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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01986010
First Posted: November 18, 2013
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • Geometric Mean Titer of HCMV-specific Neutralizing Antibody [ Time Frame: 1 month after vaccination 3 (vaccination 3 is administered at Month 6) ]

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) ]
  • 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) ]

Enrollment: 190
Actual Study Start Date: November 25, 2013
Study Completion Date: March 14, 2017
Primary Completion Date: April 19, 2016 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01986010


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01986010     History of Changes
Other Study ID Numbers: V160-001
First Submitted: November 11, 2013
First Posted: November 18, 2013
Last Update Posted: March 23, 2017
Last Verified: March 2017

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