NCT02891980

A Safety Trial to Test MVA-BN(R)-Filo and Ad26.ZEBOV Vaccines in Healthy Volunteers

A Phase I Trial to Utilize Systems Biology Approaches to Examine the Safety, Immunogenicity, and 'Omics Response to MVA-BN(R)-Filo and Ad26.ZEBOV Vaccines in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, double-blind, randomized trial to evaluate the safety and immunogenicity of two heterologous and two homologous prime-boost regimens using MVA-BN(R)-Filo and Ad26.ZEBOV administered in different sequences at Days 1 and 29 in healthy adult subjects aged 18 - 45 years. The study will evaluate the 'omics (transcriptomics, proteomics, lipidomics, metabolomics), antibodies for immunogenicity, CMI, ADCC, and plasmablast responses to MVA-BN(R)-Filo and Ad26.ZEBOV vaccines. The primary objectives of this study are: 1) To assess the safety and reactogenicity of each study group. 2) To assess responses to the study vaccination by study group after the first, second and third dose by transcriptomics. 3) To assess the peak antibody response to the study vaccination by study group to filovirus antigens.

Detailed description

This is a Phase 1, double-blind, randomized trial to evaluate the safety and immunogenicity of two heterologous and two homologous prime-boost regimens using MVA-BN(R)-Filo and Ad26.ZEBOV administered in different sequences at Days 1 and 29 in healthy adult subjects aged 18 - 45 years. The two heterologous prime-boost groups will also receive MVA-BN(R)-Filo at day 366. Sixty subjects will be randomized 1:1:1:1 to one of four study groups (15 per group). Subjects and study staff will be blinded to a subject's study vaccine assignment within study vaccination schedule (e.g., enrollment into Group 1 or 4 versus 2 or 3 will be known). The study will evaluate the 'omics (transcriptomics, proteomics, lipidomics, metabolomics), antibodies for immunogenicity, CMI, ADCC, and plasmablast responses to MVA-BN(R)-Filo and Ad26.ZEBOV vaccines. The primary objectives of this study are: 1) To assess the safety and reactogenicity of each study group. 2) To assess responses to the study vaccination by study group after the first, second and third dose by transcriptomics. 3) To assess the peak antibody response to the study vaccination by study group to filovirus antigens. Secondary objectives are: 1) To assess antigen-specific cell-mediated immune (CMI) responses to the study vaccination by study group. 2) To assess antibody-dependent cell-mediated cytotoxicity (ADCC) responses to the study vaccination by study group.

Conditions

• Ebola Disease
• Marburg Disease

Interventions

Type	Name	Description
BIOLOGICAL	Ad26 Zaire Ebola Vaccine	A recombinant adenovirus vector comprising a polynucleotide encoding a filovirus antigenic protein, wherein the recombinant adenovirus vector comprises an adenovirus 26 capsid protein.
BIOLOGICAL	MVA Multi-Filo Ebola Vaccine	A multivalent MVA-BN Filovirus vaccine, designed to protect against Ebola Zaire, Ebola Sudan and Marburg virus.

Timeline

• Start date: 2017-03-24
• Primary completion: 2019-03-21
• Completion: 2019-03-21
• First posted: 2016-09-08
• Last updated: 2025-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study