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

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 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.