The Study of Immunization in People Living With HIV Undergoing an ATI for Elicitation of VRC01-lineage Antibodies

Exclusion Criteria

• •1. Current receipt of ART other than nucleoside reverse transcriptase inhibitor and integrase inhibitor.
• •2. Receipt of long-acting ART within 3 months of enrollment.
• •3. Documented history of resistance to any components of the current ARV regimen.
• •4. Known resistance to 1 or more drugs in 2 or more ARV drug classes. NOTE: M184V/I is an exception and should not be considered when assessing this criterion. Prior HIV resistance testing is not required.
• •5. ART initiation during acute HIV-1 infection (defined as within 1 year of HIV-1 acquisition, if known).
• •6. History of an HIV-associated malignancy (including Kaposi's sarcoma), and any type of lymphoma or virus-associated cancers.
• •7. History of HIV-associated neurocognitive disease or progressive multifocal leukoencephalopathy.
• •8. History of HIV-related illness under US Centers for Disease Control (CDC) Category C (except for recurrent pneumonia) within 10 years prior to screening, based on available medical history and assessed by the Investigator for clinical relevance. Anyone with a history of CD4 \< 200 cells/mm3 on one or more occasions, based on available medical history and assessed by the Investigator for clinical relevance. Documentation of every case with history of CD4 \< 200 cells/mm3 must be provided to the Sponsor and PSRT, who will determine eligibility on a case-by-case basis. NOTE: History of treated and resolved pulmonary tuberculosis (TB) will not be exclusionary.
• •9. Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery within 36 months prior to enrollment or for whom such therapies are expected in the subsequent 12 months. NOTE: Minor surgical removal of localized skin cancers (squamous cell carcinoma, basal cell carcinoma) is not exclusionary.
• •10. Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg), hepatitis C antibody without documented history of prior treatment and clearance, or hepatitis C virus RNA (HCV-RNA) in blood.
• •11. Diagnosis of cirrhosis.
• •12. Current untreated or incompletely treated active TB disease or untreated latent TB infection. NOTE: Individuals who are on treatment for latent TB with at least 4 weeks of treatment completed are not excluded.
• •13. Volunteer who is breastfeeding or pregnant.
• •14. Body mass index (BMI) ≥ 40. Enrollment of individuals with BMI ≥ 40, whom the site investigator assesses are in good health, may be considered by PSRT approval.
• •15. Diabetes mellitus (DM). Type 2 DM controlled with diet alone (and confirmed by HgbA1c ≤ 8% within the last 6 months) or a history of isolated gestational diabetes are not exclusionary. Enrollment of individuals with Type 2 DM that is well controlled on hypoglycemic agent(s) may be considered by the PSRT on a case-by-case basis
• •16. History of or current clinical atherosclerotic cardiovascular disease (ASCVD), as defined by 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines, including a previous diagnosis of any of the following:
• •* Acute myocardial infarction
• •* Acute coronary syndromes
• •* Stable or unstable angina
• •* Coronary or other arterial revascularization
• •* Stroke
• •* Transient ischemic attack
• •* Peripheral arterial disease presumed to be of atherosclerotic origin
• •17. Previous or current recipient of an investigational HIV vaccine (previous placebo/control recipients are not excluded).
• •18. Receipt of non-HIV experimental vaccine(s) received within the last 1 year. Exceptions include vaccines that have subsequently undergone licensure or Emergency Use Authorization (EUA) by the FDA or World Health Organization (WHO) emergency use listing (EUL), or if outside the US, by the national Regulatory Authority (RA) authorizing this clinical trial.
• •19. Congenital or acquired immunodeficiency, including systemic medication use likely to impair immune response to vaccine in the opinion of the site investigator, such as history of systemic corticosteroids (long-term use), immunosuppressive anti-cancer or other immunosuppressive agents, interleukins, systemic interferons, systemic chemotherapy, or other medications considered significant by the investigator within the 24 weeks prior. Note: HIV is not exclusionary.
• •20. Blood products or immunoglobulin within 16 weeks prior to enrollment; receipt of immunoglobulin within 16 weeks prior to enrollment requires PSRT approval.
• •21. Previous receipt of any anti-HIV monoclonal antibody.
• •22. Receipt of any of the following vaccines within 4 weeks prior to enrollment:
• •* Live replicating vaccines
• •* Any mRNA-based vaccine with FDA licensure, FDA EUA, or WHO EUL
• •* ACAM2000 vaccine \> 30 days prior with a vaccination scab still present.
• •23. Receipt of any vaccines that are not covered in #22 above within 14 days prior to enrollment. Please note this includes replication incompetent vaccines such as the Jynneos vaccine for the prevention of mpox (formerly known as monkeypox) disease.
• •24. Initiation of antigen-based immunotherapy (AIT) for allergies within the previous year (stable immunotherapy is not exclusionary); inclusion of participants who initiated immunotherapy within the previous year requires PSRT approval. Note: Any AIT should be scheduled at least 14 days prior to enrollment.
• •25. Receipt of investigational research agents with a half-life of 7 or fewer days within 4 weeks prior to enrollment. If a potential participant has received investigational agents with a half-life of greater than 7 days (or unknown half-life) within the past year, PSRT approval is required for enrollment.
• •26. History of serious reaction (eg, hypersensitivity, anaphylaxis) to any vaccine or component of the study vaccine, including imidazoquinolone (eg, imiquimod).
• •27. Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.
• •28. Idiopathic urticaria within the past year.
• •29. Bleeding disorder diagnosed by a clinician which would make study procedures a contraindication (eg, factor deficiency, coagulopathy, platelet disorder requiring special precautions).
• •30. Seizure disorder; febrile seizures as a child or seizures secondary to alcohol withdrawal more than 5 years ago are not exclusionary.
• •31. Asplenia or functional asplenia.
• •32. Active duty and reserve US military personnel.
• •33. Any other chronic or clinically significant condition that, in the clinical judgment of the investigator, would jeopardize the safety or rights of the study participant, including but not limited to: clinically significant forms of substance use or alcohol use disorder(s), serious psychiatric disorders, persons with any suicide attempt within the past 1 year (if between 1 and 2 years, consult PSRT for approval), or cancer that, in the clinical judgement of the site investigator, has potential for recurrence (excluding basal cell carcinoma).
• •34. A participant with a history of a potential immune-mediated medical condition (PIMMC), either active or remote. Specific examples are listed in Appendix I (AESI Index). Not exclusionary: 1) Remote history of Bell's palsy (\> 2 years ago) not associated with other neurologic symptoms and 2) mild psoriasis that does not require ongoing systemic treatment.
• •35. Investigator concern for difficulty with venous access based on clinical history and physical examination. For example, persons with a history of intravenous drug use or substantial difficulty with previous blood draws.