Cytomegalovirus Infections
Conditions
Brief summary
The purpose of the study is to assess the safety and tolerability of a 3-dose regimen of V160 administered by intramuscular (IM) injection in healthy Japanese male participants by cytomegalovirus (CMV) serostatus. There is no formal hypothesis.
Interventions
BIOLOGICALV160
V160 administered as a 0.5 mL (100 Units) IM injection containing 225 mcg aluminum phosphate adjuvant (APA)
OTHERPlacebo
Saline solution (0.9% sodium chloride \[NaCl\] administered as a 0.5 mL IM injection
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy based on medical history and physical examination * Serologically confirmed to be CMV seropositive or CMV seronegative at Visit 1 * If of reproductive potential, agrees to the following from randomization through at least 4 weeks after the last dose of V160-/placebo (from Day 1 through Month 7): 1) practice abstinence from heterosexual activity and remain abstinent, or 2) use contraception unless confirmed to be azoospermic as detailed in the protocol
Exclusion criteria
* History of any allergic reaction or anaphylactic reaction to any vaccine component that required medical intervention * Plans donation of sperm any time from signing the informed consent through 1 month after receiving the last dose of study drug * Is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition that requires immunosuppressive medication. * Has a condition in which repeated venipuncture or injections post more than minimal risk for the participant, such as hemophilia, thrombocytopenia, other severe coagulation disorders, or significantly impaired venous access * Has major psychiatric illness including: any history or schizophrenia or severe psychosis, bipolar disorder requiring therapy, or suicidal ideation within 3 years. * Has previously received any CMV vaccine * Had any live virus vaccine administered or scheduled to be administered in the period from 4 weeks prior to, and 4 weeks following receipt of study drug * Had any inactivated vaccine administered or scheduled within the period from 14 days prior to, through 14 days following study drug * Had administration of any immune globulin or blood product within 90 days prior to injection with study drug or scheduled within 30 days thereafter * Has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/d for persons weighing \>10 kg) for ≥14 consecutive days and has not completed treatment at least 30 days prior to study entry * Has received systemic corticosteroids exceeding physiologic replacement doses (≈5 mg/d prednisone equivalent) within 14 days prior to the first vaccination (participants using inhaled, nasal, or topical steroids are considered eligible for the study) * Has received any anti-viral agent (e.g. letermovir, ganciclovir, valganciclovir, foscarnet, and valacyclovir) with proven or potential activity against CMV 14 days prior to vaccination or is likely to receive such an agent within 14 days after vaccination * Receiving or has received in the year prior to enrollment immunosuppressive therapies including but not limited to rapamycin (also sirolimus), tacrolimus (also FK-506), or other therapies used for solid organ/cell transplant, radiation therapy, immunosuppressive/cytotoxic immunotherapy, chemotherapy and other immunosuppressive therapies known to interfere with the immune response. Topical tacrolimus is allowed provided that it is not used within 14 days prior to, or 14 days following study drug * Has participated in another clinical trial in the past 4 weeks, or plans to participate in a treatment-based trial or a trial in which an invasive procedure is to be performed while enrolled in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Up to 5 days after each vaccination | Participants used the vaccination report card (VRC) to document the presence of any solicited injection-site AEs (pain/tenderness, erythema/redness, and swelling) that occurred in the 5 days after each vaccination. The percentage of participants with a solicited injection-site AE was reported. |
| Percentage of Participants With a Solicited Systemic Adverse Event (AE) | Up to 14 days after each vaccination | Participants used the vaccination report card (VRC) to document the presence of any solicited systemic AEs (headache, fatigue, muscle pain, joint pain) that occurred in the 14 days after each vaccination. The percentage of participants with a solicited systemic AE is reported. |
| Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) | Up to 14 days after each vaccination | An SAE is defined as any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical event. The percentage of participants with an SAE considered to be at least possibly related to the study intervention will be reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer (GMT) of CMV-specific Neutralizing Antibody (NAb) | 1 month after third vaccination (at 7 months) | The NAb GMT in initially CMV-seronegative participants vaccinated with a 3-dose regimen of V160 administered IM was assessed. |
| Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Day 1: 0, 10, 20, and 30 minutes postvaccination | The number of participants with positive viral leakage in injection-site swab and adhesive tape swab (defined by viral load in injection-site swab/adhesive tape swab ≥ assay defined threshold cutoff value) will be assessed. |
| Number of Participants With Viral Detection of V160 in Plasma | Day 1 (predose, at dosing, and 3 hours postdose), Day 3, Day 7, and Day 14 | The number of participants with positive viral detection in plasma (defined by viral load in plasma ≥assay defined threshold cutoff value) was assessed. |
| Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Day 1 (predose), 3, 7, and 14 and Months 2, 6, and 7 | The number of participants with positive wild-type viral shedding in urine or saliva (defined by viral load in saliva/urine ≥ assay defined threshold cutoff value) will be assessed. |
Countries
Japan
Participant flow
Recruitment details
Healthy male participants 20 to 64 years of age were recruited at study sites in Japan.
Participants by arm
| Arm | Count |
|---|---|
| V160: CMV Seropositive at Baseline Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant. | 6 |
| Placebo: CMV Seropositive at Baseline Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6. | 3 |
| V160: CMV Seronegative at Baseline Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant. | 6 |
| Placebo: CMV Seronegative at Baseline Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6. | 3 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | V160: CMV Seropositive at Baseline | Placebo: CMV Seropositive at Baseline | V160: CMV Seronegative at Baseline | Placebo: CMV Seronegative at Baseline | Total |
|---|---|---|---|---|---|
| Age, Continuous | 44.8 Years STANDARD_DEVIATION 16.4 | 36.3 Years STANDARD_DEVIATION 16 | 33.8 Years STANDARD_DEVIATION 11.5 | 24.7 Years STANDARD_DEVIATION 5.5 | 36.4 Years STANDARD_DEVIATION 14.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 3 Participants | 6 Participants | 3 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 3 Participants | 6 Participants | 3 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 6 Participants | 3 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 6 / 6 | 5 / 6 | 1 / 3 | 2 / 3 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 3 | 0 / 3 |
Outcome results
Primary
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Participants used the vaccination report card (VRC) to document the presence of any solicited injection-site AEs (pain/tenderness, erythema/redness, and swelling) that occurred in the 5 days after each vaccination. The percentage of participants with a solicited injection-site AE was reported.
Time frame: Up to 5 days after each vaccination
Population: All randomized participants who received at least 1 vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V160: CMV Seronegative at Baseline | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | 100.0 Percentage of participants |
| V160: CMV Seropositive at Baseline | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | 83.3 Percentage of participants |
| Placebo: CMV Seronegative at Baseline | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | 0.0 Percentage of participants |
| Placebo: CMV Seropositive at Baseline | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | 33.3 Percentage of participants |
Primary
Percentage of Participants With a Solicited Systemic Adverse Event (AE)
Participants used the vaccination report card (VRC) to document the presence of any solicited systemic AEs (headache, fatigue, muscle pain, joint pain) that occurred in the 14 days after each vaccination. The percentage of participants with a solicited systemic AE is reported.
Time frame: Up to 14 days after each vaccination
Population: All randomized participants who received at least 1 vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V160: CMV Seronegative at Baseline | Percentage of Participants With a Solicited Systemic Adverse Event (AE) | 33.3 Percentage of participants |
| V160: CMV Seropositive at Baseline | Percentage of Participants With a Solicited Systemic Adverse Event (AE) | 16.7 Percentage of participants |
| Placebo: CMV Seronegative at Baseline | Percentage of Participants With a Solicited Systemic Adverse Event (AE) | 33.3 Percentage of participants |
| Placebo: CMV Seropositive at Baseline | Percentage of Participants With a Solicited Systemic Adverse Event (AE) | 66.7 Percentage of participants |
Primary
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
An SAE is defined as any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical event. The percentage of participants with an SAE considered to be at least possibly related to the study intervention will be reported
Time frame: Up to 14 days after each vaccination
Population: All randomized participants who received at least 1 vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V160: CMV Seronegative at Baseline | Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) | 0.0 Percentage of participants |
| V160: CMV Seropositive at Baseline | Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) | 0.0 Percentage of participants |
| Placebo: CMV Seronegative at Baseline | Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) | 0.0 Percentage of participants |
| Placebo: CMV Seropositive at Baseline | Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) | 0.0 Percentage of participants |
Secondary
Geometric Mean Titer (GMT) of CMV-specific Neutralizing Antibody (NAb)
The NAb GMT in initially CMV-seronegative participants vaccinated with a 3-dose regimen of V160 administered IM was assessed.
Time frame: 1 month after third vaccination (at 7 months)
Population: All randomized participants who were CMV-seronegative at baseline, received all 3 vaccinations, and did not deviate from the protocol in ways that could affect the immune response
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V160: CMV Seronegative at Baseline | Geometric Mean Titer (GMT) of CMV-specific Neutralizing Antibody (NAb) | 3651 Geometric Mean Titer |
| V160: CMV Seropositive at Baseline | Geometric Mean Titer (GMT) of CMV-specific Neutralizing Antibody (NAb) | NA Geometric Mean Titer |
95% CI: [23.9, 252.4]
Secondary
Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab
The number of participants with positive viral leakage in injection-site swab and adhesive tape swab (defined by viral load in injection-site swab/adhesive tape swab ≥ assay defined threshold cutoff value) will be assessed.
Time frame: Day 1: 0, 10, 20, and 30 minutes postvaccination
Population: All randomized participants who received at least one vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| V160: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from injection-site - 0 min PD1 | 6 Participants |
| V160: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from injection-site - 10 min PD1 | 3 Participants |
| V160: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from injection-site - 20 min PD1 | 4 Participants |
| V160: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from injection-site - 30 min PD1 | 3 Participants |
| V160: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (inside) - 10 min PD1 | 1 Participants |
| V160: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (inside) - 20 min PD1 | 0 Participants |
| V160: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (inside) - 30 min PD1 | 0 Participants |
| V160: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (outside) - 10 min PD1 | 0 Participants |
| V160: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (outside) - 20 min PD1 | 0 Participants |
| V160: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (outside) - 30 min PD1 | 0 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from injection-site - 20 min PD1 | 4 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (outside) - 20 min PD1 | 0 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from injection-site - 30 min PD1 | 4 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (inside) - 10 min PD1 | 2 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (inside) - 20 min PD1 | 3 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (inside) - 30 min PD1 | 0 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (outside) - 30 min PD1 | 0 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (outside) - 10 min PD1 | 0 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from injection-site - 0 min PD1 | 6 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from injection-site - 10 min PD1 | 4 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (outside) - 10 min PD1 | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (inside) - 30 min PD1 | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (outside) - 30 min PD1 | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from injection-site - 0 min PD1 | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from injection-site - 30 min PD1 | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (inside) - 20 min PD1 | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (outside) - 20 min PD1 | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from injection-site - 10 min PD1 | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (inside) - 10 min PD1 | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from injection-site - 20 min PD1 | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (inside) - 10 min PD1 | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (outside) - 10 min PD1 | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (inside) - 20 min PD1 | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (outside) - 30 min PD1 | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (inside) - 30 min PD1 | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from injection-site - 10 min PD1 | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from injection-site - 20 min PD1 | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from injection-site - 30 min PD1 | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from injection-site - 0 min PD1 | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab | Swab from adhesive tape (outside) - 20 min PD1 | 0 Participants |
Secondary
Number of Participants With Viral Detection of V160 in Plasma
The number of participants with positive viral detection in plasma (defined by viral load in plasma ≥assay defined threshold cutoff value) was assessed.
Time frame: Day 1 (predose, at dosing, and 3 hours postdose), Day 3, Day 7, and Day 14
Population: All randomized participants who received at least one vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| V160: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Plasma | Day 1 (predose) | 0 Participants |
| V160: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Plasma | 0 min postdose in Day 1 | 1 Participants |
| V160: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Plasma | 3 hr postdose in Day 1 | 0 Participants |
| V160: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Plasma | Day 3 postdose | 6 Participants |
| V160: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Plasma | Day 7 postdose | 0 Participants |
| V160: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Plasma | Day 14 postdose | 0 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Plasma | Day 14 postdose | 0 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Plasma | Day 3 postdose | 6 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Plasma | Day 1 (predose) | 0 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Plasma | 3 hr postdose in Day 1 | 0 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Plasma | 0 min postdose in Day 1 | 0 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Plasma | Day 7 postdose | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Plasma | 0 min postdose in Day 1 | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Plasma | 3 hr postdose in Day 1 | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Plasma | Day 3 postdose | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Plasma | Day 14 postdose | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Plasma | Day 7 postdose | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Viral Detection of V160 in Plasma | Day 1 (predose) | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Plasma | Day 7 postdose | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Plasma | Day 14 postdose | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Plasma | 0 min postdose in Day 1 | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Plasma | Day 3 postdose | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Plasma | Day 1 (predose) | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Viral Detection of V160 in Plasma | 3 hr postdose in Day 1 | 0 Participants |
Secondary
Number of Participants With Wild-Type CMV Detection in Urine and Saliva
The number of participants with positive wild-type viral shedding in urine or saliva (defined by viral load in saliva/urine ≥ assay defined threshold cutoff value) will be assessed.
Time frame: Day 1 (predose), 3, 7, and 14 and Months 2, 6, and 7
Population: All randomized participants who received at least one vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| V160: CMV Seronegative at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Day 1 (predose) | 0 Participants |
| V160: CMV Seronegative at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Month 6 (predose 3) | 0 Participants |
| V160: CMV Seronegative at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Month 2 (predose 2) | 0 Participants |
| V160: CMV Seronegative at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Day 3 (postdose [PD] 1) | 0 Participants |
| V160: CMV Seronegative at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Month 7 (PD3) | 0 Participants |
| V160: CMV Seronegative at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Day 7 (PD1) | 0 Participants |
| V160: CMV Seronegative at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Day 14 (PD1) | 0 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Month 6 (predose 3) | 0 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Day 14 (PD1) | 1 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Day 7 (PD1) | 0 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Month 2 (predose 2) | 1 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Month 7 (PD3) | 1 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Day 3 (postdose [PD] 1) | 0 Participants |
| V160: CMV Seropositive at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Day 1 (predose) | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Day 14 (PD1) | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Day 1 (predose) | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Day 3 (postdose [PD] 1) | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Day 7 (PD1) | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Month 2 (predose 2) | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Month 6 (predose 3) | 0 Participants |
| Placebo: CMV Seronegative at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Month 7 (PD3) | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Day 7 (PD1) | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Month 7 (PD3) | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Month 6 (predose 3) | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Day 3 (postdose [PD] 1) | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Day 1 (predose) | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Month 2 (predose 2) | 0 Participants |
| Placebo: CMV Seropositive at Baseline | Number of Participants With Wild-Type CMV Detection in Urine and Saliva | Day 14 (PD1) | 0 Participants |