drugset / Trial / NCT02598388
Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo
Phase 2
Completed
578 enrolled
Janssen Vaccines & Prevention B.V.
Walter Reed Army Institute of Research (WRAIR) · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens in healthy and in HIV-infected adults.
Timeline
- Start
- 2015-12-10
- Primary completion
- 2018-12-12
- Completion
- 2018-12-12
Publications
- Ake JA, Paolino K, Hutter JN, Cicatelli SB, Eller LA, Eller MA, Costanzo MC, Paquin-Proulx D, Robb ML, Tran CL, Anova L, Jagodzinski LL, Ward LA, Kilgore N, Rusnak J, Bounds C, Badorrek CS, Hooper JW, Kwilas SA, Ilsbroux I, Anumendem DN, Gaddah A, Shukarev G, Bockstal V, Luhn K, Douoguih M, Robinson C. Safety and Immunogenicity of an Accelerated Ebola Vaccination Schedule in People with and without Human Immunodeficiency Virus: A Randomized Clinical Trial. Vaccines (Basel). 2024 May 4;12(5):497. doi: 10.3390/vaccines12050497.
- Mwesigwa B, Sawe F, Oyieko J, Mwakisisile J, Viegas E, Akintunde GA, Kosgei J, Kokogho A, Ntinginya N, Jani I, Shukarev G, Hooper JW, Kwilas SA, Ward LA, Rusnak J, Bounds C, Overman R, Badorrek CS, Eller LA, Eller MA, Polyak CS, Moodley A, Tran CL, Costanzo MC, Leggat DJ, Paquin-Proulx D, Naluyima P, Anumendem DN, Gaddah A, Luhn K, Hendriks J, McLean C, Douoguih M, Kibuuka H, Robb ML, Robinson C, Ake JA. Safety and Immunogenicity of Accelerated Heterologous 2-Dose Ebola Vaccine Regimens in Adults With and Without HIV in Africa. Clin Infect Dis. 2024 Oct 15;79(4):888-900. doi: 10.1093/cid/ciae215.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ADENOVIRUS TYPE 26 ENCODING EBOLA VIRUS GLYCOPROTEIN | Vaccine | 0.5 ml | Intramuscular |
| Subject | MVA-BN-Filo | Vaccine | 0.5 ml | Intramuscular |