Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults

Inclusion Criteria

• HIV infection documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral assay.

A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.

WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment.

• Ages ≥ 18 to ≤ 65 years old
• Able and willing to give written informed consent.
• Able and willing to provide adequate locator information.
• Able and willing to comply with time requirements for protocol-specified visits and evaluations.
• Able and willing to commit to all study visits including follow-up through Day 168 (Week 24).
• Continuous ART prior to screening, defined as not missing more than 9 total days and never more than 4 consecutive days in the last 3 months.
• On a stable ART regimen defined as no changes in any ART medication within the 30 days prior to screening.
• Permitted ART regimens include:
• 1) At least 3 ART agents (not counting ritonavir or cobicistat as one of the agents if less than a 200mg total daily dose). One of the agents must include an integrase inhibitor, NNRTI (Non-Nucleoside Reverse Transcriptase Inhibitors), or a boosted-PI (protease inhibitor).

OR

• 2) Two ART agents in which one of the agents is either a boosted protease inhibitor or an integrase inhibitor.

NOTE: Other potent fully suppressive antiretroviral combinations will be considered on a case-by-case basis.

NOTE: Changes in drug formulation or dose are allowed (e g, TDF to TAF, ritonavir to cobicistat or separate ART agent dosing to fixed-dose combination), but none within 30 days prior to screening.

NOTE: Prior changes in, or elimination of, medications for easier dosing schedule, intolerance, toxicity, an improved side effect profile or within a drug class are permitted if an alternative suppressive regimen was maintained, but not within 30 days prior to screening.

• Ability and willingness of participant to continue ART throughout the study.
• Plasma HIV-1 RNA 60mL/min

Hepatic: Serum total bilirubin - Total bilirubin 150 mm Hg systolic and >100 mm Hg diastolic.

Note: Elevated BP occurring during research leukapheresis procedures completed within the past 12 months are excluded from this requirement. Isolated elevations must be noted as acceptable and signed by study PI or designee.

• History of auto-immune disease, including Type I diabetes mellitus, with specific exception of:
• Vitiligo
• Resolved childhood atopic dermatitis
• Psoriasis (with the exception of psoriatic arthritis) not requiring systemic treatment (within the past 2 years).
• Grave's disease with subsequent return to a euthyroid state (clinically and by laboratory testing).
• Seizure disorder: History of seizure(w) within the past 3 years. Also exclude if participant has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
• History of unexplained syncope or fainting episodes within 12 months of study screening.
• History of Asplenia - absence of normal spleen function as indicated by:
• Splenectomy
• Sickle cell disease
• Bleeding disorder including factor deficiency, coagulopathy or platelet disorder that requires special precautions (easy bruising without a formal diagnosis is not exclusionary).
• Allergy to eggs and/or egg products.
• History of anaphylaxis or severe adverse reaction to vaccines including symptoms such as hives, respirator