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

Inclusion 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, unlessapproved 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 studyresults.

• 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 isotherwise 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 beforejoining the study until 8 weeks after the last vaccination and must have a negativepregnancy test on enrollment day.

• Women of pregnancy potential must agree not to seek pregnancy through methods likeIVF from 21 days before joining the study until 8 weeks after the last vaccination.

Exclusion Criteria:

• 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 areallowed).

• Received non-HIV investigational vaccines within the last year, unless they are nowlicensed or authorized.

• Immunodeficiency or medications that impair immune response, such as high-dosesteroids.

• 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 polyethyleneglycol.

• 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, includingsubstance use, psychiatric disorders, recent suicide attempts, or cancer withpotential for recurrence.

• Asthma that requires frequent or high-dose medication, recent emergency care, ormultiple daily medications.

• History of certain immune-mediated conditions (mild, localized conditions may beokay).

• Allergy to local anesthetics like Novocaine or Lidocaine.

• Difficulty with venous access, such as history of intravenous drug use or problemswith blood draws.