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

Dengue Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01477580
• Other study ID #: V180-001
• Status: Completed
• Phase: Phase 1
• Start date: July 23, 2012
• Est. completion date: December 11, 2014

Study information

• Verified date: January 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 11, 2014
• Est. primary completion date: January 23, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Dengue

Intervention

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
• 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
• Medium-dose V180 (non-adjuvanted)
Three 0.5-mL intramuscular doses of medium-dose V180 with no adjuvant at Months 0, 1, and 2
• 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
• 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
• 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
• High-dose V180 (non-adjuvanted)
Three 0.5-mL intramuscular doses of high-dose V180 with no adjuvant at Months 0, 1, and 2
• 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
• 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
• 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
• 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
• 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
Three 0.5-mL intramuscular doses of phosphate-buffered saline at Months 0, 1, and 2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (2)

Manoff 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 — View Citation

Manoff SB, Sausser M, Russell AF, Martin J, Radley D, Hyatt D, Roberts CC, Lickliter J, Krishnarajah J, Bett A, Dubey S, Finn T, Coller BA, Stek J. Immunogenicity and safety of an investigational tetravalent recombinant subunit vaccine for dengue: results of a Phase I randomized clinical trial in flavivirus-Naïve adults. Hum Vaccin Immunother. 2018 Nov 14. doi: 10.1080/21645515.2018.1546523. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion rate for each serotype		28 days postdose 3 (Day 84)
Primary	Geometric mean titer (GMT) of virus neutralizing antibodies for each serotype		28 days postdose 3 (Day 84)