Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06306196
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-18
Brief Title:
Immunogenicity and Safety of Hecolin in HIV PositiveNegative Adults and in Children
Sponsor:
International Vaccine Institute
Organization:
International Vaccine Institute
Study Overview
Official Title:
A Phase 2b Open-label Study to Evaluate the Immunogenicity and Safety of Hecolin in HIV PositiveNegative Adult Participants Followed by a Randomized Placebo-controlled Observer-blind Study to Evaluate the Immunogenicity and Safety of Hecolin in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
The primary goal of this clinical trial is to demonstrate non-inferiority of 30 µg of Hecolin in healthy children compared to healthy adults as measured by seroresponse rates SR of anti-HEV IgG titers 4 weeks after 3 doses 0 1 and 6 months and to assess and descriptively compare safety profile data intra and inter age Strata As secondary objectives Geometric Mean Concentration GMC of anti-HEV IgG ELISA will be evaluated 4 weeks after 3 doses 0 1 and 6 months and 4 weeks after 2 doses 0- and 6-months dose in healthy children SR and GMC will also be evaluated 24 weeks after 3 doses and 2 doses The immune response will be compared among adult participants between HIV positive and HIV negative individuals and between virally suppressed and virally unsuppressed HIV positive individuals
Detailed Description:
The primary objective of the study is to demonstrate immune non-inferiority of 30 µg Hecolin when given to healthy children 2-17 years as compared to healthy adults 18-45 years as measured by seroresponse rates SR of anti- HEV IgG ELISA antibody titers 4 weeks after the 3 doses given at 0 1- 6-months Co-primary objective is to assess safety in each age cohort and descriptively compare lower age cohorts with higher age cohorts Other immune parameters would be assessed as secondary objectives Healthy children and adolescents collectively 2-17 years will be compared for immune non-inferiority with healthy adults 18-45 years as measured by geometric mean concentration GMC of anti-HEV IgG ELISA antibody titers 4 weeks after the 3 doses given at 0 1- 6-months Among children 2-17 years 3 doses of Hecolin given at 0 1 and 6 months will be compared with 2 doses of Hecolin given at 1 and 6 months in terms of immune non-inferiority of SR and GMC of anti-HEV IgG ELISA antibody titers The immune response will be compared between HIV positive and HIV negative adults in terms of SR and GMC as measured by anti-HEV IgG ELISA antibody titers at 4 weeks after completing 3 doses of Hecolin 0 1 and 6 months
A total of 860 participants will be enrolled in the study and will be divided into 4 age strata 18-45 years Cohort A 12-17 years Cohort B 6-11 years Cohort C and 2-5 years Cohort D having 410 175 175 and 100 participants respectively Cohort A will be further divided into Arm A1 and A2 having 232 HIV -ve and 178 HIV ve participants respectively All participants in cohort A will receive intramuscular injection of 3 doses of 30 µg Hecolin at 0 1 and 6 months Cohort B will be further divided into Arm B1 B2 and B3 having 70 70 and 35 participants respectively Arm B1 will receive intramuscular injection of 3 doses of 30 µg Hecolin at 0 1 and 6 months Arm B2 will receive intramuscular injection of 2 doses of 30 µg Hecolin at 0 and 6 months while Arm B3 will receive intramuscular injection of comparator placebo intramuscularly at 0 1 and 6 months Similarly Cohort C will be further divided into Arm C1 C2 and C3 having 70 70 and 35 participants respectively Arm C1 will receive intramuscular injection of 3 doses of 30 µg Hecolin at 0 1 and 6 months Arm C2 will receive intramuscular injection of 2 doses of 30 µg Hecolin at 0 and 6 months while Arm C3 will receive intramuscular injection of comparator placebo intramuscularly at 0 1 and 6 months Cohort D will be further divided into Arm D1 D2 and D3 having 40 40 and 20 participants respectively Arm D1 will receive intramuscular injection of 3 doses of 30 µg Hecolin at 0 1 and 6 months Arm D2 will receive intramuscular injection of 2 doses of 30 µg Hecolin at 0 and 6 months while Arm D3 will receive intramuscular injection of comparator placebo intramuscularly at 01 and 6 months
A total of 6 blood samples for immunogenicity will be collected from all participants at Day 0 baseline one month after first vaccination one month after second vaccination 6 months after first vaccination one month after third vaccination and at 6 months after third vaccination
Blood samples will be collected at screening and one month after third vaccination from the HIV arm to document CD4 T cells and HIV Viral load
All participants will be observed at the study site for 30 minutes after each Investigational Product IP injection for any reactogenicity events Local and systemic solicited adverse events will be recorded in a diary card during 7 days after each IP dose while unsolicited adverse events will be recorded during the 4 weeks after each IP injection Serious adverse events SAEs Medically attended adverse events MAAEs and Adverse of special interest AESI will be recorded during the entire study period ie until 6 months post last dose
A total of 860 participants will be enrolled in the study and will be divided into 4 age strata 18-45 years Cohort A 12-17 years Cohort B 6-11 years Cohort C and 2-5 years Cohort D having 410 175 175 and 100 participants respectively Cohort A will be further divided into Arm A1 and A2 having 232 HIV -ve and 178 HIV ve participants respectively All participants in cohort A will receive intramuscular injection of 3 doses of 30 µg Hecolin at 0 1 and 6 months Cohort B will be further divided into Arm B1 B2 and B3 having 70 70 and 35 participants respectively Arm B1 will receive intramuscular injection of 3 doses of 30 µg Hecolin at 0 1 and 6 months Arm B2 will receive intramuscular injection of 2 doses of 30 µg Hecolin at 0 and 6 months while Arm B3 will receive intramuscular injection of comparator placebo intramuscularly at 0 1 and 6 months Similarly Cohort C will be further divided into Arm C1 C2 and C3 having 70 70 and 35 participants respectively Arm C1 will receive intramuscular injection of 3 doses of 30 µg Hecolin at 0 1 and 6 months Arm C2 will receive intramuscular injection of 2 doses of 30 µg Hecolin at 0 and 6 months while Arm C3 will receive intramuscular injection of comparator placebo intramuscularly at 0 1 and 6 months Cohort D will be further divided into Arm D1 D2 and D3 having 40 40 and 20 participants respectively Arm D1 will receive intramuscular injection of 3 doses of 30 µg Hecolin at 0 1 and 6 months Arm D2 will receive intramuscular injection of 2 doses of 30 µg Hecolin at 0 and 6 months while Arm D3 will receive intramuscular injection of comparator placebo intramuscularly at 01 and 6 months
A total of 6 blood samples for immunogenicity will be collected from all participants at Day 0 baseline one month after first vaccination one month after second vaccination 6 months after first vaccination one month after third vaccination and at 6 months after third vaccination
Blood samples will be collected at screening and one month after third vaccination from the HIV arm to document CD4 T cells and HIV Viral load
All participants will be observed at the study site for 30 minutes after each Investigational Product IP injection for any reactogenicity events Local and systemic solicited adverse events will be recorded in a diary card during 7 days after each IP dose while unsolicited adverse events will be recorded during the 4 weeks after each IP injection Serious adverse events SAEs Medically attended adverse events MAAEs and Adverse of special interest AESI will be recorded during the entire study period ie until 6 months post last dose
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