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

NCT ID: NCT03486834

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 2200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2021-06-30

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.

Conditions

Cytomegalovirus (CMV) Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

V160

Intervention Type: BIOLOGICAL

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.

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.

Group Type: EXPERIMENTAL

V160

Intervention Type: BIOLOGICAL

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.

Placebo

Intervention Type: DRUG

Saline solution administered as a 0.5 mL IM injection

Placebo

Participants received placebo (saline solution) by IM injection on Day 1, Month 2, and Month 6.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Saline solution administered as a 0.5 mL IM injection

Interventions

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.

Intervention Type: BIOLOGICAL

Placebo

Saline solution administered as a 0.5 mL IM injection

Intervention Type: DRUG

Other Intervention Names

Human cytomegalovirus vaccine

Eligibility 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Alabama Clinical Therapeutics ( Site 0025)

Birmingham, Alabama, United States

Achieve Clinical Research, LLC ( Site 0055)

Birmingham, Alabama, United States

Synexus US Phoenix Southeast ( Site 0057)

Chandler, Arizona, United States

Inland Empire Liver Foundation ( Site 0026)

Rialto, California, United States

Integrated Research of Inland, Inc. ( Site 0042)

Riverside, California, United States

California Research Foundation ( Site 0286)

San Diego, California, United States

Bayview Research Group, LLC ( Site 0012)

Valley Village, California, United States

Diablo Clinical Research, Inc ( Site 0009)

Walnut Creek, California, United States

Emerson Clinical Research Institute ( Site 0297)

Washington D.C., District of Columbia, United States

Clinical Research of South Florida ( Site 0047)

Coral Gables, Florida, United States

Indago Research & Health Center, Inc ( Site 0007)

Hialeah, Florida, United States

NF Research Center LLC ( Site 0013)

Hialeah, Florida, United States

Best Quality Research Inc. ( Site 0031)

Hialeah, Florida, United States

Care Partners Clinical Research, LLC ( Site 0002)

Jacksonville, Florida, United States

L&C Professional Medical Research Institute ( Site 0021)

Miami, Florida, United States

Advanced Medical Research Institute ( Site 0296)

Miami, Florida, United States

Kendall South Medical Center, Inc ( Site 0008)

Miami, Florida, United States

New Age Medical Research Corporation ( Site 0018)

Miami, Florida, United States

Clinical Associates of Orlando, LLC ( Site 0032)

Orlando, Florida, United States

Columbus Regional Research Institute ( Site 0298)

Columbus, Georgia, United States

Heartland Research Associates, LLC ( Site 0044)

Augusta, Kansas, United States

Heartland Research Associates, LLC ( Site 0023)

Newton, Kansas, United States

Heartland Research Associates, LLC ( Site 0019)

Wichita, Kansas, United States

ACC Pediatric Research ( Site 0022)

Haughton, Louisiana, United States

University of Maryland School of Medicine ( Site 0041)

Baltimore, Maryland, United States

St Michaels Med Center ( Site 0285)

Newark, New Jersey, United States

Albuquerque Clinical Trials ( Site 0052)

Albuquerque, New Mexico, United States

Mid Hudson Medical Research ( Site 0294)

New Windsor, New York, United States

Carolina Women's Research and Wellness Center ( Site 0035)

Durham, North Carolina, United States

PMG Research of Raleigh, LLC ( Site 0048)

Raleigh, North Carolina, United States

PMG Research of Wilmington ( Site 0006)

Wilmington, North Carolina, United States

Cincinnati Children's Hospital Medical Center ( Site 0003)

Cincinnati, Ohio, United States

Senders Pediatrics ( Site 0060)

Cleveland, Ohio, United States

Rapid Medical Research, Inc. ( Site 0038)

Cleveland, Ohio, United States

Lynn Health Science Institute ( Site 0287)

Oklahoma City, Oklahoma, United States

Coastal Pediatric Research ( Site 0010)

Charleston, South Carolina, United States

Parkside Pediatric ( Site 0288)

Greenville, South Carolina, United States

Coastal Carolina Research Center ( Site 0053)

Mt. Pleasant, South Carolina, United States

Palmetto Clinical Research ( Site 0289)

Summerville, South Carolina, United States

Tekton Research, Inc. ( Site 0036)

Austin, Texas, United States

Coastal Bend Clinical Research ( Site 0299)

Corpus Christi, Texas, United States

Radiant Research - Dallas ( Site 0045)

Dallas, Texas, United States

University of Texas Medical Branch at Galveston ( Site 0049)

Galveston, Texas, United States

Juno Research, LLC ( Site 0293)

Houston, Texas, United States

Accurate Clinical Management, LLC ( Site 0028)

Pasadena, Texas, United States

Diagnostics Research Group ( Site 0001)

San Antonio, Texas, United States

Synexus Research ( Site 0058)

San Antonio, Texas, United States

Crossroads Clinical Research LLC ( Site 0283)

Victoria, Texas, United States

Health Research of Hampton Roads, Inc. ( Site 0014)

Newport News, Virginia, United States

Clinical Research Associates of Tidewater ( Site 0056)

Norfolk, Virginia, United States

York Clinical Research, LLC ( Site 0033)

Norfolk, Virginia, United States

National Clinical Research-Richmond, Inc. ( Site 0051)

Richmond, Virginia, United States

Multicare / Rockwood Clinic ( Site 0034)

Spokane, Washington, United States

Premier Clinical Research Group ( Site 0050)

Spokane, Washington, United States

Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 0247)

Blacktown, New South Wales, Australia

Paratus Clinical Kanwal - Trial Clinic ( Site 0243)

Kanwal, New South Wales, Australia

Holdsworth House Medical Practice ( Site 0241)

Sydney, New South Wales, Australia

University of the Sunshine Coast Clinical Trials Centre ( Site 0244)

Morayfield, Queensland, Australia

University of the Sunshine Coast Clinical Trials Centre ( Site 0245)

Sippy Downs, Queensland, Australia

Vaccine Evaluation Center ( Site 0264)

Vancouver, British Columbia, Canada

PrimeHealth Clinical Research ( Site 0070)

Toronto, Ontario, Canada

Clinique OVO ( Site 0067)

Montreal, Quebec, Canada

McGill University Health Centre - Vaccine Study Centre ( Site 0064)

Pierrefonds, Quebec, Canada

CHUQ - Unite de Recherche en Sante Publique ( Site 0065)

Québec, Quebec, Canada

Diex Recherche Quebec Inc ( Site 0069)

Québec, Quebec, Canada

Diex Recherche Sherbrooke Inc. ( Site 0066)

Sherbrooke, Quebec, Canada

Diex Recherche Victoriaville Inc. ( Site 0068)

Victoriaville, Quebec, Canada

Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0186)

Espoo, , Finland

Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0188)

Helsinki, , Finland

Ita-Helsingin Rokotetutkimuskeskus ( Site 0184)

Helsinki, , Finland

Jarvenpaan rokotetutkimuskeskus ( Site 0185)

Järvenpää, , Finland

Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0190)

Kokkola, , Finland

Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0187)

Oulu, , Finland

Pori Vaccine Research Center ( Site 0182)

Pori, , Finland

Seinajoki Vaccine Research Center ( Site 0189)

Seinäjoki, , Finland

Tampereen yliopisto Rokotetutkimuskeskus ( Site 0181)

Tampere, , Finland

Turku Vaccine Research Center ( Site 0183)

Turku, , Finland

Rambam Medical Center - Health Care Campus ( Site 0219)

Haifa, , Israel

Hadassah Ein Kerem Medical Center ( Site 0216)

Jerusalem, , Israel

Meir MC ( Site 0213)

Kfar Saba, , Israel

Western Galilee Hospital ( Site 0212)

Nahariya, , Israel

Rabin Medical Center ( Site 0218)

Petah Tikva, , Israel

Sakhnin west neighbourhood ( Site 0211)

Sakhnin, , Israel

Sourasky Medical Center ( Site 0217)

Tel Aviv, , Israel

Maccabi Healthcare Services ( Site 0220)

Tel Aviv, , Israel

Limited Liability Company Medical Centre Aibolit ( Site 0229)

Kazan', , Russia

LLC Scientific Research Medical Complex Your Health. ( Site 0230)

Kazan', , Russia

City Clinical Hospital 13 of Moscow ( Site 0232)

Moscow, , Russia

Antenatal clinic #22 ( Site 0225)

Saint Petersburg, , Russia

Siberian State Medical University ( Site 0231)

Tomsk, , Russia

Central City Hospital 7 ( Site 0237)

Yekaterinburg, , Russia

Hospital Clinic de Barcelona ( Site 0155)

Barcelona, , Spain

Hospital Universitario 12 de Octubre ( Site 0152)

Madrid, , Spain

Hospital Universitario La Paz ( Site 0157)

Madrid, , Spain

Hospital Clinico Universitario de Santiago ( Site 0151)

Santiago de Compostela, , Spain

Countries

United States; Australia; Canada; Finland; Israel; Russia; Spain

References

Das R, Blazquez-Gamero D, Bernstein DI, Gantt S, Bautista O, Beck K, Conlon A, Rosenbloom DIS, Wang D, Ritter M, Arnold B, Annunziato P, Russell KL; V160-002 study group. Safety, efficacy, and immunogenicity of a replication-defective human cytomegalovirus vaccine, V160, in cytomegalovirus-seronegative women: a double-blind, randomised, placebo-controlled, phase 2b trial. Lancet Infect Dis. 2023 Dec;23(12):1383-1394. doi: 10.1016/S1473-3099(23)00343-2. Epub 2023 Aug 31.

Reference Type: RESULT

PMID: 37660711 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017-004233-86

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V160-002

Identifier Type: -

Identifier Source: org_study_id