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

Korábbi kezelés

• 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.
• Hives previously caused by immunization.
• Asthma that requires frequent or high-dose medication, recent emergency care, or multiple daily medications.

Más betegség

• Diabetes, unless it is well-controlled Type 2 diabetes or gestational diabetes.
• History of myocarditis or pericarditis.
• Started allergy immunotherapy in the past year (unless stable and approved).
• Serious allergic reactions to any mRNA vaccine or drugs containing polyethylene glycol.
• History of hereditary or acquired angioedema.
• Bleeding disorder that would make study procedures unsafe.
• Seizures or use of seizure medications in the past 3 years.
• Any other significant condition that could affect safety or participation, including substance use, psychiatric disorders, recent suicide attempts, or cancer with potential for recurrence.
• 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.

Egyéb

• Breastfeeding or pregnant.
• Body mass index (BMI) of 40 or higher, unless in good health and approved.
• Taken investigational research agents recently.
• Any episode of hives (urticaria) within the past year.
• Chronic hives (urticaria).
• Absence of spleen or non-functional spleen.
• Active duty and reserve US military personnel.

• 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.