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

• ClinicalTrials.gov Identifier: NCT03486834
• Recruitment Status: Active, not recruiting
• First Posted: April 3, 2018
• Last Update Posted: September 23, 2019
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Study Director: Medical Director; Merck Sharp & Dohme Corp.

More 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
• 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

• 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