Safety and Immunogenicity of HIV-1 Vaccines C62-M4 or C1C62-M3M4 in Persons With HIV-1 Suppressed on ART

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.

Note: The term "licensed" refers to a US FDA-approved kit, which is required for all IND studies. World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) 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 = 70 years old
• Able and willing to give written informed consent.
• Able and willing to provide adequate locator information.
• Able and willing to comply with all study requirements through D196 Week 28.
• Continuous antiretroviral therapy (ART) prior to screening, defined as not missing more than 14 total days and never more than 7 consecutive days in the last 3 months prior to screening.
• No change in any ART medication in the 30 days prior to screening.

Permitted ART regimens include:

• At least 3 ART agents (not counting ritonavir or cobicistat as one of the agents if less than a 200 mg 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

• Two (2) 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, tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (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 /= 90 days prior to screening is not enrollment is not exclusionary.
• Use of any of the following agents within 90 days prior to enrollment: immunomodulatory, cytokine, or growth stimulating factors such as systemic cytotoxic chemotherapy or immune globulin.
• Intent to use immunomodulatory treatment during the study.
• Use of systemic corticosteroids or topical steroids over a total area exceeding 225 cm2 within 30 days prior to enrollment, or anticipated need for periodic use of systemic corticosteroids during the study.

Note: Participants receiving stable physiologic doses of glucocorticoids, defined as the equivalent of prednisone =10 mg/day, will not be excluded. Participants receiving inhaled, intranasal, topical (as defined), intermittent intra-articular corticosteroids, or topical imiquimod will not be excluded.

Note: Concomitant use of oral/systemic /intra-articular/inhaled/intranasal corticosteroids is prohibited for participants receiving ritonavir or cobicistat.

• Use of any investigational HIV vaccine or HIV immunotherapy. Note: Exceptions allowed per PI review and approval.
• Any experimental non-HIV vaccination within the 6 months prior to enrollment. Note: receipt of FDA or Emergency Use Authorization (EUA) approved or licensed COVID-19 vaccines is not exclusionary if = 14 days prior to enrollment on a case by case review by PI or designee.
• Prior