Safety and Immunogenicity of the Human Cytomegalovirus (CMV) Vaccine (V160) in Healthy Japanese Men (V160-003)

• ClinicalTrials.gov Identifier: NCT03840174
• Recruitment Status: Completed
• First Posted: February 15, 2019
• Results First Posted: November 15, 2021
• Last Update Posted: November 22, 2021
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

Brief Summary:

The purpose of the study is to assess the safety and tolerability of a 3-dose regimen of V160 administered by intramuscular (IM) injection in healthy Japanese male participants by cytomegalovirus (CMV) serostatus. There is no formal hypothesis.

Condition or disease	Intervention/treatment	Phase
Cytomegalovirus Infections	Biological: V160; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Phase I Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of V160 (Human Cytomegalovirus Vaccine) in Healthy Japanese Men
• Actual Study Start Date: March 8, 2019
• Actual Primary Completion Date: November 7, 2019
• Actual Study Completion Date: November 7, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: V160; Participants will receive V160 vaccination by IM injection on Day 1, Month 2, and Month 6.	Biological: V160; V160 administered as a 0.5 mL (100 Units) IM injection containing 225 mcg aluminum phosphate adjuvant (APA)
Placebo Comparator: Placebo; Participants will receive placebo by IM injection on Day 1, Month 2, and Month 6.	Other: Placebo; Saline solution (0.9% sodium chloride [NaCl] administered as a 0.5 mL IM injection

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With a Solicited Injection-site Adverse Event (AE) [ Time Frame: Up to 5 days after each vaccination ]
   Participants used the vaccination report card (VRC) to document the presence of any solicited injection-site AEs (pain/tenderness, erythema/redness, and swelling) that occurred in the 5 days after each vaccination. The percentage of participants with a solicited injection-site AE was reported.
2. Percentage of Participants With a Solicited Systemic Adverse Event (AE) [ Time Frame: Up to 14 days after each vaccination ]
   Participants used the vaccination report card (VRC) to document the presence of any solicited systemic AEs (headache, fatigue, muscle pain, joint pain) that occurred in the 14 days after each vaccination. The percentage of participants with a solicited systemic AE is reported.
3. Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) [ Time Frame: Up to 14 days after each vaccination ]
   An SAE is defined as any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical event. The percentage of participants with an SAE considered to be at least possibly related to the study intervention will be reported

Secondary Outcome Measures :

1. Geometric Mean Titer (GMT) of CMV-specific Neutralizing Antibody (NAb) [ Time Frame: 1 month after third vaccination (at 7 months) ]
   The NAb GMT in initially CMV-seronegative participants vaccinated with a 3-dose regimen of V160 administered IM was assessed.
2. Number of Participants With Viral Detection of V160 in Plasma [ Time Frame: Day 1 (predose, at dosing, and 3 hours postdose), Day 3, Day 7, and Day 14 ]
   The number of participants with positive viral detection in plasma (defined by viral load in plasma ≥assay defined threshold cutoff value) was assessed.
3. Number of Participants With Wild-Type CMV Detection in Urine and Saliva [ Time Frame: Day 1 (predose), 3, 7, and 14 and Months 2, 6, and 7 ]
   The number of participants with positive wild-type viral shedding in urine or saliva (defined by viral load in saliva/urine ≥ assay defined threshold cutoff value) will be assessed.
4. Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab [ Time Frame: Day 1: 0, 10, 20, and 30 minutes postvaccination ]
   The number of participants with positive viral leakage in injection-site swab and adhesive tape swab (defined by viral load in injection-site swab/adhesive tape swab ≥ assay defined threshold cutoff value) will be assessed.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 64 Years (Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Healthy Japanese male participants between the ages of 20 and 64 (inclusive)
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Healthy based on medical history and physical examination
• Serologically confirmed to be CMV seropositive or CMV seronegative at Visit 1
• If of reproductive potential, agrees to the following from randomization through at least 4 weeks after the last dose of V160-/placebo (from Day 1 through Month 7): 1) practice abstinence from heterosexual activity and remain abstinent, or 2) use contraception unless confirmed to be azoospermic as detailed in the protocol

Exclusion Criteria:

• History of any allergic reaction or anaphylactic reaction to any vaccine component that required medical intervention
• Plans donation of sperm any time from signing the informed consent through 1 month after receiving the last dose of study drug
• 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 post more than minimal risk for the participant, such as hemophilia, thrombocytopenia, other severe coagulation disorders, or significantly impaired venous access
• Has major psychiatric illness including: any history or schizophrenia or severe psychosis, bipolar disorder requiring therapy, or suicidal ideation within 3 years.
• Has previously received any 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 study drug
• Had any inactivated vaccine administered or scheduled within the period from 14 days prior to, through 14 days following study drug
• Had administration of any immune globulin or blood product within 90 days prior to injection with study drug or scheduled within 30 days thereafter
• Has 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 study entry
• Has 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 study)

• Has received any anti-viral agent (e.g. letermovir, ganciclovir, valganciclovir, foscarnet, and valacyclovir) with proven or potential activity against CMV 14 days prior to vaccination or is likely to receive such an agent within 14 days after vaccination

  • Receiving or has received in the year prior to enrollment immunosuppressive therapies including but not limited to rapamycin (also sirolimus), tacrolimus (also FK-506), 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 14 days prior to, or 14 days following study drug
• Has 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.

Contacts and Locations

Locations

Japan

Souseikai PS Clinic ( Site 0001)

Fukuoka, Japan, 812-0025

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme Corp.

  Study Documents (Full-Text)

Documents provided by Merck Sharp & Dohme Corp.:

Study Protocol and Statistical Analysis Plan  [PDF] November 19, 2018

More Information

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT03840174
• Other Study ID Numbers: V160-003; V160-003 ( Other Identifier: Merck Protocol Number ); 194648 ( Registry Identifier: JAPIC-CTI )
• First Posted: February 15, 2019
• Results First Posted: November 15, 2021
• Last Update Posted: November 22, 2021
• Last Verified: November 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

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Cytomegalovirus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections