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

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ClinicalTrials.gov Identifier: NCT03486834
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : November 9, 2018
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

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.



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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


Contacts
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

  Hide Study Locations
Locations
United States, Alabama
Alabama Clinical Therapeutics ( Site 0025) Recruiting
Birmingham, Alabama, United States, 35205
Contact: Study Coordinator    205-933-8522      
Achieve Clinical Research, LLC ( Site 0055) Recruiting
Birmingham, Alabama, United States, 35216
Contact: Study Coordinator    205-757-8212      
United States, Arizona
Synexus US Phoenix Southeast ( Site 0057) Recruiting
Chandler, Arizona, United States, 85224
Contact: Study Coordinator    480-775-1115      
United States, California
Inland Empire Liver Foundation ( Site 0026) Recruiting
Rialto, California, United States, 92377
Contact: Study Coordinator    909-883-2999      
Integrated Research Group ( Site 0042) Recruiting
Riverside, California, United States, 92506
Contact: Study Coordinator    951-781-7199      
Bayview Research Group, LLC ( Site 0012) Recruiting
Valley Village, California, United States, 91607
Contact: Study Coordinator    8008318308123      
Diablo Clinical Research, Inc ( Site 0009) Recruiting
Walnut Creek, California, United States, 94598
Contact: Study Coordinator    925-930-7267      
United States, Florida
Clinical Research of South Florida ( Site 0047) Recruiting
Coral Gables, Florida, United States, 33134
Contact: Study Coordinator    305-445-5637      
Indago Research & Health Center, Inc ( Site 0007) Recruiting
Hialeah, Florida, United States, 33012
Contact: Study Coordinator    305-825-6588      
NF Research Center LLC ( Site 0013) Recruiting
Hialeah, Florida, United States, 33012
Contact: Study Coordinator    786-660-8890      
Best Quality Research Inc. ( Site 0031) Recruiting
Hialeah, Florida, United States, 33016
Contact: Study Coordinator    786-313-3506      
Care Partners Clinical Research, LLC ( Site 0002) Recruiting
Jacksonville, Florida, United States, 32277
Contact: Study Coordinator    904-296-3260      
L&C Professional Medical Research Institute ( Site 0021) Recruiting
Miami, Florida, United States, 33144
Contact: Study Coordinator    305-269-1616      
Kendall South Medical Center, Inc ( Site 0008) Recruiting
Miami, Florida, United States, 33185
Contact: Study Coordinator    305-388-1118      
New Age Medical Research Corporation ( Site 0018) Recruiting
Miami, Florida, United States, 33186
Contact: Study Coordinator    305-596-9901      
Clinical Associates of Orlando, LLC ( Site 0032) Recruiting
Orlando, Florida, United States, 32806
Contact: Study Coordinator    407-269-0322      
United States, Kansas
Heartland Research Associates, LLC ( Site 0044) Recruiting
Augusta, Kansas, United States, 67010
Contact: Study Coordinator    316-689-6629      
Heartland Research Associates, LLC ( Site 0023) Recruiting
Newton, Kansas, United States, 67114
Contact: Study Coordinator    316-689-6629      
Heartland Research Associates, LLC ( Site 0019) Recruiting
Wichita, Kansas, United States, 67205
Contact: Study Coordinator    316-462-0423      
United States, Louisiana
ACC Pediatric Research ( Site 0022) Recruiting
Haughton, Louisiana, United States, 71037
Contact: Study Coordinator    318-949-0539      
United States, Maryland
University of Maryland School of Medicine ( Site 0041) Recruiting
Baltimore, Maryland, United States, 21201
Contact: Study Coordinator    410-706-5328      
United States, New Mexico
Albuquerque Clinical Trials ( Site 0052) Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Study Coordinator    505-224-7407      
United States, North Carolina
Carolina Women's Research and Wellness Center ( Site 0035) Recruiting
Durham, North Carolina, United States, 27713
Contact: Study Coordinator    919-251-9223      
PMG Research of Raleigh, LLC ( Site 0048) Recruiting
Raleigh, North Carolina, United States, 27609
Contact: Study Coordinator    919-783-4895      
PMG Research of Wilmington ( Site 0006) Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Study Coordinator    910-799-5500      
United States, Ohio
Senders Pediatrics ( Site 0060) Recruiting
Cleveland, Ohio, United States, 44121
Contact: Study Coordinator    216-291-9210      
Rapid Medical Research, Inc. ( Site 0038) Recruiting
Cleveland, Ohio, United States, 44122
Contact: Study Coordinator    2166820320286      
United States, South Carolina
Coastal Pediatric Research ( Site 0010) Recruiting
Charleston, South Carolina, United States, 29414
Contact: Study Coordinator    843-518-5642      
Coastal Carolina Research Center ( Site 0053) Recruiting
Mount Pleasant, South Carolina, United States, 29464
Contact: Study Coordinator    843-856-3784      
United States, Texas
Tekton Research, Inc. ( Site 0036) Recruiting
Austin, Texas, United States, 78745
Contact: Study Coordinator    512-388-5717      
Radiant Research - Dallas ( Site 0045) Recruiting
Dallas, Texas, United States, 75234
Contact: Study Coordinator    972-241-1222      
University of Texas Medical Branch at Galveston ( Site 0049) Recruiting
Galveston, Texas, United States, 77555-1115
Contact: Study Coordinator    409-772-5278      
Accurate Clinical Management, LLC ( Site 0028) Recruiting
Pasadena, Texas, United States, 77504
Contact: Study Coordinator    281-481-8557      
Diagnostics Research Group ( Site 0001) Recruiting
San Antonio, Texas, United States, 78229
Contact: Study Coordinator    210-692-7157      
Synexus Research ( Site 0058) Recruiting
San Antonio, Texas, United States, 78229
Contact: Study Coordinator    210-614-7483      
Crossroads Clinical Research LLC ( Site 0283) Recruiting
Victoria, Texas, United States, 77901
Contact: Study Coordinator    361-288-4668      
United States, Virginia
Health Research of Hampton Roads, Inc. ( Site 0014) Recruiting
Newport News, Virginia, United States, 23606
Contact: Study Coordinator    757-591-8100      
Clinical Research Assoc Tidewater ( Site 0056) Recruiting
Norfolk, Virginia, United States, 23507
Contact: Study Coordinator    757-627-7446      
York Clinical Research, LLC ( Site 0033) Recruiting
Norfolk, Virginia, United States, 23510
Contact: Study Coordinator    757-373-8478      
National Clinical Research-Richmond, Inc. ( Site 0051) Recruiting
Richmond, Virginia, United States, 23294
Contact: Study Coordinator    804372213328      
United States, Washington
Multicare / Rockwood Clinic ( Site 0034) Recruiting
Spokane, Washington, United States, 99202
Contact: Study Coordinator    509-459-1590      
Premier Clinical Research Group ( Site 0050) Recruiting
Spokane, Washington, United States, 99202
Contact: Study Coordinator    509-343-3710      
Canada, British Columbia
Vaccine Evaluation Center ( Site 0264) Recruiting
Vancouver, British Columbia, Canada, V5Z 4H4
Contact: Study Coordinator    6048752151      
Canada, Ontario
PrimeHealth Clinical Research ( Site 0070) Recruiting
Toronto, Ontario, Canada, M4S 1Y2
Contact: Study Coordinator    4164868444      
Canada, Quebec
Clinique OVO ( Site 0067) Recruiting
Montreal, Quebec, Canada, H4P 2S4
Contact: Study Coordinator    5147982000759      
McGill University Health Centre - Vaccine Study Centre ( Site 0064) Recruiting
Pierrefonds, Quebec, Canada, H9H 4Y6
Contact: Study Coordinator    5146247855      
Diex Recherche Sherbrooke Inc. ( Site 0066) Recruiting
Sherbrooke, Quebec, Canada, J1L 0H8
Contact: Study Coordinator    8193462887      
Diex Recherche Victoriaville Inc. ( Site 0068) Recruiting
Victoriaville, Quebec, Canada, G6P 6P6
Contact: Study Coordinator    8192601172      
Canada
CHUQ - Unite de Recherche en Sante Publique ( Site 0065) Recruiting
Quebec, Canada, G1E 7G9
Contact: Study Coordinator    4186667000240      
Diex Recherche Quebec Inc ( Site 0069) Recruiting
Quebec, Canada, G1N 4V3
Contact: Study Coordinator    4186146124      
Finland
Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0186) Recruiting
Espoo, Finland, 02230
Contact: Study Coordinator    +358503951189      
Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0188) Recruiting
Helsinki, Finland, 00100
Contact: Study Coordinator    +358962270360      
Ita-Helsingin Rokotetutkimuskeskus ( Site 0184) Recruiting
Helsinki, Finland, 00930
Contact: Study Coordinator    +358401904115      
Jarvenpaan rokotetutkimuskeskus ( Site 0185) Recruiting
Jarvenpaa, Finland, 04400
Contact: Study Coordinator    +358504372661      
Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0190) Recruiting
Kokkola, Finland, 67100
Contact: Study Coordinator    +35868349582      
Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0187) Recruiting
Oulu, Finland, 90220
Contact: Study Coordinator    +358505310004      
Pori Vaccine Research Center ( Site 0182) Recruiting
Pori, Finland, 28100
Contact: Study Coordinator    +358505246532      
Seinäjoki Vaccine Research Center ( Site 0189) Recruiting
Seinäjoki, Finland, 60100
Contact: Study Coordinator    +358504377326      
Tampereen yliopisto Rokotetutkimuskeskus ( Site 0181) Recruiting
Tampere, Finland, 33100
Contact: Study Coordinator    +358505099135      
Turku Vaccine Research Center ( Site 0183) Recruiting
Turku, Finland, 20520
Contact: Study Coordinator    +35822361844      
Israel
Hadassah Ein Kerem Medical Center ( Site 0216) Recruiting
Jerusalem, Israel, 9112001
Contact: Study Coordinator    +97226779372      
Meir MC ( Site 0213) Recruiting
Kfar Saba, Israel, 4428164
Contact: Study Coordinator    +97297433364      
Rabin Medical Center ( Site 0218) Recruiting
Petah-Tikva, Israel, 4941492
Contact: Study Coordinator    +97239271824      
Sakhnin west neighbourhood ( Site 0211) Recruiting
Sakhnin, Israel, 3081000
Contact: Study Coordinator    +97246745729      
Sourasky Medical Center ( Site 0217) Recruiting
Tel Aviv, Israel, 6423906
Contact: Study Coordinator    +97236974845      
Russian Federation
Central City Hospital 7 ( Site 0237) Recruiting
Ekaterinburg, Russian Federation, 620137
Contact: Study Coordinator    +79122411379      
Limited Liability Company Medical Centre Aibolit ( Site 0229) Recruiting
Kazan, Russian Federation, 420073
Contact: Study Coordinator    +79600480104      
LLC Scientific Research Medical Complex Your Health. ( Site 0230) Recruiting
Kazan, Russian Federation, 420097
Contact: Study Coordinator    +79872980006      
City Clinical Hospital 13 of Moscow ( Site 0232) Recruiting
Moscow, Russian Federation, 115280
Contact: Study Coordinator    +79166852535      
Antenatal clinic #22 ( Site 0225) Recruiting
Saint Petersburg, Russian Federation, 194354
Contact: Study Coordinator    +78212963108      
Siberian State Medical University ( Site 0231) Recruiting
Tomsk, Russian Federation, 634050
Contact: Study Coordinator    +79039155110      
Spain
Hospital Clinic de Barcelona ( Site 0155) Recruiting
Barcelona, Spain, 08036
Contact: Study Coordinator    +34932275754      
Hospital Universitario 12 de Octubre ( Site 0152) Recruiting
Madrid, Spain, 28041
Contact: Study Coordinator    +34913908569      
Hospital Universitario La Paz ( Site 0157) Recruiting
Madrid, Spain, 28046
Contact: Study Coordinator    +34912071466      
Hospital Clinico Universitario de Santiago ( Site 0151) Recruiting
Santiago de Compostela, Spain, 15706
Contact: Study Coordinator    +34981950615      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03486834     History of Changes
Other Study ID Numbers: V160-002
2017-004233-86 ( EudraCT Number )
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases