Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04607408
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2020-10-16
Brief Title:
Evaluating Safety and Immune Response to the HIV-1 CH505 TransmittedFounder gp120 Adjuvanted With GLA-SE in Healthy HIV-exposed Uninfected Infants
Sponsor:
HIV Vaccine Trials Network
Organization:
HIV Vaccine Trials Network
Study Overview
Official Title:
A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of the HIV-1 CH505 TransmittedFounder gp120 Adjuvanted With GLA-SE in Healthy HIV-exposed Uninfected Infants
Status:
COMPLETED
Status Verified Date:
2024-08
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:
HVTN 135
Brief Summary:
This study will evaluate the safety and immune response in healthy HIV-exposed and uninfected infants to the protein vaccine CH505TF gp120 adjuvanted with GLA-SE
Detailed Description:
This study will evaluate the safety and immune response in healthy HIV-exposed and uninfected infants to the protein vaccine CH505TF gp120 adjuvanted with GLA-SE
This study will enroll 38 mother-infant pairs To quantify the maternal HIV antibody response mothers will also be enrolled in the study but will not receive study product Infants will receive the CH505TF gp120 protein adjuvanted with GLA-SE at Weeks 0 8 16 32 and 54 The first dose will be given within the first five days of life
The study will be conducted in three parts Parts A B and C and to ensure safety enrollment will proceed in stages
Part A Initial Safety will enroll first 5 infants in Part A will receive a low dose of protein with a low dose of adjuvant and 2 infants will receive placebo
After safety review post first vaccination of infants in Part A Part B will enroll In Part B Safety Ramp-Up 2 infants will receive a higher dose of protein with a higher dose of adjuvant and 2 infants will receive placebo
After safety review post first vaccination of infants in Part B Part C will enroll In Part C Immunogenicity 5 infants will receive low dose protein with higher dose of adjuvant 16 infants will receive a higher dose of protein with higher dose of adjuvant and 6 infants will receive placebo
There are 14 scheduled clinic visits over 245 months For infants study visits may include physical examinations medical history vaccine injections HIV testing and blood cord blood and stool collection For mothers study visits may include medical history physical examinations questionnaires risk reduction counseling and blood breastmilk and stool collection
This study will enroll 38 mother-infant pairs To quantify the maternal HIV antibody response mothers will also be enrolled in the study but will not receive study product Infants will receive the CH505TF gp120 protein adjuvanted with GLA-SE at Weeks 0 8 16 32 and 54 The first dose will be given within the first five days of life
The study will be conducted in three parts Parts A B and C and to ensure safety enrollment will proceed in stages
Part A Initial Safety will enroll first 5 infants in Part A will receive a low dose of protein with a low dose of adjuvant and 2 infants will receive placebo
After safety review post first vaccination of infants in Part A Part B will enroll In Part B Safety Ramp-Up 2 infants will receive a higher dose of protein with a higher dose of adjuvant and 2 infants will receive placebo
After safety review post first vaccination of infants in Part B Part C will enroll In Part C Immunogenicity 5 infants will receive low dose protein with higher dose of adjuvant 16 infants will receive a higher dose of protein with higher dose of adjuvant and 6 infants will receive placebo
There are 14 scheduled clinic visits over 245 months For infants study visits may include physical examinations medical history vaccine injections HIV testing and blood cord blood and stool collection For mothers study visits may include medical history physical examinations questionnaires risk reduction counseling and blood breastmilk and stool collection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UM1AI068614 | NIH | None | httpsreporternihgovquickSearchUM1AI068614 |