Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06080243
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-12
First Post:
2023-08-28
Brief Title:
Assessment of Safety Immunogenicity and Efficacy of R21Matrix-M1 Malaria Vaccine in Healthy WOCBP in Mali
Sponsor:
European Vaccine Initiative
Organization:
European Vaccine Initiative
Study Overview
Official Title:
A Phase II Randomised Controlled Trial to Evaluate the Safety Immunogenicity and Efficacy of the R21Matrix-M1 Malaria Vaccine in Healthy African Women of Childbearing Potential in Mali
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
This will be a double-blind individually randomised trial to assess the safety tolerability immunogenicity and protective efficacy of two and three doses of the R21Matrix-M1 malaria vaccine or placebo given at 4 week intervals in healthy women of childbearing potential WOCBP who are on pregnancy prevention during vaccination but report plans to become pregnant in the near future
Participants will be randomised in Year 1 into three groups in a 111 ratio
Arm 1 n110 will receive three doses of R21Matrix-M1 malaria vaccine at months 0 1 and 2
Arm 2 n110 will receive normal saline placebo at month 0 and two doses of R21Matrix-M1 malaria vaccine at months 1 and 2
Arm 3 n110 will receive three of doses normal saline placebo at months 0 1 and 2 In Year 2 Non-pregnant participants in arms 1 and 2 will be randomised in a 11 ratio to receive a booster dose of R21Matrix-M1 malaria vaccine or placebo at the beginning of the malaria transmission season Participants in the control group arm 3 will receive normal saline placebo
Initial follow-up will be for two years after dose three with an efficacy analysis at 6 12 18 and 24 months after dose 3
Participants will be monitored for safety tolerability immunogenicity and malaria infection during the follow-up period
Participants will also be monitored for pregnancy over 12 months post primary and booster vaccination and those who become pregnant will be followed during their pregnancy and for 1 year post-delivery as well as their offspring for safety and malaria infection
Participants will be randomised in Year 1 into three groups in a 111 ratio
Arm 1 n110 will receive three doses of R21Matrix-M1 malaria vaccine at months 0 1 and 2
Arm 2 n110 will receive normal saline placebo at month 0 and two doses of R21Matrix-M1 malaria vaccine at months 1 and 2
Arm 3 n110 will receive three of doses normal saline placebo at months 0 1 and 2 In Year 2 Non-pregnant participants in arms 1 and 2 will be randomised in a 11 ratio to receive a booster dose of R21Matrix-M1 malaria vaccine or placebo at the beginning of the malaria transmission season Participants in the control group arm 3 will receive normal saline placebo
Initial follow-up will be for two years after dose three with an efficacy analysis at 6 12 18 and 24 months after dose 3
Participants will be monitored for safety tolerability immunogenicity and malaria infection during the follow-up period
Participants will also be monitored for pregnancy over 12 months post primary and booster vaccination and those who become pregnant will be followed during their pregnancy and for 1 year post-delivery as well as their offspring for safety and malaria infection
Detailed Description:
The design will be a double blind placebo-controlled study Malian adult WOCBP between 18 and 35 years of age who consent to participate will be randomised to receive R21Matrix-M1vaccine or normal saline to assess the safety immunogenicity and protective efficacy of R21Matrix-M1 Vaccine
Randomisation and Study Arms Consenting participants who have satisfied all the eligibility criteria and completed the baseline assessment will be individually randomised within the study groups using an electronic randomisation system into three arms in a 111 ratio
Arm 1 Participants will receive three doses of R21Matrix-M1 malaria vaccine at months 0 1 and 2
Arm 2 will receive normal saline placebo at month 0 and two doses of R21Matrix-M1 malaria vaccine at month 1 and 2
Arm 3 will receive three doses of normal saline placebo at months 0 1 and 2
Participants will be assessed for safety immunogenicity and efficacy for 12 months After 12 months non-pregnant participants in arms 1 and 2 will be randomised in a 11 ratio half in each of these two arms will receive a booster dose of R21Matrix-M1 vaccine and half will receive a placebo injection normal saline and be followed up for an additional 12 months
All injections will be administered intramuscularly in the deltoid region preferably of the non-dominant arm Post third injection participants will be followed through the malaria transmission rainy season approximately 6 months and then the ensuing dry season for an additional 6 months Participants will be monitored for safety immunogenicity and protective efficacy malaria infection during the follow-up period
For any women who become pregnant during the two-year period first year and second year of the trial follow up will continue through the end of pregnancy and any viable newbornsinfants and their mothers will be followed through the first year of life
Randomisation and Study Arms Consenting participants who have satisfied all the eligibility criteria and completed the baseline assessment will be individually randomised within the study groups using an electronic randomisation system into three arms in a 111 ratio
Arm 1 Participants will receive three doses of R21Matrix-M1 malaria vaccine at months 0 1 and 2
Arm 2 will receive normal saline placebo at month 0 and two doses of R21Matrix-M1 malaria vaccine at month 1 and 2
Arm 3 will receive three doses of normal saline placebo at months 0 1 and 2
Participants will be assessed for safety immunogenicity and efficacy for 12 months After 12 months non-pregnant participants in arms 1 and 2 will be randomised in a 11 ratio half in each of these two arms will receive a booster dose of R21Matrix-M1 vaccine and half will receive a placebo injection normal saline and be followed up for an additional 12 months
All injections will be administered intramuscularly in the deltoid region preferably of the non-dominant arm Post third injection participants will be followed through the malaria transmission rainy season approximately 6 months and then the ensuing dry season for an additional 6 months Participants will be monitored for safety immunogenicity and protective efficacy malaria infection during the follow-up period
For any women who become pregnant during the two-year period first year and second year of the trial follow up will continue through the end of pregnancy and any viable newbornsinfants and their mothers will be followed through the first year of life
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