAL
-
eOD-GT8 60mer mRNA Vaccine
100µg, Intramuscularly
Sponsors & Collaborators
-
ModernaTX, Inc.
collaborator INDUSTRY -
George Washington University
collaborator OTHER -
Fred Hutchinson Cancer Center
collaborator OTHER -
Emory University
collaborator OTHER -
UT Health San Antonio
collaborator UNKNOWN -
International AIDS Vaccine Initiative
lead NETWORK
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-11-12
- Primary Completion
- 2023-06-20
- Completion
- 2024-07-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Clinical Trial of PGDM1400 and PGT121 and VRC07-523LS Monoclonal Antibodies in HIV-infected and HIV-uninfected Adults
NCT03205917 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA Followed by DV701B1.1-RNA in Adults Without HIV
NCT06919016 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Safety and Immunogenicity Study of 2 Investigational Preventive HIV Vaccines
NCT01264445 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Immunogenicity Study of Different Vaccine Regimens of Trivalent Ad26.Mos.HIV or Tetravalent Ad26.Mos4.HIV Along With Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults
NCT02788045 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Immunogenicity of HIV-1 Vaccines C62-M4 or C1C62-M3M4 in Persons With HIV-1 Suppressed on ART
NCT05604209 ·Status: COMPLETED ·Phase: PHASE1
-
Immunogenicity and Safety of 4 Prime-boost Combinations of HIV Vaccine Candidates in Healthy Volunteers
NCT02038842 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety, PK and Antiviral Activity of PGT121 Monoclonal Antibody in HIV-uninfected and HIV-infected Adults
NCT02960581 ·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
-
Safety & Immunogenicity of HIV Vaccines in Healthy Kenyan Adults
NCT02099994 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety of and Immune Response to Two Different HIV Vaccines, Each Followed by a Adenoviral Vaccine Boost, in HIV Uninfected Adults
NCT00270218 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluating the Safety and Immune Response to an HIV Vaccine in Healthy, HIV-Uninfected Adults Who Have Participated in Previous HIV Vaccine Clinical Trials and in Adults Who Have Not Participated in Previous HIV Vaccine Clinical Trials
NCT01376726 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Immunogenicity Study of Three Candidate HIV-1 Vaccines, Administered in Combination to Healthy HIV-1 Uninfected Adults
NCT01151319 ·Status: COMPLETED ·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
-
Effectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection
NCT00002441 ·Status: COMPLETED ·Phase: PHASE3
-
Safety of Recombinant HIV Vaccines in HIV Infected Young Adults on Stable Therapy
NCT00107549 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Safety of a Gene and Cell Therapy Product in Participants With HIV That is Well-Controlled on Antiretroviral Therapy
NCT04561258 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluating the Safety and Immune Response to Three Different Prime-Boost HIV Vaccine Regimens in Healthy, HIV-Uninfected Adults
NCT01970449 ·Status: WITHDRAWN ·Phase: PHASE1
-
A Study of Safety, Tolerability, and Immunogenicity of the MRKAd5 Gag/Pol/Nef Vaccine in Healthy Adults (V520-016)
NCT00849680 ·Status: COMPLETED ·Phase: PHASE1
-
Safety of and Immune Response to Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination in HIV Uninfected Adults
NCT00083603 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Tetravalent Ad26.Mos4.HIV Along With Either Clade C gp140 Plus Adjuvant OR With a Combination of Mosaic and Clade C gp140 Plus Adjuvant in Healthy HIV Uninfected Adults
NCT02935686 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Evaluating the Safety and Immune Response to Three HIV Vaccine Schedules in Healthy, HIV-Uninfected Adults
NCT01783977 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1/2a Study of PGT121, VRC07-523LS and PGDM1400 Monoclonal Antibodies in HIV-uninfected and HIV-infected Adults
NCT03721510 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Immunogenicity of Recombinant HIV Vaccines for HIV/AIDS
NCT01881581 ·Status: UNKNOWN ·Phase: PHASE1
-
Safety and Immunogenicity of a Vaccine Dendritic Cell-based Pulsed With Autologous Heat-inactivated in HIV-1 Infected Patients
NCT02767193 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial to Evaluate Ad35-GRIN/ENV HIV Vaccine in Healthy Adult Volunteers
NCT00851383 ·Status: COMPLETED ·Phase: PHASE1