This Phase 1, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, and immune responses of the investigational HCMV-TB vaccine candidate VIR-1778 in adults in overall good health without HIV who are cytomegalovirus (CMV) seropositive. Participants will receive two doses of either VIR-1778 or placebo administered 12 weeks apart. The study will assess the safety of VIR-1778, its ability to induce immune responses against Mycobacterium tuberculosis (TB) antigens, and the presence of vaccine-derived virus in blood, saliva, and urine. The study is based on the hypothesis that VIR-1778 will be safe and well tolerated and will induce CD4+ and CD8+ T-cell responses against TB antigens. Approximately 116 participants will be enrolled.
At least 18 years old at screening and up to 55 years old on day of enrollment.
Access to a participating HVTN CRS 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. If a potential participant is already enrolled in another clinical trial, approvals are required prior to enrollment into HVTN 606.
Known significant exposure to TB in the 2 years prior to enrollment, as determined by the site investigator based on potential participant report and available medical records.
History of prior active TB disease, as determined by the site investigator based on participant report and available medical, laboratory, or radiographic records.
Current anti-TB prophylaxis or therapy.
Evidence of active TB disease as determined by the site investigator.
Sequential
VIR-1778 (5 × 10^5 ffu)
Biological/VaccineLive attenuated human cytomegalovirus (HCMV)-vectored tuberculosis (TB) vaccine candidate expressing seven Mycobacterium tuberculosis antigens (TB7Ag). Administered as a 1 mL subcutaneous injection in the deltoid at Week 0 and Week 12.
VIR-1778 (5 × 10^6 ffu)
Biological/VaccineLive attenuated human cytomegalovirus (HCMV)-vectored tuberculosis (TB) vaccine candidate expressing seven Mycobacterium tuberculosis antigens (TB7Ag). Administered as a 1 mL subcutaneous injection in the deltoid at Week 0 and Week 12.
HT Diluent Placebo
Other interventionHT buffer placebo containing 20 mM histidine and 10% trehalose-dihydrate without active vaccine. Administered as a 1 mL subcutaneous injection in the deltoid at Week 0 and Week 12.
Incidence of solicited local reactogenicity
Incidence and severity of solicited local reactogenicity following receipt of study vaccine.
Incidence of solicited systemic reactogenicity
Incidence and severity of solicited systemic reactogenicity following receipt of study vaccine.
Incidence of adverse events (AEs)
Incidence of adverse events following receipt of study product.
Incidence of serious adverse events (SAEs)
Incidence of serious adverse events.
Frequency of insert-specific CD4 T-cell responses
Frequency (percentages of T cells responding) of CD4 T-cell responses to the VIR-1778-derived TB7Ag fusion protein above baseline, as measured by intracellular cytokine staining (ICS) and flow cytometry.
Functional parameters of insert-specific CD4 T-cell responses to synthetic TB peptides
Functional profile (cell surface markers, cytokines, or functional markers) of insert-specific CD4 T-cell responses to the VIR-1778-derived TB7Ag fusion protein measured by intracellular cytokine staining (ICS) and flow cytometry.
Phenotypic profile (markers of memory phenotype) of insert-specific CD4 T-cell responses
Phenotypic profile (markers of memory phenotype) of insert-specific CD4 T-cell responses to the VIR-1778-derived TB7Ag fusion protein measured by flow cytometry
Frequency of insert-specific CD8 T-cell responses
Frequency (percentages of T cells responding) of insert-specific CD8 T-cell responses to the VIR-1778-derived TB7Ag fusion protein above baseline, as measured by intracellular cytokine staining (ICS) and flow cytometry.
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