V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03486834 |
Recruitment Status :
Completed
First Posted : April 3, 2018
Results First Posted : November 10, 2021
Last Update Posted : November 10, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cytomegalovirus (CMV) Infections | Biological: V160 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Double-Blind, Randomized, Placebo-Controlled Phase 2b, Multi-center Study to Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of a 2-Dose and a 3-Dose Regimen of V160 (Cytomegalovirus [CMV] Vaccine) in Healthy Seronegative Women, 16 to 35 Years of Age |
Actual Study Start Date : | April 30, 2018 |
Actual Primary Completion Date : | October 30, 2020 |
Actual Study Completion Date : | June 30, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: V160 3-Dose Regimen
Participants received 3 doses of vaccine V160 (100 Units/0.5 mL dose with Merck aluminum phosphate adjuvant [MAPA], 4°C stable formulation) administered by intramuscular (IM) injection on Day 1, Month 2, and Month 6.
|
Biological: V160
V160 was administered as a 0.5 mL (100 Units/0.5 mL dose with Merck aluminum phosphate adjuvant [MAPA], 4°C stable formulation) IM injection.
Other Name: Human cytomegalovirus vaccine |
Experimental: V160 2-Dose Regimen
Participants received 2 doses of vaccine V160 (100 Units/0.5 mL dose with MAPA, 4°C stable formulation) administered IM on Day 1 and Month 6 and a placebo-saline solution at Month 2.
|
Biological: V160
V160 was administered as a 0.5 mL (100 Units/0.5 mL dose with Merck aluminum phosphate adjuvant [MAPA], 4°C stable formulation) IM injection.
Other Name: Human cytomegalovirus vaccine Drug: Placebo Saline solution administered as a 0.5 mL IM injection |
Placebo Comparator: Placebo
Participants received placebo (saline solution) by IM injection on Day 1, Month 2, and Month 6.
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Drug: Placebo
Saline solution administered as a 0.5 mL IM injection |
- Number of Participants Who Became Infected With Wild-Type Cytomegalovirus Infection Starting at 4 Weeks Post Last Dose (V160 3-dose Regimen Group and Placebo Group) [ Time Frame: 4 weeks post last vaccination (Month 7) up to ~Month 24 ]Cytomegalovirus infection (CMVi) was defined as the detection of wild-type cytomegalovirus (CMV) (non vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 3-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 3-dose regimen group compared to the placebo group was assessed.
- Number of Participants With Solicited Injection-site Adverse Events [ Time Frame: Up to 5 days after each vaccination ]An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and pain.
- Number of Participants With Solicited Systemic AEs [ Time Frame: Up to 14 days after each vaccination ]An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, joint pain/arthralgia, muscle pain/myalgia, and headache.
- Number of Participants With Vaccine-related Serious Adverse Events [ Time Frame: Up to 14 days after each vaccination ]A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with V160 or placebo, the number of participants with vaccine-related serious adverse events was assessed.
- Number of Participants Who Became Infected With Wild-Type CMV Infection Starting at 4 Weeks Post Last Dose (V160 2-dose Regimen Group and Placebo Group) [ Time Frame: 4 weeks post last vaccination (Month 7) up to ~Month 24 ]CMVi is defined as detection of wild-type CMV (non-vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 2-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 2-dose regimen group compared to the placebo group was assessed.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 16 Years to 35 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy based on medical history and physical examination.
- Serologically confirmed to be CMV seronegative prior to receiving the first dose of V160/placebo
- Have direct exposure to young children (≤5 years of age) at home or occupationally
- Of childbearing potential
- Agrees to avoid becoming pregnant during the 6-month treatment period and for at least 4 weeks after the last dose of study drug by either 1) practicing abstinence from heterosexual activity, or 2) use a highly-effective method of birth control (as specified in the protocol) during heterosexual activity.
Exclusion Criteria:
- Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might expose the participant to risk by participating in the trial, confound the results of the trial, or interfere with participation for the full duration of the trial, as assessed by the investigator
- Has history of allergic reaction or anaphylactic reaction to any vaccine component that required medical intervention or of any severe allergic reaction to any vaccine component that required medical intervention.
- Has a recent (<72 hours) history of febrile illness (temperature ≥100.4°F/38.0°C, oral equivalent)
- 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 pose more than minimal risk for the participant.
- A woman of childbearing potential (WOCBP) who has a positive pregnancy test at screening or within 24 hours before the first dose of study treatment.
- Has previously received a 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 any dose of trial vaccine.
- Had any inactivated vaccine administered or scheduled within the period from 14 days prior to, through 14 days following, any dose of trial vaccine.
- Had administration of any immune globulin or blood product within 90 days prior to injection with V160/placebo or scheduled within 30 days thereafter.
- 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 trial entry.
- 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 trial).
- Received any anti-viral agent with proven or potential activity against CMV two weeks prior to vaccination or is likely to receive such an agent within 2 weeks after vaccination.
- Receiving or has received in the year prior to enrollment immunosuppressive therapies 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 2 weeks prior to, or 2 weeks following a V160 dose.
- 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.
- Plans donation of eggs at any time from signing the informed consent through 1 month after receiving the last dose of the trial V160/placebo.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486834

United States, Alabama | |
Alabama Clinical Therapeutics ( Site 0025) | |
Birmingham, Alabama, United States, 35205 | |
Achieve Clinical Research, LLC ( Site 0055) | |
Birmingham, Alabama, United States, 35216 | |
United States, Arizona | |
Synexus US Phoenix Southeast ( Site 0057) | |
Chandler, Arizona, United States, 85224 | |
United States, California | |
Inland Empire Liver Foundation ( Site 0026) | |
Rialto, California, United States, 92377 | |
Integrated Research of Inland, Inc. ( Site 0042) | |
Riverside, California, United States, 92506 | |
California Research Foundation ( Site 0286) | |
San Diego, California, United States, 92123 | |
Bayview Research Group, LLC ( Site 0012) | |
Valley Village, California, United States, 91607 | |
Diablo Clinical Research, Inc ( Site 0009) | |
Walnut Creek, California, United States, 94598 | |
United States, District of Columbia | |
Emerson Clinical Research Institute ( Site 0297) | |
Washington, District of Columbia, United States, 20011 | |
United States, Florida | |
Clinical Research of South Florida ( Site 0047) | |
Coral Gables, Florida, United States, 33134 | |
Indago Research & Health Center, Inc ( Site 0007) | |
Hialeah, Florida, United States, 33012 | |
NF Research Center LLC ( Site 0013) | |
Hialeah, Florida, United States, 33012 | |
Best Quality Research Inc. ( Site 0031) | |
Hialeah, Florida, United States, 33016 | |
Care Partners Clinical Research, LLC ( Site 0002) | |
Jacksonville, Florida, United States, 32277 | |
L&C Professional Medical Research Institute ( Site 0021) | |
Miami, Florida, United States, 33144 | |
Advanced Medical Research Institute ( Site 0296) | |
Miami, Florida, United States, 33174 | |
Kendall South Medical Center, Inc ( Site 0008) | |
Miami, Florida, United States, 33185 | |
New Age Medical Research Corporation ( Site 0018) | |
Miami, Florida, United States, 33186 | |
Clinical Associates of Orlando, LLC ( Site 0032) | |
Orlando, Florida, United States, 32806 | |
United States, Georgia | |
Columbus Regional Research Institute ( Site 0298) | |
Columbus, Georgia, United States, 31904 | |
United States, Kansas | |
Heartland Research Associates, LLC ( Site 0044) | |
Augusta, Kansas, United States, 67010 | |
Heartland Research Associates, LLC ( Site 0023) | |
Newton, Kansas, United States, 67114 | |
Heartland Research Associates, LLC ( Site 0019) | |
Wichita, Kansas, United States, 67205 | |
United States, Louisiana | |
ACC Pediatric Research ( Site 0022) | |
Haughton, Louisiana, United States, 71037 | |
United States, Maryland | |
University of Maryland School of Medicine ( Site 0041) | |
Baltimore, Maryland, United States, 21201 | |
United States, New Jersey | |
St Michaels Med Center ( Site 0285) | |
Newark, New Jersey, United States, 07102 | |
United States, New Mexico | |
Albuquerque Clinical Trials ( Site 0052) | |
Albuquerque, New Mexico, United States, 87102 | |
United States, New York | |
Mid Hudson Medical Research ( Site 0294) | |
New Windsor, New York, United States, 12553 | |
United States, North Carolina | |
Carolina Women's Research and Wellness Center ( Site 0035) | |
Durham, North Carolina, United States, 27713 | |
PMG Research of Raleigh, LLC ( Site 0048) | |
Raleigh, North Carolina, United States, 27609 | |
PMG Research of Wilmington ( Site 0006) | |
Wilmington, North Carolina, United States, 28401 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center ( Site 0003) | |
Cincinnati, Ohio, United States, 45229 | |
Senders Pediatrics ( Site 0060) | |
Cleveland, Ohio, United States, 44121 | |
Rapid Medical Research, Inc. ( Site 0038) | |
Cleveland, Ohio, United States, 44122 | |
United States, Oklahoma | |
Lynn Health Science Institute ( Site 0287) | |
Oklahoma City, Oklahoma, United States, 73112 | |
United States, South Carolina | |
Coastal Pediatric Research ( Site 0010) | |
Charleston, South Carolina, United States, 29414 | |
Parkside Pediatric ( Site 0288) | |
Greenville, South Carolina, United States, 29607 | |
Coastal Carolina Research Center ( Site 0053) | |
Mount Pleasant, South Carolina, United States, 29464 | |
Palmetto Clinical Research ( Site 0289) | |
Summerville, South Carolina, United States, 29485 | |
United States, Texas | |
Tekton Research, Inc. ( Site 0036) | |
Austin, Texas, United States, 78745 | |
Coastal Bend Clinical Research ( Site 0299) | |
Corpus Christi, Texas, United States, 78413 | |
Radiant Research - Dallas ( Site 0045) | |
Dallas, Texas, United States, 75234 | |
University of Texas Medical Branch at Galveston ( Site 0049) | |
Galveston, Texas, United States, 77555-1115 | |
Juno Research, LLC ( Site 0293) | |
Houston, Texas, United States, 77074 | |
Accurate Clinical Management, LLC ( Site 0028) | |
Pasadena, Texas, United States, 77504 | |
Diagnostics Research Group ( Site 0001) | |
San Antonio, Texas, United States, 78229 | |
Synexus Research ( Site 0058) | |
San Antonio, Texas, United States, 78229 | |
Crossroads Clinical Research LLC ( Site 0283) | |
Victoria, Texas, United States, 77901 | |
United States, Virginia | |
Health Research of Hampton Roads, Inc. ( Site 0014) | |
Newport News, Virginia, United States, 23606 | |
Clinical Research Associates of Tidewater ( Site 0056) | |
Norfolk, Virginia, United States, 23507 | |
York Clinical Research, LLC ( Site 0033) | |
Norfolk, Virginia, United States, 23510 | |
National Clinical Research-Richmond, Inc. ( Site 0051) | |
Richmond, Virginia, United States, 23294 | |
United States, Washington | |
Multicare / Rockwood Clinic ( Site 0034) | |
Spokane, Washington, United States, 99202 | |
Premier Clinical Research Group ( Site 0050) | |
Spokane, Washington, United States, 99202 | |
Australia, New South Wales | |
Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 0247) | |
Blacktown, New South Wales, Australia, 2148 | |
Paratus Clinical Kanwal - Trial Clinic ( Site 0243) | |
Kanwal, New South Wales, Australia, 2259 | |
Holdsworth House Medical Practice ( Site 0241) | |
Sydney, New South Wales, Australia, 2010 | |
Australia, Queensland | |
University of the Sunshine Coast Clinical Trials Centre ( Site 0244) | |
Morayfield, Queensland, Australia, 4506 | |
University of the Sunshine Coast Clinical Trials Centre ( Site 0245) | |
Sippy Downs, Queensland, Australia, 4556 | |
Canada, British Columbia | |
Vaccine Evaluation Center ( Site 0264) | |
Vancouver, British Columbia, Canada, V5Z 4H4 | |
Canada, Ontario | |
PrimeHealth Clinical Research ( Site 0070) | |
Toronto, Ontario, Canada, M4S 1Y2 | |
Canada, Quebec | |
Clinique OVO ( Site 0067) | |
Montreal, Quebec, Canada, H4P 2S4 | |
McGill University Health Centre - Vaccine Study Centre ( Site 0064) | |
Pierrefonds, Quebec, Canada, H9H 4Y6 | |
Diex Recherche Sherbrooke Inc. ( Site 0066) | |
Sherbrooke, Quebec, Canada, J1L 0H8 | |
Diex Recherche Victoriaville Inc. ( Site 0068) | |
Victoriaville, Quebec, Canada, G6P 6P6 | |
Canada | |
CHUQ - Unite de Recherche en Sante Publique ( Site 0065) | |
Quebec, Canada, G1E 7G9 | |
Diex Recherche Quebec Inc ( Site 0069) | |
Quebec, Canada, G1N 4V3 | |
Finland | |
Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0186) | |
Espoo, Finland, 02230 | |
Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0188) | |
Helsinki, Finland, 00100 | |
Ita-Helsingin Rokotetutkimuskeskus ( Site 0184) | |
Helsinki, Finland, 00930 | |
Jarvenpaan rokotetutkimuskeskus ( Site 0185) | |
Jarvenpaa, Finland, 04400 | |
Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0190) | |
Kokkola, Finland, 67100 | |
Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0187) | |
Oulu, Finland, 90220 | |
Pori Vaccine Research Center ( Site 0182) | |
Pori, Finland, 28100 | |
Seinajoki Vaccine Research Center ( Site 0189) | |
Seinajoki, Finland, 60100 | |
Tampereen yliopisto Rokotetutkimuskeskus ( Site 0181) | |
Tampere, Finland, 33100 | |
Turku Vaccine Research Center ( Site 0183) | |
Turku, Finland, 20520 | |
Israel | |
Rambam Medical Center - Health Care Campus ( Site 0219) | |
Haifa, Israel, 3109601 | |
Hadassah Ein Kerem Medical Center ( Site 0216) | |
Jerusalem, Israel, 9112001 | |
Meir MC ( Site 0213) | |
Kfar Saba, Israel, 4428164 | |
Western Galilee Hospital ( Site 0212) | |
Nahariya, Israel, 2222214 | |
Rabin Medical Center ( Site 0218) | |
Petah-Tikva, Israel, 4941492 | |
Sakhnin west neighbourhood ( Site 0211) | |
Sakhnin, Israel, 3081000 | |
Sourasky Medical Center ( Site 0217) | |
Tel Aviv, Israel, 6423906 | |
Maccabi Healthcare Services ( Site 0220) | |
Tel Aviv, Israel, 6789140 | |
Russian Federation | |
Central City Hospital 7 ( Site 0237) | |
Ekaterinburg, Russian Federation, 620137 | |
Limited Liability Company Medical Centre Aibolit ( Site 0229) | |
Kazan, Russian Federation, 420073 | |
LLC Scientific Research Medical Complex Your Health. ( Site 0230) | |
Kazan, Russian Federation, 420097 | |
City Clinical Hospital 13 of Moscow ( Site 0232) | |
Moscow, Russian Federation, 115280 | |
Antenatal clinic #22 ( Site 0225) | |
Saint Petersburg, Russian Federation, 194354 | |
Siberian State Medical University ( Site 0231) | |
Tomsk, Russian Federation, 634050 | |
Spain | |
Hospital Clinic de Barcelona ( Site 0155) | |
Barcelona, Spain, 08036 | |
Hospital Universitario 12 de Octubre ( Site 0152) | |
Madrid, Spain, 28041 | |
Hospital Universitario La Paz ( Site 0157) | |
Madrid, Spain, 28046 | |
Hospital Clinico Universitario de Santiago ( Site 0151) | |
Santiago de Compostela, Spain, 15706 |
Study Director: | Medical Director | Merck Sharp & Dohme LLC |
Documents provided by Merck Sharp & Dohme LLC:
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT03486834 |
Other Study ID Numbers: |
V160-002 2017-004233-86 ( EudraCT Number ) |
First Posted: | April 3, 2018 Key Record Dates |
Results First Posted: | November 10, 2021 |
Last Update Posted: | November 10, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf |
URL: | http://engagezone.msd.com/ds_documentation.php |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Prevention of cytomegalovirus infection (CMVi) |
Cytomegalovirus Infections Infections Herpesviridae Infections DNA Virus Infections |
Virus Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |