Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-Based Anti-Cytomegalovirus (CMV) Vaccine (Triplex®)

Inclusion Criteria

• HIV-1 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 load.

NOTE: The term "licensed" refers to a US FDA-approved kit, which is required for all IND studies.

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. 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.

• Currently on continuous ART for ≥48 weeks prior to study entry. This is defined as continuous ART consisting of at least 2 nucleoside reverse transcriptase inhibitors (NRTIs) and either a protease inhibitor boosted with low dose ritonavir or with cobicistat, an integrase inhibitor, or an non-nucleoside reverse transcriptase inhibitor (NNRTI) for the 48-week period prior to study entry with no ART interruption longer than 7 consecutive days.

NOTE 1: Other ART regimens may be acceptable. For a list of acceptable ART regimens, please see the A5355 PSWP. For any regimens not listed, sites must consult the protocol team.

NOTE 2: Modifications to ART regimens prior to study entry are allowable except for the time period noted in the protocol.

• HIV-1 RNA level 30 days apart, with the most recent value obtained within 45 days prior to entry.

NOTE: Single determinations that are between the assay quantification limit and 500 copies/mL (i.e., "blips") are allowed as long as the preceding and subsequent determinations are both below the level of quantification. The screening value may serve as the subsequent undetectable value following a blip.

• CD4+ cell count >250 cells/μL, obtained within 45 days prior to study entry at any US laboratory that has a CLIA certification or its equivalent.
• The following laboratory values, obtained within 45 days prior to entry (unless otherwise noted) by any US laboratory that has a CLIA certification or its equivalent:
• Hemoglobin ≥ 9.0 g/dL
• Platelet count ≥ 75,000/mm3
• Estimated Glomerular Filtration Rate (eGFR) >50 mL/min/1.73m2 or creatinine clearance (CrCl) >50 mL/min using the Cockcroft-Gault equation on the FSTRF website.
• Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), and alkaline phosphatase ≤ 3 X ULN
• Hemoglobin A1c (HgbA1c) 30 mIU/mL
• Surgically sterile following a successful vasectomy

NOTE: The participant may not be able to provide written proof of a partner's vasectomy, sterilization, or menopausal status, since the participant's partner is not usually enrolled in the same study to provide consent for release of this information. The verbal report from the participant of their partner's status should be written into the source documents.

• Ability and willingness of participant to provide informed consent.
• Willingness of participant to have study samples obtained and stored.

NOTE: Although agreement to provide genital secretion at each time-point is required for all participants, inability to produce genital secretion samples at one or more time-point is not exclusionary

Exclusion Criteria

• Unapproved modification in ART regimen within the 12 weeks prior to study entry, or anticipated/intended modification of ART during the study period.

NOTE: Certain modifications of ART doses during the 12 weeks prior to study entry are permitted. In addition, change in formulation (e.g., from standard formulation to fixed-dose combination) is allowed within 12 weeks prior to study entry. A within-class s