This study is to test an experimental HIV Vaccine. About 12 participants, aged 18-55 years and who already have cytomegalovirus (CMV) will take part in this study. Participants will come to the clinic for scheduled visits about 21 times over 12 months.
At least 18 years old at screening and up to 55 years old on day of enrollment.
Access to a participating clinical research site and willingness to be followed for the planned duration of the study.
Demonstrates an understanding of the study and is able and willing to provide informed consent.
Agrees not to enroll in another study of an investigational agent during participation in the trial.
Blood products or immunoglobulin within 16 weeks prior to enrollment; receipt of immunoglobulin within 16 weeks prior to enrollment requires approval.
Of pregnancy potential, pregnant, or breastfeeding.
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 more than 7 days (or unknown half-life) within the past year, approval is required for enrollment.
Use of (val)acyclovir, (val)ganciclovir, letermovir, foscarnet, or another antiviral with anti-CMV activity within 30 days prior to the first vaccination. Chronic or suppressive use of (val)acyclovir is not permitted. Short-term use (defined as less than 10 days) of (val)acyclovir is permitted at standard doses provided there have been no more than 2 courses of (val)acyclovir over the last 6 months. Topical use is not exclusionary.
Parallel
VIR-1388
Biological/VaccineTreatment 1 (T1): VIR-1388, 6.9 × 10\^7 ffu to be administered as three 1 mL subcutaneous (SC) injections (total dose = 3 mL) at week 0 (month 0) and week 12 (month 3).
Placebo
Biological/VaccineControl 1 (C1): Placebo for VIR-1388 \[HT Diluent Placebo\] to be administered as three 1 mL SC injections (total dose = 3 mL) at week 0 (month 0) and week 12 (month 3).
Number of Participants with Local Reactions
Local reactogenicity signs and symptoms will be collected for a minimum of 14 days following receipt of any study product
Number of Participants with Systemic Reactions
Systemic reactogenicity signs and symptoms will be collected for a minimum of 14 days following receipt of any study product
Number of Participants with Serious Adverse Events (SAEs)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Number of Participants With VIR-1388 Detected in Plasma
Detection of VIR-1388 viremia by quantitative polymerase chain reaction (qPCR) in plasma
Number of Participants With VIR-1388 Detected in Saliva
Detection of VIR-1388 shedding by qPCR in saliva
Number of Participants With VIR-1388 Detected in Urine
Detection of VIR-1388 shedding by qPCR in urine
Magnitude of HIV-1 Mfuse1-Specific CD4 T-Cell Responses at Additional Timepoints responses to VIR-1388derived HIV-1 Mfuse1 (containing portions of Gag, Pol and Nef)
Level of CD4 T-cell responses to HIV-1 Mfuse1 at additional timepoints in participants who have a response in the primary assay. Responses will be measured using intracellular cytokine staining (ICS) and flow cytometry.
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