Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05978037
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2023-07-14
Brief Title:
A Study to Assess the Safety and Effectiveness of Two Experimental Malaria Vaccines
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
An Open Label Phase IIIa Clinical Trial to Assess the Safety Immunogenicity and Efficacy of the Malaria Vaccine Candidate RH52-virus-like Particle VLP in Matrix-MTM and to Compare the Safety and Immunogenicity of the Malaria Vaccine Candidates RH52-VLP in Matrix-MTM and RH51 Soluble Protein in Matrix-MTM Used in Various Regimens
Status:
RECRUITING
Status Verified Date:
2023-07
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:
Malaria is a major public health problem There were around 240 million cases of malaria and 627000 deaths worldwide in 2020 There is a great need for a safe effective malaria vaccine and the team at University of Oxford is trying to make vaccines which can prevent serious illness and death
This study is being done to assess an experimental malaria vaccine for its ability to prevent malaria illness This is done using a blood-stage challenge model This is when volunteers are infected with malaria parasites using malaria-infected red blood cells
The vaccine we are testing in this part of the study is called RH52-VLP It is given with an adjuvant called Matrix-M This is a substance to improve the bodys response to a vaccination RH52-VLP is being tested for the first time in humans in this trial The Matrix-M adjuvant has been given to tens of thousands of people with no major concerns such as illness
The aim is to use this vaccine and adjuvant to help the body make an immune response against parts of the malaria parasite This study will assess
1 The safety of the vaccine in healthy participants
2 The response of the human immune system to the vaccine
3 The ability of the vaccine to prevent malaria illness Group 2 only We will do this by giving healthy adult participants aged 18-45 three of the vaccines andor expose participants to malaria infection at the Centre for Clinical Vaccinology and Tropical Medicine CCVTM Churchill Hospital in Oxford We will then do blood tests and collect information about any symptoms that occur after vaccination There will be 19 to 54 visits lasting between 3 months to 2 years and 2 months
This study is being done to assess an experimental malaria vaccine for its ability to prevent malaria illness This is done using a blood-stage challenge model This is when volunteers are infected with malaria parasites using malaria-infected red blood cells
The vaccine we are testing in this part of the study is called RH52-VLP It is given with an adjuvant called Matrix-M This is a substance to improve the bodys response to a vaccination RH52-VLP is being tested for the first time in humans in this trial The Matrix-M adjuvant has been given to tens of thousands of people with no major concerns such as illness
The aim is to use this vaccine and adjuvant to help the body make an immune response against parts of the malaria parasite This study will assess
1 The safety of the vaccine in healthy participants
2 The response of the human immune system to the vaccine
3 The ability of the vaccine to prevent malaria illness Group 2 only We will do this by giving healthy adult participants aged 18-45 three of the vaccines andor expose participants to malaria infection at the Centre for Clinical Vaccinology and Tropical Medicine CCVTM Churchill Hospital in Oxford We will then do blood tests and collect information about any symptoms that occur after vaccination There will be 19 to 54 visits lasting between 3 months to 2 years and 2 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None