Study of a Dengue Vaccine (V180) in Healthy Adults (V180-001)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01477580
First received: November 18, 2011
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

This study will determine whether at least one formulation of an experimental dengue vaccine (V180) is safe and causes an immune response.


Condition Intervention Phase
Dengue
Biological: Low-dose V180 with low-dose ISCOMATRIX™ adjuvant
Biological: Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant
Biological: Medium-dose V180 (non-adjuvanted)
Biological: Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant
Biological: Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant
Biological: Medium-dose V180 with Alhydrogel™ adjuvant
Biological: High-dose V180 (non-adjuvanted)
Biological: High-dose V180 with low-dose ISCOMATRIX™ adjuvant
Biological: High-dose V180 with medium-dose ISCOMATRIX™ adjuvant
Biological: Low-dose V180 with high-dose ISCOMATRIX™ adjuvant
Biological: Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant
Biological: High-dose V180 with high-dose ISCOMATRIX™ adjuvant
Biological: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Tetravalent Recombinant Subunit Dengue Vaccine (V180) in Healthy Adults

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Seroconversion rate for each serotype [ Time Frame: 28 days postdose 3 (Day 84) ] [ Designated as safety issue: No ]
  • Geometric mean titer (GMT) of virus neutralizing antibodies for each serotype [ Time Frame: 28 days postdose 3 (Day 84) ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low-dose V180 with low-dose ISCOMATRIX™ adjuvant Biological: Low-dose V180 with low-dose ISCOMATRIX™ adjuvant
Three 0.5-mL intramuscular doses of low-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Experimental: Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant Biological: Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant
Three 0.5-mL intramuscular doses of low-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Experimental: Medium-dose Non-adjuvanted V180 Biological: Medium-dose V180 (non-adjuvanted)
Three 0.5-mL intramuscular doses of medium-dose V180 with no adjuvant at Months 0, 1, and 2
Experimental: Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant Biological: Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant
Three 0.5-mL intramuscular doses of medium-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Experimental: Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant Biological: Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant
Three 0.5-mL intramuscular doses of medium-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Experimental: Medium-Dose V180 with Alhydrogel™ adjuvant Biological: Medium-dose V180 with Alhydrogel™ adjuvant
Three 0.5-mL intramuscular doses of medium-dose V180 containing Alhydrogel™ adjuvant at Months 0, 1, and 2
Experimental: High-dose Non-adjuvanted V180 Biological: High-dose V180 (non-adjuvanted)
Three 0.5-mL intramuscular doses of high-dose V180 with no adjuvant at Months 0, 1, and 2
Experimental: High-dose V180 with low-dose ISCOMATRIX™ adjuvant Biological: High-dose V180 with low-dose ISCOMATRIX™ adjuvant
Three 0.5-mL intramuscular doses of high-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Experimental: High-dose V180 with medium-dose ISCOMATRIX™ adjuvant Biological: High-dose V180 with medium-dose ISCOMATRIX™ adjuvant
Three 0.5-mL intramuscular doses of high-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Experimental: Low-dose V180 with high-dose ISCOMATRIX™ adjuvant Biological: Low-dose V180 with high-dose ISCOMATRIX™ adjuvant
Three 0.5-mL intramuscular doses of low-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Experimental: Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant Biological: Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant
Three 0.5-mL intramuscular doses of medium-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Experimental: High-dose V180 with high-dose ISCOMATRIX™ adjuvant Biological: High-dose V180 with high-dose ISCOMATRIX™ adjuvant
Three 0.5-mL intramuscular doses of high-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Placebo Comparator: Placebo Biological: Placebo
Three 0.5-mL intramuscular doses of phosphate-buffered saline at Months 0, 1, and 2

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Selected Inclusion Criteria:

  • In good health
  • Voluntarily agrees to participate by giving written informed consent
  • Able to read, understand, and complete study questionnaires
  • Able to complete all scheduled visits and comply with study procedures
  • Access to a telephone
  • Agrees to avoid unusual, vigorous exercise from 72 hours before any dose of study vaccine/placebo through 15 days after that dose
  • Weighs ≥110 pounds (50 kg) and has a body mass index (BMI) of 19 to 32 kg/m^2
  • No fever (temperature ≥100.4°F/38.0°C) for 72 hours prior to vaccination
  • Females of reproductive potential agree to remain abstinent or to use 2 acceptable methods of birth control from enrollment through 6 weeks after the last dose of study vaccine/placebo

Selected Exclusion Criteria:

  • History of receiving any flavivirus vaccine (e.g. Japanese encephalitis, tick-borne encephalitis, or yellow fever) or planned receipt of any such vaccine during the study period
  • History of any flavivirus infection or serologic evidence of any flavivirus infection, including West Nile, dengue, yellow fever, Saint Louis encephalitis (if available), Kunjin, Murray Valley encephalitis, and Japanese encephalitis
  • History of residence for a cumulative period of >1 year in a country where dengue, Japanese encephalitis virus, or yellow fever virus is common
  • Planned travel to an area where dengue is common through 28 days after receiving the last dose of study vaccine/placebo
  • Known hypersensitivity to any component of the dengue vaccine
  • Abuse of drugs or alcohol within 12 months prior to screening
  • Pregnant or breastfeeding, or expecting to conceive in the time from enrollment through 6 weeks after the last dose of study vaccine/placebo
  • Positive serum test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and/or hepatitis C antibody
  • Known, suspected, or a history of immunocompromise
  • History of malignancy within 5 years prior to enrollment
  • Poorly controlled diabetes mellitus
  • Use of any immunosuppressive therapy (except topical and inhaled/nebulized steroids)
  • Receipt of any licensed non-live vaccine within 14 days prior to the first dose of study vaccine/placebo or plans to receive a licensed non-live vaccine during the time between receiving the first dose and 28 days after receiving the last dose of study vaccine/placebo
  • Receipt of any licensed live vaccine within 30 days prior to the first dose of study vaccine/placebo or plans to receive a licensed live vaccine during the time between receiving the first dose and 28 after receiving the last dose of study vaccine/placebo
  • Received investigational drugs or vaccines within 2 months prior to the first dose of study vaccine/placebo
  • History of receiving 1 or more doses of an investigational dengue vaccine
  • Participation in another clinical study within 42 days prior to enrollment, or plans to participate in another clinical study from enrollment through 1 year after the last dose of study vaccine/placebo
  • Planned donation of eggs or sperm from the time of enrollment through 28 days after the last dose of study vaccine/placebo
  • Prior receipt of a blood transfusion or blood products within 6 months prior to the first dose of study vaccine/placebo
  • Hospitalization for acute illness within 3 months prior to the first dose of vaccine/placebo
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01477580     History of Changes
Other Study ID Numbers: V180-001
Study First Received: November 18, 2011
Last Updated: July 21, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Aluminum Hydroxide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014