NCT02891980

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

Completed Phase 1 Last updated 29 July 2025

What this trial tests

Phase 1 trial testing Ad26 Zaire Ebola Vaccine in Ebola Disease in 65 participants. Completed in 21 March 2019.

Timeline

24 March 2017

Primary endpoint
21 March 2019

21 March 2019

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	65
Start date	24 March 2017
Primary completion	21 March 2019
Estimated completion	21 March 2019
Sites	1 location across United States

Drugs / interventions tested

• Ad26 Zaire Ebola Vaccine — full drug profile →
• MVA Multi-Filo Ebola Vaccine — full drug profile →

Conditions studied

• Ebola Disease — all drugs for Ebola Disease →
• Marburg Disease — all drugs for Marburg Disease →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 45, any sex, with Ebola Disease or Marburg Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Viral Emerging Diseases: Challenges in Developing Vaccination Strategies.
   Trovato M, Sartorius R, D'Apice L, Manco R, et al · · 2020 · cited 87× · PMID 33013898 · DOI 10.3389/fimmu.2020.02130
2. Ebola: Lessons on Vaccine Development.
   Feldmann H, Feldmann F, Marzi A. · · 2018 · cited 40× · PMID 30200851 · DOI 10.1146/annurev-micro-090817-062414
3. Vaccines against Ebola virus and Marburg virus: recent advances and promising candidates.
   Suschak JJ, Schmaljohn CS. · · 2019 · cited 37× · PMID 31589088 · DOI 10.1080/21645515.2019.1651140
4. Emerging Strategies and Progress in the Medical Management of Marburg Virus Disease.
   Musafiri S, Siddig EE, Nkuranga JB, Rukundo A, et al · · 2025 · cited 3× · PMID 40333077 · DOI 10.3390/pathogens14040322
5. A Phase 1 randomized trial of homologous and heterologous filovirus vaccines with a late booster dose.
   Rostad CA, Yildirim I, Kao C, Yi J, et al · · 2024 · cited 3× · PMID 39715748 · DOI 10.1038/s41541-024-01042-4
6. Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network.
   Atmar RL, Abate G, Deming ME, George SL, et al · · 2025 · cited 1× · PMID 41071737 · DOI 10.1093/cid/ciaf380