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

NCT03486834 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: V160-0022017-004233-86
• Study Type: interventional
• Target: 2,200
• Locations: 7 countries
• Sites: 95

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

Keywords

Prevention of cytomegalovirus infection (CMVi)

Outcome Measures

Primary Outcomes (4)

• 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)

  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.

  4 weeks post last vaccination (Month 7) up to ~Month 24

• Number of Participants With Solicited Injection-site Adverse Events

  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.

  Up to 5 days after each vaccination

• Number of Participants With Solicited Systemic AEs

  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.

  Up to 14 days after each vaccination

• Number of Participants With Vaccine-related Serious Adverse Events

  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.

  Up to 14 days after each vaccination

Secondary Outcomes (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)

  4 weeks post last vaccination (Month 7) up to ~Month 24

Study Arms (3)

V160 3-Dose Regimen

EXPERIMENTAL

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 2-Dose Regimen

EXPERIMENTAL

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; Drug: Placebo

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

V160 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.

Also known as: Human cytomegalovirus vaccine

V160 2-Dose Regimen; V160 3-Dose Regimen

Placebo DRUG

Saline solution administered as a 0.5 mL IM injection

Placebo; V160 2-Dose Regimen

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (95)

Alabama Clinical Therapeutics ( Site 0025)

Birmingham, Alabama, 35205, United States

Location

Achieve Clinical Research, LLC ( Site 0055)

Birmingham, Alabama, 35216, United States

Location

Synexus US Phoenix Southeast ( Site 0057)

Chandler, Arizona, 85224, United States

Location

Inland Empire Liver Foundation ( Site 0026)

Rialto, California, 92377, United States

Location

Integrated Research of Inland, Inc. ( Site 0042)

Riverside, California, 92506, United States

Location

California Research Foundation ( Site 0286)

San Diego, California, 92123, United States

Location

Bayview Research Group, LLC ( Site 0012)

Valley Village, California, 91607, United States

Location

Diablo Clinical Research, Inc ( Site 0009)

Walnut Creek, California, 94598, United States

Location

Emerson Clinical Research Institute ( Site 0297)

Washington D.C., District of Columbia, 20011, United States

Location

Clinical Research of South Florida ( Site 0047)

Coral Gables, Florida, 33134, United States

Location

Indago Research & Health Center, Inc ( Site 0007)

Hialeah, Florida, 33012, United States

Location

NF Research Center LLC ( Site 0013)

Hialeah, Florida, 33012, United States

Location

Best Quality Research Inc. ( Site 0031)

Hialeah, Florida, 33016, United States

Location

Care Partners Clinical Research, LLC ( Site 0002)

Jacksonville, Florida, 32277, United States

Location

L&C Professional Medical Research Institute ( Site 0021)

Miami, Florida, 33144, United States

Location

Advanced Medical Research Institute ( Site 0296)

Miami, Florida, 33174, United States

Location

Kendall South Medical Center, Inc ( Site 0008)

Miami, Florida, 33185, United States

Location

New Age Medical Research Corporation ( Site 0018)

Miami, Florida, 33186, United States

Location

Clinical Associates of Orlando, LLC ( Site 0032)

Orlando, Florida, 32806, United States

Location

Columbus Regional Research Institute ( Site 0298)

Columbus, Georgia, 31904, United States

Location

Heartland Research Associates, LLC ( Site 0044)

Augusta, Kansas, 67010, United States

Location

Heartland Research Associates, LLC ( Site 0023)

Newton, Kansas, 67114, United States

Location

Heartland Research Associates, LLC ( Site 0019)

Wichita, Kansas, 67205, United States

Location

ACC Pediatric Research ( Site 0022)

Haughton, Louisiana, 71037, United States

Location

University of Maryland School of Medicine ( Site 0041)

Baltimore, Maryland, 21201, United States

Location

St Michaels Med Center ( Site 0285)

Newark, New Jersey, 07102, United States

Location

Albuquerque Clinical Trials ( Site 0052)

Albuquerque, New Mexico, 87102, United States

Location

Mid Hudson Medical Research ( Site 0294)

New Windsor, New York, 12553, United States

Location

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

Durham, North Carolina, 27713, United States

Location

PMG Research of Raleigh, LLC ( Site 0048)

Raleigh, North Carolina, 27609, United States

Location

PMG Research of Wilmington ( Site 0006)

Wilmington, North Carolina, 28401, United States

Location

Cincinnati Children's Hospital Medical Center ( Site 0003)

Cincinnati, Ohio, 45229, United States

Location

Senders Pediatrics ( Site 0060)

Cleveland, Ohio, 44121, United States

Location

Rapid Medical Research, Inc. ( Site 0038)

Cleveland, Ohio, 44122, United States

Location

Lynn Health Science Institute ( Site 0287)

Oklahoma City, Oklahoma, 73112, United States

Location

Coastal Pediatric Research ( Site 0010)

Charleston, South Carolina, 29414, United States

Location

Parkside Pediatric ( Site 0288)

Greenville, South Carolina, 29607, United States

Location

Coastal Carolina Research Center ( Site 0053)

Mt. Pleasant, South Carolina, 29464, United States

Location

Palmetto Clinical Research ( Site 0289)

Summerville, South Carolina, 29485, United States

Location

Tekton Research, Inc. ( Site 0036)

Austin, Texas, 78745, United States

Location

Coastal Bend Clinical Research ( Site 0299)

Corpus Christi, Texas, 78413, United States

Location

Radiant Research - Dallas ( Site 0045)

Dallas, Texas, 75234, United States

Location

University of Texas Medical Branch at Galveston ( Site 0049)

Galveston, Texas, 77555-1115, United States

Location

Juno Research, LLC ( Site 0293)

Houston, Texas, 77074, United States

Location

Accurate Clinical Management, LLC ( Site 0028)

Pasadena, Texas, 77504, United States

Location

Diagnostics Research Group ( Site 0001)

San Antonio, Texas, 78229, United States

Location

Synexus Research ( Site 0058)

San Antonio, Texas, 78229, United States

Location

Crossroads Clinical Research LLC ( Site 0283)

Victoria, Texas, 77901, United States

Location

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

Newport News, Virginia, 23606, United States

Location

Clinical Research Associates of Tidewater ( Site 0056)

Norfolk, Virginia, 23507, United States

Location

York Clinical Research, LLC ( Site 0033)

Norfolk, Virginia, 23510, United States

Location

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

Richmond, Virginia, 23294, United States

Location

Multicare / Rockwood Clinic ( Site 0034)

Spokane, Washington, 99202, United States

Location

Premier Clinical Research Group ( Site 0050)

Spokane, Washington, 99202, United States

Location

Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 0247)

Blacktown, New South Wales, 2148, Australia

Location

Paratus Clinical Kanwal - Trial Clinic ( Site 0243)

Kanwal, New South Wales, 2259, Australia

Location

Holdsworth House Medical Practice ( Site 0241)

Sydney, New South Wales, 2010, Australia

Location

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

Morayfield, Queensland, 4506, Australia

Location

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

Sippy Downs, Queensland, 4556, Australia

Location

Vaccine Evaluation Center ( Site 0264)

Vancouver, British Columbia, V5Z 4H4, Canada

Location

PrimeHealth Clinical Research ( Site 0070)

Toronto, Ontario, M4S 1Y2, Canada

Location

Clinique OVO ( Site 0067)

Montreal, Quebec, H4P 2S4, Canada

Location

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

Pierrefonds, Quebec, H9H 4Y6, Canada

Location

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

Québec, Quebec, G1E 7G9, Canada

Location

Diex Recherche Quebec Inc ( Site 0069)

Québec, Quebec, G1N 4V3, Canada

Location

Diex Recherche Sherbrooke Inc. ( Site 0066)

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Diex Recherche Victoriaville Inc. ( Site 0068)

Victoriaville, Quebec, G6P 6P6, Canada

Location

Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0186)

Espoo, 02230, Finland

Location

Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0188)

Helsinki, 00100, Finland

Location

Ita-Helsingin Rokotetutkimuskeskus ( Site 0184)

Helsinki, 00930, Finland

Location

Jarvenpaan rokotetutkimuskeskus ( Site 0185)

Jarvenpaa, 04400, Finland

Location

Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0190)

Kokkola, 67100, Finland

Location

Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0187)

Oulu, 90220, Finland

Location

Pori Vaccine Research Center ( Site 0182)

Pori, 28100, Finland

Location

Seinajoki Vaccine Research Center ( Site 0189)

Seinäjoki, 60100, Finland

Location

Tampereen yliopisto Rokotetutkimuskeskus ( Site 0181)

Tampere, 33100, Finland

Location

Turku Vaccine Research Center ( Site 0183)

Turku, 20520, Finland

Location

Rambam Medical Center - Health Care Campus ( Site 0219)

Haifa, 3109601, Israel

Location

Hadassah Ein Kerem Medical Center ( Site 0216)

Jerusalem, 9112001, Israel

Location

Meir MC ( Site 0213)

Kfar Saba, 4428164, Israel

Location

Western Galilee Hospital ( Site 0212)

Nahariya, 2222214, Israel

Location

Rabin Medical Center ( Site 0218)

Petah Tikva, 4941492, Israel

Location

Sakhnin west neighbourhood ( Site 0211)

Sakhnin, 3081000, Israel

Location

Sourasky Medical Center ( Site 0217)

Tel Aviv, 6423906, Israel

Location

Maccabi Healthcare Services ( Site 0220)

Tel Aviv, 6789140, Israel

Location

Limited Liability Company Medical Centre Aibolit ( Site 0229)

Kazan', 420073, Russia

Location

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

Kazan', 420097, Russia

Location

City Clinical Hospital 13 of Moscow ( Site 0232)

Moscow, 115280, Russia

Location

Antenatal clinic #22 ( Site 0225)

Saint Petersburg, 194354, Russia

Location

Siberian State Medical University ( Site 0231)

Tomsk, 634050, Russia

Location

Central City Hospital 7 ( Site 0237)

Yekaterinburg, 620137, Russia

Location

Hospital Clinic de Barcelona ( Site 0155)

Barcelona, 08036, Spain

Location

Hospital Universitario 12 de Octubre ( Site 0152)

Madrid, 28041, Spain

Location

Hospital Universitario La Paz ( Site 0157)

Madrid, 28046, Spain

Location

Hospital Clinico Universitario de Santiago ( Site 0151)

Santiago de Compostela, 15706, Spain

Location

Related Publications (1)

• 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.

  PMID: 37660711 RESULT

MeSH Terms

Conditions

Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 3, 2018
• Study Start: April 30, 2018
• Primary Completion: October 30, 2020
• Study Completion: June 30, 2021
• Last Updated: January 23, 2024
• Results First Posted: November 10, 2021

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

ES (4); FI (10); RU (6); AU (5); US (54); CA (8); IL (8)