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

The objective of this clinical trial is to assess the safety, tolerability, and ability to evaluate a desired immune response of two vaccinations – a prime (eOD-GT8 60mer) mRNA vaccine and boost (Core-g28v2 60mer) mRNA vaccine, in uninfected healthy adults. The study is evaluating the immune response to the vaccine immunogens, specifically the development of precursors to broadly neutralizing antibodies (bnABs). The ultimate goal is the development of a series of vaccine immunogens that prevents human immunodeficiency virus (HIV) infection. Participants will be enrolled for durations ranging from six to 11 months depending on the arm of the study to which they are randomized. They will be compensated for their time. Outpatient evaluations, radiologic examinations, and blood analysis will be conducted at University Hospital to measure the effects of the vaccine.

Basic Inclusion Criteria: Must Answer Yes

1. Are you willing to have an HIV test, risk reduction counseling, and receive HIV test results? Must be yes.
2. Are you willing to not get pregnant, or get anyone else pregnant during the study? Must be yes.
3. Do you agree to not donate any blood or tissue, during the study? Must be yes.
   Basic Exclusion Criteria:
   DNQ If:
4. Have you tested positive for HIV-1 or HIV-2? Must be no.
5. Have you been diagnosed with any Infectious disease diagnosis: chronic hepatitis B infection, current hepatitis C infection, or active syphilis? Must be no.
6. Do you have a history of splenectomy (spleen removal)? Must be no.
7. Do you have a history of myocarditis (inflammation of the middle heart) or pericarditis (swelling of the membrane surrounding the heart)? Must be no.
8. Are you currently pregnant, breastfeeding, or planning to become pregnant during the study? Must be no.
9. Do you have a history of immunodeficiency or autoimmune disease? Must be no.
10. Do you have a recent history (last 2 years) of substance abuse or alcohol abuse? Must be no.
11. Do you have a bleeding disorder diagnosed by a physician? Must be no.
12. Must be no. Within the last 6 months:
    • Had unprotected sexual intercourse with a known person living with HIV, a partner known to be at high risk for HIV, or a casual partner (i.e., no continuing established relationship)
    • Engaged in sex work
    • Frequent excessive daily alcohol use or frequent binge drinking, or any other use of illicit drugs
    • History of newly acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus-2, chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B-or hepatitis C
    • Three or more sexual partners

Meet Your Clinical Research Team