A Systems Biology Phase 1 Evaluation of the Safety, Reactogenicity, and Immunogenicity of Chimpanzee Adenovirus Type 3- Vectored Zaire Ebolavirus (ChAd3-EBO-Z) and Modified Vaccinia Ankara- Vectored Multivalent Filovirus (MVA-BN(R)-Filo) Vaccine Candidates

This initial, proof of concept study will focus on identifying significant differences in response to the Ebolavirus Zaire vaccine (ChAd3-EBO-Z) when administered with placebo, MVA-BN(R)-Filo, or ChAd3-EBO-Z boosters after 8 days. All 60 participants will receive the ChAd3-EBO-Z vaccine and then randomized into each booster group (20 receiving each type of booster). Subjects will be followed-up for 6 months to monitor for safety outcomes and efficacy measures. There is no formal hypothesis for this study. The primary objective of this study is to assess the safety and reactogenicity of study products by study group when administered IM to healthy adults.

Start Date12 Nov 2018

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT02548078

/ CompletedPhase 2

Safety and Immunogenicity Study of GSK Biologicals' Investigational Recombinant Chimpanzee Adenovirus Type 3-vectored Ebola Zaire Vaccine (GSK3390107A) in Children in Africa

The purpose of this study is to assess the safety and reactogenicity of a single IM dose of the GSK3390107A (ChAd3 EBO-Z) vaccine, overall and in children aged 1 to 5, 6 to 12, and 13 to 17 years, separately.
Considering the risk of exposure to Ebola and the potential (based on animal data) for the investigational GSK3390107A (ChAd3-EBO-Z) vaccine to afford at least partial protection, all children in the study will receive the investigational GSK3390107A (ChAd3 EBO-Z) vaccine. The children in the Group GSK3390107A+Nimenrix will receive the investigational GSK3390107A (ChAd3-EBO-Z) vaccine at Day 0 of the study, whereas the children in the Group Nimenrix+GSK3390107A will receive Nimenrix at Day 0 (as a control). At Month 6, the children in the Group Nimenrix+GSK3390107A will receive the investigational GSK3390107A (ChAd3-EBO-Z) vaccine (provided that no safety concerns are raised), whereas the children in the Group GSK3390107A+Nimenrix will receive Nimenrix.

Start Date09 Nov 2015

Sponsor / Collaborator

GSK Plc

NCT02495246

/ CompletedPhase 1IIT

A Phase I, Safety and Immunogenicity Trial of the Heterologous Prime-boost Regimen Combining the Monovalent Zaire Ebola Viral Vector Candidates ChAd3-EBO-Z and Ad26.ZEBOV in Healthy UK Adults

This is a clinical trial in which healthy volunteers will be administered two experimental Ebola vaccines: ChAd3-EBO-Z and Ad26.ZEBOV. Four groups of volunteers will be vaccinated with both vaccines one after the other in a prime/boost regimen.
All ChAd3-EBO-Z doses are 1x10^11 vp and all Ad26.ZEBOV doses are 5x10^10 vp.
Group 1 will receive a ChAd3-EBO-Z priming vaccine and an Ad26.ZEBOV boosting vaccine 28 days later.
Group 2 will receive an Ad26.ZEBOV priming vaccine and a ChAd3-EBO-Z boosting vaccine 28 days later.
Group 3 will receive a ChAd3-EBO-Z priming vaccine and an Ad26.ZEBOV boosting vaccine 56 days later.
Group 4 will receive an Ad26.ZEBOV priming vaccine and a ChAd3-EBO-Z boosting vaccine 56 days later.
The study will assess the safety of the vaccinations, and the immune responses to vaccination. Immune responses are measured by tests on blood samples.
The ChAd3-EBO-Z and Ad26.ZEBOV vaccines are called viral vectored vaccines. They are made from viruses which are modified so that they cannot multiply. The viruses have extra DNA in them so that after injection, the body makes Ebola proteins (but Ebola does not develop), so that the immune system builds a response to Ebola without having been infected by it.
Healthy volunteers will be recruited in Oxford and London, England. The study will be co-funded by GSK Biologicals and Crucell Holland BV.

Start Date21 Sep 2015

Sponsor / Collaborator

University of Oxford

100 Clinical Results associated with Monovalent Ebola vaccine(National Institute of Allergy & Infectious Diseases)

100 Translational Medicine associated with Monovalent Ebola vaccine(National Institute of Allergy & Infectious Diseases)

100 Patents (Medical) associated with Monovalent Ebola vaccine(National Institute of Allergy & Infectious Diseases)

Literatures (Medical) associated with Monovalent Ebola vaccine(National Institute of Allergy & Infectious Diseases)

01 Jun 2020·The Lancet Infectious DiseasesQ1 · MEDICINE

Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in children in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial

Q1 · MEDICINE

Article

Author: Kaali, Seyram ; Ayuk, Leo ; Ndour, Cheikh T ; Owusu-Agyei, Seth ; Traore, Awa ; Mboup, Souleymane ; Sall, Fatima ; Koram, Kwadwo A ; Dosoo, David ; Ballou, William R ; Ekedi, Melanie ; Sow, Samba O ; Opoku, Nick ; Vernet, Marie-Astrid ; Boahen, Owusu ; Cheick Haidara, Fadima ; Kinge, Thompson N ; Keshinro, Babajide ; Hogrefe, Wayne R ; Bourguignon, Patricia ; Vernet, Guy ; Yawson, Abena Kunadu ; Seydi, Moussa ; Ndiaye, Birahim P ; Asante, Kwaku P ; Kokogho, Afoke ; Thiongane, Aliou ; Tejiokem, Mathurin ; Roman, François ; Gobert, Patrice ; Pitmang, Simon ; De Ryck, Iris ; Eneida Almeida Dos Santos, Irma ; Camara, Makhtar ; Koutsoukos, Marguerite ; Amusu, Senate ; Bigna, Jean Joel ; Tapia, Milagritos D ; Levine, Myron ; Bilong, Catherine ; Debois, Muriel ; Mbaye, Khardiata D ; Sztein, Marcelo ; Dièye, Siry ; Jongert, Erik ; Oguche, Stephen ; Coly, Daouda

BACKGROUNDDuring the large 2013-16 Ebola virus outbreak caused by the Zaire Ebola virus, about 20% of cases were reported in children. This study is the first, to our knowledge, to evaluate an Ebola vaccine in children younger than 6 years. We aimed to evaluate the safety, reactogenicity, and immunogenicity of a monovalent, recombinant, chimpanzee adenovirus type-3 vectored Zaire Ebola glycoprotein vaccine (ChAd3-EBO-Z) in a paediatric population.METHODSThis phase 2, randomised, observer-blind, controlled trial was done in a vaccine centre in Mali and a university hospital centre in Senegal. Healthy children were randomly assigned through a web-based system (1:1; stratified by age group, gender, and centre) to receive ChAd3-EBO-Z (day 0) and meningococcal serogroups A,C,W-135,Y tetanus toxoid conjugate vaccine (MenACWY-TT; month 6), or MenACWY-TT (day 0) and ChAd3-EBO-Z (month 6). The study was observer-blind from study start until interim day 30 analysis and became single-blind as of interim analysis. Primary outcomes assessed were serious adverse events (up to study end, month 12), solicited local or general adverse events (7 days post-vaccination), unsolicited adverse events (30 days post-vaccination), haematological or biochemical abnormalities, and clinical symptoms of thrombocytopenia (day 0-6). As secondary endpoints, we evaluated anti-glycoprotein Zaire Ebola virus antibody titres (ELISA) pre-vaccination and 30 days post-vaccination. This study is registered with ClinicalTrials.gov, NCT02548078.FINDINGSFrom Nov 11, 2015, to May 9, 2016, of 776 children screened for eligibility, 600 were randomly assigned (200 [33%] in each age strata: 1-5, 6-12, 13-17 years), 300 (50%) to the ChAd3-EBO-Z/MenACWY-TT group and 300 (50%) to the MenACWY-TT/ChAd3-EBO-Z group; all were included in the total vaccinated cohort. Post-day 0 vaccination, the most common solicited injection site symptom was pain (127 [42%] of 300 in the ChAd3-EBO-Z/MenACWY-TT group vs 60 [20%] of 300 in the MenACWY-TT/ChAd3-EBO-Z group); the most common solicited general adverse event was fever (95 [32%] of 300 in the ChAd3-EBO-Z/MenACWY-TT group vs 28 [9%] of 300 in the MenACWY-TT/ChAd3-EBO-Z group). Unsolicited adverse events post-day 0 vaccination were reported by 41 (14%) of 300 participants in the ChAd3-EBO-Z/MenACWY-TT group and 24 (8%) of 300 MenACWY-TT/ChAd3-EBO-Z recipients. Serious adverse events were reported for two (1%) of 300 children in each group; none were considered vaccination related. No clinical symptoms of thrombocytopenia were reported. At day 30, anti-glycoprotein Ebola virus antibody geometric mean concentrations (GMC) in the ChAd3-EBO-Z/MenACWY-TT group were 1564 (95% CI 1340-1826) for those aged 13-17 years, 1395 (1175-1655) for 6-12 years, and 2406 (1942-2979) for 1-5 years. Anti-glycoprotein Ebola virus IgG antibody responses persisted up to 12 months post-vaccination, with a GMC of 716 (95% CI 619-828) for those aged 13-17 years, 752 (645-876) for 6-12 years, and 1424 (1119-1814) for 1-5 years.INTERPRETATIONChAd3-EBO-Z was immunogenic and well tolerated in children aged 1-17 years. This study provides the first ChAd3-EBO-Z data in a paediatric population. Further development should focus on multivalent approaches including Sudan and Marburg strains, and heterologous prime-boost strategies, for instance using modified vaccinia Ankara-based vaccine to boost the immune response.FUNDINGEU's Horizon 2020 research and innovation programme and GlaxoSmithKline Biologicals SA.

01 Jun 2020·The Lancet Infectious Diseases

Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in adults in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial

Article

Author: Mboup, Souleymane ; Keshinro, Babajide ; Debois, Muriel ; Jongert, Erik ; Roman, François ; Sow, Samba O ; Thiongane, Aliou ; Bourguignon, Patricia ; Vernet, Guy ; Kinge, Thompson N ; Asante, Kwaku P ; Oguche, Stephen ; Mbaye, Khardiata D ; Ake, Julie A ; Hogrefe, Wayne R ; Koutsoukos, Marguerite ; Koram, Kwadwo A ; Akintunde, Gideon A ; Ndour, Cheikh T ; Tapia, Milagritos D ; Ndiaye, Birahim P ; Bigna, Jean Joel ; Naficy, Abdi ; Günther, Stephan ; De Ryck, Iris ; Ballou, William R

BACKGROUNDThe 2014 Zaire Ebola virus disease epidemic accelerated vaccine development for the virus. We aimed to assess the safety, reactogenicity, and immunogenicity of one dose of monovalent, recombinant, chimpanzee adenovirus type-3 vectored Zaire Ebola glycoprotein vaccine (ChAd3-EBO-Z) in adults.METHODSThis phase 2, randomised, observer-blind, controlled trial was done in study centres in Cameroon, Mali, Nigeria, and Senegal. Healthy adults (≥18 years) were randomly assigned with a web-based system (1:1; minimisation procedure accounting for age, gender, centre) to receive ChAd3-EBO-Z (day 0), or saline placebo (day 0) and ChAd3-EBO-Z (month 6). The study was observer-blind until planned interim day 30 analysis, single-blind until month 6, and open-label after month 6 vaccination. Primary outcomes assessed in the total vaccinated cohort, which comprised all participants with at least one study dose administration documented, were serious adverse events (up to study end, month 12); and for a subcohort were solicited local or general adverse events (7 days post-vaccination), unsolicited adverse events (30 days post-vaccination), haematological or biochemical abnormalities, and clinical symptoms of thrombocytopenia (day 0-6). Secondary endpoints (subcohort; per-protocol cohort) evaluated anti-glycoprotein Ebola virus antibody titres (ELISA) pre-vaccination and 30 days post-vaccination. This study is registered with ClinicalTrials.gov, NCT02485301.FINDINGSBetween July 22, 2015, and Dec 10, 2015, 3030 adults were randomly assigned; 3013 were included in the total vaccinated cohort (1509 [50·1%] in the ChAd3-EBO-Z group and 1504 [49·9%] in the placebo/ChAd3-EBO-Z group), 17 were excluded because no vaccine was administered. The most common solicited injection site symptom was pain (356 [48%] of 748 in the ChAd3-EBO-Z group vs 57 [8%] of 751 in the placebo/ChAd3-EBO-Z group); the most common solicited general adverse event was headache (345 [46%] in the ChAd3-EBO-Z group vs 136 [18%] in the placebo/ChAd3-EBO-Z group). Unsolicited adverse events were reported by 123 (16%) of 749 in the ChAd3-EBO-Z group and 119 (16%) of 751 in the placebo/ChAd3-EBO-Z group. Serious adverse events were reported for 11 (1%) of 1509 adults in the ChAd3-EBO-Z group, and 18 (1%) of 1504 in the placebo/ChAd3-EBO-Z group; none were considered vaccination-related. No clinically meaningful thrombocytopenia was reported. At day 30, anti-glycoprotein Ebola virus antibody geometric mean concentration was 900 (95% CI 824-983) in the ChAd3-EBO-Z group. There were no treatment-related deaths.INTERPRETATIONChAd3-EBO-Z was immunogenic and well tolerated in adults. Our findings provide a strong basis for future development steps, which should concentrate on multivalent approaches (including Sudan and Marburg strains). Additionally, prime-boost approaches should be a focus with a ChAd3-based vaccine for priming and boosted by a modified vaccinia Ankara-based vaccine.FUNDINGEU's Horizon 2020 research and innovation programme and GlaxoSmithKline Biologicals SA.

12 Oct 2017·New England Journal of MedicineQ1 · MEDICINE

Phase 2 Placebo-Controlled Trial of Two Vaccines to Prevent Ebola in Liberia

Q1 · MEDICINE

Article

Author: Wolfson, Julian ; Hensley, Lisa ; Feinberg, Mark ; Lane, H Clifford ; Follmann, Dean ; Grund, Birgit ; Marchand, Jonathan ; Higgs, Elizabeth ; Gupta, Swati ; Logue, James ; Kieh, Mark ; Eckes, Risa ; Grandits, Greg ; Neaton, James D ; Kateh, Francis ; Bolay, Fatorma ; Nyenswah, Tolbert ; Badio, Moses ; Stavale, Eric ; Kennedy, Stephen B ; Janosko, Krisztina ; Nason, Martha ; Roman, François ; Johnson, Melvin ; Monath, Thomas ; Ballou, Ripley

BACKGROUNDThe safety and efficacy of vaccines to prevent Ebola virus disease (EVD) were unknown when the incidence of EVD was peaking in Liberia.METHODSWe initiated a randomized, placebo-controlled, phase 3 trial of the chimpanzee adenovirus 3 vaccine (ChAd3-EBO-Z) and the recombinant vesicular stomatitis virus vaccine (rVSV∆G-ZEBOV-GP) in Liberia. A phase 2 subtrial was embedded to evaluate safety and immunogenicity. Because the incidence of EVD declined in Liberia, the phase 2 component was expanded and the phase 3 component was eliminated.RESULTSA total of 1500 adults underwent randomization and were followed for 12 months. The median age of the participants was 30 years; 36.6% of the participants were women. During the week after the administration of vaccine or placebo, adverse events occurred significantly more often with the active vaccines than with placebo; these events included injection-site reactions (in 28.5% of the patients in the ChAd3-EBO-Z group and 30.9% of those in the rVSV∆G-ZEBOV-GP group, as compared with 6.8% of those in the placebo group), headache (in 25.1% and 31.9%, vs. 16.9%), muscle pain (in 22.3% and 26.9%, vs. 13.3%), feverishness (in 23.9% and 30.5%, vs. 9.0%), and fatigue (in 14.0% and 15.4%, vs. 8.8%) (P<0.001 for all comparisons); these differences were not seen at 1 month. Serious adverse events within 12 months after injection were seen in 40 participants (8.0%) in the ChAd3-EBO-Z group, in 47 (9.4%) in the rVSV∆G-ZEBOV-GP group, and in 59 (11.8%) in the placebo group. By 1 month, an antibody response developed in 70.8% of the participants in the ChAd3-EBO-Z group and in 83.7% of those in the rVSV∆G-ZEBOV-GP group, as compared with 2.8% of those in the placebo group (P<0.001 for both comparisons). At 12 months, antibody responses in participants in the ChAd3-EBO-Z group (63.5%) and in those in the rVSV∆G-ZEBOV-GP group (79.5%) remained significantly greater than in those in the placebo group (6.8%, P<0.001 for both comparisons).CONCLUSIONSA randomized, placebo-controlled phase 2 trial of two vaccines that was rapidly initiated and completed in Liberia showed the capability of conducting rigorous research during an outbreak. By 1 month after vaccination, the vaccines had elicited immune responses that were largely maintained through 12 months. (Funded by the National Institutes of Allergy and Infectious Diseases and the Liberian Ministry of Health; PREVAIL I ClinicalTrials.gov number, NCT02344407 .).

100 Deals associated with Monovalent Ebola vaccine(National Institute of Allergy & Infectious Diseases)

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Indication	Highest Phase	Country/Location	Organization	Date
Hemorrhagic Fever, Ebola	Phase 3	-	Okairos AG	-
Virus Diseases	Preclinical	Senegal	GSK Plc	15 Jul 2015
Virus Diseases	Preclinical	Nigeria	GSK Plc	15 Jul 2015
Virus Diseases	Preclinical	Mali	GSK Plc	15 Jul 2015
Virus Diseases	Preclinical	Cameroon	GSK Plc	15 Jul 2015
Immune System Diseases	Preclinical	United States	National Institute of Allergy & Infectious Diseases	27 Aug 2014

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03583606 (CTgov)	Phase 1	Hemorrhagic Fever, Ebola	61	Placebo+ChAd3-EBO-Z (ChAd3-EBO-Z + Placebo)	htpvfsakil(aejbkzgyaz) = yajfogluhy oqdeguxpdu (nszdejhedz, kkgtkzxfrb - brvwdmpcom) View more	-	02 Jun 2021
				ChAd3-EBO-Z (ChAd3-EBO-Z + ChAd3-EBO-Z)	htpvfsakil(aejbkzgyaz) = vjjywvedze oqdeguxpdu (nszdejhedz, pmxzndnmmi - zbeffdzywj) View more
NCT02548078 (Pubmed) Manual	Phase 2	Hemorrhagic Fever, Ebola	600	ChAd3-EBO-Z+MenACWY-TT (ChAd3-EBO-Z/MenACWY-TT group)	(kkdxjnboth) = rwygirnard pinqnnzbjg (juvdfdgzxt ) View more	Positive	01 Jun 2020
				ChAd3-EBO-Z+MenACWY-TT (MenACWY-TT/ChAd3-EBO-Z group)	(kkdxjnboth) = peeqaynrcb pinqnnzbjg (juvdfdgzxt ) View more
NCT02485912 (CTgov)	Phase 1	Hemorrhagic Fever, Ebola	40	MVA-EBO Z+ChAd3-EBO Z (Group 1)	kgndhhobwo(jbbgnqokph) = ipagsnjlur qadrokzzdv (pubiiwmnhv, qhzbikgwto - iywtvweqzw) View more	-	06 Feb 2019
				MVA-EBO Z+ChAd3-EBO Z (Group 2)	kgndhhobwo(jbbgnqokph) = usxjfxodlf qadrokzzdv (pubiiwmnhv, otmoufhodx - utvelozdfe) View more
NCT02548078 (CTgov)	Phase 2	Virus Diseases	600	solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135+GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A) (GSK3390107A+Nimenrix Group)	(ouimbjeivk) = hvkiuwwcoj sseshochxe (vncbigwxpj, hopeygrivi - cvkotwaiso) View more	-	03 May 2018
				solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135+GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A) (Nimenrix+GSK3390107A Group)	(ouimbjeivk) = mxckqkvbrl sseshochxe (vncbigwxpj, ahrzfodfhc - uimsrkbbhp) View more
NCT02485301 (CTgov)	Phase 2	Virus Diseases	3,024	GSK3390107A vaccine (GSK3390107A Group)	hbzuxayfup(cwrgfnmpci) = dhvmnobvua kpwpmyvllm (yavrgfiqcf, ltnwhdqsfk - cnhbrrsalt) View more	-	04 Jan 2018
				Placebo+GSK3390107A (Placebo+GSK3390107A Group)	hbzuxayfup(cwrgfnmpci) = jmecunplid kpwpmyvllm (yavrgfiqcf, tjfnrkyjxm - bwygwcnsyh) View more

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Monovalent Ebola vaccine(National Institute of Allergy & Infectious Diseases)

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