Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587503
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Safety and Immunogenicity of rVSVΔG-ZEBOV-GP Vaccination When Dosed Concurrently With mRNA COVID-19 Vaccine Booster Doses
Sponsor:
None
Organization:
None
Study Overview
Official Title:
EbolaCov A Phase IV Single-centre Single-blinded Randomized Controlled Trial to Assess Safety and Immunogenicity of rVSVΔG-ZEBOV-GP Vaccination When Dosed Concurrent With mRNA COVID-19 Vaccine Booster Doses in Healthy African Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Concurrent vaccination scheduling for key target populations in Rwanda such as healthcare workers may confer significant advantages in the provision of vaccine coverage to several infectious diseases This is a phase IV vaccine trial that looks to establish if two licenced vaccines the rVSVΔG-ZEBOV-GP vaccine for protection against Ebola virus and messenger ribonucleic acid mRNA COVID vaccine for protection against SARS-CoV-2 virus given concurrently to self selected healthy adult volunteers confers an acceptable safety profile and immunogenicity response
Detailed Description:
Vaccines for the prevention of severe disease caused by Ebola virus and SARS-CoV-2 virus are routinely offered to adults at higher risk of exposure in African settings For protection from Ebola virus the main target populations are epidemiologically-identified and include healthcare workers refugees and people living in outbreak zones These target populations are also routinely offered vaccines for other vaccine-preventable diseases However there are currently no data on whether the co-administration of rVSVΔG-ZEBOV-GP with other vaccines has an acceptable profile of reactogenicity and antigen-specific immunogenicity and concomitant use of rVSVΔG-ZEBOV-GP with other vaccines is not recommended Clinical trial data on the co-administration of rVSVΔG-ZEBOV-GP with other vaccines prioritised for the same population and especially in the context of a new era in mRNA vaccine technology would have significant relevance to how protection to more than one disease can be provided at a single visit to a vaccination clinic This in turn has the potential to improve vaccine coverage and improve the efficiency of vaccine policy and logistics as well as being the first step evaluation in the evaluation of Vesicular stomatitis virus-vectored vaccine technology with lipid-enveloped mRNA platforms that are going to be increasingly used in other formulations against otherfuture infectious diseases targets
There are no preliminary data in this first-of-kind study
The advent of the SARS-CoV-2 virus and COVID-19 pandemic signalled the accelerated development of lipid-nanoparticle mRNA vaccine technology with great success The mRNA platform is highly adaptable to new disease targets including cancer and infectious diseases pathogens and a multitude of vaccine candidates are currently in development for outstanding global health priorities that have eluded pre-pandemic technologies However there remains very little known about using mRNA technologies in combination with or concurrent to other vaccine technologies and whether there are any adverse signals associated with safety or antigen-specific immune responseprotection Earlier trials have focussed on using SARS-CoV-2 mRNA vaccines in combination with adjuvant-protein vaccines for seasonal influenza and herpes-zoster virus in setup and have reported favourable safety and humoral immune responses that has resulted in recommended concurrent vaccine dose administration into the annual seasonal vaccination schedule of UK nationals These study data have significantly supported public confidence in accepting two licenced vaccines at the same time and significant efficiency gains in vaccine coverage and public protection The concurrent administration of mRNA vaccines with attenuated or replication-incompetent viral-vectored vaccines has not to our knowledge been assessed although many trials reported favourable safety and immunogenicity with heterologous combinations of these vaccine platforms for protection against COVID-19 Since existing mRNA COVID-19 vaccines and new mRNA constructs against other infectious diseases are expected to become routine immunisations for key members of the population such as healthcare workers and older adults research is needed to inform whether concurrent or co-administration with other vaccines are possible For African populations the risk of disease outbreaks from Ebola remains high and the future use of rVSVΔG-ZEBOV-GP is expected along with other measures to mitigate the risks to healthcare workers and the wider public Assessing the safety and immunogenicity of rVSVΔG-ZEBOV-GP vaccine in the context of expected gains in public confidence and policy implementation with co-administration with mRNA vaccine technologies is a major subject of interest for African populations and preparedness for future disease outbreaks
This is a single-centre randomized single-blinded vaccine safety and immunogenicity study in healthy adults living in Rwanda The EbolaCov trial aims to inform whether the Ebola vaccine rVSVΔG-ZEBOV-GP can be administered concurrent to a BioNTech - Pfizer COVID-19 booster dose without an unacceptable increase in reactogenicity andor loss of humoral immunogenicity to Ebola vaccine antigen
The investigators aim to primarily recruit participants who are current healthcare workers although the study will be open all eligible members of the public Participants of both genders aged 18-50 years who are in good health and who are able to provide written informed consent will be eligible for inclusion in this study The recruitment target is recruit 72 participants who will be randomised in a 11 ratio to one of two groups
There will be four study visits over 6 months Participants will be monitored for any reactions and other adverse events for 7 days after each immunisation via self reported e-diary and for significant adverse events throughout the study
The geometric mean titre GMT and antigen-specific antibody titre will be measured by glycoprotein-enzyme-linked immunosorbent assay at baseline 28-days and 180-days after vaccination
There are no preliminary data in this first-of-kind study
The advent of the SARS-CoV-2 virus and COVID-19 pandemic signalled the accelerated development of lipid-nanoparticle mRNA vaccine technology with great success The mRNA platform is highly adaptable to new disease targets including cancer and infectious diseases pathogens and a multitude of vaccine candidates are currently in development for outstanding global health priorities that have eluded pre-pandemic technologies However there remains very little known about using mRNA technologies in combination with or concurrent to other vaccine technologies and whether there are any adverse signals associated with safety or antigen-specific immune responseprotection Earlier trials have focussed on using SARS-CoV-2 mRNA vaccines in combination with adjuvant-protein vaccines for seasonal influenza and herpes-zoster virus in setup and have reported favourable safety and humoral immune responses that has resulted in recommended concurrent vaccine dose administration into the annual seasonal vaccination schedule of UK nationals These study data have significantly supported public confidence in accepting two licenced vaccines at the same time and significant efficiency gains in vaccine coverage and public protection The concurrent administration of mRNA vaccines with attenuated or replication-incompetent viral-vectored vaccines has not to our knowledge been assessed although many trials reported favourable safety and immunogenicity with heterologous combinations of these vaccine platforms for protection against COVID-19 Since existing mRNA COVID-19 vaccines and new mRNA constructs against other infectious diseases are expected to become routine immunisations for key members of the population such as healthcare workers and older adults research is needed to inform whether concurrent or co-administration with other vaccines are possible For African populations the risk of disease outbreaks from Ebola remains high and the future use of rVSVΔG-ZEBOV-GP is expected along with other measures to mitigate the risks to healthcare workers and the wider public Assessing the safety and immunogenicity of rVSVΔG-ZEBOV-GP vaccine in the context of expected gains in public confidence and policy implementation with co-administration with mRNA vaccine technologies is a major subject of interest for African populations and preparedness for future disease outbreaks
This is a single-centre randomized single-blinded vaccine safety and immunogenicity study in healthy adults living in Rwanda The EbolaCov trial aims to inform whether the Ebola vaccine rVSVΔG-ZEBOV-GP can be administered concurrent to a BioNTech - Pfizer COVID-19 booster dose without an unacceptable increase in reactogenicity andor loss of humoral immunogenicity to Ebola vaccine antigen
The investigators aim to primarily recruit participants who are current healthcare workers although the study will be open all eligible members of the public Participants of both genders aged 18-50 years who are in good health and who are able to provide written informed consent will be eligible for inclusion in this study The recruitment target is recruit 72 participants who will be randomised in a 11 ratio to one of two groups
There will be four study visits over 6 months Participants will be monitored for any reactions and other adverse events for 7 days after each immunisation via self reported e-diary and for significant adverse events throughout the study
The geometric mean titre GMT and antigen-specific antibody titre will be measured by glycoprotein-enzyme-linked immunosorbent assay at baseline 28-days and 180-days after vaccination
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