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Trial record 1 of 1 for:    NCT03486834
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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
Recruitment Status : Active, not recruiting
First Posted : April 3, 2018
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2200 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
Actual Primary Completion Date : October 30, 2020
Estimated Study Completion Date : June 20, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: V160 3-Dose Regimen
Participants will receive V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.
 Biological: V160
V160 administered as a 0.5 mL (100 Units) IM injection containing Merck aluminum phosphate adjuvant (MAPA)
Experimental: V160 2-Dose Regimen
Participants will receive V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.
 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
Placebo Comparator: Placebo
Participants will receive placebo by IM injection on Day 1, Month 3, and Month 6.
 Drug: Placebo
Saline solution administered as a 0.5 mL IM injection


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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 :
  1. 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.


Eligibility Criteria
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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.
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03486834    
Other Study ID Numbers: V160-002
2017-004233-86 ( EudraCT Number )
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases