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

Eligibility Criteria

• * Understands the study and agrees to complete the consent process.
• * Can attend all clinic visits until the end of the study.
• * Agrees to follow all study procedures.
• * Will not join another study with experimental treatments during this trial, unless approved by both study sponsors.
• * Generally healthy according to the study doctor.
• * Physical exam and lab results show no major issues that could affect safety or study results.
• * Agrees to discuss HIV risk and prevention.
• * Hemoglobin levels: at least 11.0 g/dL for women and 13.0 g/dL for men.
• * White blood cell count between 2,500 to 12,000/mm³ (higher levels okay if health is otherwise good and approved).
• * Platelet count between 125,000 to 550,000/mm³.
• * ALT enzyme level less than 2.5 times the upper limit of normal.
• * Serum creatinine level within 1.1 times the upper limit of normal.
• * Serum calcium level at least 8.5 mg/dL.
• * Blood pressure within acceptable range (systolic 90-140 mmHg, diastolic 50-90 mmHg), with average below 140/90 mmHg and no single reading over 160/100 mmHg.
• * Negative HIV test.
• * Negative for Hepatitis C.
• * Negative for Hepatitis B.
• * Women who can become pregnant must use effective contraception from 21 days before joining the study until 8 weeks after the last vaccination and must have a negative pregnancy test on enrollment day.
• * Women of pregnancy potential must agree not to seek pregnancy through methods like IVF from 21 days before joining the study until 8 weeks after the last vaccination.
• * Breastfeeding or pregnant.
• * Body mass index (BMI) of 40 or higher, unless in good health and approved.
• * Diabetes, unless it is well-controlled Type 2 diabetes or gestational diabetes.
• * Previous or current investigational HIV vaccine recipients (placebo recipients are allowed).
• * Received non-HIV investigational vaccines within the last year, unless they are now licensed or authorized.
• * Immunodeficiency or medications that impair immune response, such as high-dose steroids.
• * Received blood products or immunoglobulin within 16 weeks before enrollment.
• * Received certain vaccines within the last 4 weeks before enrollment.
• * Received other vaccines within 14 days before enrollment.
• * History of myocarditis or pericarditis.
• * Started allergy immunotherapy in the past year (unless stable and approved).
• * Taken investigational research agents recently.
• * Serious allergic reactions to any mRNA vaccine or drugs containing polyethylene glycol.
• * History of hereditary or acquired angioedema.
• * Any episode of hives (urticaria) within the past year.
• * Chronic hives (urticaria).
• * Hives previously caused by immunization.
• * Bleeding disorder that would make study procedures unsafe.
• * Seizures or use of seizure medications in the past 3 years.
• * Absence of spleen or non-functional spleen.
• * Active duty and reserve US military personnel.
• * Any other significant condition that could affect safety or participation, including substance use, psychiatric disorders, recent suicide attempts, or cancer with potential for recurrence.
• * Asthma that requires frequent or high-dose medication, recent emergency care, or multiple daily medications.
• * History of certain immune-mediated conditions (mild, localized conditions may be okay).
• * Allergy to local anesthetics like Novocaine or Lidocaine.
• * Difficulty with venous access, such as history of intravenous drug use or problems with blood draws.