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

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.

Timeline

Start

2017-03-24

Primary completion

2019-03-21

Completion

2019-03-21

Publications

• Rostad CA, Yildirim I, Kao C, Yi J, Kamidani S, Peters E, Stephens K, Gibson T, Hsiao HM, Singh K, Spearman P, McCracken C, Agbakoba V, Tomashek KM, Goll JB, Gelber CE, Johnson RA, Lee S, Maner-Smith K, Bosinger S, Ortlund EA, Chen X, Anderson LJ, Wrammert J, Suthar M, Rouphael N, Anderson EJ. A Phase 1 randomized trial of homologous and heterologous filovirus vaccines with a late booster dose. NPJ Vaccines. 2024 Dec 23;9(1):255. doi: 10.1038/s41541-024-01042-4.

Drugs

Indications