A Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of MVA-BN Yellow Fever Vaccine With and Without Montanide ISA-720 Adjuvant in 18-45 Year Old Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

July 5, 2016

Primary Completion Date

March 22, 2018

Study Completion Date

March 22, 2018

Conditions
Yellow FeverYellow Fever Immunisation
Interventions
DRUG

ISA-720

The vaccine adjuvant ISA 720 will be used with Modified Vaccinia Ankara-Bavarian Nordic-Yellow Fever (MVA-BN-YF) as vaccine adjuvant with a depot effect. This comprises slow release of antigen at the injection site, protection of antigen against degradation and strong stimulation of the immune response.

BIOLOGICAL

MVA Smallpox Vaccine

Modified Vaccinia Ankara-Bavarian Nordic Smallpox Vaccine (MVA BN(R)) is a purified live vaccine will be used as an active comparator.

BIOLOGICAL

MVA-BN Yellow Fever Vaccine

Modified Vaccinia Ankara-Bavarian Nordic-Yellow Fever (MVA-BN-YF) clinical trial material is manufactured in CEF cells derived from Specific Pathogen Free (SPF) eggs in a bioreactor culture using serum free medium.

OTHER

Placebo

0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection.

OTHER

Placebo

0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection.

BIOLOGICAL

YF Vax 17D Strain

Yellow Fever Vaccine (YF-VAX) is a vaccine prepared by culturing the 17D-204 strain of yellow fever virus in living avian leucosis virus-free (ALV-free) chicken embryos. Will be used as an active comparator.

Trial Locations (2)

52242-2600

University of Iowa - Vaccine Research and Education Unit, Iowa City

63104-1015

Saint Louis University Center for Vaccine Development, St Louis

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02743455 - A Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of MVA-BN Yellow Fever Vaccine With and Without Montanide ISA-720 Adjuvant in 18-45 Year Old Healthy Volunteers | Biotech Hunter | Biotech Hunter