Phase 1b Trial to Evaluate Safety, Tolerability and Immune Responses of 2 Monovalent Chimpanzee Adenoviral Vectored Filovirus (Ebola-S and Marburg) Vaccines to Healthy Adults, Collection of Plasma/Serum for the Purposes of Assay Development
Sponsor study identifier
interventional
32
1 country
1
Study Start
January 6, 2021
Actual (reported)Primary Completion
December 14, 2021
Actual (reported)Study Completion
December 14, 2021
Actual (reported)Primary Objective:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 14, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 10, 2020
Actual (reported)January 6, 2021
Actual (reported)January 26, 2021
Actual (reported)December 14, 2021
Actual (reported)December 14, 2021
Actual (reported)Safety of Ebola and Marburg vaccines assessed by clinical observation.
Safety of Ebola and Marburg vaccines, as seen in local reactogenicity signs and symptoms with diary questionnaire card.
7 Days
Safety of Ebola and Marburg vaccines assessed by clinical observation.
Safety of Ebola and Marburg vaccines, as seen in systemic reactogenicity signs and symptoms with diary questionnaire card.
7 Days
Safety of Ebola and Marburg vaccines assessed by change from baseline in levels of Complete Blood Count (CBC).
Safety of Ebola and Marburg vaccines assessed by change in levels of Complete Blood Count (CBC) w/differential count as laboratory measures of safety from baseline.
A total of 16 healthy adults will be enrolled and vaccinated with a single dose of vaccine. Group 1 (N = 16) will receive a single injection of cAd3-Marburg at 1 x 10\^11 Particle Units (PU) vaccine.
A total of 16 healthy adults will be enrolled and vaccinated with a single dose of vaccine. Group 2 (N = 16) will receive a single injection of cAd3-EBO-S at 1 x 10\^11 Particle Units (PU) vaccine.
A total of 16 healthy adults will be enrolled and vaccinated with a single dose of vaccine. Group 1 (N = 16) will receive a single injection of cAd3-Marburg at 1 x 10\^11 Particle Units (PU) vaccine.
A total of 16 healthy adults will be enrolled and vaccinated with a single dose of vaccine. Group 2 (N = 16) will receive a single injection of cAd3-EBO-S at 1 x 10\^11 Particle Units (PU) vaccine.
Oklahoma Blood Institute (OBI)
Oklahoma City, Oklahoma, 73104, United States
Sanchez A, Kiley MP, Klenk HD, Feldmann H. Sequence analysis of the Marburg virus nucleoprotein gene: comparison to Ebola virus and other non-segmented negative-strand RNA viruses. J Gen Virol. 1992 Feb;73 ( Pt 2):347-57. doi: 10.1099/0022-1317-73-2-347.
Sanchez A, Kiley MP, Holloway BP, Auperin DD. Sequence analysis of the Ebola virus genome: organization, genetic elements, and comparison with the genome of Marburg virus. Virus Res. 1993 Sep;29(3):215-40. doi: 10.1016/0168-1702(93)90063-s.
Roxana Rustomjee, MBChB
The Albert B. Sabin Vaccine Institute
Michael Stevenson, MD
Oklahoma Blood Institute
David Hoover, MD
ICON plc
Tuan Le, MD
Oklahoma Blood Institute
32 participants (actual enrollment reported by the registry).
First Submitted
December 10, 2020
First Posted
January 26, 2021
Study Start
January 6, 2021
Actual (reported)Evaluating the Live-Attenuated Human Parainfluenza Virus Type 3 Vectored Vaccine Candidate Expressing Ebolavirus Zaire Glycoprotein as the Sole Envelope Glycoprotein
6 months
Safety of Ebola and Marburg vaccines assessed by change from baseline in levels of Creatinine.
Safety of Ebola and Marburg vaccines assessed by change in levels of Creatinine as laboratory measures of safety from baseline.
6 months
Safety of Ebola and Marburg vaccines assessed by change from baseline in levels of Alanine Transaminase (ALT).
Safety of Ebola and Marburg vaccines assessed by change in levels of Alanine Transaminase (ALT) as laboratory measures of safety from baseline.
6 months
Safety of Ebola and Marburg vaccines assessed by adverse experiences.
Safety of Ebola and Marburg vaccines assessed by adverse events of all severities (Mild, moderate, and severe)
28 days
Safety of Ebola and Marburg vaccines assessed by serious adverse experiences.
Safety of Ebola and Marburg vaccines assessed by serious adverse events of all severities (Mild, moderate, and severe)
6 months
Evaluation of antibody response to cAd3-EBO-S and cAd3 Marburg vaccines
Measured at Day 1, 15, 22, 29, 36, 43, 50, 57, and 64
Collection of sufficient post-vaccination plasma to support further development of filovirus assays.
May be collected at Day 29, 36, 43, 50, 57 and/or 64
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Geisbert TW, Jahrling PB. Exotic emerging viral diseases: progress and challenges. Nat Med. 2004 Dec;10(12 Suppl):S110-21. doi: 10.1038/nm1142.
Hensley LE, Jones SM, Feldmann H, Jahrling PB, Geisbert TW. Ebola and Marburg viruses: pathogenesis and development of countermeasures. Curr Mol Med. 2005 Dec;5(8):761-72. doi: 10.2174/156652405774962344.
Ledgerwood JE, DeZure AD, Stanley DA, Coates EE, Novik L, Enama ME, Berkowitz NM, Hu Z, Joshi G, Ploquin A, Sitar S, Gordon IJ, Plummer SA, Holman LA, Hendel CS, Yamshchikov G, Roman F, Nicosia A, Colloca S, Cortese R, Bailer RT, Schwartz RM, Roederer M, Mascola JR, Koup RA, Sullivan NJ, Graham BS; VRC 207 Study Team. Chimpanzee Adenovirus Vector Ebola Vaccine. N Engl J Med. 2017 Mar 9;376(10):928-938. doi: 10.1056/NEJMoa1410863. Epub 2014 Nov 26.
Primary Completion
December 14, 2021
Actual (reported)Study Completion
December 14, 2021
Actual (reported)Last Updated
August 3, 2022
Record last verified: 2022-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: