V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002)

• ClinicalTrials.gov Identifier: NCT03486834
• Recruitment Status: Completed
• First Posted: April 3, 2018
• Results First Posted: November 10, 2021
• Last Update Posted: November 10, 2021
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Study Description

Brief Summary:

This study evaluated the safety, tolerability, and efficacy of the cytomegalovirus (CMV) vaccine (V160) administered in a 2-dose or 3-dose regimen to healthy seronegative women 16 to 35 years of age. Participants received 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 were followed to approximately Month 24. The primary hypothesis of the study was 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 (CMV) Infections	Biological: V160; Drug: Placebo	Phase 2

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.

Secondary Outcome Measures :

1. 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.

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 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.

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 LLC

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme LLC

  Study Documents (Full-Text)

Documents provided by Merck Sharp & Dohme LLC:

Study Protocol and Statistical Analysis Plan  [PDF] May 7, 2019

More Information

• 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
• 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

Keywords provided by Merck Sharp & Dohme LLC:

Prevention of cytomegalovirus infection (CMVi)

Additional relevant MeSH terms:

Cytomegalovirus Infections; Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs