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)

Exclusion Criteria

• •1. Positive test for HIV-1 or HIV-2;
• •2. Any clinically relevant abnormality on history or examination, including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids (the use of topical or inhaled steroids is permitted), immunosuppressive, anticancer, antituberculosis, or other medications considered significant by the Investigator within the previous 6 months; Note: The following exceptions are permitted and will not exclude study participation: use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis, or a short course (duration of 10 days or less or a single injection) of corticosteroid for a non-chronic condition (based on Investigator's clinical judgment) at least 2 weeks prior to enrolment in this study.
• •3. Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the Investigator makes the participant unsuitable for participation in the study; Note: All chronic conditions must be considered stable, there can be no significant change of medications within the previous 2 months, and for diabetics HgbA1c must be \<10%.
• •4. History of substance abuse or alcohol abuse;
• •5. Reported behavior that puts the participant at risk for HIV infection within 6 months prior to screening, as defined by:
• •* Unprotected sexual intercourse with a known HIV-infected person, a partner known to be at high risk for HIV infection, or a casual partner (ie, 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
• •6. If female, pregnant or planning a pregnancy during the period of enrolment until 4 months after the last IP administration; or lactating;
• •7. Bleeding disorder that was diagnosed by a physician (eg, factor deficiency, coagulopathy, or platelet disorder that requires special precautions) Note: A participant who states that he or she has easy bruising or bleeding, but does not have a formal diagnosis and has IM vaccinations and blood draws without any adverse experience is eligible;
• •8. Infectious disease diagnosis: chronic hepatitis B-infection (HBsAg-positive), current hepatitis C infection (HCV Ab-positive and HCV RNA positive), or active syphilis (screening and confirmatory tests);
• •9. History of splenectomy;
• •10. Any of the following abnormal laboratory parameters listed below at screening:
• •Hematology
• •* Hemoglobin ≤10.5 g/dl or ≤6.5 mmol/L in females; ≤11.0 g/dl or ≤6.8 mmol/L in males
• •* Absolute Neutrophil Count (ANC) ≤1,000/mm3 or ≤1.0 × 109 cells/L
• •* Absolute Lymphocyte Count (ALC) ≤650/mm3 or ≤0.65 × 109 cells/L
• •* Platelets ≤125,000 cells/mm3 or ≤125 × 109 cells/L Chemistry
• •* Creatinine ≥1.1 × upper limit of normal (ULN)
• •* AST ≥1.25 × ULN
• •* ALT ≥1.25 × ULN Urinalysis
• •Clinically significant abnormal dipstick confirmed by microscopy:
• •11. Receipt of live attenuated vaccine within the previous 30 days or planned receipt within 30 days after IP administration; or receipt of other vaccine (including all authorized or approved COVID-19 vaccinations) within the previous 14 days or planned receipt within 14 days after IP administration. (Exception is live attenuated influenza vaccine within 14 days); Note 1: COVID-19 vaccinations: Participants should not have received any COVID-19 vaccinations in the 14 days before or 14 days after IP administration.
• •Note 2: COVID-19 immunoprophylaxis will be permitted prior to and/or during the study provided the agent has received either Emergency Use Approval from FDA, Conditional Marketing Authorization from EMA, or granted licensure from a country's regulatory agency.
• •12. Receipt of blood transfusion or blood-derived products within the previous 3 months;
• •13. Participation in another clinical study of an IP currently, within the previous 3 months or expected participation during this study; Note: Concurrent participation in an observational study not requiring blood or tissue sample collection is not an exclusion;
• •14. Prior receipt of any investigational HIV vaccine candidate or HIV monoclonal antibody; Note: Receipt of placebo in a previous monoclonal antibody including HIV monoclonal antibody study will not exclude a participant from participation if documentation is available and the Medical Monitor gives approval.
• •15. History of significant local or systemic reactogenicity to vaccines (eg, anaphylaxis, respiratory difficulties, angioedema, injection site necrosis, or ulceration); (This includes individuals with history of anaphylaxis and/or severe hypersensitivity reaction to mRNA vaccines or its excipients)
• •16. Psychiatric condition that compromises the safety of the participant and precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years;
• •17. Seizure disorder: A participant who has had a seizure in the last 3 years is excluded. (Not excluded: a participant with a history of seizures who has neither required medications nor had a seizure for 3 years);
• •18. History of malignancy in the past 5 years (prior to screening) or ongoing malignancy (a history of completely excised malignancy that is considered cured is not an exclusion);
• •19. Active, serious infections as assessed by the Investigator requiring antibiotic, antiviral or antifungal therapy within 30 days prior to enrolment;
• •20. Body mass index (BMI) ≥35;
• •21. Body weight \<110 pounds (50 kg);
• •22. Prior daily use of NSAID/aspirin that cannot be held for 5 days prior to the leukapheresis procedure (if applicable at the study site);
• •23. If, in the opinion of the PI, it is not in the best interest of the participant to participate in the study.