Study of a Dengue Vaccine (V180) in Healthy Adults (V180-001)
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
1 other identifier
interventional
98
0 countries
N/A
Brief Summary
This study will determine whether at least one formulation of an experimental dengue vaccine (V180) is safe and causes an immune response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2012
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2011
CompletedFirst Posted
Study publicly available on registry
November 22, 2011
CompletedStudy Start
First participant enrolled
July 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 11, 2014
CompletedJanuary 15, 2019
January 1, 2019
1.5 years
November 18, 2011
January 11, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Seroconversion rate for each serotype
28 days postdose 3 (Day 84)
Geometric mean titer (GMT) of virus neutralizing antibodies for each serotype
28 days postdose 3 (Day 84)
Study Arms (13)
Low-dose V180 with low-dose ISCOMATRIX™ adjuvant
EXPERIMENTALLow-dose V180 with medium-dose ISCOMATRIX™ adjuvant
EXPERIMENTALMedium-dose Non-adjuvanted V180
EXPERIMENTALMedium-dose V180 with low-dose ISCOMATRIX™ adjuvant
EXPERIMENTALMedium-dose V180 with medium-dose ISCOMATRIX™ adjuvant
EXPERIMENTALMedium-Dose V180 with Alhydrogel™ adjuvant
EXPERIMENTALHigh-dose Non-adjuvanted V180
EXPERIMENTALHigh-dose V180 with low-dose ISCOMATRIX™ adjuvant
EXPERIMENTALHigh-dose V180 with medium-dose ISCOMATRIX™ adjuvant
EXPERIMENTALLow-dose V180 with high-dose ISCOMATRIX™ adjuvant
EXPERIMENTALMedium-dose V180 with high-dose ISCOMATRIX™ adjuvant
EXPERIMENTALHigh-dose V180 with high-dose ISCOMATRIX™ adjuvant
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Three 0.5-mL intramuscular doses of low-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Three 0.5-mL intramuscular doses of low-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Three 0.5-mL intramuscular doses of medium-dose V180 with no adjuvant at Months 0, 1, and 2
Three 0.5-mL intramuscular doses of medium-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Three 0.5-mL intramuscular doses of medium-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Three 0.5-mL intramuscular doses of medium-dose V180 containing Alhydrogel™ adjuvant at Months 0, 1, and 2
Three 0.5-mL intramuscular doses of high-dose V180 with no adjuvant at Months 0, 1, and 2
Three 0.5-mL intramuscular doses of high-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Three 0.5-mL intramuscular doses of high-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Three 0.5-mL intramuscular doses of low-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Three 0.5-mL intramuscular doses of medium-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Three 0.5-mL intramuscular doses of high-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Three 0.5-mL intramuscular doses of phosphate-buffered saline at Months 0, 1, and 2
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Manoff SB, Sausser M, Falk Russell A, Martin J, Radley D, Hyatt D, Roberts CC, Lickliter J, Krishnarajah J, Bett A, Dubey S, Finn T, Coller BA. Immunogenicity and safety of an investigational tetravalent recombinant subunit vaccine for dengue: results of a Phase I randomized clinical trial in flavivirus-naive adults. Hum Vaccin Immunother. 2019;15(9):2195-2204. doi: 10.1080/21645515.2018.1546523. Epub 2019 Jun 3.
PMID: 30427741BACKGROUNDManoff SB, George SL, Bett AJ, Yelmene ML, Dhanasekaran G, Eggemeyer L, Sausser ML, Dubey SA, Casimiro DR, Clements DE, Martyak T, Pai V, Parks DE, Coller BA. Preclinical and clinical development of a dengue recombinant subunit vaccine. Vaccine. 2015 Dec 10;33(50):7126-34. doi: 10.1016/j.vaccine.2015.09.101. Epub 2015 Oct 14.
PMID: 26458804RESULTDurbin AP, Pierce KK, Kirkpatrick BD, Grier P, Sabundayo BP, He H, Sausser M, Russell AF, Martin J, Hyatt D, Cook M, Sachs JR, Lee AW, Wang L, Coller BA, Whitehead SS. Immunogenicity and Safety of a Tetravalent Recombinant Subunit Dengue Vaccine in Adults Previously Vaccinated with a Live Attenuated Tetravalent Dengue Vaccine: Results of a Phase-I Randomized Clinical Trial. Am J Trop Med Hyg. 2020 Aug;103(2):855-863. doi: 10.4269/ajtmh.20-0042. Epub 2020 May 7.
PMID: 32394880DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2011
First Posted
November 22, 2011
Study Start
July 23, 2012
Primary Completion
January 23, 2014
Study Completion
December 11, 2014
Last Updated
January 15, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will share
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf