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V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002) | Clinical Trials | Clareo Health

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

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

NCT03486834•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

16 - 35 years

Sex

FEMALE

Healthy Volunteers

Yes

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.
+6 more criteria

Locations (95)

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

Key Dates

Start Date

April 30, 2018

Primary Completion Date

October 30, 2020

Completion Date

June 30, 2021

Last Updated

January 23, 2024

Enrollment

2,200

ACTUAL participants

Conditions

Cytomegalovirus (CMV) Infections

Interventions

V160

BIOLOGICAL

Placebo

DRUG