Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119067
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2005-07-06
Brief Title:
Anthrax Vaccine Clinical Trial to Assess Dose Reduction and Route Change
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Anthrax Vaccine Adsorbed Human Reactogenicity and Immunogenicity Trial to Address Change in Route of Administration and Dose Reduction
Status:
COMPLETED
Status Verified Date:
2024-05
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:
AVRP
Brief Summary:
Anthrax Clinical Trial Objectives
To assess whether
Anthrax vaccine AVA or BioThrax BioPort Corp Lansing MI administered by the intramuscular IM route elicits antibody responses that are not inferior ie non-inferior to that achieved by the currently licensed schedule
BioThrax administered by the IM route and containing fewer numbers of doses elicits antibody responses that are not inferior ie non-inferior to that achieved by the currently licensed schedule
Differences in reactogenicity exist between the IM and subcutaneous SQ administration of BioThrax
Additionally for the final report we will assess whether
Occurrence of adverse events following AVA administration is influenced by selected risk factors
To assess whether
Anthrax vaccine AVA or BioThrax BioPort Corp Lansing MI administered by the intramuscular IM route elicits antibody responses that are not inferior ie non-inferior to that achieved by the currently licensed schedule
BioThrax administered by the IM route and containing fewer numbers of doses elicits antibody responses that are not inferior ie non-inferior to that achieved by the currently licensed schedule
Differences in reactogenicity exist between the IM and subcutaneous SQ administration of BioThrax
Additionally for the final report we will assess whether
Occurrence of adverse events following AVA administration is influenced by selected risk factors
Detailed Description:
This study is a 43-month prospective randomized double-blind placebo-controlled comparison of immunogenicity and reactogenicity elicited by BioThrax given by different routes of administration SQ versus IM and dosing regimens as many as 8 doses versus as few as 4 doses Sterile saline is used as the placebo where doses are dropped in regimens using AVA and in the all-placebo study group
This study is conducted among a total of 1564 healthy adult men and women 18 to 61 years of age at five sites in the United States Participants were randomized into one of 6 study groups with 260 participants per group One group receives BioThrax given as currently licensed SQ with 6 doses followed by annual boosters another group is given placebo IM 130 participants or SQ 130 participants in the currently licensed dosing regimen The four other groups receive BioThrax IM in modified dosing regimens placebo is given when a dose of BioThrax is omitted from the licensed dosing regimen There are a total of 25 required visits for this study during which all participants receive an injection of vaccine or placebo 8 injections total have a blood sample drawn 16 or 17 total and have an in-clinic examination for adverse events 22 total
Immunogenicity is assessed by assaying 16 serial blood samples obtained from all participants and a 17th sample from a subset of participants before vaccination and at other specified times Total anti-protective antigen IgG antibody anti-PA IgG is quantified using a standardized and validated enzyme-linked immunosorbent assay ELISA the primary study endpoints are 4-fold rise in antibody titer and antibody concentration relative to the pre-vaccination titers or assay reactivity threshold A subset of serum samples is also assayed in an in vitro toxin neutralization assay TNA to measure the functional activity of anti-BioThrax antibodies The kinetics of the immune response to BioThrax are examined at 3 time points in the study and blood samples from a subset of participants will be further tested in correlates of protection and immunogenetics substudies All adverse events AEs including vaccine reactogenicity are actively monitored While all AEs will be ascertained among study participants several endpoints will be defined based on the likelihood of their occurrence andor their clinical importance Of primary interest is the occurrence of local AEs such as warmth tenderness itching pain arm motion limitation erythema induration nodule and bruise Systemic AEs such as fever fatigue muscle ache headache temperature and painful axillary adenopathy are also evaluated
This study is expected to provide the basis for consideration of change in route of BioThrax administration from SQ to IM and reduction in number of vaccine doses required for primary and booster immunization
There is an interim analysis of data collected through each participants first 7 months of this study for consideration in changing the route of BioThrax administration from SQ to IM and elimination of the 2 week vaccine priming dose
At the end of the study the Sponsor will present the entire results of the trial to FDA for consideration in elimination of additional doses from the licensed BioThrax schedule At that time the Sponsor will also supplement these data with results from parallel non-human primate challenge studies and additional research on immunologic correlates of protection
This study is conducted among a total of 1564 healthy adult men and women 18 to 61 years of age at five sites in the United States Participants were randomized into one of 6 study groups with 260 participants per group One group receives BioThrax given as currently licensed SQ with 6 doses followed by annual boosters another group is given placebo IM 130 participants or SQ 130 participants in the currently licensed dosing regimen The four other groups receive BioThrax IM in modified dosing regimens placebo is given when a dose of BioThrax is omitted from the licensed dosing regimen There are a total of 25 required visits for this study during which all participants receive an injection of vaccine or placebo 8 injections total have a blood sample drawn 16 or 17 total and have an in-clinic examination for adverse events 22 total
Immunogenicity is assessed by assaying 16 serial blood samples obtained from all participants and a 17th sample from a subset of participants before vaccination and at other specified times Total anti-protective antigen IgG antibody anti-PA IgG is quantified using a standardized and validated enzyme-linked immunosorbent assay ELISA the primary study endpoints are 4-fold rise in antibody titer and antibody concentration relative to the pre-vaccination titers or assay reactivity threshold A subset of serum samples is also assayed in an in vitro toxin neutralization assay TNA to measure the functional activity of anti-BioThrax antibodies The kinetics of the immune response to BioThrax are examined at 3 time points in the study and blood samples from a subset of participants will be further tested in correlates of protection and immunogenetics substudies All adverse events AEs including vaccine reactogenicity are actively monitored While all AEs will be ascertained among study participants several endpoints will be defined based on the likelihood of their occurrence andor their clinical importance Of primary interest is the occurrence of local AEs such as warmth tenderness itching pain arm motion limitation erythema induration nodule and bruise Systemic AEs such as fever fatigue muscle ache headache temperature and painful axillary adenopathy are also evaluated
This study is expected to provide the basis for consideration of change in route of BioThrax administration from SQ to IM and reduction in number of vaccine doses required for primary and booster immunization
There is an interim analysis of data collected through each participants first 7 months of this study for consideration in changing the route of BioThrax administration from SQ to IM and elimination of the 2 week vaccine priming dose
At the end of the study the Sponsor will present the entire results of the trial to FDA for consideration in elimination of additional doses from the licensed BioThrax schedule At that time the Sponsor will also supplement these data with results from parallel non-human primate challenge studies and additional research on immunologic correlates of protection
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