Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding NP-GT8 and IL-12, With or Without a TLR-agonist-Adjuvanted HIV Env Trimer 4571 Boost, in Adults Without HIV

Inclusion Criteria

• Able and willing to complete the informed consent process, including an Assessment of Understanding (AoU): volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly.
• 18 to 55 years old, inclusive, on day of enrollment.
• Available for clinic follow-up through the last clinic visit and willing to be contacted at least 12 months after the last vaccine administration.
• Willing to undergo leukapheresis.
• Agrees not to enroll in another study of an investigational agent during participation in the trial.
• In good general health according to the clinical judgement of the site investigator.
• Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity in the clinical judgement of the site investigator.
• Assessed as low risk for HIV acquisition per low-risk guidelines, agrees to discuss HIV-infection risks, agrees to risk-reduction counseling, and agrees to avoid behaviors associated with high risk of HIV exposure through the final study visit. Low risk may include persons stably taking HIV pre-exposure prophylaxis (PrEP) as prescribed for 6 months or longer.
• Hemoglobin:
• ≥ 11.0 g/dL for volunteers who were assigned female sex at birth.
• ≥ 13.0 g/dL for volunteers who were assigned male sex at birth and transgender males who have been on hormone therapy for more than 6 consecutive months.
• ≥ 12.0 g/dL for transgender females who have been on hormone therapy for more than 6 consecutive months.
• For transgender participants who have been on hormone therapy for less than 6 consecutive months, determine hemoglobin eligibility based on the sex assigned at birth.
• Platelets = 125,000-550,000/mm3
• White blood cell (WBC) count = 2,500-12,000/mm3 (not exclusionary: if count greater than 12,000 with investigation showing general good health and PSRT approval). The Leukapheresis Center may impose a higher lower limit of 3,500/mm3
• Alanine aminotransferase (ALT) 8.5 mg/dL.
• Blood pressure in the range of 90 to 2 years ago) not associated with other neurologic symptoms, 2) mild psoriasis that does not require ongoing systemic treatment.
• History of allergy to local anesthetic (Novocaine, Lidocaine).
• Investigator concern for difficulty with venous access based upon clinical history and physical examination. For example, history of IV drug abuse or substantial difficulty with previous blood draws.
• Presence of implanted electronic medical device (eg, pacemaker, implantable cardioverter defibrillator).
• Presence of surgical or traumatic metal implant in either upper arm and/or upper torso.
• History of cardiac arrhythmia (eg, supraventricular tachycardia, atrial fibrillation) (Not excluded: sinus arrhythmia).
• Tattoo overlying the injection sites preventing assessment of reactogenicity in the view of the investigator or skin condition at the injection sites.
• History or presence of keloid scar formation or hypertrophic scar