Safety, Tolerability, and Efficacy of the Human Cytomegalovirus Vaccine (V160) in Healthy Women 16 to 35 Years of Age (V160-002)
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| ClinicalTrials.gov Identifier: NCT03486834 |
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Recruitment Status :
Recruiting
First Posted : April 3, 2018
Last Update Posted : November 9, 2018
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
- Study Details
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cytomegalovirus Infections | Biological: V160 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 2100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Prevention |
| Official Title: | 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 |
| Actual Study Start Date : | April 30, 2018 |
| Estimated Primary Completion Date : | May 14, 2021 |
| Estimated Study Completion Date : | May 14, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Cytomegalovirus Infections
| Arm | Intervention/treatment |
|---|---|
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Experimental: V160 3-Dose Regimen
Participants will receive V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.
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Biological: V160
V160 administered as a 0.5 mL (100 Units) IM injection containing Merck aluminum phosphate adjuvant (MAPA) |
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Experimental: V160 2-Dose Regimen
Participants will receive V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.
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Biological: V160
V160 administered as a 0.5 mL (100 Units) IM injection containing Merck aluminum phosphate adjuvant (MAPA) Drug: Placebo Saline solution administered as a 0.5 mL IM injection |
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Placebo Comparator: Placebo
Participants will receive placebo by IM injection on Day 1, Month 3, and Month 6.
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Drug: Placebo
Saline solution administered as a 0.5 mL IM injection |
Primary Outcome Measures :
- Incidence of Cytomegalovirus Infection in the 3-dose Regimen Group [ Time Frame: Up to Month 36 ]CMV infection is defined as detection of CMV (non-vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. The incidence of CMV infection in participants receiving the 3-dose V160 regimen will be assessed.
- Solicited Injection-site AEs [ Time Frame: Up to 5 days after each vaccination ]The percentage of participants with one or more solicited injection-site AE (pain/tenderness, erythema/redness, swelling) will be assessed.
- Solicited Systemic AEs [ Time Frame: Up to 14 days after each vaccination ]The percentage of participants with one or more solicited systemic AEs (headache, fatigue, muscle pain, joint pain) will be assessed.
- Vaccine-related Serious Adverse Events (SAEs) [ Time Frame: Up to 14 days after each vaccination ]The percentage of participants with a vaccine-related SAE will be assessed.
Secondary Outcome Measures :
- Incidence of Cytomegalovirus Infection in the 2-dose Regimen Group [ Time Frame: Up to Month 36 ]CMV infection is defined as detection of CMV (non-vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. The incidence of CMV infection in participants receiving the 2-dose V160 regimen will be assessed.
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| Ages Eligible for Study: | 16 Years to 35 Years (Child, Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486834
Contacts
| Contact: Toll Free Number | 1-888-577-8839 | Trialsites@merck.com |
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Locations
| United States, Alabama | |
| Alabama Clinical Therapeutics ( Site 0025) | Recruiting |
| Birmingham, Alabama, United States, 35205 | |
| Contact: Study Coordinator 205-933-8522 | |
| Achieve Clinical Research, LLC ( Site 0055) | Recruiting |
| Birmingham, Alabama, United States, 35216 | |
| Contact: Study Coordinator 205-757-8212 | |
| United States, Arizona | |
| Synexus US Phoenix Southeast ( Site 0057) | Recruiting |
| Chandler, Arizona, United States, 85224 | |
| Contact: Study Coordinator 480-775-1115 | |
| United States, California | |
| Inland Empire Liver Foundation ( Site 0026) | Recruiting |
| Rialto, California, United States, 92377 | |
| Contact: Study Coordinator 909-883-2999 | |
| Integrated Research Group ( Site 0042) | Recruiting |
| Riverside, California, United States, 92506 | |
| Contact: Study Coordinator 951-781-7199 | |
| Bayview Research Group, LLC ( Site 0012) | Recruiting |
| Valley Village, California, United States, 91607 | |
| Contact: Study Coordinator 8008318308123 | |
| Diablo Clinical Research, Inc ( Site 0009) | Recruiting |
| Walnut Creek, California, United States, 94598 | |
| Contact: Study Coordinator 925-930-7267 | |
| United States, Florida | |
| Clinical Research of South Florida ( Site 0047) | Recruiting |
| Coral Gables, Florida, United States, 33134 | |
| Contact: Study Coordinator 305-445-5637 | |
| Indago Research & Health Center, Inc ( Site 0007) | Recruiting |
| Hialeah, Florida, United States, 33012 | |
| Contact: Study Coordinator 305-825-6588 | |
| NF Research Center LLC ( Site 0013) | Recruiting |
| Hialeah, Florida, United States, 33012 | |
| Contact: Study Coordinator 786-660-8890 | |
| Best Quality Research Inc. ( Site 0031) | Recruiting |
| Hialeah, Florida, United States, 33016 | |
| Contact: Study Coordinator 786-313-3506 | |
| Care Partners Clinical Research, LLC ( Site 0002) | Recruiting |
| Jacksonville, Florida, United States, 32277 | |
| Contact: Study Coordinator 904-296-3260 | |
| L&C Professional Medical Research Institute ( Site 0021) | Recruiting |
| Miami, Florida, United States, 33144 | |
| Contact: Study Coordinator 305-269-1616 | |
| Kendall South Medical Center, Inc ( Site 0008) | Recruiting |
| Miami, Florida, United States, 33185 | |
| Contact: Study Coordinator 305-388-1118 | |
| New Age Medical Research Corporation ( Site 0018) | Recruiting |
| Miami, Florida, United States, 33186 | |
| Contact: Study Coordinator 305-596-9901 | |
| Clinical Associates of Orlando, LLC ( Site 0032) | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Study Coordinator 407-269-0322 | |
| United States, Kansas | |
| Heartland Research Associates, LLC ( Site 0044) | Recruiting |
| Augusta, Kansas, United States, 67010 | |
| Contact: Study Coordinator 316-689-6629 | |
| Heartland Research Associates, LLC ( Site 0023) | Recruiting |
| Newton, Kansas, United States, 67114 | |
| Contact: Study Coordinator 316-689-6629 | |
| Heartland Research Associates, LLC ( Site 0019) | Recruiting |
| Wichita, Kansas, United States, 67205 | |
| Contact: Study Coordinator 316-462-0423 | |
| United States, Louisiana | |
| ACC Pediatric Research ( Site 0022) | Recruiting |
| Haughton, Louisiana, United States, 71037 | |
| Contact: Study Coordinator 318-949-0539 | |
| United States, Maryland | |
| University of Maryland School of Medicine ( Site 0041) | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Study Coordinator 410-706-5328 | |
| United States, New Mexico | |
| Albuquerque Clinical Trials ( Site 0052) | Recruiting |
| Albuquerque, New Mexico, United States, 87102 | |
| Contact: Study Coordinator 505-224-7407 | |
| United States, North Carolina | |
| Carolina Women's Research and Wellness Center ( Site 0035) | Recruiting |
| Durham, North Carolina, United States, 27713 | |
| Contact: Study Coordinator 919-251-9223 | |
| PMG Research of Raleigh, LLC ( Site 0048) | Recruiting |
| Raleigh, North Carolina, United States, 27609 | |
| Contact: Study Coordinator 919-783-4895 | |
| PMG Research of Wilmington ( Site 0006) | Recruiting |
| Wilmington, North Carolina, United States, 28401 | |
| Contact: Study Coordinator 910-799-5500 | |
| United States, Ohio | |
| Senders Pediatrics ( Site 0060) | Recruiting |
| Cleveland, Ohio, United States, 44121 | |
| Contact: Study Coordinator 216-291-9210 | |
| Rapid Medical Research, Inc. ( Site 0038) | Recruiting |
| Cleveland, Ohio, United States, 44122 | |
| Contact: Study Coordinator 2166820320286 | |
| United States, South Carolina | |
| Coastal Pediatric Research ( Site 0010) | Recruiting |
| Charleston, South Carolina, United States, 29414 | |
| Contact: Study Coordinator 843-518-5642 | |
| Coastal Carolina Research Center ( Site 0053) | Recruiting |
| Mount Pleasant, South Carolina, United States, 29464 | |
| Contact: Study Coordinator 843-856-3784 | |
| United States, Texas | |
| Tekton Research, Inc. ( Site 0036) | Recruiting |
| Austin, Texas, United States, 78745 | |
| Contact: Study Coordinator 512-388-5717 | |
| Radiant Research - Dallas ( Site 0045) | Recruiting |
| Dallas, Texas, United States, 75234 | |
| Contact: Study Coordinator 972-241-1222 | |
| University of Texas Medical Branch at Galveston ( Site 0049) | Recruiting |
| Galveston, Texas, United States, 77555-1115 | |
| Contact: Study Coordinator 409-772-5278 | |
| Accurate Clinical Management, LLC ( Site 0028) | Recruiting |
| Pasadena, Texas, United States, 77504 | |
| Contact: Study Coordinator 281-481-8557 | |
| Diagnostics Research Group ( Site 0001) | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Study Coordinator 210-692-7157 | |
| Synexus Research ( Site 0058) | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Study Coordinator 210-614-7483 | |
| Crossroads Clinical Research LLC ( Site 0283) | Recruiting |
| Victoria, Texas, United States, 77901 | |
| Contact: Study Coordinator 361-288-4668 | |
| United States, Virginia | |
| Health Research of Hampton Roads, Inc. ( Site 0014) | Recruiting |
| Newport News, Virginia, United States, 23606 | |
| Contact: Study Coordinator 757-591-8100 | |
| Clinical Research Assoc Tidewater ( Site 0056) | Recruiting |
| Norfolk, Virginia, United States, 23507 | |
| Contact: Study Coordinator 757-627-7446 | |
| York Clinical Research, LLC ( Site 0033) | Recruiting |
| Norfolk, Virginia, United States, 23510 | |
| Contact: Study Coordinator 757-373-8478 | |
| National Clinical Research-Richmond, Inc. ( Site 0051) | Recruiting |
| Richmond, Virginia, United States, 23294 | |
| Contact: Study Coordinator 804372213328 | |
| United States, Washington | |
| Multicare / Rockwood Clinic ( Site 0034) | Recruiting |
| Spokane, Washington, United States, 99202 | |
| Contact: Study Coordinator 509-459-1590 | |
| Premier Clinical Research Group ( Site 0050) | Recruiting |
| Spokane, Washington, United States, 99202 | |
| Contact: Study Coordinator 509-343-3710 | |
| Canada, British Columbia | |
| Vaccine Evaluation Center ( Site 0264) | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 4H4 | |
| Contact: Study Coordinator 6048752151 | |
| Canada, Ontario | |
| PrimeHealth Clinical Research ( Site 0070) | Recruiting |
| Toronto, Ontario, Canada, M4S 1Y2 | |
| Contact: Study Coordinator 4164868444 | |
| Canada, Quebec | |
| Clinique OVO ( Site 0067) | Recruiting |
| Montreal, Quebec, Canada, H4P 2S4 | |
| Contact: Study Coordinator 5147982000759 | |
| McGill University Health Centre - Vaccine Study Centre ( Site 0064) | Recruiting |
| Pierrefonds, Quebec, Canada, H9H 4Y6 | |
| Contact: Study Coordinator 5146247855 | |
| Diex Recherche Sherbrooke Inc. ( Site 0066) | Recruiting |
| Sherbrooke, Quebec, Canada, J1L 0H8 | |
| Contact: Study Coordinator 8193462887 | |
| Diex Recherche Victoriaville Inc. ( Site 0068) | Recruiting |
| Victoriaville, Quebec, Canada, G6P 6P6 | |
| Contact: Study Coordinator 8192601172 | |
| Canada | |
| CHUQ - Unite de Recherche en Sante Publique ( Site 0065) | Recruiting |
| Quebec, Canada, G1E 7G9 | |
| Contact: Study Coordinator 4186667000240 | |
| Diex Recherche Quebec Inc ( Site 0069) | Recruiting |
| Quebec, Canada, G1N 4V3 | |
| Contact: Study Coordinator 4186146124 | |
| Finland | |
| Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0186) | Recruiting |
| Espoo, Finland, 02230 | |
| Contact: Study Coordinator +358503951189 | |
| Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0188) | Recruiting |
| Helsinki, Finland, 00100 | |
| Contact: Study Coordinator +358962270360 | |
| Ita-Helsingin Rokotetutkimuskeskus ( Site 0184) | Recruiting |
| Helsinki, Finland, 00930 | |
| Contact: Study Coordinator +358401904115 | |
| Jarvenpaan rokotetutkimuskeskus ( Site 0185) | Recruiting |
| Jarvenpaa, Finland, 04400 | |
| Contact: Study Coordinator +358504372661 | |
| Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0190) | Recruiting |
| Kokkola, Finland, 67100 | |
| Contact: Study Coordinator +35868349582 | |
| Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0187) | Recruiting |
| Oulu, Finland, 90220 | |
| Contact: Study Coordinator +358505310004 | |
| Pori Vaccine Research Center ( Site 0182) | Recruiting |
| Pori, Finland, 28100 | |
| Contact: Study Coordinator +358505246532 | |
| Seinäjoki Vaccine Research Center ( Site 0189) | Recruiting |
| Seinäjoki, Finland, 60100 | |
| Contact: Study Coordinator +358504377326 | |
| Tampereen yliopisto Rokotetutkimuskeskus ( Site 0181) | Recruiting |
| Tampere, Finland, 33100 | |
| Contact: Study Coordinator +358505099135 | |
| Turku Vaccine Research Center ( Site 0183) | Recruiting |
| Turku, Finland, 20520 | |
| Contact: Study Coordinator +35822361844 | |
| Israel | |
| Hadassah Ein Kerem Medical Center ( Site 0216) | Recruiting |
| Jerusalem, Israel, 9112001 | |
| Contact: Study Coordinator +97226779372 | |
| Meir MC ( Site 0213) | Recruiting |
| Kfar Saba, Israel, 4428164 | |
| Contact: Study Coordinator +97297433364 | |
| Rabin Medical Center ( Site 0218) | Recruiting |
| Petah-Tikva, Israel, 4941492 | |
| Contact: Study Coordinator +97239271824 | |
| Sakhnin west neighbourhood ( Site 0211) | Recruiting |
| Sakhnin, Israel, 3081000 | |
| Contact: Study Coordinator +97246745729 | |
| Sourasky Medical Center ( Site 0217) | Recruiting |
| Tel Aviv, Israel, 6423906 | |
| Contact: Study Coordinator +97236974845 | |
| Russian Federation | |
| Central City Hospital 7 ( Site 0237) | Recruiting |
| Ekaterinburg, Russian Federation, 620137 | |
| Contact: Study Coordinator +79122411379 | |
| Limited Liability Company Medical Centre Aibolit ( Site 0229) | Recruiting |
| Kazan, Russian Federation, 420073 | |
| Contact: Study Coordinator +79600480104 | |
| LLC Scientific Research Medical Complex Your Health. ( Site 0230) | Recruiting |
| Kazan, Russian Federation, 420097 | |
| Contact: Study Coordinator +79872980006 | |
| City Clinical Hospital 13 of Moscow ( Site 0232) | Recruiting |
| Moscow, Russian Federation, 115280 | |
| Contact: Study Coordinator +79166852535 | |
| Antenatal clinic #22 ( Site 0225) | Recruiting |
| Saint Petersburg, Russian Federation, 194354 | |
| Contact: Study Coordinator +78212963108 | |
| Siberian State Medical University ( Site 0231) | Recruiting |
| Tomsk, Russian Federation, 634050 | |
| Contact: Study Coordinator +79039155110 | |
| Spain | |
| Hospital Clinic de Barcelona ( Site 0155) | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Study Coordinator +34932275754 | |
| Hospital Universitario 12 de Octubre ( Site 0152) | Recruiting |
| Madrid, Spain, 28041 | |
| Contact: Study Coordinator +34913908569 | |
| Hospital Universitario La Paz ( Site 0157) | Recruiting |
| Madrid, Spain, 28046 | |
| Contact: Study Coordinator +34912071466 | |
| Hospital Clinico Universitario de Santiago ( Site 0151) | Recruiting |
| Santiago de Compostela, Spain, 15706 | |
| Contact: Study Coordinator +34981950615 | |
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Director | Merck Sharp & Dohme Corp. |
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT03486834 History of Changes |
| Other Study ID Numbers: |
V160-002 2017-004233-86 ( EudraCT Number ) |
| First Posted: | April 3, 2018 Key Record Dates |
| Last Update Posted: | November 9, 2018 |
| Last Verified: | November 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
|
Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases |