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Cytomegalovirus (CMV) InfectionsPhase 2NCT03486834

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

A Phase 2 study testing V160 in people with Cytomegalovirus (CMV) Infections, run by Merck Sharp & Dohme LLC at 95 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cytomegalovirus (CMV) Infections
What is being tested?
V160
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,200 participants
Where
95 sitesin 7 countries
Study dates
30 Apr 2018to 30 Jun 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

95 sites in 7 countries.

95 sites in 7 countries

United States54 sites

  • Albuquerque Clinical Trials ( Site 0052)

    Albuquerque, New Mexico, 87102

  • Heartland Research Associates, LLC ( Site 0044)

    Augusta, Kansas, 67010

  • Tekton Research, Inc. ( Site 0036)

    Austin, Texas, 78745

  • University of Maryland School of Medicine ( Site 0041)

    Baltimore, Maryland, 21201

  • Alabama Clinical Therapeutics ( Site 0025)

    Birmingham, Alabama, 35205

  • Achieve Clinical Research, LLC ( Site 0055)

    Birmingham, Alabama, 35216

  • Synexus US Phoenix Southeast ( Site 0057)

    Chandler, Arizona, 85224

  • Coastal Pediatric Research ( Site 0010)

    Charleston, South Carolina, 29414

  • Cincinnati Children's Hospital Medical Center ( Site 0003)

    Cincinnati, Ohio, 45229

  • Senders Pediatrics ( Site 0060)

    Cleveland, Ohio, 44121

  • Rapid Medical Research, Inc. ( Site 0038)

    Cleveland, Ohio, 44122

  • Columbus Regional Research Institute ( Site 0298)

    Columbus, Georgia, 31904

  • Clinical Research of South Florida ( Site 0047)

    Coral Gables, Florida, 33134

  • Coastal Bend Clinical Research ( Site 0299)

    Corpus Christi, Texas, 78413

  • Radiant Research - Dallas ( Site 0045)

    Dallas, Texas, 75234

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

    Durham, North Carolina, 27713

  • University of Texas Medical Branch at Galveston ( Site 0049)

    Galveston, Texas, 77555-1115

  • Parkside Pediatric ( Site 0288)

    Greenville, South Carolina, 29607

  • ACC Pediatric Research ( Site 0022)

    Haughton, Louisiana, 71037

  • Indago Research & Health Center, Inc ( Site 0007)

    Hialeah, Florida, 33012

  • NF Research Center LLC ( Site 0013)

    Hialeah, Florida, 33012

  • Best Quality Research Inc. ( Site 0031)

    Hialeah, Florida, 33016

  • Juno Research, LLC ( Site 0293)

    Houston, Texas, 77074

  • Care Partners Clinical Research, LLC ( Site 0002)

    Jacksonville, Florida, 32277

  • L&C Professional Medical Research Institute ( Site 0021)

    Miami, Florida, 33144

  • Advanced Medical Research Institute ( Site 0296)

    Miami, Florida, 33174

  • Kendall South Medical Center, Inc ( Site 0008)

    Miami, Florida, 33185

  • New Age Medical Research Corporation ( Site 0018)

    Miami, Florida, 33186

  • Coastal Carolina Research Center ( Site 0053)

    Mt. Pleasant, South Carolina, 29464

  • Mid Hudson Medical Research ( Site 0294)

    New Windsor, New York, 12553

  • St Michaels Med Center ( Site 0285)

    Newark, New Jersey, 07102

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

    Newport News, Virginia, 23606

  • Heartland Research Associates, LLC ( Site 0023)

    Newton, Kansas, 67114

  • Clinical Research Associates of Tidewater ( Site 0056)

    Norfolk, Virginia, 23507

  • York Clinical Research, LLC ( Site 0033)

    Norfolk, Virginia, 23510

  • Lynn Health Science Institute ( Site 0287)

    Oklahoma City, Oklahoma, 73112

  • Clinical Associates of Orlando, LLC ( Site 0032)

    Orlando, Florida, 32806

  • Accurate Clinical Management, LLC ( Site 0028)

    Pasadena, Texas, 77504

  • PMG Research of Raleigh, LLC ( Site 0048)

    Raleigh, North Carolina, 27609

  • Inland Empire Liver Foundation ( Site 0026)

    Rialto, California, 92377

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

    Richmond, Virginia, 23294

  • Integrated Research of Inland, Inc. ( Site 0042)

    Riverside, California, 92506

  • Diagnostics Research Group ( Site 0001)

    San Antonio, Texas, 78229

  • Synexus Research ( Site 0058)

    San Antonio, Texas, 78229

  • California Research Foundation ( Site 0286)

    San Diego, California, 92123

  • Multicare / Rockwood Clinic ( Site 0034)

    Spokane, Washington, 99202

  • Premier Clinical Research Group ( Site 0050)

    Spokane, Washington, 99202

  • Palmetto Clinical Research ( Site 0289)

    Summerville, South Carolina, 29485

  • Bayview Research Group, LLC ( Site 0012)

    Valley Village, California, 91607

  • Crossroads Clinical Research LLC ( Site 0283)

    Victoria, Texas, 77901

  • Diablo Clinical Research, Inc ( Site 0009)

    Walnut Creek, California, 94598

  • Emerson Clinical Research Institute ( Site 0297)

    Washington D.C., District of Columbia, 20011

  • Heartland Research Associates, LLC ( Site 0019)

    Wichita, Kansas, 67205

  • PMG Research of Wilmington ( Site 0006)

    Wilmington, North Carolina, 28401

Other trials in United States

Finland10 sites

  • Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0186)

    Espoo, 02230

  • Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0188)

    Helsinki, 00100

  • Ita-Helsingin Rokotetutkimuskeskus ( Site 0184)

    Helsinki, 00930

  • Jarvenpaan rokotetutkimuskeskus ( Site 0185)

    Jarvenpaa, 04400

  • Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0190)

    Kokkola, 67100

  • Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0187)

    Oulu, 90220

  • Pori Vaccine Research Center ( Site 0182)

    Pori, 28100

  • Seinajoki Vaccine Research Center ( Site 0189)

    Seinäjoki, 60100

  • Tampereen yliopisto Rokotetutkimuskeskus ( Site 0181)

    Tampere, 33100

  • Turku Vaccine Research Center ( Site 0183)

    Turku, 20520

Other trials in Finland

Canada8 sites

  • Clinique OVO ( Site 0067)

    Montreal, Quebec, H4P 2S4

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

    Pierrefonds, Quebec, H9H 4Y6

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

    Québec, Quebec, G1E 7G9

  • Diex Recherche Quebec Inc ( Site 0069)

    Québec, Quebec, G1N 4V3

  • Diex Recherche Sherbrooke Inc. ( Site 0066)

    Sherbrooke, Quebec, J1L 0H8

  • PrimeHealth Clinical Research ( Site 0070)

    Toronto, Ontario, M4S 1Y2

  • Vaccine Evaluation Center ( Site 0264)

    Vancouver, British Columbia, V5Z 4H4

  • Diex Recherche Victoriaville Inc. ( Site 0068)

    Victoriaville, Quebec, G6P 6P6

Other trials in Canada

Israel8 sites

  • Rambam Medical Center - Health Care Campus ( Site 0219)

    Haifa, 3109601

  • Hadassah Ein Kerem Medical Center ( Site 0216)

    Jerusalem, 9112001

  • Meir MC ( Site 0213)

    Kfar Saba, 4428164

  • Western Galilee Hospital ( Site 0212)

    Nahariya, 2222214

  • Rabin Medical Center ( Site 0218)

    Petah Tikva, 4941492

  • Sakhnin west neighbourhood ( Site 0211)

    Sakhnin, 3081000

  • Sourasky Medical Center ( Site 0217)

    Tel Aviv, 6423906

  • Maccabi Healthcare Services ( Site 0220)

    Tel Aviv, 6789140

Other trials in Israel

Russia6 sites

  • Limited Liability Company Medical Centre Aibolit ( Site 0229)

    Kazan', 420073

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

    Kazan', 420097

  • City Clinical Hospital 13 of Moscow ( Site 0232)

    Moscow, 115280

  • Antenatal clinic #22 ( Site 0225)

    Saint Petersburg, 194354

  • Siberian State Medical University ( Site 0231)

    Tomsk, 634050

  • Central City Hospital 7 ( Site 0237)

    Yekaterinburg, 620137

Other trials in Russia

Australia5 sites

  • Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 0247)

    Blacktown, New South Wales, 2148

  • Paratus Clinical Kanwal - Trial Clinic ( Site 0243)

    Kanwal, New South Wales, 2259

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

    Morayfield, Queensland, 4506

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

    Sippy Downs, Queensland, 4556

  • Holdsworth House Medical Practice ( Site 0241)

    Sydney, New South Wales, 2010

Other trials in Australia

Spain4 sites

  • Hospital Clinic de Barcelona ( Site 0155)

    Barcelona, 08036

  • Hospital Universitario 12 de Octubre ( Site 0152)

    Madrid, 28041

  • Hospital Universitario La Paz ( Site 0157)

    Madrid, 28046

  • Hospital Clinico Universitario de Santiago ( Site 0151)

    Santiago de Compostela, 15706

Other trials in Spain

About this study

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

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.

Being tested
V160, Placebo
Keywords
Prevention of cytomegalovirus infection (CMVi)
Medical subject headings
Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • V160Biological

    Also called Human cytomegalovirus vaccine

    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.

  • PlaceboDrug

    Saline solution administered as a 0.5 mL IM injection

Study groups in NCT03486834
Study groupRoleWhat they receive
V160 3-Dose RegimenExperimentalParticipants 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.
Receives: Biological: V160
V160 2-Dose RegimenExperimentalParticipants 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.
Receives: Biological: V160; Drug: Placebo
PlaceboPlacebo comparatorParticipants received placebo (saline solution) by IM injection on Day 1, Month 2, and Month 6.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: Up to 5 days after each vaccination

  3. 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.

    Measured: Up to 14 days after each vaccination

  4. 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.

    Measured: Up to 14 days after each vaccination

Secondary outcomes (1)

  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)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2018
  2. Study start30 Apr 2018
  3. Primary completion30 Oct 2020
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03486834
Sponsor's protocol ID
V160-002
Other IDs
2017-004233-86, 2017
Status last verified
Jan 2024
First submitted
28 Mar 2018
Last updated
23 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 37660711

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing V160 in people with Cytomegalovirus (CMV) Infections, run by Merck Sharp & Dohme LLC at 95 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Finland, Canada, Israel, Russia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 4 weeks post last vaccination (Month 7) up to ~Month 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03486834, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.

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