New mRNA HIV vaccines enter early human testing

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Able and willing to provide informed consent. * Age 18 to 60 years. * Documented HIV infection. * Lowest (nadir) CD4+ count between 250 and 450 cells/mm³. * On stable combination antiretroviral therapy (ART) for at least 48 weeks prior to screening. * Plasma HIV RNA \<50 copies/mL for at least 48 weeks prior to enrollment, allowing limited transient increases. * CD4+ count \>450 cells/mm³ and CD4+ percentage ≥15%. * Willing and able to comply with study visits and procedures. * Agrees not to participate in another investigational study during participation unless approved. * In general good health, with no clinically significant findings on physical exam or laboratory testing. * Hemoglobin ≥11.0 g/dL (women) or ≥13.0 g/dL (men). * Absolute neutrophil count ≥750/mm³. * Platelet count ≥100,000/mm³. * ALT \<2.5 × upper limit of normal. * Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m². * Serum creatinine ≤1.1 × upper limit of normal. * Serum calcium \>8.5 mg/dL. * Blood pressure within acceptable limits. * Agrees to use condoms during the specified period when ART is interrupted until HIV RNA is undetectable. * No evidence of active hepatitis C infection. * No evidence of active hepatitis B infection. * For individuals of pregnancy potential: negative pregnancy test prior to enrollment and agreement to use effective contraception during the required study period. * Agreement not to seek pregnancy during the required study period. Exclusion Criteria: * Current use of ART that includes non-nucleoside reverse transcriptase inhibitors (NNRTIs). * Use of long-acting ART within 3 months prior to enrollment. * Known resistance to any component of the current ART regimen (excluding M184V/I mutation). * Resistance to one or more drugs in two or more ART classes (excluding M184V/I mutation). * Initiation of ART during acute HIV infection (within 1 year of HIV acquisition, if known). * History of advanced HIV-related illness (CDC Category C), except recurrent pneumonia, within 10 years prior to screening, or history of CD4 count \<200 cells/mm³ within the past 10 years. * History of severe HIV-related conditions, including opportunistic infections, HIV-associated cancers, lymphoma, neurocognitive disease, or progressive multifocal leukoencephalopathy. * Active or recent non-HIV-related cancer requiring systemic treatment within 36 months or expected need for treatment within 12 months (excluding minor skin cancers). * Active hepatitis B or hepatitis C infection. * Significant liver disease, including cirrhosis or advanced fatty liver disease. * Untreated or incompletely treated active or latent tuberculosis. * Pregnancy or breastfeeding. * Body mass index (BMI) ≥40 kg/m², unless approved. * Diabetes mellitus, except well-controlled type 2 diabetes as allowed. * History of or current atherosclerotic cardiovascular disease, including heart attack, angina, stroke, or peripheral arterial disease. * Previous receipt of an investigational HIV vaccine (prior placebo recipients allowed). * Receipt of a non-HIV investigational vaccine within 1 year, unless approved or licensed. * Conditions causing impaired immune function or use of immunosuppressive medications within the specified timeframe. * Prior receipt of anti-HIV monoclonal antibody therapy. * Receipt of certain vaccines within restricted timeframes prior to enrollment (including live or mRNA vaccines within 4 weeks). * Receipt of other vaccines within 14 days prior to enrollment. * History of myocarditis or pericarditis. * Recent initiation of allergy immunotherapy within 1 year (unless stable or approved). * Recent use of investigational agents within restricted timeframes prior to enrollment. * History of severe allergic reaction to mRNA vaccines or polyethylene glycol-containing products. * History of angioedema. * Idiopathic urticaria within the past year. * Chronic urticaria or urticaria within the past year. * History of urticaria associated with vaccination. * Bleeding disorders or use of systemic anticoagulants. * Conditions associated with increased risk of clotting or bleeding. * History of seizures within the past 3 years or use of anti-seizure medications within that period. * Absence of spleen or impaired splenic function. * Active duty or reserve military personnel (U.S.). * Any clinically significant medical, psychiatric, or substance use condition that may affect safety or study participation. * Uncontrolled or severe asthma. * History of immune-mediated medical conditions, except limited stable or resolved conditions as allowed. * Allergy to local anesthetics (e.g., lidocaine). * Difficulty with venous access that would interfere with study procedures.