Ignite Creation Date:
2024-05-06 @ 3:45 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02368119
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2015-02-05
Brief Title:
Ebola CVD-Mali 2000 Bivalent VRC-EBOAdc069-00-vp cAd3-EBO
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A PHASE IB DOUBLE-BLIND CLINICAL TRIAL TO EVALUATE THE SAFETY TOLERABILITY AND IMMUNOGENICITY OF TWO DIFFERENT DOSAGE LEVELS OF EBOLA CHIMPANZEE ADENOVIRUS VECTOR VACCINE VRC-EBOADC069-00-VP cAd3-EBO AND THE HETEROLOGOUS PRIME-BOOST CANDIDATE VACCINE REGIMEN OF cAD3-EBO FOLLOWED BY MVA-VECTORED VACCINE IN HEALTHY ADULTS 18-65 YEARS OF AGE IN BAMAKO MALI
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 it 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
This study will assess the safety of a single dose of the bivalent Ebola Zaire candidate vaccine VRC-EBOADC069-00-VP cAD3-EBO when administered to healthy Malian adult volunteers age 18-65 years mostly health care workers and other front line workers eg individuals who incinerate contaminated materials at one of 2 dosage levels 20 x 1010 vp or 2 x 1011 vp It is impossible for someone to get an Ebola infection from this vaccine
Heterologous booster dose allocation - Each participant will be offered the opportunity to be included in the booster step of this study After obtaining consent and the additional review of pertinent medical history participants in each group will be randomized to receive the candidate booster vaccine MVA-EbolaZ or placebo
This will be the first clinical trial in Mali with bivalent cAd3-based Ebola vaccine and the first where the dosage level contains 1011 vp It follows completion of a Phase Ib trial in Malian health care workers that tested three dosage levels of monovalent cAd3-EBO Z vaccine The data generated in West Africans Mali on the tolerability and immunogenicity of the bivalent vaccine will be compared to clinical and immunologic responses documented in in parallel studies in East African subjects Uganda and North American subjects NIH Bethesda MD USA
Objectives
To see if an Ebola vaccine is safe and to study immune responses to it
To study the effect of the MVA-EbolaZ booster on the immune response
Eligibility
- Healthy adults ages 18-65
This study will assess the safety of a single dose of the bivalent Ebola Zaire candidate vaccine VRC-EBOADC069-00-VP cAD3-EBO when administered to healthy Malian adult volunteers age 18-65 years mostly health care workers and other front line workers eg individuals who incinerate contaminated materials at one of 2 dosage levels 20 x 1010 vp or 2 x 1011 vp It is impossible for someone to get an Ebola infection from this vaccine
Heterologous booster dose allocation - Each participant will be offered the opportunity to be included in the booster step of this study After obtaining consent and the additional review of pertinent medical history participants in each group will be randomized to receive the candidate booster vaccine MVA-EbolaZ or placebo
This will be the first clinical trial in Mali with bivalent cAd3-based Ebola vaccine and the first where the dosage level contains 1011 vp It follows completion of a Phase Ib trial in Malian health care workers that tested three dosage levels of monovalent cAd3-EBO Z vaccine The data generated in West Africans Mali on the tolerability and immunogenicity of the bivalent vaccine will be compared to clinical and immunologic responses documented in in parallel studies in East African subjects Uganda and North American subjects NIH Bethesda MD USA
Objectives
To see if an Ebola vaccine is safe and to study immune responses to it
To study the effect of the MVA-EbolaZ booster on the immune response
Eligibility
- Healthy adults ages 18-65
Detailed Description:
This is a phase 1B double-blind randomized study to examine the safety tolerability and immunogenicity of two different dosage levels of investigational Ebola vaccine
The vaccine is a recombinant chimpanzee adenovirus Type 3-vectored Ebolavirus vaccine cAd3-EBO VRC-EBOADC069-00-VP The vaccine encodes wild type WT glycoproteins GP from Zaire and Sudan species of Ebola virus The primary objective is to assess the safety of a single dose intramuscular injection of the bivalent vaccine at one of 2 dosage levels 20 X 1010 vp or 2 x 1011 vp and to assess the safety of the heterologous prime boost regimen of cAd3-EBO followed by MVA-EbolaZ or Phosphate Buffered Saline PBS placebo A secondary objective is to assess the immunogenicity generated by 2 different dosage levels of the bivalent Ebola candidate vaccine
Enrolment of Group 1 participants
The first 20 Malian volunteers will be vaccinated in a staggered fashion For safety reasons the first 10 Malian subjects to receive a vaccine dose in Group 1 will be vaccinated on day 1 and we will wait 24 hours before vaccinating 10 subsequent volunteers After these 20 volunteers in Group 1 have been vaccinated and followed up for 7 days an interim safety review ISR1 will be performed by the DSMB Enrolment of subjects into Group 2 will commence only after the DSMB has assessed the data and indicated that it is safe to do so
Half of Group 1 participants will be randomly assigned to receive the low dose and the remaining 10 will be randomized to receive the high dose
Enrolment of Group 2 participants
The 40 subjects in Group 2 will be accrued as rapidly as possible The 40 Malian volunteers in Group 2 will be vaccinated over several days to limit wastage of the available doses of cAd3 EBO As a result a proposed scheme would be 10 per vaccination day This could be adjusted as needed to limit wastage but no more than 20 participants would be vaccinated in 1 day After the total of 40 volunteers in Group 2 have been vaccinated and followed up for 7 days an interim safety review ISR2 will be performed by the DSMB
Prime Boost Vaccine Randomization 4-16 weeks after priming dose Each participant will be offered the opportunity to be included in the booster step of this study After obtaining consent and the additional review of pertinent medical history participants in each group will be randomized to receive the candidate booster vaccine MVA-EbolaZ or PBS placebo
The vaccine is a recombinant chimpanzee adenovirus Type 3-vectored Ebolavirus vaccine cAd3-EBO VRC-EBOADC069-00-VP The vaccine encodes wild type WT glycoproteins GP from Zaire and Sudan species of Ebola virus The primary objective is to assess the safety of a single dose intramuscular injection of the bivalent vaccine at one of 2 dosage levels 20 X 1010 vp or 2 x 1011 vp and to assess the safety of the heterologous prime boost regimen of cAd3-EBO followed by MVA-EbolaZ or Phosphate Buffered Saline PBS placebo A secondary objective is to assess the immunogenicity generated by 2 different dosage levels of the bivalent Ebola candidate vaccine
Enrolment of Group 1 participants
The first 20 Malian volunteers will be vaccinated in a staggered fashion For safety reasons the first 10 Malian subjects to receive a vaccine dose in Group 1 will be vaccinated on day 1 and we will wait 24 hours before vaccinating 10 subsequent volunteers After these 20 volunteers in Group 1 have been vaccinated and followed up for 7 days an interim safety review ISR1 will be performed by the DSMB Enrolment of subjects into Group 2 will commence only after the DSMB has assessed the data and indicated that it is safe to do so
Half of Group 1 participants will be randomly assigned to receive the low dose and the remaining 10 will be randomized to receive the high dose
Enrolment of Group 2 participants
The 40 subjects in Group 2 will be accrued as rapidly as possible The 40 Malian volunteers in Group 2 will be vaccinated over several days to limit wastage of the available doses of cAd3 EBO As a result a proposed scheme would be 10 per vaccination day This could be adjusted as needed to limit wastage but no more than 20 participants would be vaccinated in 1 day After the total of 40 volunteers in Group 2 have been vaccinated and followed up for 7 days an interim safety review ISR2 will be performed by the DSMB
Prime Boost Vaccine Randomization 4-16 weeks after priming dose Each participant will be offered the opportunity to be included in the booster step of this study After obtaining consent and the additional review of pertinent medical history participants in each group will be randomized to receive the candidate booster vaccine MVA-EbolaZ or PBS 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