Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613789
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Comparing the Safety and Immunogenicity of 426cModCore-C4b Vaccine Adjuvanted with 3M-052-AF Alum in Infants with Perinatal HIV Exposure Who Are Without HIV At Birth
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of 426cModCore-C4b Vaccine Adjuvanted with 3M-052-AF Alum in Infants with Perinatal HIV Exposure Who Are Without HIV At Birth
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:
HVTN 316
Brief Summary:
The purpose of this study is to evaluate the safety and immunogenicity of 426cModCore-C4b vaccine adjuvanted with 3M-052-AF Alum in infants with perinatal HIV exposure who are without HIV at birth
Detailed Description:
This study will compare the safety and immunogenicity of an experimental HIV vaccine in infants with perinatal HIV exposure who are without HIV at birth The study vaccine is called 426cModCore-C4b The vaccine is mixed with an adjuvant called 3M-052-AF Alum
This study is divided into 2 parts Part A and B Part A has 4 groups while Part B has 2 groups Part A of the study is testing the vaccine alone or in combination with different doses of adjuvant Part B is testing study vaccine and the safest dose of adjuvants from Part A versus placebo Depending on their group participants will receive 426cModCore-C4b 426cModCore-C4b vaccine adjuvanted with 3M-052-AF Alum or a placebo by injection at Months 0 3 and 7
Additional study visits will occur at Day 1 Week 2 Month 3 12 Month 7 12 Month 10 Year 1 Year 1 12 and Year 1 34 Study visits may include physical exams blood and saliva collection for the infants and questionnaires counselling blood and optional breastmilk collection for the mothers of infants
This study is divided into 2 parts Part A and B Part A has 4 groups while Part B has 2 groups Part A of the study is testing the vaccine alone or in combination with different doses of adjuvant Part B is testing study vaccine and the safest dose of adjuvants from Part A versus placebo Depending on their group participants will receive 426cModCore-C4b 426cModCore-C4b vaccine adjuvanted with 3M-052-AF Alum or a placebo by injection at Months 0 3 and 7
Additional study visits will occur at Day 1 Week 2 Month 3 12 Month 7 12 Month 10 Year 1 Year 1 12 and Year 1 34 Study visits may include physical exams blood and saliva collection for the infants and questionnaires counselling blood and optional breastmilk collection for the mothers of infants
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