ClinicalTrials.gov

History of Changes for Study: NCT03486834
Safety, Tolerability, and Efficacy of the Human Cytomegalovirus Vaccine (V160) in Healthy Women 16 to 35 Years of Age (V160-002)
Latest version (submitted October 13, 2021) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 March 28, 2018 None (earliest Version on record)
2 April 3, 2018 Study Status and Oversight
3 May 16, 2018 Recruitment Status, Study Status and Contacts/Locations
4 May 24, 2018 Contacts/Locations and Study Status
5 May 29, 2018 Contacts/Locations and Study Status
6 June 7, 2018 Study Status and Contacts/Locations
7 June 14, 2018 Contacts/Locations and Study Status
8 June 20, 2018 Contacts/Locations and Study Status
9 June 27, 2018 Contacts/Locations and Study Status
10 July 4, 2018 Study Status and Contacts/Locations
11 July 19, 2018 Contacts/Locations and Study Status
12 July 25, 2018 Contacts/Locations and Study Status
13 August 1, 2018 Contacts/Locations and Study Status
14 August 7, 2018 Contacts/Locations and Study Status
15 August 13, 2018 Eligibility and Study Status
16 August 22, 2018 Contacts/Locations and Study Status
17 August 31, 2018 Contacts/Locations and Study Status
18 September 6, 2018 Study Status and Contacts/Locations
19 September 11, 2018 Contacts/Locations and Study Status
20 September 18, 2018 Contacts/Locations and Study Status
21 November 8, 2018 Study Status and Contacts/Locations
22 November 22, 2018 Contacts/Locations and Study Status
23 December 20, 2018 Contacts/Locations, Study Status and IPDSharing
24 January 24, 2019 Study Status and Contacts/Locations
25 February 6, 2019 Study Status and Contacts/Locations
26 February 14, 2019 Contacts/Locations and Study Status
27 March 14, 2019 Contacts/Locations and Study Status
28 March 26, 2019 Contacts/Locations and Study Status
29 April 5, 2019 Contacts/Locations and Study Status
30 April 11, 2019 Contacts/Locations and Study Status
31 April 17, 2019 Contacts/Locations and Study Status
32 May 22, 2019 Study Status and Contacts/Locations
33 May 29, 2019 Contacts/Locations and Study Status
34 June 7, 2019 Study Status and Contacts/Locations
35 June 12, 2019 Contacts/Locations and Study Status
36 June 20, 2019 Contacts/Locations and Study Status
37 June 27, 2019 Contacts/Locations and Study Status
38 July 4, 2019 Contacts/Locations and Study Status
39 July 10, 2019 Contacts/Locations and Study Status
40 July 18, 2019 Contacts/Locations and Study Status
41 July 25, 2019 Contacts/Locations and Study Status
42 August 8, 2019 Study Status and Contacts/Locations
43 September 5, 2019 Contacts/Locations and Study Status
44 September 20, 2019 Recruitment Status, Contacts/Locations and Study Status
45 December 1, 2020 Study Status
46 February 10, 2021 Study Status and Study Design
47 April 8, 2021 Study Status
48 July 9, 2021 Recruitment Status, Study Status
Show
Results Submission Events
49 October 13, 2021 Outcome Measures, Study Status, Arms and Interventions, Conditions, Study Identification, Document Section, Results, Eligibility and Study Description
Comparison Format:

Scroll up to access the controls

Study NCT03486834
Submitted Date:  March 28, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: V160-002
Brief Title: Safety, Tolerability, and Efficacy of the Human Cytomegalovirus Vaccine (V160) in Healthy Women 16 to 35 Years of Age (V160-002)
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
Secondary IDs: 2017-004233-86 [EudraCT Number]
Open or close this module Study Status
Record Verification: March 2018
Overall Status: Not yet recruiting
Study Start: May 4, 2018
Primary Completion: May 14, 2021 [Anticipated]
Study Completion: May 14, 2021 [Anticipated]
First Submitted: March 28, 2018
First Submitted that
Met QC Criteria:
March 28, 2018
First Posted: April 3, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
March 28, 2018
Last Update Posted: April 3, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Merck Sharp & Dohme LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Cytomegalovirus Infections
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 2100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 16 Years
Maximum Age: 35 Years
Sex: Female
Gender Based:
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 2 allowable methods of birth control 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
  • 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.
Open or close this module Contacts/Locations
Study Officials: Medical Director
Study Director
Merck Sharp & Dohme LLC
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services