Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618885
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Safety and Immunogenicity of SUM-101 Malaria Vaccine in Children and Infants Living in Burkina Faso
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1b Randomised Controlled Age De-escalation Dose-finding Study to Evaluate the Safety Reactogenicity and Immunogenicity of Full-length MSP1GLA-SE SUM-101 Malaria Vaccine in Healthy Young Children and Infants in Burkina Faso
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
SUM-101
Brief Summary:
This clinical trial aims to learn about the safety and immunogenicity of the blood-stage malaria vaccine candidate SUM-101 in infants and children paving the way for its incorporation into a multi-stage malaria vaccine This will be the first time SUM-101 will be evaluated for safety and immunogenicity in infants and children The main questions it aims to answer are
Are the 3 doses of full-length MSP1GLA-SE SUM-101 in young children and infants safe
Do the 3 doses of full-length MSP1GLA-SE SUM-101 in young children and infants produce any reactogenicity
How is the immunogenicity in young children and infants generated by the 3 doses of full-length MSP1GLA-SE SUM-101
What is the optimal dose of the full-length MSP1GLA-SE SUM-101 in young children and infants The study will be divided into two arms with 5 groups conducted at a single centre In total 69 healthy malaria-pre-exposed infants and children aged 5 months to 5 years will be enrolled in this study
Participants will be included in one of the following groups
Arm 1_Group 1 open-label design This will be the first cohort enrolled to assess safety in children 18 months - 5 years before the vaccination of infants commences Therefore all participants in Arm 1 will receive three doses of SUM-101 vaccine 25µg MSP1 5µg GLA-SE on D0 D28 and D56
Arm 2_Group 2-5 randomised controlled double-blind design This will be the second cohort enrolled to assess safety in the target population infants aged 5-17 months Infants will be assigned to Groups 2-5 to enable evaluation of two doses of MSP1 25µg and 10µg and two doses of GLA-SE 5µg and 25µg The infants in each group will be randomised into A a vaccine arm 12 participants and B a control arm 3 participants All participants in Groups 2-5 will receive three doses of either SUM-101 vaccine or Verorab Rabies vaccine on D0 D28 and D56
Participants will visit the clinic for screening and once selected for enrolment No later than 28 days after selection participants will receive the 1st vaccination Visit Day 0 and 2nd and 3rd Vaccination on Day 28 and Day 56 On Day 1 to 6 days post each vaccination Day 1-6 Day 29-34 and Day 57-62 each participant will be visited at home daily by a field worker for assessment and recording of any solicited and unsolicited AEs Reactogenicity visits
Are the 3 doses of full-length MSP1GLA-SE SUM-101 in young children and infants safe
Do the 3 doses of full-length MSP1GLA-SE SUM-101 in young children and infants produce any reactogenicity
How is the immunogenicity in young children and infants generated by the 3 doses of full-length MSP1GLA-SE SUM-101
What is the optimal dose of the full-length MSP1GLA-SE SUM-101 in young children and infants The study will be divided into two arms with 5 groups conducted at a single centre In total 69 healthy malaria-pre-exposed infants and children aged 5 months to 5 years will be enrolled in this study
Participants will be included in one of the following groups
Arm 1_Group 1 open-label design This will be the first cohort enrolled to assess safety in children 18 months - 5 years before the vaccination of infants commences Therefore all participants in Arm 1 will receive three doses of SUM-101 vaccine 25µg MSP1 5µg GLA-SE on D0 D28 and D56
Arm 2_Group 2-5 randomised controlled double-blind design This will be the second cohort enrolled to assess safety in the target population infants aged 5-17 months Infants will be assigned to Groups 2-5 to enable evaluation of two doses of MSP1 25µg and 10µg and two doses of GLA-SE 5µg and 25µg The infants in each group will be randomised into A a vaccine arm 12 participants and B a control arm 3 participants All participants in Groups 2-5 will receive three doses of either SUM-101 vaccine or Verorab Rabies vaccine on D0 D28 and D56
Participants will visit the clinic for screening and once selected for enrolment No later than 28 days after selection participants will receive the 1st vaccination Visit Day 0 and 2nd and 3rd Vaccination on Day 28 and Day 56 On Day 1 to 6 days post each vaccination Day 1-6 Day 29-34 and Day 57-62 each participant will be visited at home daily by a field worker for assessment and recording of any solicited and unsolicited AEs Reactogenicity visits
Detailed Description:
The study will be divided into two arms conducted at a single centre In total 69 volunteers will be enrolled in this Phase Ib study to assess the safety reactogenicity and immunogenicity of SUM-101 in healthy malaria pre-exposed infants and children aged 5 months to 5 years
Arm 1_Group 1 open-label design This will be the first cohort enrolled to assess safety in children 18 months - 5 years before the vaccination of infants commences Therefore all participants in Group 1 n9 with n3 sentinels will receive three doses of SUM-101 vaccine 25µg MSP1 5µg GLA-SE on D0 D28 and D56 in an open-label design Female and male participants will be enrolled
Arm 2_Group 2-5 randomised controlled double-blind design This will be the second cohort enrolled to assess safety in the target population infants aged 5-17 months Infants will be assigned to Groups 2-5 15 participants in each group with n4 sentinels to enable evaluation of two doses of MSP1 25µg and 10µg and two doses of GLA-SE 5µg and 25µg To reduce bias the vaccination of Groups 2-5 will be conducted in a double-blind manner The infants in each group will be randomised into A a vaccine arm 12 participants and B a control arm 3 participants Female and male participants will be enrolled All participants in Groups 2-5 will receive three doses of either SUM-101 vaccine or Verorab Rabies vaccine on D0 D28 and D56
Sentinel participants The first 3 participants enrolled in Group 1 will be sentinels who will be vaccinated in an open label manner To ensure blinding the first 4 participants enrolled in Groups 2-5 will be sentinels who will be vaccinated with either SUM-101 or control vaccine The sentinel participants will be vaccinated in the following order Arm1_Group 1 sentinels On the first day the first participant will be enrolled and vaccinated alone and observed on the day following vaccination If there are no safety concerns another two participants will be enrolled and vaccinated in a sequential manner at least 48 hours after the first participant and with a minimum interval between participants of 60 min to allow monitoring of any acute events The remaining participants will be vaccinated at least 72 hours after the third sentinel participant as long as there are no safety concerns
Arm2_Groups 2-5 sentinels On the first day two participants will be enrolled and vaccinated in a sequential manner with a minimum interval between the participants of 60 min to allow monitoring of any acute events These two vaccinated participants will then be observed on the day following vaccination If there are no safety concerns another two participants will be enrolled and vaccinated in a sequential manner at least 48 hours after the first participant and with a minimum interval between participants of 60 min to allow monitoring of any acute events The remaining participants will be vaccinated at least 72 hours after the fourth sentinel participant as long as there are no safety concerns
Arm 1_Group 1 open-label design This will be the first cohort enrolled to assess safety in children 18 months - 5 years before the vaccination of infants commences Therefore all participants in Group 1 n9 with n3 sentinels will receive three doses of SUM-101 vaccine 25µg MSP1 5µg GLA-SE on D0 D28 and D56 in an open-label design Female and male participants will be enrolled
Arm 2_Group 2-5 randomised controlled double-blind design This will be the second cohort enrolled to assess safety in the target population infants aged 5-17 months Infants will be assigned to Groups 2-5 15 participants in each group with n4 sentinels to enable evaluation of two doses of MSP1 25µg and 10µg and two doses of GLA-SE 5µg and 25µg To reduce bias the vaccination of Groups 2-5 will be conducted in a double-blind manner The infants in each group will be randomised into A a vaccine arm 12 participants and B a control arm 3 participants Female and male participants will be enrolled All participants in Groups 2-5 will receive three doses of either SUM-101 vaccine or Verorab Rabies vaccine on D0 D28 and D56
Sentinel participants The first 3 participants enrolled in Group 1 will be sentinels who will be vaccinated in an open label manner To ensure blinding the first 4 participants enrolled in Groups 2-5 will be sentinels who will be vaccinated with either SUM-101 or control vaccine The sentinel participants will be vaccinated in the following order Arm1_Group 1 sentinels On the first day the first participant will be enrolled and vaccinated alone and observed on the day following vaccination If there are no safety concerns another two participants will be enrolled and vaccinated in a sequential manner at least 48 hours after the first participant and with a minimum interval between participants of 60 min to allow monitoring of any acute events The remaining participants will be vaccinated at least 72 hours after the third sentinel participant as long as there are no safety concerns
Arm2_Groups 2-5 sentinels On the first day two participants will be enrolled and vaccinated in a sequential manner with a minimum interval between the participants of 60 min to allow monitoring of any acute events These two vaccinated participants will then be observed on the day following vaccination If there are no safety concerns another two participants will be enrolled and vaccinated in a sequential manner at least 48 hours after the first participant and with a minimum interval between participants of 60 min to allow monitoring of any acute events The remaining participants will be vaccinated at least 72 hours after the fourth sentinel participant as long as there are no safety concerns
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