Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Tolerability, and Efficacy of the Human Cytomegalovirus Vaccine (V160) in Healthy Women 16 to 35 Years of Age (V160-002)

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 : Active, not recruiting
First Posted : April 3, 2018
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study will evaluate the safety, tolerability, and efficacy of Human Cytomegalovirus (CMV) vaccine V160 administered in a 2-dose or 3-dose regimen in healthy seronegative women 16 to 35 years of age. Participants will receive blinded V160 on Day 1, Month 2, and Month 6 (3-dose regimen), V160 on Day 1 and Month 6 and placebo at Month 2 (2-dose regimen), or placebo on Day 1, Month 2, and Month 6, and will be followed to approximately Month 36. The primary hypothesis of the study is that administration of a 3-dose regimen of V160 will reduce the incidence of primary CMV infection compared to placebo.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Infections Biological: V160 Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2100 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
Estimated Primary Completion Date : May 14, 2021
Estimated Study Completion Date : May 14, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: V160 3-Dose Regimen
Participants will receive V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.
Biological: V160
V160 administered as a 0.5 mL (100 Units) IM injection containing Merck aluminum phosphate adjuvant (MAPA)

Experimental: V160 2-Dose Regimen
Participants will receive V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.
Biological: V160
V160 administered as a 0.5 mL (100 Units) IM injection containing Merck aluminum phosphate adjuvant (MAPA)

Drug: Placebo
Saline solution administered as a 0.5 mL IM injection

Placebo Comparator: Placebo
Participants will receive placebo by IM injection on Day 1, Month 3, and Month 6.
Drug: Placebo
Saline solution administered as a 0.5 mL IM injection




Primary Outcome Measures :
  1. Incidence of Cytomegalovirus Infection in the 3-dose Regimen Group [ Time Frame: Up to Month 36 ]
    CMV infection is defined as detection of CMV (non-vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. The incidence of CMV infection in participants receiving the 3-dose V160 regimen will be assessed.

  2. Solicited Injection-site AEs [ Time Frame: Up to 5 days after each vaccination ]
    The percentage of participants with one or more solicited injection-site AE (pain/tenderness, erythema/redness, swelling) will be assessed.

  3. Solicited Systemic AEs [ Time Frame: Up to 14 days after each vaccination ]
    The percentage of participants with one or more solicited systemic AEs (headache, fatigue, muscle pain, joint pain) will be assessed.

  4. Vaccine-related Serious Adverse Events (SAEs) [ Time Frame: Up to 14 days after each vaccination ]
    The percentage of participants with a vaccine-related SAE will be assessed.


Secondary Outcome Measures :
  1. Incidence of Cytomegalovirus Infection in the 2-dose Regimen Group [ Time Frame: Up to Month 36 ]
    CMV infection is defined as detection of CMV (non-vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. The incidence of CMV infection in participants receiving the 2-dose V160 regimen will be assessed.



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy based on medical history and physical examination
  • Serologically confirmed to be CMV seronegative
  • Have direct exposure to young children (≤5 years of age) at home or occupationally
  • Of child bearing 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 history of allergic reaction or anaphylactic reaction to any vaccine component that required medical intervention
  • 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.

Information from the National Library of Medicine

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


Locations
Hide Hide 95 study locations
Layout table for location information
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
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme Corp.

Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03486834    
Other Study ID Numbers: V160-002
2017-004233-86 ( EudraCT Number )
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases