V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002)
- Conditions
- Cytomegalovirus (CMV) Infections
- Interventions
- Biological: V160Drug: Placebo
- Registration Number
- NCT03486834
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description V160 2-Dose Regimen V160 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. Placebo Placebo Participants received placebo (saline solution) by IM injection on Day 1, Month 2, and Month 6. V160 3-Dose Regimen V160 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. V160 2-Dose Regimen Placebo 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.
- Primary Outcome Measures
Name Time Method 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) 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.
Number of Participants With Solicited Injection-site Adverse Events 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.
Number of Participants With Solicited Systemic AEs 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.
Number of Participants With Vaccine-related Serious Adverse Events 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
Name Time Method 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 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.
Trial Locations
- Locations (95)
PrimeHealth Clinical Research ( Site 0070)
🇨🇦Toronto, Ontario, Canada
St Michaels Med Center ( Site 0285)
🇺🇸Newark, New Jersey, United States
Indago Research & Health Center, Inc ( Site 0007)
🇺🇸Hialeah, Florida, United States
California Research Foundation ( Site 0286)
🇺🇸San Diego, California, United States
L&C Professional Medical Research Institute ( Site 0021)
🇺🇸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
Cincinnati Children's Hospital Medical Center ( Site 0003)
🇺🇸Cincinnati, Ohio, United States
Senders Pediatrics ( Site 0060)
🇺🇸Cleveland, Ohio, United States
Juno Research, LLC ( Site 0293)
🇺🇸Houston, Texas, United States
Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0187)
🇫🇮Oulu, Finland
Lynn Health Science Institute ( Site 0287)
🇺🇸Oklahoma City, Oklahoma, United States
Achieve Clinical Research, LLC ( Site 0055)
🇺🇸Birmingham, Alabama, United States
Integrated Research of Inland, Inc. ( Site 0042)
🇺🇸Riverside, California, United States
Emerson Clinical Research Institute ( Site 0297)
🇺🇸Washington, District of Columbia, United States
Bayview Research Group, LLC ( Site 0012)
🇺🇸Valley Village, California, United States
Diablo Clinical Research, Inc ( Site 0009)
🇺🇸Walnut Creek, California, United States
Care Partners Clinical Research, LLC ( Site 0002)
🇺🇸Jacksonville, Florida, United States
Clinical Research of South Florida ( Site 0047)
🇺🇸Coral Gables, Florida, United States
Heartland Research Associates, LLC ( Site 0044)
🇺🇸Augusta, Kansas, United States
Advanced Medical Research Institute ( Site 0296)
🇺🇸Miami, Florida, United States
Heartland Research Associates, LLC ( Site 0023)
🇺🇸Newton, Kansas, United States
University of Maryland School of Medicine ( Site 0041)
🇺🇸Baltimore, Maryland, United States
Carolina Women's Research and Wellness Center ( Site 0035)
🇺🇸Durham, North Carolina, United States
Albuquerque Clinical Trials ( Site 0052)
🇺🇸Albuquerque, New Mexico, United States
PMG Research of Wilmington ( Site 0006)
🇺🇸Wilmington, North Carolina, United States
Parkside Pediatric ( Site 0288)
🇺🇸Greenville, South Carolina, United States
Rapid Medical Research, Inc. ( Site 0038)
🇺🇸Cleveland, Ohio, United States
Accurate Clinical Management, LLC ( Site 0028)
🇺🇸Pasadena, 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
Synexus Research ( Site 0058)
🇺🇸San Antonio, Texas, United States
Crossroads Clinical Research LLC ( Site 0283)
🇺🇸Victoria, Texas, United States
Holdsworth House Medical Practice ( Site 0241)
🇦🇺Sydney, New South Wales, Australia
Paratus Clinical Kanwal - Trial Clinic ( Site 0243)
🇦🇺Kanwal, New South Wales, Australia
University of the Sunshine Coast Clinical Trials Centre ( Site 0244)
🇦🇺Morayfield, Queensland, Australia
McGill University Health Centre - Vaccine Study Centre ( Site 0064)
🇨🇦Pierrefonds, Quebec, Canada
Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0190)
🇫🇮Kokkola, Finland
Meir MC ( Site 0213)
🇮🇱Kfar Saba, Israel
Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0186)
🇫🇮Espoo, Finland
Vaccine Evaluation Center ( Site 0264)
🇨🇦Vancouver, British Columbia, Canada
Ita-Helsingin Rokotetutkimuskeskus ( Site 0184)
🇫🇮Helsinki, Finland
Seinajoki Vaccine Research Center ( Site 0189)
🇫🇮Seinajoki, Finland
Tampereen yliopisto Rokotetutkimuskeskus ( Site 0181)
🇫🇮Tampere, Finland
Hospital Clinic de Barcelona ( Site 0155)
🇪🇸Barcelona, Spain
Sakhnin west neighbourhood ( Site 0211)
🇮🇱Sakhnin, Israel
Sourasky Medical Center ( Site 0217)
🇮🇱Tel Aviv, Israel
City Clinical Hospital 13 of Moscow ( Site 0232)
🇷🇺Moscow, Russian Federation
LLC Scientific Research Medical Complex Your Health. ( Site 0230)
🇷🇺Kazan, Russian Federation
Antenatal clinic #22 ( Site 0225)
🇷🇺Saint Petersburg, Russian Federation
Siberian State Medical University ( Site 0231)
🇷🇺Tomsk, Russian Federation
Hospital Universitario 12 de Octubre ( Site 0152)
🇪🇸Madrid, Spain
CHUQ - Unite de Recherche en Sante Publique ( Site 0065)
🇨🇦Quebec, Canada
Diex Recherche Quebec Inc ( Site 0069)
🇨🇦Quebec, Canada
Alabama Clinical Therapeutics ( Site 0025)
🇺🇸Birmingham, Alabama, United States
Hospital Universitario La Paz ( Site 0157)
🇪🇸Madrid, Spain
Hospital Clinico Universitario de Santiago ( Site 0151)
🇪🇸Santiago de Compostela, Spain
Premier Clinical Research Group ( Site 0050)
🇺🇸Spokane, Washington, United States
Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 0247)
🇦🇺Blacktown, New South Wales, Australia
Synexus US Phoenix Southeast ( Site 0057)
🇺🇸Chandler, Arizona, United States
Inland Empire Liver Foundation ( Site 0026)
🇺🇸Rialto, California, United States
Best Quality Research Inc. ( Site 0031)
🇺🇸Hialeah, Florida, United States
NF Research Center LLC ( Site 0013)
🇺🇸Hialeah, Florida, United States
PMG Research of Raleigh, LLC ( Site 0048)
🇺🇸Raleigh, North Carolina, United States
Columbus Regional Research Institute ( Site 0298)
🇺🇸Columbus, Georgia, United States
ACC Pediatric Research ( Site 0022)
🇺🇸Haughton, Louisiana, United States
Mid Hudson Medical Research ( Site 0294)
🇺🇸New Windsor, New York, United States
Palmetto Clinical Research ( Site 0289)
🇺🇸Summerville, South Carolina, United States
Diagnostics Research Group ( Site 0001)
🇺🇸San Antonio, Texas, United States
York Clinical Research, LLC ( Site 0033)
🇺🇸Norfolk, Virginia, United States
Clinical Research Associates of Tidewater ( Site 0056)
🇺🇸Norfolk, Virginia, United States
Health Research of Hampton Roads, Inc. ( Site 0014)
🇺🇸Newport News, Virginia, United States
Multicare / Rockwood Clinic ( Site 0034)
🇺🇸Spokane, Washington, United States
Clinique OVO ( Site 0067)
🇨🇦Montreal, Quebec, Canada
University of the Sunshine Coast Clinical Trials Centre ( Site 0245)
🇦🇺Sippy Downs, Queensland, Australia
Diex Recherche Sherbrooke Inc. ( Site 0066)
🇨🇦Sherbrooke, Quebec, Canada
Jarvenpaan rokotetutkimuskeskus ( Site 0185)
🇫🇮Jarvenpaa, Finland
Hadassah Ein Kerem Medical Center ( Site 0216)
🇮🇱Jerusalem, Israel
Rambam Medical Center - Health Care Campus ( Site 0219)
🇮🇱Haifa, Israel
Pori Vaccine Research Center ( Site 0182)
🇫🇮Pori, Finland
Rabin Medical Center ( Site 0218)
🇮🇱Petah-Tikva, Israel
Limited Liability Company Medical Centre Aibolit ( Site 0229)
🇷🇺Kazan, Russian Federation
Diex Recherche Victoriaville Inc. ( Site 0068)
🇨🇦Victoriaville, Quebec, Canada
Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0188)
🇫🇮Helsinki, Finland
Turku Vaccine Research Center ( Site 0183)
🇫🇮Turku, Finland
Maccabi Healthcare Services ( Site 0220)
🇮🇱Tel Aviv, Israel
Coastal Carolina Research Center ( Site 0053)
🇺🇸Mount Pleasant, South Carolina, United States
Western Galilee Hospital ( Site 0212)
🇮🇱Nahariya, Israel
Central City Hospital 7 ( Site 0237)
🇷🇺Ekaterinburg, Russian Federation
Clinical Associates of Orlando, LLC ( Site 0032)
🇺🇸Orlando, Florida, United States
Coastal Pediatric Research ( Site 0010)
🇺🇸Charleston, South Carolina, United States
Tekton Research, Inc. ( Site 0036)
🇺🇸Austin, Texas, United States
National Clinical Research-Richmond, Inc. ( Site 0051)
🇺🇸Richmond, Virginia, United States
Heartland Research Associates, LLC ( Site 0019)
🇺🇸Wichita, Kansas, United States