Cytomegalovirus Infections
Conditions
Brief summary
This study will evaluate the safety, tolerability, and immunogenicity of various doses, formulations, and routes of administration of Human Cytomegalovirus (HCMV) vaccine V160 administered in a 3-dose regimen in healthy adults. The initial treatment arm of HCMV seropositive participants will receive V160 Low Dose without adjuvant by intramuscular injection. Escalation of the V160 dose, inclusion of adjuvant, administration by intradermal injection, and vaccination of HCMV seronegative participants will be performed only after review of safety data of previous treatment arms. The purpose of the study is to identify vaccine formulations associated with optimal safety profile and HCMV-specific immune response for evaluation in subsequent clinical studies of V160.
Interventions
BIOLOGICALV160 Low Dose IM
V160 administered as a 0.75 mL intramuscular injection
BIOLOGICALV160 Medium Dose IM
V160 administered as a 0.75 mL intramuscular injection
BIOLOGICALV160 High Dose IM
V160 administered as a 0.75 mL intramuscular injection
BIOLOGICALV160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IM
V160 plus MAPA administered as a 0.75 mL intramuscular injection
BIOLOGICALV160 High Dose plus MAPA 225 µg /dose IM
V160 plus MAPA administered as a 0.75 mL intramuscular injection
BIOLOGICALV160 Maximum Dose IM
V160 administered as a 0.75 mL intramuscular injection
OTHERPlacebo IM
Placebo administered as a 0.75 mL intramuscular injection
BIOLOGICALV160 Medium Dose ID
V160 administered as a 0.1 mL intradermal injection
OTHERPlacebo ID
Placebo administered as a 0.1 mL intradermal 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
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy based on medical history and physical examination * Serologically confirmed to be HCMV seronegative or HCMV seropositive * Agrees to avoid unusual, unaccustomed strenuous, vigorous physical exercise/activity from 72 hours before through 72 hours after each dose of study vaccine * Body weight ≥110 lbs (50 kg) and body mass index (BMI) of 19 to 32 kg/m\^2 * If of reproductive potential, agrees to the following during the study and for 4 weeks after the last dose of study vaccine: 1) practice abstinence from heterosexual activity, or 2) use or have their partner use 2 allowable methods of birth control during heterosexual activity
Exclusion criteria
* Has previously received any cytomegalovirus vaccine * Has history of allergic reaction or anaphylactic reaction to any vaccine component that required medical intervention * Has history of any severe allergic reaction that required medical intervention * Is pregnant or breastfeeding or expecting to conceive from 2 weeks before the study through 1 month after the last dose of study vaccine * Plans to donate eggs or sperm from study start through 1 month after the last dose of study drug * Has impairment of immunologic function including, but not limited to autoimmune disease, splenectomy, or human immunodeficiency virus acquired immunodeficiency syndrome (HIV/AIDS) * Received systemic corticosteroids for ≥14 consecutive days and has not completed treatment within 30 days of study start * Received immunosuppressive therapy including, but not limited to rapamycin and equivalents, tacrolimus, FK-506, fujimycin, or other therapies used for solid organ/cell transplant, radiation therapy, immunosuppressive/cytotoxic chemotherapy, or other therapy known to interfere with the immune response within 1 year of study start * Has a condition in which repeated venipuncture or injections pose more than minimal risk, such as hemophilia, thrombocytopenia or other severe coagulation disorders, or significantly impaired venous access * Has a condition that requires active medical intervention or monitoring such as diabetes mellitus, autoimmune disease, or a clinically significant chronic medical condition that is considered progressive * Has history within the past 5 years or current drug or alcohol abuse * Has major psychiatric illness * Is legally or mentally incapacitated * Has participated in another clinical study in the past 4 weeks, or plans during the present study to participate in a treatment-based study or a study in which an invasive procedure is performed * Has received valganciclovir, ganciclovir, valacyclovir, foscarnet, or cidofovir from 4 weeks prior to 1 month following each V160 vaccination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3 | Month 7 (1 month after vaccination 3 at Month 6) | Serum samples for measuring neutralizing antibodies using the Merck Neutralizing Antibody (NAb) assay were collected at month 7. The LiCor-based near-infrared dye (NIRDye) In-Cell Western (ICW) HCMV microneutralization assay was used to detect and quantify anti-HCMV neutralizing antibodies. The primary hypothesis was that for HCMV-seronegative participants, at least 1 of the vaccination groups receiving V160 formulated with or without adjuvant would exhibit higher HCMV-specific neutralizing antibody titers than the placebo group. |
| Percentage of Participants With a Serious Vaccine-Related Adverse Event | Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26) | A serious adverse event is any adverse event occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. A serious vaccine-related adverse event was determined by the investigator to be related to the vaccine. |
| Percentage of Participants Who Discontinued Study Treatment Due to an AE | Up to Month 6 | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. |
| Percentage of Participants With Events of Clinical Interest (ECI) | Up to 18 months | An event of clinical interest (ECI) is identified as any overdose, elevated liver values meeting threshold criteria (aspartate aminotransferase or alanine aminotransferase ≥3x upper limit of normal (ULN); total bilirubin ≥2x ULN, and, at the same time, alkaline phosphatase \<2xULN). Additionally, confirmed, diagnosed autoimmune conditions are considered ECIs. |
| Percentage of Participants With an Adverse Event (AE) | Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26) | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. |
| Percentage of Participants With an Injection-site AE | Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26) | Injection-site AEs are defined as redness, swelling, and pain/tenderness. |
| Percentage of Participants With a Systemic AE | Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26) | A Systemic AE includes, but is not exclusive of, the following AEs: fatigue, myalgia, headache and joint pain |
| Percentage of Participants With a Serious Adverse Event (SAE) | Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26) | A serious adverse event is any adverse event occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | Month 7 (1 month after vaccination 3 at Month 6) | In response to HCMV-specific stimulation of whole blood specimens the whole Blood Cytokine Stimulation (WBStim) assay was used to detect the secretion of interferon gamma (IFN -γ) by an ELISA assay. Results are presented for the following HCMV proteins: pp65, IE1, and gB. |
| Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 1 and 2 (one month after vaccination 1 [Day 1] and vaccination 2 [Month 1]) | Serum samples for measuring neutralizing antibodies using the Merck NAb assay were collected at months 1 and 2. The LiCor-based near-infrared dye (NIRDye) In-Cell Western (ICW) HCMV microneutralization assay was used to detect and quantify anti-HCMV neutralizing antibodies. Values below the lower limit of titer are represented by NA. |
| Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | Month 7 (1 month after vaccination 3 at Month 6) | In order to evaluate the cellular immune response to the vaccine(s), the HCMV enzyme-linked immunospot (ELISPOT) assay was used to detect interferon gamma (IFN-γ) secreting HCMV-specific cells from peripheral blood mononuclear cells (PBMCs). Results are expressed as the frequency of spot forming cells (SFCs) per million PBMCs (SFC/10\^6 PBMCs). Results are presented for the following HCMV proteins: pp65, Immediate early Protein 1 (IE1), Immediate early Protein 2 (IE2), Glycoprotein B (gB), and also for purified HCMV virion stock. |
Participant flow
Recruitment details
Healthy males and females age 18 years of age and older were enrolled in this trial.
Participants by arm
| Arm | Count |
|---|---|
| HCMV Seropositive (+) V160 10u Intramuscular (IM) Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 | 13 |
| HCMV + V160 30u IM Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 | 14 |
| HCMV+ V160 100u IM Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 | 14 |
| HCMV+ V160 100u MAPA IM Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6 | 10 |
| HCMV+ V160 250u IM Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 | 11 |
| HCMV+ Placebo IM Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 | 19 |
| HCMV+ V160 30u ID Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6 | 10 |
| HCMV+ Placebo ID Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6 | 4 |
| HCMV Seronegative (-) V160 10u IM Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 | 12 |
| HCMV- V160 30u IM Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6 | 10 |
| HCMV- V160 30u MAPA IM Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6 | 10 |
| HCMV- V160 100u IM Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6 | 11 |
| HCMV- V160 100u MAPA IM Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6 | 10 |
| HCMV- V160 250u IM Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 | 11 |
| HCMV- V160 Placebo IM Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 | 16 |
| HCMV- V160 30u ID Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6 | 11 |
| HCMV- Placebo ID Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6 | 4 |
| Total | 190 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 | 2 | 2 | 2 | 2 | 0 | 0 | 4 | 2 | 0 | 1 | 1 | 1 | 2 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Status Not Recorded | 2 | 4 | 2 | 0 | 1 | 2 | 0 | 0 | 2 | 1 | 7 | 7 | 9 | 9 | 5 | 10 | 4 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 3 | 0 | 2 | 4 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | HCMV Seropositive (+) V160 10u Intramuscular (IM) | HCMV + V160 30u IM | HCMV+ V160 100u IM | HCMV+ V160 100u MAPA IM | HCMV+ V160 250u IM | HCMV+ Placebo IM | HCMV+ V160 30u ID | HCMV+ Placebo ID | HCMV Seronegative (-) V160 10u IM | HCMV- V160 30u IM | HCMV- V160 30u MAPA IM | HCMV- V160 100u IM | HCMV- V160 100u MAPA IM | HCMV- V160 250u IM | HCMV- V160 Placebo IM | HCMV- V160 30u ID | HCMV- Placebo ID | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 44.1 Years STANDARD_DEVIATION 14.8 | 47.7 Years STANDARD_DEVIATION 14.5 | 44.9 Years STANDARD_DEVIATION 13.2 | 48.8 Years STANDARD_DEVIATION 10.6 | 46.4 Years STANDARD_DEVIATION 13.7 | 46.5 Years STANDARD_DEVIATION 15.1 | 51.7 Years STANDARD_DEVIATION 18.9 | 47.5 Years STANDARD_DEVIATION 16.7 | 45.0 Years STANDARD_DEVIATION 11.8 | 32.5 Years STANDARD_DEVIATION 10.9 | 39.0 Years STANDARD_DEVIATION 16.6 | 41.1 Years STANDARD_DEVIATION 14.5 | 53.1 Years STANDARD_DEVIATION 10.7 | 40.0 Years STANDARD_DEVIATION 14.4 | 44.9 Years STANDARD_DEVIATION 15.7 | 36.1 Years STANDARD_DEVIATION 12.7 | 31.5 Years STANDARD_DEVIATION 13.1 | 44.1 Years STANDARD_DEVIATION 14.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 3 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 13 Participants | 12 Participants | 8 Participants | 10 Participants | 19 Participants | 7 Participants | 4 Participants | 10 Participants | 10 Participants | 8 Participants | 11 Participants | 10 Participants | 9 Participants | 15 Participants | 11 Participants | 4 Participants | 170 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 6 Participants | 4 Participants | 5 Participants | 8 Participants | 0 Participants | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 4 Participants | 1 Participants | 0 Participants | 47 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 10 Participants | 7 Participants | 6 Participants | 5 Participants | 8 Participants | 9 Participants | 3 Participants | 8 Participants | 7 Participants | 7 Participants | 10 Participants | 8 Participants | 9 Participants | 10 Participants | 10 Participants | 3 Participants | 127 Participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 9 Participants | 6 Participants | 7 Participants | 10 Participants | 6 Participants | 2 Participants | 7 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 8 Participants | 6 Participants | 2 Participants | 109 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 5 Participants | 4 Participants | 4 Participants | 9 Participants | 4 Participants | 2 Participants | 5 Participants | 4 Participants | 4 Participants | 5 Participants | 4 Participants | 5 Participants | 8 Participants | 5 Participants | 2 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 14 | 0 / 14 | 0 / 10 | 0 / 11 | 0 / 19 | 0 / 10 | 0 / 4 | 0 / 12 | 0 / 10 | 0 / 10 | 0 / 11 | 0 / 10 | 0 / 11 | 0 / 16 | 0 / 11 | 0 / 4 |
| other Total, other adverse events | 9 / 13 | 13 / 14 | 12 / 14 | 10 / 10 | 11 / 11 | 12 / 19 | 10 / 10 | 2 / 4 | 9 / 12 | 9 / 10 | 9 / 10 | 11 / 11 | 9 / 10 | 10 / 11 | 10 / 16 | 11 / 11 | 4 / 4 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 | 0 / 14 | 0 / 10 | 0 / 11 | 0 / 19 | 0 / 10 | 0 / 4 | 0 / 12 | 0 / 10 | 0 / 10 | 0 / 11 | 0 / 10 | 0 / 11 | 0 / 16 | 0 / 11 | 0 / 4 |
Outcome results
Primary
Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3
Serum samples for measuring neutralizing antibodies using the Merck Neutralizing Antibody (NAb) assay were collected at month 7. The LiCor-based near-infrared dye (NIRDye) In-Cell Western (ICW) HCMV microneutralization assay was used to detect and quantify anti-HCMV neutralizing antibodies. The primary hypothesis was that for HCMV-seronegative participants, at least 1 of the vaccination groups receiving V160 formulated with or without adjuvant would exhibit higher HCMV-specific neutralizing antibody titers than the placebo group.
Time frame: Month 7 (1 month after vaccination 3 at Month 6)
Population: All randomized participants who received at least 1 dose of the study vaccine or placebo and had at least 1 valid neutralizing antibody result.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| HCMV Seropositive (+) V160 10u Intramuscular (IM) | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3 | 3301 Geometric Mean Titer |
| HCMV + V160 30u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3 | 4177 Geometric Mean Titer |
| HCMV+ V160 100u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3 | 7740 Geometric Mean Titer |
| HCMV+ V160 100u MAPA IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3 | 5701 Geometric Mean Titer |
| HCMV+ V160 250u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3 | 3535 Geometric Mean Titer |
| HCMV+ Placebo IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3 | 8601 Geometric Mean Titer |
| HCMV+ V160 30u ID | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3 | 2224 Geometric Mean Titer |
| HCMV+ Placebo ID | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3 | 328 Geometric Mean Titer |
| HCMV Seronegative (-) V160 10u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3 | 1532 Geometric Mean Titer |
| HCMV- V160 30u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3 | 1361 Geometric Mean Titer |
| HCMV- V160 30u MAPA IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3 | 820 Geometric Mean Titer |
| HCMV- V160 100u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3 | 2573 Geometric Mean Titer |
| HCMV- V160 100u MAPA IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3 | 1241 Geometric Mean Titer |
| HCMV- V160 250u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3 | 1261 Geometric Mean Titer |
| HCMV- V160 Placebo IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3 | 20 Geometric Mean Titer |
Comparison: GMT Ratio: GMT V160/GMT placebo95% CI: [0.8, 2.6]
Comparison: GMT Ratio: GMT V160/GMT placebo95% CI: [1.1, 3.2]
Comparison: GMT Ratio: GMT V160/GMT placebo95% CI: [1.6, 7.4]
Comparison: GMT Ratio: GMT V160/GMT placebo95% CI: [1.4, 4.6]
Comparison: GMT Ratio: GMT V160/GMT placebo95% CI: [0.9, 3]
Comparison: GMT Ratio: GMT V160/GMT placebo95% CI: [2.2, 7]
Comparison: GMT Ratio: GMT V160/GMT placebop-value: <0.00195% CI: [9.5, 28.4]Two sample t-test
Comparison: GMT Ratio: GMT V160/GMT placebop-value: <0.00195% CI: [49.5, 118.6]Two sample t-test
Comparison: GMT Ratio: GMT V160/GMT placebop-value: <0.00195% CI: [40.1, 115.6]Two sample t-test
Comparison: GMT Ratio: GMT V160/GMT placebop-value: <0.00195% CI: [23.8, 70.7]Two sample t-test
Comparison: GMT Ratio: GMT V160/GMT placebop-value: <0.00195% CI: [87, 190.3]Two sample t-test
Comparison: GMT Ratio: GMT V160/GMT placebop-value: <0.00195% CI: [30.5, 126.1]Two sample t-test
Comparison: GMT Ratio: GMT V160/GMT placebop-value: <0.00195% CI: [31.9, 124.6]Two sample t-test
Primary
Percentage of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Time frame: Up to Month 6
Population: All randomized participants who received at least 1 vaccination and had follow-up safety data available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HCMV Seropositive (+) V160 10u Intramuscular (IM) | Percentage of Participants Who Discontinued Study Treatment Due to an AE | 0 Percentage of participants |
| HCMV + V160 30u IM | Percentage of Participants Who Discontinued Study Treatment Due to an AE | 7.1 Percentage of participants |
| HCMV+ V160 100u IM | Percentage of Participants Who Discontinued Study Treatment Due to an AE | 0 Percentage of participants |
| HCMV+ V160 100u MAPA IM | Percentage of Participants Who Discontinued Study Treatment Due to an AE | 0 Percentage of participants |
| HCMV+ V160 250u IM | Percentage of Participants Who Discontinued Study Treatment Due to an AE | 0 Percentage of participants |
| HCMV+ Placebo IM | Percentage of Participants Who Discontinued Study Treatment Due to an AE | 0 Percentage of participants |
| HCMV+ V160 30u ID | Percentage of Participants Who Discontinued Study Treatment Due to an AE | 0 Percentage of participants |
| HCMV+ Placebo ID | Percentage of Participants Who Discontinued Study Treatment Due to an AE | 0 Percentage of participants |
| HCMV Seronegative (-) V160 10u IM | Percentage of Participants Who Discontinued Study Treatment Due to an AE | 0 Percentage of participants |
| HCMV- V160 30u IM | Percentage of Participants Who Discontinued Study Treatment Due to an AE | 0 Percentage of participants |
| HCMV- V160 30u MAPA IM | Percentage of Participants Who Discontinued Study Treatment Due to an AE | 0 Percentage of participants |
| HCMV- V160 100u IM | Percentage of Participants Who Discontinued Study Treatment Due to an AE | 9.1 Percentage of participants |
| HCMV- V160 100u MAPA IM | Percentage of Participants Who Discontinued Study Treatment Due to an AE | 0 Percentage of participants |
| HCMV- V160 250u IM | Percentage of Participants Who Discontinued Study Treatment Due to an AE | 9.1 Percentage of participants |
| HCMV- V160 Placebo IM | Percentage of Participants Who Discontinued Study Treatment Due to an AE | 0 Percentage of participants |
| HCMV- V160 30u ID | Percentage of Participants Who Discontinued Study Treatment Due to an AE | 9.1 Percentage of participants |
| HCMV- Placebo ID | Percentage of Participants Who Discontinued Study Treatment Due to an AE | 0 Percentage of participants |
Primary
Percentage of Participants With an Adverse Event (AE)
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Time frame: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Population: All randomized participants who received at least 1 vaccination and had follow-up safety data available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HCMV Seropositive (+) V160 10u Intramuscular (IM) | Percentage of Participants With an Adverse Event (AE) | 75.0 Percentage of participants |
| HCMV + V160 30u IM | Percentage of Participants With an Adverse Event (AE) | 92.9 Percentage of participants |
| HCMV+ V160 100u IM | Percentage of Participants With an Adverse Event (AE) | 84.6 Percentage of participants |
| HCMV+ V160 100u MAPA IM | Percentage of Participants With an Adverse Event (AE) | 100.0 Percentage of participants |
| HCMV+ V160 250u IM | Percentage of Participants With an Adverse Event (AE) | 100.0 Percentage of participants |
| HCMV+ Placebo IM | Percentage of Participants With an Adverse Event (AE) | 57.9 Percentage of participants |
| HCMV+ V160 30u ID | Percentage of Participants With an Adverse Event (AE) | 100.0 Percentage of participants |
| HCMV+ Placebo ID | Percentage of Participants With an Adverse Event (AE) | 50.0 Percentage of participants |
| HCMV Seronegative (-) V160 10u IM | Percentage of Participants With an Adverse Event (AE) | 75.0 Percentage of participants |
| HCMV- V160 30u IM | Percentage of Participants With an Adverse Event (AE) | 90.0 Percentage of participants |
| HCMV- V160 30u MAPA IM | Percentage of Participants With an Adverse Event (AE) | 90.0 Percentage of participants |
| HCMV- V160 100u IM | Percentage of Participants With an Adverse Event (AE) | 100.0 Percentage of participants |
| HCMV- V160 100u MAPA IM | Percentage of Participants With an Adverse Event (AE) | 90.0 Percentage of participants |
| HCMV- V160 250u IM | Percentage of Participants With an Adverse Event (AE) | 90.9 Percentage of participants |
| HCMV- V160 Placebo IM | Percentage of Participants With an Adverse Event (AE) | 56.3 Percentage of participants |
| HCMV- V160 30u ID | Percentage of Participants With an Adverse Event (AE) | 100.0 Percentage of participants |
| HCMV- Placebo ID | Percentage of Participants With an Adverse Event (AE) | 100.0 Percentage of participants |
Primary
Percentage of Participants With an Injection-site AE
Injection-site AEs are defined as redness, swelling, and pain/tenderness.
Time frame: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Population: All randomized participants who received at least 1 vaccination and had follow-up safety data available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HCMV Seropositive (+) V160 10u Intramuscular (IM) | Percentage of Participants With an Injection-site AE | 58.3 Percentage of participants |
| HCMV + V160 30u IM | Percentage of Participants With an Injection-site AE | 85.7 Percentage of participants |
| HCMV+ V160 100u IM | Percentage of Participants With an Injection-site AE | 69.2 Percentage of participants |
| HCMV+ V160 100u MAPA IM | Percentage of Participants With an Injection-site AE | 80.0 Percentage of participants |
| HCMV+ V160 250u IM | Percentage of Participants With an Injection-site AE | 100.0 Percentage of participants |
| HCMV+ Placebo IM | Percentage of Participants With an Injection-site AE | 26.3 Percentage of participants |
| HCMV+ V160 30u ID | Percentage of Participants With an Injection-site AE | 90.0 Percentage of participants |
| HCMV+ Placebo ID | Percentage of Participants With an Injection-site AE | 0.0 Percentage of participants |
| HCMV Seronegative (-) V160 10u IM | Percentage of Participants With an Injection-site AE | 66.7 Percentage of participants |
| HCMV- V160 30u IM | Percentage of Participants With an Injection-site AE | 80.0 Percentage of participants |
| HCMV- V160 30u MAPA IM | Percentage of Participants With an Injection-site AE | 80.0 Percentage of participants |
| HCMV- V160 100u IM | Percentage of Participants With an Injection-site AE | 90.9 Percentage of participants |
| HCMV- V160 100u MAPA IM | Percentage of Participants With an Injection-site AE | 90.0 Percentage of participants |
| HCMV- V160 250u IM | Percentage of Participants With an Injection-site AE | 81.8 Percentage of participants |
| HCMV- V160 Placebo IM | Percentage of Participants With an Injection-site AE | 31.3 Percentage of participants |
| HCMV- V160 30u ID | Percentage of Participants With an Injection-site AE | 100.0 Percentage of participants |
| HCMV- Placebo ID | Percentage of Participants With an Injection-site AE | 50.0 Percentage of participants |
Primary
Percentage of Participants With a Serious Adverse Event (SAE)
A serious adverse event is any adverse event occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event
Time frame: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Population: All randomized participants who received at least 1 vaccination and had follow-up safety data available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HCMV Seropositive (+) V160 10u Intramuscular (IM) | Percentage of Participants With a Serious Adverse Event (SAE) | 0 Percentage of participants |
| HCMV + V160 30u IM | Percentage of Participants With a Serious Adverse Event (SAE) | 0 Percentage of participants |
| HCMV+ V160 100u IM | Percentage of Participants With a Serious Adverse Event (SAE) | 0 Percentage of participants |
| HCMV+ V160 100u MAPA IM | Percentage of Participants With a Serious Adverse Event (SAE) | 0 Percentage of participants |
| HCMV+ V160 250u IM | Percentage of Participants With a Serious Adverse Event (SAE) | 0 Percentage of participants |
| HCMV+ Placebo IM | Percentage of Participants With a Serious Adverse Event (SAE) | 0 Percentage of participants |
| HCMV+ V160 30u ID | Percentage of Participants With a Serious Adverse Event (SAE) | 0 Percentage of participants |
| HCMV+ Placebo ID | Percentage of Participants With a Serious Adverse Event (SAE) | 0 Percentage of participants |
| HCMV Seronegative (-) V160 10u IM | Percentage of Participants With a Serious Adverse Event (SAE) | 0 Percentage of participants |
| HCMV- V160 30u IM | Percentage of Participants With a Serious Adverse Event (SAE) | 0 Percentage of participants |
| HCMV- V160 30u MAPA IM | Percentage of Participants With a Serious Adverse Event (SAE) | 0 Percentage of participants |
| HCMV- V160 100u IM | Percentage of Participants With a Serious Adverse Event (SAE) | 0 Percentage of participants |
| HCMV- V160 100u MAPA IM | Percentage of Participants With a Serious Adverse Event (SAE) | 0 Percentage of participants |
| HCMV- V160 250u IM | Percentage of Participants With a Serious Adverse Event (SAE) | 0 Percentage of participants |
| HCMV- V160 Placebo IM | Percentage of Participants With a Serious Adverse Event (SAE) | 0 Percentage of participants |
| HCMV- V160 30u ID | Percentage of Participants With a Serious Adverse Event (SAE) | 0 Percentage of participants |
| HCMV- Placebo ID | Percentage of Participants With a Serious Adverse Event (SAE) | 0 Percentage of participants |
Primary
Percentage of Participants With a Serious Vaccine-Related Adverse Event
A serious adverse event is any adverse event occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. A serious vaccine-related adverse event was determined by the investigator to be related to the vaccine.
Time frame: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Population: All randomized participants who received at least 1 vaccination and had follow-up safety data available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HCMV Seropositive (+) V160 10u Intramuscular (IM) | Percentage of Participants With a Serious Vaccine-Related Adverse Event | 0 Percentage of participants |
| HCMV + V160 30u IM | Percentage of Participants With a Serious Vaccine-Related Adverse Event | 0 Percentage of participants |
| HCMV+ V160 100u IM | Percentage of Participants With a Serious Vaccine-Related Adverse Event | 0 Percentage of participants |
| HCMV+ V160 100u MAPA IM | Percentage of Participants With a Serious Vaccine-Related Adverse Event | 0 Percentage of participants |
| HCMV+ V160 250u IM | Percentage of Participants With a Serious Vaccine-Related Adverse Event | 0 Percentage of participants |
| HCMV+ Placebo IM | Percentage of Participants With a Serious Vaccine-Related Adverse Event | 0 Percentage of participants |
| HCMV+ V160 30u ID | Percentage of Participants With a Serious Vaccine-Related Adverse Event | 0 Percentage of participants |
| HCMV+ Placebo ID | Percentage of Participants With a Serious Vaccine-Related Adverse Event | 0 Percentage of participants |
| HCMV Seronegative (-) V160 10u IM | Percentage of Participants With a Serious Vaccine-Related Adverse Event | 0 Percentage of participants |
| HCMV- V160 30u IM | Percentage of Participants With a Serious Vaccine-Related Adverse Event | 0 Percentage of participants |
| HCMV- V160 30u MAPA IM | Percentage of Participants With a Serious Vaccine-Related Adverse Event | 0 Percentage of participants |
| HCMV- V160 100u IM | Percentage of Participants With a Serious Vaccine-Related Adverse Event | 0 Percentage of participants |
| HCMV- V160 100u MAPA IM | Percentage of Participants With a Serious Vaccine-Related Adverse Event | 0 Percentage of participants |
| HCMV- V160 250u IM | Percentage of Participants With a Serious Vaccine-Related Adverse Event | 0 Percentage of participants |
| HCMV- V160 Placebo IM | Percentage of Participants With a Serious Vaccine-Related Adverse Event | 0 Percentage of participants |
| HCMV- V160 30u ID | Percentage of Participants With a Serious Vaccine-Related Adverse Event | 0 Percentage of participants |
| HCMV- Placebo ID | Percentage of Participants With a Serious Vaccine-Related Adverse Event | 0 Percentage of participants |
Primary
Percentage of Participants With a Systemic AE
A Systemic AE includes, but is not exclusive of, the following AEs: fatigue, myalgia, headache and joint pain
Time frame: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Population: All randomized participants who received at least 1 vaccination and had follow-up safety data available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HCMV Seropositive (+) V160 10u Intramuscular (IM) | Percentage of Participants With a Systemic AE | 66.7 Percentage of participants |
| HCMV + V160 30u IM | Percentage of Participants With a Systemic AE | 64.3 Percentage of participants |
| HCMV+ V160 100u IM | Percentage of Participants With a Systemic AE | 69.2 Percentage of participants |
| HCMV+ V160 100u MAPA IM | Percentage of Participants With a Systemic AE | 90.0 Percentage of participants |
| HCMV+ V160 250u IM | Percentage of Participants With a Systemic AE | 90.9 Percentage of participants |
| HCMV+ Placebo IM | Percentage of Participants With a Systemic AE | 57.9 Percentage of participants |
| HCMV+ V160 30u ID | Percentage of Participants With a Systemic AE | 80.0 Percentage of participants |
| HCMV+ Placebo ID | Percentage of Participants With a Systemic AE | 50.0 Percentage of participants |
| HCMV Seronegative (-) V160 10u IM | Percentage of Participants With a Systemic AE | 66.7 Percentage of participants |
| HCMV- V160 30u IM | Percentage of Participants With a Systemic AE | 90.0 Percentage of participants |
| HCMV- V160 30u MAPA IM | Percentage of Participants With a Systemic AE | 70.0 Percentage of participants |
| HCMV- V160 100u IM | Percentage of Participants With a Systemic AE | 100.0 Percentage of participants |
| HCMV- V160 100u MAPA IM | Percentage of Participants With a Systemic AE | 70.0 Percentage of participants |
| HCMV- V160 250u IM | Percentage of Participants With a Systemic AE | 90.9 Percentage of participants |
| HCMV- V160 Placebo IM | Percentage of Participants With a Systemic AE | 56.3 Percentage of participants |
| HCMV- V160 30u ID | Percentage of Participants With a Systemic AE | 100.0 Percentage of participants |
| HCMV- Placebo ID | Percentage of Participants With a Systemic AE | 100.0 Percentage of participants |
Primary
Percentage of Participants With Events of Clinical Interest (ECI)
An event of clinical interest (ECI) is identified as any overdose, elevated liver values meeting threshold criteria (aspartate aminotransferase or alanine aminotransferase ≥3x upper limit of normal (ULN); total bilirubin ≥2x ULN, and, at the same time, alkaline phosphatase \<2xULN). Additionally, confirmed, diagnosed autoimmune conditions are considered ECIs.
Time frame: Up to 18 months
Population: All randomized participants who received at least 1 vaccination and had follow-up safety data available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HCMV Seropositive (+) V160 10u Intramuscular (IM) | Percentage of Participants With Events of Clinical Interest (ECI) | 0 Percentage of participants |
| HCMV + V160 30u IM | Percentage of Participants With Events of Clinical Interest (ECI) | 0 Percentage of participants |
| HCMV+ V160 100u IM | Percentage of Participants With Events of Clinical Interest (ECI) | 0 Percentage of participants |
| HCMV+ V160 100u MAPA IM | Percentage of Participants With Events of Clinical Interest (ECI) | 0 Percentage of participants |
| HCMV+ V160 250u IM | Percentage of Participants With Events of Clinical Interest (ECI) | 0 Percentage of participants |
| HCMV+ Placebo IM | Percentage of Participants With Events of Clinical Interest (ECI) | 0 Percentage of participants |
| HCMV+ V160 30u ID | Percentage of Participants With Events of Clinical Interest (ECI) | 0 Percentage of participants |
| HCMV+ Placebo ID | Percentage of Participants With Events of Clinical Interest (ECI) | 0 Percentage of participants |
| HCMV Seronegative (-) V160 10u IM | Percentage of Participants With Events of Clinical Interest (ECI) | 0 Percentage of participants |
| HCMV- V160 30u IM | Percentage of Participants With Events of Clinical Interest (ECI) | 0 Percentage of participants |
| HCMV- V160 30u MAPA IM | Percentage of Participants With Events of Clinical Interest (ECI) | 0 Percentage of participants |
| HCMV- V160 100u IM | Percentage of Participants With Events of Clinical Interest (ECI) | 0 Percentage of participants |
| HCMV- V160 100u MAPA IM | Percentage of Participants With Events of Clinical Interest (ECI) | 0 Percentage of participants |
| HCMV- V160 250u IM | Percentage of Participants With Events of Clinical Interest (ECI) | 0 Percentage of participants |
| HCMV- V160 Placebo IM | Percentage of Participants With Events of Clinical Interest (ECI) | 0 Percentage of participants |
| HCMV- V160 30u ID | Percentage of Participants With Events of Clinical Interest (ECI) | 0 Percentage of participants |
| HCMV- Placebo ID | Percentage of Participants With Events of Clinical Interest (ECI) | 0 Percentage of participants |
Secondary
Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides
In response to HCMV-specific stimulation of whole blood specimens the whole Blood Cytokine Stimulation (WBStim) assay was used to detect the secretion of interferon gamma (IFN -γ) by an ELISA assay. Results are presented for the following HCMV proteins: pp65, IE1, and gB.
Time frame: Month 7 (1 month after vaccination 3 at Month 6)
Population: All randomized participants who received at least 1 dose of the study vaccine or placebo and had at least 1 valid whole blood interferon-gamma result.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HCMV Seropositive (+) V160 10u Intramuscular (IM) | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | IE1 | 90 ug/mL |
| HCMV Seropositive (+) V160 10u Intramuscular (IM) | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | pp65 | 168 ug/mL |
| HCMV Seropositive (+) V160 10u Intramuscular (IM) | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | gB | 53 ug/mL |
| HCMV + V160 30u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | pp65 | 193 ug/mL |
| HCMV + V160 30u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | IE1 | 70 ug/mL |
| HCMV + V160 30u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | gB | 40 ug/mL |
| HCMV+ V160 100u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | IE1 | 13 ug/mL |
| HCMV+ V160 100u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | pp65 | 79 ug/mL |
| HCMV+ V160 100u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | gB | 64 ug/mL |
| HCMV+ V160 100u MAPA IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | gB | 27 ug/mL |
| HCMV+ V160 100u MAPA IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | pp65 | 86 ug/mL |
| HCMV+ V160 100u MAPA IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | IE1 | 35 ug/mL |
| HCMV+ V160 250u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | pp65 | 211 ug/mL |
| HCMV+ V160 250u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | gB | 27 ug/mL |
| HCMV+ V160 250u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | IE1 | 20 ug/mL |
| HCMV+ Placebo IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | IE1 | 27 ug/mL |
| HCMV+ Placebo IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | pp65 | 64 ug/mL |
| HCMV+ Placebo IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | gB | 62 ug/mL |
| HCMV+ V160 30u ID | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | gB | 16 ug/mL |
| HCMV+ V160 30u ID | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | pp65 | 112 ug/mL |
| HCMV+ V160 30u ID | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | IE1 | 24 ug/mL |
| HCMV+ Placebo ID | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | IE1 | 62 ug/mL |
| HCMV+ Placebo ID | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | pp65 | 64 ug/mL |
| HCMV+ Placebo ID | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | gB | 7 ug/mL |
| HCMV Seronegative (-) V160 10u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | pp65 | 97 ug/mL |
| HCMV Seronegative (-) V160 10u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | IE1 | 35 ug/mL |
| HCMV Seronegative (-) V160 10u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | gB | 10 ug/mL |
| HCMV- V160 30u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | IE1 | 28 ug/mL |
| HCMV- V160 30u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | pp65 | 24 ug/mL |
| HCMV- V160 30u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | gB | 5 ug/mL |
| HCMV- V160 30u MAPA IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | IE1 | 40 ug/mL |
| HCMV- V160 30u MAPA IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | pp65 | 89 ug/mL |
| HCMV- V160 30u MAPA IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | gB | 7 ug/mL |
| HCMV- V160 100u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | gB | 10 ug/mL |
| HCMV- V160 100u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | IE1 | 11 ug/mL |
| HCMV- V160 100u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | pp65 | 8 ug/mL |
| HCMV- V160 100u MAPA IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | IE1 | 45 ug/mL |
| HCMV- V160 100u MAPA IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | pp65 | 28 ug/mL |
| HCMV- V160 100u MAPA IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | gB | 9 ug/mL |
| HCMV- V160 250u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | pp65 | 24 ug/mL |
| HCMV- V160 250u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | gB | 5 ug/mL |
| HCMV- V160 250u IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | IE1 | 40 ug/mL |
| HCMV- V160 Placebo IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | IE1 | 5 ug/mL |
| HCMV- V160 Placebo IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | gB | 6 ug/mL |
| HCMV- V160 Placebo IM | Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides | pp65 | 5 ug/mL |
Secondary
Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma
In order to evaluate the cellular immune response to the vaccine(s), the HCMV enzyme-linked immunospot (ELISPOT) assay was used to detect interferon gamma (IFN-γ) secreting HCMV-specific cells from peripheral blood mononuclear cells (PBMCs). Results are expressed as the frequency of spot forming cells (SFCs) per million PBMCs (SFC/10\^6 PBMCs). Results are presented for the following HCMV proteins: pp65, Immediate early Protein 1 (IE1), Immediate early Protein 2 (IE2), Glycoprotein B (gB), and also for purified HCMV virion stock.
Time frame: Month 7 (1 month after vaccination 3 at Month 6)
Population: All randomized participants who received at least 1 dose of the study vaccine or placebo and had at least 1 valid PBMC interferon-gamma result.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HCMV Seropositive (+) V160 10u Intramuscular (IM) | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE2 | 122 SFC/10^6 PBMCs |
| HCMV Seropositive (+) V160 10u Intramuscular (IM) | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE1 | 855 SFC/10^6 PBMCs |
| HCMV Seropositive (+) V160 10u Intramuscular (IM) | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | Virus | 1190 SFC/10^6 PBMCs |
| HCMV Seropositive (+) V160 10u Intramuscular (IM) | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | pp65 | 819 SFC/10^6 PBMCs |
| HCMV Seropositive (+) V160 10u Intramuscular (IM) | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | gB | 195 SFC/10^6 PBMCs |
| HCMV + V160 30u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | gB | 287 SFC/10^6 PBMCs |
| HCMV + V160 30u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE2 | 101 SFC/10^6 PBMCs |
| HCMV + V160 30u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | pp65 | 419 SFC/10^6 PBMCs |
| HCMV + V160 30u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | Virus | 384 SFC/10^6 PBMCs |
| HCMV + V160 30u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE1 | 340 SFC/10^6 PBMCs |
| HCMV+ V160 100u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | gB | 1137 SFC/10^6 PBMCs |
| HCMV+ V160 100u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | Virus | 2134 SFC/10^6 PBMCs |
| HCMV+ V160 100u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE1 | 419 SFC/10^6 PBMCs |
| HCMV+ V160 100u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE2 | 309 SFC/10^6 PBMCs |
| HCMV+ V160 100u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | pp65 | 1384 SFC/10^6 PBMCs |
| HCMV+ V160 100u MAPA IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE2 | 72 SFC/10^6 PBMCs |
| HCMV+ V160 100u MAPA IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | Virus | 1348 SFC/10^6 PBMCs |
| HCMV+ V160 100u MAPA IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE1 | 370 SFC/10^6 PBMCs |
| HCMV+ V160 100u MAPA IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | pp65 | 1105 SFC/10^6 PBMCs |
| HCMV+ V160 100u MAPA IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | gB | 217 SFC/10^6 PBMCs |
| HCMV+ V160 250u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE2 | 93 SFC/10^6 PBMCs |
| HCMV+ V160 250u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | pp65 | 1206 SFC/10^6 PBMCs |
| HCMV+ V160 250u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | Virus | 1708 SFC/10^6 PBMCs |
| HCMV+ V160 250u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE1 | 417 SFC/10^6 PBMCs |
| HCMV+ V160 250u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | gB | 253 SFC/10^6 PBMCs |
| HCMV+ Placebo IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE2 | 32 SFC/10^6 PBMCs |
| HCMV+ Placebo IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE1 | 379 SFC/10^6 PBMCs |
| HCMV+ Placebo IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | Virus | 937 SFC/10^6 PBMCs |
| HCMV+ Placebo IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | pp65 | 1080 SFC/10^6 PBMCs |
| HCMV+ Placebo IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | gB | 294 SFC/10^6 PBMCs |
| HCMV+ V160 30u ID | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | Virus | 1357 SFC/10^6 PBMCs |
| HCMV+ V160 30u ID | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | gB | 140 SFC/10^6 PBMCs |
| HCMV+ V160 30u ID | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE1 | 200 SFC/10^6 PBMCs |
| HCMV+ V160 30u ID | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | pp65 | 800 SFC/10^6 PBMCs |
| HCMV+ V160 30u ID | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE2 | 49 SFC/10^6 PBMCs |
| HCMV+ Placebo ID | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE2 | 119 SFC/10^6 PBMCs |
| HCMV+ Placebo ID | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | pp65 | 886 SFC/10^6 PBMCs |
| HCMV+ Placebo ID | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE1 | 776 SFC/10^6 PBMCs |
| HCMV+ Placebo ID | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | gB | 105 SFC/10^6 PBMCs |
| HCMV+ Placebo ID | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | Virus | 668 SFC/10^6 PBMCs |
| HCMV Seronegative (-) V160 10u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | pp65 | 468 SFC/10^6 PBMCs |
| HCMV Seronegative (-) V160 10u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE2 | 22 SFC/10^6 PBMCs |
| HCMV Seronegative (-) V160 10u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE1 | 358 SFC/10^6 PBMCs |
| HCMV Seronegative (-) V160 10u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | gB | 14 SFC/10^6 PBMCs |
| HCMV Seronegative (-) V160 10u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | Virus | 79 SFC/10^6 PBMCs |
| HCMV- V160 30u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE2 | 34 SFC/10^6 PBMCs |
| HCMV- V160 30u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | Virus | 268 SFC/10^6 PBMCs |
| HCMV- V160 30u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | pp65 | 865 SFC/10^6 PBMCs |
| HCMV- V160 30u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | gB | 38 SFC/10^6 PBMCs |
| HCMV- V160 30u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE1 | 913 SFC/10^6 PBMCs |
| HCMV- V160 30u MAPA IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE2 | 146 SFC/10^6 PBMCs |
| HCMV- V160 30u MAPA IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE1 | 577 SFC/10^6 PBMCs |
| HCMV- V160 30u MAPA IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | gB | 185 SFC/10^6 PBMCs |
| HCMV- V160 30u MAPA IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | pp65 | 380 SFC/10^6 PBMCs |
| HCMV- V160 30u MAPA IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | Virus | 621 SFC/10^6 PBMCs |
| HCMV- V160 100u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE2 | 86 SFC/10^6 PBMCs |
| HCMV- V160 100u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | pp65 | 1325 SFC/10^6 PBMCs |
| HCMV- V160 100u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | gB | 86 SFC/10^6 PBMCs |
| HCMV- V160 100u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE1 | 933 SFC/10^6 PBMCs |
| HCMV- V160 100u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | Virus | 777 SFC/10^6 PBMCs |
| HCMV- V160 100u MAPA IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | Virus | 413 SFC/10^6 PBMCs |
| HCMV- V160 100u MAPA IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | gB | 135 SFC/10^6 PBMCs |
| HCMV- V160 100u MAPA IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | pp65 | 512 SFC/10^6 PBMCs |
| HCMV- V160 100u MAPA IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE2 | 131 SFC/10^6 PBMCs |
| HCMV- V160 100u MAPA IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE1 | 742 SFC/10^6 PBMCs |
| HCMV- V160 250u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE1 | 1796 SFC/10^6 PBMCs |
| HCMV- V160 250u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE2 | 194 SFC/10^6 PBMCs |
| HCMV- V160 250u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | Virus | 1160 SFC/10^6 PBMCs |
| HCMV- V160 250u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | pp65 | 1145 SFC/10^6 PBMCs |
| HCMV- V160 250u IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | gB | 174 SFC/10^6 PBMCs |
| HCMV- V160 Placebo IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | pp65 | 19 SFC/10^6 PBMCs |
| HCMV- V160 Placebo IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE1 | 12 SFC/10^6 PBMCs |
| HCMV- V160 Placebo IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | Virus | 17 SFC/10^6 PBMCs |
| HCMV- V160 Placebo IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | IE2 | 10 SFC/10^6 PBMCs |
| HCMV- V160 Placebo IM | Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma | gB | 18 SFC/10^6 PBMCs |
Secondary
Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2
Serum samples for measuring neutralizing antibodies using the Merck NAb assay were collected at months 1 and 2. The LiCor-based near-infrared dye (NIRDye) In-Cell Western (ICW) HCMV microneutralization assay was used to detect and quantify anti-HCMV neutralizing antibodies. Values below the lower limit of titer are represented by NA.
Time frame: Month 1 and 2 (one month after vaccination 1 [Day 1] and vaccination 2 [Month 1])
Population: All randomized participants who received at least 1 dose of the study vaccine or placebo and had at least 1 valid neutralizing antibody result.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HCMV Seropositive (+) V160 10u Intramuscular (IM) | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 1 | 3124 Geometric Mean Titer |
| HCMV Seropositive (+) V160 10u Intramuscular (IM) | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 2 | 3144 Geometric Mean Titer |
| HCMV + V160 30u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 1 | 5186 Geometric Mean Titer |
| HCMV + V160 30u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 2 | 5443 Geometric Mean Titer |
| HCMV+ V160 100u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 1 | 6232 Geometric Mean Titer |
| HCMV+ V160 100u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 2 | 6959 Geometric Mean Titer |
| HCMV+ V160 100u MAPA IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 1 | 6695 Geometric Mean Titer |
| HCMV+ V160 100u MAPA IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 2 | 7022 Geometric Mean Titer |
| HCMV+ V160 250u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 2 | 4261 Geometric Mean Titer |
| HCMV+ V160 250u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 1 | 3831 Geometric Mean Titer |
| HCMV+ Placebo IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 2 | 9412 Geometric Mean Titer |
| HCMV+ Placebo IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 1 | 9127 Geometric Mean Titer |
| HCMV+ V160 30u ID | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 1 | 2335 Geometric Mean Titer |
| HCMV+ V160 30u ID | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 2 | 2313 Geometric Mean Titer |
| HCMV+ Placebo ID | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 1 | 73 Geometric Mean Titer |
| HCMV+ Placebo ID | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 2 | 143 Geometric Mean Titer |
| HCMV Seronegative (-) V160 10u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 1 | 95 Geometric Mean Titer |
| HCMV Seronegative (-) V160 10u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 2 | 264 Geometric Mean Titer |
| HCMV- V160 30u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 2 | 264 Geometric Mean Titer |
| HCMV- V160 30u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 1 | 65 Geometric Mean Titer |
| HCMV- V160 30u MAPA IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 1 | 91 Geometric Mean Titer |
| HCMV- V160 30u MAPA IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 2 | 288 Geometric Mean Titer |
| HCMV- V160 100u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 2 | 590 Geometric Mean Titer |
| HCMV- V160 100u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 1 | 134 Geometric Mean Titer |
| HCMV- V160 100u MAPA IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 2 | 589 Geometric Mean Titer |
| HCMV- V160 100u MAPA IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 1 | 281 Geometric Mean Titer |
| HCMV- V160 250u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 1 | 183 Geometric Mean Titer |
| HCMV- V160 250u IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 2 | 451 Geometric Mean Titer |
| HCMV- V160 Placebo IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 2 | NA Geometric Mean Titer |
| HCMV- V160 Placebo IM | Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 | Month 1 | NA Geometric Mean Titer |