Clinical Trials Logo
  1. Home
  2. HIV-1 Infection
  3. NCT05414786

A Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644)

HIV-1-infection Clinical Trial

Official title:
A Phase 1 Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) in HIV-1 Uninfected Adults in Good General Health

Clinical Trial Summary

A Phase 1 Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) in HIV-1 Uninfected Adults in Good General Health.

Clinical Trial Description

A Phase 1 Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) in HIV-1 Uninfected Adults in Good General Health. The hypothesis is that eOD-GT8 60mer mRNA Vaccine as a "germline-targeting" immunogen will generate detectable VRC01-class IgG B-cells in African populations. Eighteen participants. An over-enrollment of up to 2 participants will be permitted to facilitate rapid enrollment. Participants who leave the study for any reason will not be replaced. Adults ≥18 and ≤50 years of age who meet all protocol inclusion criteria, who do not meet any protocol exclusion criteria, who understand the study (as demonstrated by the Assessment of [Informed Consent] Understanding [AOU]), and who can provide written informed consent. Administration of eOD-GT8 60mer mRNA Vaccine (100µg) will occur on Week 0 and Week 8. There is no blinding and no randomization in this open-label study. Participants will be screened up to 56 days before the first IP administration and will be actively followed for 6 months after the last IP administration. The total study duration including screening and enrollment is approximately 13 months. A participant is expected to be in the study for 10 months from screening to last study visit. The study is expected to screen and enroll over 3 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05414786
Study type Interventional
Source International AIDS Vaccine Initiative
Contact
Status Active, not recruiting
Phase Phase 1
Start date May 25, 2022
Completion date June 30, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03940521 - Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment
Completed NCT03227731 - Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women Phase 2/Phase 3
Completed NCT03570918 - MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy Phase 1
Not yet recruiting NCT06336434 - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy Phase 1/Phase 2
Active, not recruiting NCT04022967 - ANRS 12372 MODERATO Study Phase 3
Not yet recruiting NCT06282783 - Studying Topiramate for Re-Activating the HIV-1 Reservoir Phase 1/Phase 2
Not yet recruiting NCT06337032 - A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments Phase 4
Completed NCT04711265 - Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys
Recruiting NCT03536234 - Efficacy and Safety of GnRH Analogue Triptorelin for HIV-1 Reservoir Reduction in ART Treated HIV-1 Infected Patients Phase 2
Completed NCT04340388 - Contribution of Dolutegravir to Obesity and Cardiovascular Disease Phase 4
Withdrawn NCT05769569 - Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission Phase 1
Enrolling by invitation NCT05584397 - Comparing Immune Activation and Latent HIV Reservoir Size Between People Living With HIV on Tenofovir-containing Versus NRTI-free ART
Not yet recruiting NCT04894357 - Impact of V106I on Resistance to Doravirine
Completed NCT04388904 - Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Treatment-Experienced Patients Off Therapy. (ReSTART) Phase 4
Completed NCT04963712 - Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder Early Phase 1
Not yet recruiting NCT04513496 - Telemedicine in HIV Care in Buenos Aires
Not yet recruiting NCT04311944 - Early Fast-Track Versus Standard Care for Persons With HIV Initiating TLD N/A
Not yet recruiting NCT04311957 - Continuation of Protease-Inhibitor Based Second-Line Therapy vs. Switch to B/F/TAF in Virologically Suppressed Adults Phase 4
Completed NCT04568239 - Impact of M184V on the Virological Efficacy to 3TC/DTG (LAMRES)
Completed NCT03998176 - Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE Phase 4