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Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01986010
First received: November 11, 2013
Last updated: November 7, 2014
Last verified: November 2014
  Purpose

This study will evaluate the safety, tolerability, and immunogenicity of various doses, formulations, and routes of administration of Human Cytomegalovirus (HCMV) vaccine V160 administered in a 3-dose regimen in healthy adults. Each treatment arm of 10 participants will be accompanied by a placebo arm of 4 participants. The initial treatment arm of HCMV seropositive participants will receive V160 Low Dose without adjuvant by intramuscular injection. Escalation of the V160 dose, inclusion of adjuvant, administration by intradermal injection, and vaccination of HCMV seronegative participants will be performed only after review of safety data of previous treatment arms. The purpose of the study is to identify vaccine formulations associated with optimal safety profile and HCMV-specific immune response for evaluation in subsequent clinical studies of V160.


Condition Intervention Phase
Cytomegalovirus Infections
Biological: V160 Low Dose IM
Biological: V160 Medium Dose IM
Biological: V160 High Dose IM
Biological: V160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IM
Biological: V160 High Dose plus MAPA 225 µg /dose IM
Biological: V160 Maximum Dose IM
Other: Placebo IM
Biological: V160 Medium Dose ID
Other: Placebo ID
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of Participants with an Adverse Event (AE) [ Time Frame: From the time of vaccination up to 14 days after any vaccination (vaccinations are administered on Day 1, Month 1 and Month 6) ] [ Designated as safety issue: Yes ]
  • Percentage of Participants with an Injection-site AE [ Time Frame: From the time of vaccination up to 14 days after any vaccination (vaccinations are administered on Day 1, Month 1 and Month 6) ] [ Designated as safety issue: Yes ]
  • Percentage of Participants with a Systemic AE [ Time Frame: From the time of vaccination up to 14 days after any vaccination (vaccinations are administered on Day 1, Month 1 and Month 6) ] [ Designated as safety issue: Yes ]
  • Percentage of Participants with a Serious Adverse Event (SAE) [ Time Frame: From the time of vaccination up to 14 days after any vaccination (vaccinations are administered on Day 1, Month 1 and Month 6) ] [ Designated as safety issue: Yes ]
  • Geometric Mean Titer of HCMV-specific Neutralizing Antibody [ Time Frame: 1 month after vaccination 3 (vaccination 3 is administered at Month 6) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma [ Time Frame: 1 month after vaccination 3 (vaccination 3 is administered at Month 6) ] [ Designated as safety issue: No ]
  • Geometric Mean Concentration of Interferon-Gamma after Stimulation of Whole Blood Sample with Pooled HCMV Antigen Peptides [ Time Frame: 1 month after vaccination 3 (vaccination 3 is administered at Month 6) ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: November 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HCMV seropositive (+) V160 Low Dose Intramuscular (IM)
Participants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
Biological: V160 Low Dose IM
V160 administered as a 0.75 mL intramuscular injection
Experimental: HCMV seronegative (-) V160 Low Dose IM
Participants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
Biological: V160 Low Dose IM
V160 administered as a 0.75 mL intramuscular injection
Experimental: HCMV+ V160 Medium Dose IM
Participants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
Biological: V160 Medium Dose IM
V160 administered as a 0.75 mL intramuscular injection
Experimental: HCMV- V160 Medium Dose IM
Participants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
Biological: V160 Medium Dose IM
V160 administered as a 0.75 mL intramuscular injection
Experimental: HCMV+ V160 High Dose IM
Participants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
Biological: V160 High Dose IM
V160 administered as a 0.75 mL intramuscular injection
Experimental: HCMV- V160 Medium Dose plus MAPA 225 µg IM
Participants seronegative for HCMV at Baseline will receive vaccination with V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
Biological: V160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IM
V160 plus MAPA administered as a 0.75 mL intramuscular injection
Experimental: HCMV- V160 High Dose IM
Participants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
Biological: V160 High Dose IM
V160 administered as a 0.75 mL intramuscular injection
Experimental: HCMV+ V160 High Dose plus MAPA 225 µg IM
Participants seropositive for HCMV at Baseline will receive vaccination with V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
Biological: V160 High Dose plus MAPA 225 µg /dose IM
V160 plus MAPA administered as a 0.75 mL intramuscular injection
Experimental: HCMV+ V160 Maximum Dose IM
Participants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
Biological: V160 Maximum Dose IM
V160 administered as a 0.75 mL intramuscular injection
Experimental: HCMV- V160 High Dose plus MAPA 225 µg IM
Participants seronegative for HCMV at Baseline will receive vaccination with V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
Biological: V160 High Dose plus MAPA 225 µg /dose IM
V160 plus MAPA administered as a 0.75 mL intramuscular injection
Experimental: HCMV- V160 Maximum Dose IM
Participants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
Biological: V160 Maximum Dose IM
V160 administered as a 0.75 mL intramuscular injection
Placebo Comparator: HCMV+ Placebo IM
Participants seropositive for HCMV at Baseline will receive placebo by IM injection on Day 1, Month 1, and Month 6
Other: Placebo IM
Placebo administered as a 0.75 mL intramuscular injection
Placebo Comparator: HCMV- Placebo IM
Participants seronegative for HCMV at Baseline will receive placebo by IM injection on Day 1, Month 1, and Month 6
Other: Placebo IM
Placebo administered as a 0.75 mL intramuscular injection
Experimental: HCMV+ V160 Medium Dose Intradermal (ID)
Participants seropositive for HCMV at Baseline will receive V160 vaccination by ID injection on Day 1, Month 1, and Month 6
Biological: V160 Medium Dose ID
V160 administered as a 0.1 mL intradermal injection
Experimental: HCMV- V160 Medium Dose ID
Participants seronegative for HCMV at Baseline will receive V160 vaccination by ID injection on Day 1, Month 1, and Month 6
Biological: V160 Medium Dose ID
V160 administered as a 0.1 mL intradermal injection
Placebo Comparator: HCMV+ Placebo ID
Participants seropositive for HCMV at Baseline will receive placebo by ID injection on Day 1, Month 1, and Month 6
Other: Placebo ID
Placebo administered as a 0.1 mL intradermal injection
Placebo Comparator: HCMV- Placebo ID
Participants seronegative for HCMV at Baseline will receive placebo by ID injection on Day 1, Month 1, and Month 6
Other: Placebo ID
Placebo administered as a 0.1 mL intradermal injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy based on medical history and physical examination
  • Serologically confirmed to be HCMV seronegative or HCMV seropositive
  • Agrees to avoid unusual, unaccustomed strenuous, vigorous physical exercise/activity from 72 hours before through 72 hours after each dose of study vaccine
  • Body weight ≥110 lbs (50 kg) and body mass index (BMI) of 19 to 32 kg/m^2
  • If of reproductive potential, agrees to the following during the study and for 4 weeks after the last dose of study vaccine: 1) practice abstinence from heterosexual activity, or 2) use or have their partner use 2 allowable methods of birth control during heterosexual activity

Exclusion Criteria:

  • Has previously received any cytomegalovirus vaccine
  • Has history of allergic reaction or anaphylactic reaction to any vaccine component that required medical intervention
  • Has history of any severe allergic reaction that required medical intervention
  • Is pregnant or breastfeeding or expecting to conceive from 2 weeks before the study through 1 month after the last dose of study vaccine
  • Plans to donate eggs or sperm from study start through 1 month after the last dose of study drug
  • Has impairment of immunologic function including, but not limited to autoimmune disease, splenectomy, or HIV/AIDS
  • Received systemic corticosteroids for ≥14 consecutive days and has not completed treatment within 30 days of study start
  • Received immunosuppressive therapy including, but not limited to rapamycin and equivalents, tacrolimus, FK-506, fujimycin, or other therapies used for solid organ/cell transplant, radiation therapy, immunosuppressive/cytotoxic chemotherapy, or other therapy known to interfere with the immune response within 1 year of study start
  • Has a condition in which repeated venipuncture or injections pose more than minimal risk, such as hemophilia, thrombocytopenia or other severe coagulation disorders, or significantly impaired venous access
  • Has a condition that requires active medical intervention or monitoring such as diabetes mellitus, autoimmune disease, or a clinically significant chronic medical condition that is considered progressive
  • Has history within the past 5 years or current drug or alcohol abuse
  • Has major psychiatric illness
  • Is legally or mentally incapacitated
  • Has participated in another clinical study in the past 4 weeks, or plans during the present study to participate in a treatment-based study or a study in which an invasive procedure is performed
  • Has received valganciclovir, ganciclovir, valacyclovir, foscarnet, or cidofovir from 4 weeks prior to 1 month following each V160 vaccination
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01986010

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
United States, California
Call for Information (Investigational Site 0011) Recruiting
Pasadena, California, United States, 91105
Call for Information (Investigational Site 0004) Recruiting
Walnut Creek, California, United States, 94598
United States, Maryland
Call for Information (Investigational Site 0013) Recruiting
Baltimore, Maryland, United States, 21201
United States, New Jersey
Call for Information (Investigational Site 0012) Recruiting
Marlton, New Jersey, United States, 08053
United States, New York
Call for Information (Investigational Site 0001) Recruiting
Rochester, New York, United States, 14642
United States, Texas
Call for Information (Investigational Site 0014) Recruiting
Galveston, Texas, United States, 77555
United States, Virginia
Call for Information (Investigational Site 0010) Recruiting
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01986010     History of Changes
Other Study ID Numbers: V160-001
Study First Received: November 11, 2013
Last Updated: November 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cytomegalovirus Infections
DNA Virus Infections
Herpesviridae Infections
Virus Diseases
Aluminum phosphate
Adjuvants, Immunologic
Antacids
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014