Phase 1B, Open-Label, Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of the Investigational Ebola Vaccines, VRC-EBOADC069-00-VP, VRC-EBOADC076-00-VP and VRC-EBOMVA079-00-VP in Healthy Adults in Kampala Uganda
Sponsor study identifier
interventional
90
1 country
1
Study Start
January 27, 2015
Actual (reported)Primary Completion
April 19, 2017
Actual (reported)Study Completion
April 19, 2017
Actual (reported)Phase Ib study in 90 healthy adults,18 years to 65 years of age, to evaluate the safety, tolerability and immunogenicity of the VRC-EBOADC069-00-VP (cAd3-EBO) and VRC-EBOADC076-00-VP (cAd3-EBOZ) investigational Ebola vaccines in Part 1 and boosting with the VRC-EBOMVA079-00-VP (MVA-EbolaZ) investigational Ebola vaccine in Part 2. Part 1: Randomizations to cAd3-EBO or cAd3-EBOZ at two different dose levels within Group 1 will include at least 60 volunteers who have never received an investigational Ebola vaccine. Randomizations to cAd3-EBO at two different dose levels within Group 2 may include up to 30 eligible participants who previously participated in the RV247 vaccine clinical trial and received the investigational VRC-EBODNA023-00-VP (Ebola DNA WT) vaccine. Part 2: Participants in Part 1 may receive a booster vaccination with the MVA-EbolaZ vaccine at the same dose level.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 19, 2017
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.
January 27, 2015
Actual (reported)January 29, 2015
Actual (reported)February 3, 2015
Actual (reported)April 19, 2017
Actual (reported)April 19, 2017
Actual (reported)Incidence of solicited adverse events after vaccination
Incidence is reported for solicited events for 7 days after each vaccination.
7 days
Incidence of unsolicited adverse events of any severity 28 days after vaccination
Incidence is reported for unsolicited events for 28 days after each vaccination. The reporting period is Day 0 to Day 28.
28 days
Incidence of serious adverse events or new chronic medical conditions through the last study visit
Incidence is reported of serious adverse events and new chronic medical conditions for 48 weeks after vaccination.
From first study injection through 48 weeks after final study injection
Mean change from baseline in safety laboratory measures
At Days 2 or 3, 14, and 28 blood will be drawn to measure safety measures that many include complete blood count (CBC), creatinine, ALT, PT and PTT.
28 days after each vaccination
Antibody response to Ebola GP as measured by ELISA
4 weeks after each vaccination
Antibody response to Ebola GP as measured by neutralization assay
4 weeks after vaccination
T cell immune response measured by intracellular cytokine staining (ICS)
4 weeks after vaccination
Part 1: cAd3-EBOZ at 1x10(10) PU intramuscularly at Day 0; Part 2: Option to receive MVA-EbolaZ at 1x10(8) PFU intramuscularly after Study Week 36 as a boost to the Part 1 study vaccination
Part 1: cAd3-EBOZ at 1x10(11) PU intramuscularly at Day 0; Part 2: Option to receive MVA-EbolaZ at 1x10(8) PFU intramuscularly after Study Week 36 as a boost to the Part 1 study vaccination
cAd3 vaccine vector expressing Ebola glycoprotein from the Zaire strain in single dose vials at 1x10(11) PU/mL.
Makerere University Walter Reed Project
Kampala, Uganda
Kibuuka H, Berkowitz NM, Millard M, Enama ME, Tindikahwa A, Sekiziyivu AB, Costner P, Sitar S, Glover D, Hu Z, Joshi G, Stanley D, Kunchai M, Eller LA, Bailer RT, Koup RA, Nabel GJ, Mascola JR, Sullivan NJ, Graham BS, Roederer M, Michael NL, Robb ML, Ledgerwood JE; RV 247 Study Team. Safety and immunogenicity of Ebola virus and Marburg virus glycoprotein DNA vaccines assessed separately and concomitantly in healthy Ugandan adults: a phase 1b, randomised, double-blind, placebo-controlled clinical trial. Lancet. 2015 Apr 18;385(9977):1545-54. doi: 10.1016/S0140-6736(14)62385-0. Epub 2014 Dec 23.
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.
Merlin Robb, MD
US Military HIV Research Program
Julie Ledgerwood, DO
VRC, NIAID, NIH
90 participants (actual enrollment reported by the registry).
First Submitted
January 29, 2015
First Posted
February 3, 2015
Study Start
January 27, 2015
Actual (reported)A Study to Find Out if the New Ebola Vaccine is Safe and Stimulates Immunity That Might Protect Adults in Kilifi, Kenya.
Part 1: cAd3-EBO at 2x10(10) PU intramuscularly at Day 0; Part 2: Option to receive MVA-EbolaZ at 1x10(8) PFU intramuscularly after Study Week 36 as a boost to the Part 1 study vaccination
Part 1: cAd3-EBO at 2x10(11) PU intramuscularly at Day 0; Part 2: Option to receive MVA-EbolaZ at 1x10(8) PFU intramuscularly after Study Week 36 as a boost to the Part 1 study vaccination
Part 1: cAd3-EBO at 2x10(10) PU intramuscularly at Day 0 (as a boost to prior receipt of the Ebola DNA WT vaccine); Part 2: Option to receive MVA-EbolaZ at 1x10(8) PFU intramuscularly after Study Week 36 as a boost to the Part 1 study vaccination
Part 1: cAd3-EBO at 2x10(11) PU intramuscularly at Day 0 (as a boost to prior receipt of the Ebola DNA WT vaccine); Part 2: Option to receive MVA-EbolaZ at 1x10(8) PFU intramuscularly after Study Week 36 as a boost to the Part 1 study vaccination
1:1 ratio of cAd3 vaccine vectors expressing Ebola glycoprotein from the Zaire and Sudan strains filled into single dose vials at 1x10(11) PU/mL of each \[2x10(11) PU/mL total\].
MVA vaccine vector that expresses Ebola glycoprotein from the Zaire strain in single dose vials at 3.2 x 10(8) PFU/mL
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.
Sarwar UN, Costner P, Enama ME, Berkowitz N, Hu Z, Hendel CS, Sitar S, Plummer S, Mulangu S, Bailer RT, Koup RA, Mascola JR, Nabel GJ, Sullivan NJ, Graham BS, Ledgerwood JE; VRC 206 Study Team. Safety and immunogenicity of DNA vaccines encoding Ebolavirus and Marburgvirus wild-type glycoproteins in a phase I clinical trial. J Infect Dis. 2015 Feb 15;211(4):549-57. doi: 10.1093/infdis/jiu511. Epub 2014 Sep 14.
Primary Completion
April 19, 2017
Actual (reported)Study Completion
April 19, 2017
Actual (reported)Last Updated
December 5, 2017
Record last verified: 2017-09
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