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



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:16 - 35
Updated:3/29/2019
Start Date:April 30, 2018
End Date:May 14, 2021
Contact:Toll Free Number
Email:Trialsites@merck.com
Phone:1-888-577-8839

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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

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.


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.
We found this trial at
45
sites
1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
Phone: 316-462-0423
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
Phone: 205-757-8212
Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Phone: 513-636-7635
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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400 Gresham Dr
Norfolk, Virginia 23507
757-627-7446
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4410 Medical Drive
San Antonio, Texas 78229
210-692-7157
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Albuquerque, New Mexico
Phone: 505-224-7407
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Augusta, Kansas 67010
Phone: 316-689-6629
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Austin, Texas 78745
Phone: 512-388-5717
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655 West Baltimore Street
Baltimore, Maryland 21201
(410) 706-7410
Phone: 410-706-5328
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
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Birmingham, Alabama 35235
Phone: 205-933-8522
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Chandler, Arizona 85224
Phone: 480-775-1115
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Charleston, South Carolina 29414
Phone: 843-518-5642
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Cleveland, Ohio 44221
Phone: 216-291-9210
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Cleveland, Ohio 44122
Phone: 2166820320286
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801 Monterey Street
Coral Gables, Florida 33134
Phone: 305-445-5637
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Dallas, Texas 75231
Phone: 972-241-1222
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Durham, North Carolina 27713
Phone: 919-251-9223
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Galveston, Texas
Phone: 409-772-5278
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Haughton, Louisiana 71037
Phone: 318-949-0539
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Hialeah, Florida 33012
Phone: 305-825-6588
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Hialeah, Florida 33012
Phone: 786-660-8890
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Hialeah, Florida 33016
Phone: 786-313-3506
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Jacksonville, Florida 32277
Phone: 904-296-3260
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Miami, Florida
Phone: 305-269-1616
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Miami, Florida 33175
Phone: 305-388-1118
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Miami, Florida 33186
Phone: 305-596-9901
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Mount Pleasant, South Carolina 29464
Phone: 843-856-3784
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Newark, New Jersey 07102
Phone: 973-877-2663
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Newport News, Virginia 23606
Phone: 757-591-8100
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Newton, Kansas 67114
Phone: 316-689-6629
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142 West York Street
Norfolk, Virginia 23510
Phone: 757-373-8478
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Orlando, Florida 32801
Phone: 407-269-0322
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10701 Corporate Drive
Pasadena, Texas 77505
Phone: 281-481-8557
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Raleigh, North Carolina 27609
Phone: 919-783-4895
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Rialto, California 92377
Phone: 909-883-2999
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Richmond, Virginia 23294
Phone: 804372213328
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Riverside, California 92506
Phone: 951-781-7199
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San Antonio, Texas 78229
Phone: 210-614-7483
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Spokane, Washington 99202
Phone: 509-343-3710
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Spokane, Washington 99202
Phone: 509-459-1590
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Valley Village, California 91607
Phone: 8008318308123
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Vancouver, British Columbia
Phone: 6048752151
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Victoria, Texas
Phone: 361-288-4668
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Walnut creek, California 94598
Phone: 925-930-7267
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
Phone: 910-799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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