Ignite Creation Date:
2024-05-06 @ 3:19 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02267109
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2014-10-03
Brief Title:
Phase 1 Trial of Ebola Vaccine in Mali
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Phase 1b Dose-escalating Safety and Immunogenicity Trial of the Novel Monovalent Ebola Zaire Candidate Vaccine cAd3-EBO Z and the Heterologous Prime-boost Candidate Vaccine Regimen of cAD3-EBO Z Followed by MVA-BN Filo in Malian Adults Aged 18-50 Years
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ebola virus causes an infection known as Ebola virus disease EVD This is generally a severe disease which can also lead to death The 2014 outbreak of EVD in West Africa is the largest ever Researchers want to develop a vaccine to prevent Ebola infection It is impossible for someone to get an Ebola infection from this vaccine
Detailed Description:
This is a Phase 1b 1b implies that the trial is occurring in a geographic region where cases of the disease against which the vaccine is directed ie Ebola disease may occur before during or after the clinical trial open label dose-escalation study to examine the safety tolerability and immunogenicity of an investigational Ebola virus vaccine cAD3-EB Z in Malian healthy adults The vaccine is a recombinant chimpanzee adenovirus Type-3 vectored Ebola Zaire vaccine cAd3-EBO Z and consists of a recombinant replication-deficient adenovirus chimpanzee serotype 3 cAd3 vector expressing wild-type WT Ebola glycoprotein GP from the Zaire strain
A revision of the protocol on 14Dec2014 added a booster dose with MVA-BN Filo or placebo in 56 subjects in groups 1 except for first 5 vaccines 2 3A and 4 The multivalent vectored vaccine MVA-BN Filo contains an insert for the Zaire Ebola virus glycoprotein as well as the Sudan strain Ebola virus glycoprotein the Musoke strain Marburg virus glycoprotein and a nucleoprotein from the Tai-Forest Ebola virus
Forty volunteers will be enrolled into two dosage groups Another group of 40 volunteers Groups 3A-C with group 3A receiving 10x1010vp All study participants will receive one dose of the study vaccine by intramuscular injection Group 4 was added to include another 11 volunteers to receive 1-X1011vp A total of 91 volunteers have been included
Group 1 will include 20 participants who will receive the lower dose of the vaccine at 25 x 1010 vp
Group 2 will include 20 participants who will receive the higher does of vaccine at 5 x 1010 vp
Group 3A will include 10 participants to receive 10X1010 vp
Group 3B will include 15 participants to receive 25X1010 vp
Group 3C will include 15 participants to receive 5X1010 vp participants will be randomly allocated to Group 3B or 3C
Group 4 will include 11 participants to receive1x1011 vp The goal of vaccinating this group is to see if there is any added benefit to the immunogenicity of this vaccine by using a higher dose This dosage level of the monovalent vaccine has already been studied at VRCNIH in September and at CVD in Baltimore this month in November This dosage level was not studied in Oxford nor in Bamako Having data on West African subjects given this dosage will be very helpful in designing the final formulation for the field trials in Q1 of 2015 The decision will be made based on three sets of data clinical dose-response immunologic dose-response as a proxy for expected protection and manufacturing yield and cost of goods considerations
For safety reasons the first Malian volunteer to receive a vaccine dose in Group 1 will be vaccinated alone and we will wait 24 hours before vaccinating subsequent volunteers in this dose group Two further Group 1 volunteers may be vaccinated 24 hours after the first and then at least another 24 hours gap will be left before vaccinating further subjects receiving that dose of vaccine After 5 volunteers in Group 1 have been vaccinated and followed up for 7 days an interim safety review ISR1 will be performed by the DSMB Enrollment of the rest of this group may proceed only if the DSMB assesses the data and indicates that it is safe to do so
Group 2 volunteers will be vaccinated without the stepwise procedure This decision was made by the DSMB after review of safety data for 5X1010 from the UK trial and approval by the Institutional Review Boards
Group 3A who will receive a lower dosage level than Groups 1 or 2 can be vaccinated as soon as logistically possible after all subjects in Group 2 have been vaccinated Groups 3B and Group 3C will be similarly vaccinated over a period of three days at the rate of 10 subjects per day
Group 4 will vaccinate and additional 11 participants with 1X1011 and will be vaccinated over 2 days 5 subjects one day followed by another 6 subjects the next day
Heterologous boosting dose of MVA-BN Filo or placebo in 56 subjects in groups 1 except for first 5 vaccinees 2 3A and 4 will commence in January 2015 with random allocation to either vaccine or placebo
A revision of the protocol on 14Dec2014 added a booster dose with MVA-BN Filo or placebo in 56 subjects in groups 1 except for first 5 vaccines 2 3A and 4 The multivalent vectored vaccine MVA-BN Filo contains an insert for the Zaire Ebola virus glycoprotein as well as the Sudan strain Ebola virus glycoprotein the Musoke strain Marburg virus glycoprotein and a nucleoprotein from the Tai-Forest Ebola virus
Forty volunteers will be enrolled into two dosage groups Another group of 40 volunteers Groups 3A-C with group 3A receiving 10x1010vp All study participants will receive one dose of the study vaccine by intramuscular injection Group 4 was added to include another 11 volunteers to receive 1-X1011vp A total of 91 volunteers have been included
Group 1 will include 20 participants who will receive the lower dose of the vaccine at 25 x 1010 vp
Group 2 will include 20 participants who will receive the higher does of vaccine at 5 x 1010 vp
Group 3A will include 10 participants to receive 10X1010 vp
Group 3B will include 15 participants to receive 25X1010 vp
Group 3C will include 15 participants to receive 5X1010 vp participants will be randomly allocated to Group 3B or 3C
Group 4 will include 11 participants to receive1x1011 vp The goal of vaccinating this group is to see if there is any added benefit to the immunogenicity of this vaccine by using a higher dose This dosage level of the monovalent vaccine has already been studied at VRCNIH in September and at CVD in Baltimore this month in November This dosage level was not studied in Oxford nor in Bamako Having data on West African subjects given this dosage will be very helpful in designing the final formulation for the field trials in Q1 of 2015 The decision will be made based on three sets of data clinical dose-response immunologic dose-response as a proxy for expected protection and manufacturing yield and cost of goods considerations
For safety reasons the first Malian volunteer to receive a vaccine dose in Group 1 will be vaccinated alone and we will wait 24 hours before vaccinating subsequent volunteers in this dose group Two further Group 1 volunteers may be vaccinated 24 hours after the first and then at least another 24 hours gap will be left before vaccinating further subjects receiving that dose of vaccine After 5 volunteers in Group 1 have been vaccinated and followed up for 7 days an interim safety review ISR1 will be performed by the DSMB Enrollment of the rest of this group may proceed only if the DSMB assesses the data and indicates that it is safe to do so
Group 2 volunteers will be vaccinated without the stepwise procedure This decision was made by the DSMB after review of safety data for 5X1010 from the UK trial and approval by the Institutional Review Boards
Group 3A who will receive a lower dosage level than Groups 1 or 2 can be vaccinated as soon as logistically possible after all subjects in Group 2 have been vaccinated Groups 3B and Group 3C will be similarly vaccinated over a period of three days at the rate of 10 subjects per day
Group 4 will vaccinate and additional 11 participants with 1X1011 and will be vaccinated over 2 days 5 subjects one day followed by another 6 subjects the next day
Heterologous boosting dose of MVA-BN Filo or placebo in 56 subjects in groups 1 except for first 5 vaccinees 2 3A and 4 will commence in January 2015 with random allocation to either vaccine or placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None