Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00374309
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-09-08
Brief Title:
Experimental Vaccine for Prevention of Ebola Virus Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Ebola Adenoviral Vector Vaccine VRC-EBOADV018-00-VP in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2009-05-05
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:
None
Brief Summary:
This study will determine if an experimental vaccine to prevent Ebola virus infection is safe and what side effects if any it causes Ebola virus infection may range from mild to severe and may cause breathing problems severe bleeding kidney problems and shock that can lead to death The vaccine used in this study contains man-made genetic material similar to one part of the Ebola virus which is designed to stimulate an immune response to the virus The vaccine itself cannot cause Ebola virus infection because it does not contain any Ebola virus
Participants are assigned to one of three groups as they enter into the study Of the first 16 people in the study 12 receive the lowest study dose of vaccine and 4 receive placebo an inactive substance If this dose is safe then of the next 16 people who enter the study 12 receive a higher dose of the vaccine and the remaining 4 receive placebo If this dose is safe the final 12 people in the last group of 16 receive the highest study dose and 4 receive placebo The vaccine is given as a single injection in the arm on the day of enrollment
Participants keep a diary for 5 days recording their temperature symptoms and any reaction at the injection site They call a study nurse the day after vaccination to report how they feel and they return to the clinic approximately six times for follow-up evaluations These visits may include a check of vital signs physical examination blood and urine tests or other medical tests if needed
Participants are assigned to one of three groups as they enter into the study Of the first 16 people in the study 12 receive the lowest study dose of vaccine and 4 receive placebo an inactive substance If this dose is safe then of the next 16 people who enter the study 12 receive a higher dose of the vaccine and the remaining 4 receive placebo If this dose is safe the final 12 people in the last group of 16 receive the highest study dose and 4 receive placebo The vaccine is given as a single injection in the arm on the day of enrollment
Participants keep a diary for 5 days recording their temperature symptoms and any reaction at the injection site They call a study nurse the day after vaccination to report how they feel and they return to the clinic approximately six times for follow-up evaluations These visits may include a check of vital signs physical examination blood and urine tests or other medical tests if needed
Detailed Description:
Study Design
This is a Phase I randomized placebo-controlled double-blinded study to examine safety tolerability and immune response of a recombinant Ebola adenovirus serotype 5 vector Ebola-rAd5 vaccine in healthy adults The hypothesis is that this vaccine will be safe and elicit immune responses to Ebola The primary objective is to evaluate the safety and tolerability of the investigational vaccine VRC-EBOADV018-00-VP in healthy subjects The secondary objectives include immunogenicity evaluations and adenovirus serotype 5 antibody titers Ad5 Ab at Weeks 0 4 and 24 Exploratory evaluations include immunogenicity evaluations at Weeks 2 12 and 48
Product Description
VRC-EBOADV018-00-VP is a recombinant product composed of two replication-deficient recombinant adenovirus serotype 5 rAd5 vectors encoding for glycoprotein GP one from the Zaire strain and one from the Sudan-Gulu strain of Ebola The final formulation buffer will be used as the diluent and as the placebo control Crucell placebo Injections will be administered intramuscularly IM by needle and syringe
Subjects
Healthy adult subjects ages 18 to 50 years old
Study Plan
Forty-eight subjects will receive a 1 mL intramuscular IM deltoid injection via needle and syringe of the study agent or placebo in a deltoid muscle as shown in the schema Dose escalation will occur about three weeks after the last injection in the preceding dose group following an interim safety data review by a Data and Safety Monitoring Board DSMB provided that there are no significant toxicities No more than one subject per day will be enrolled for the first 6 enrollments into each dosage group and the sixth subject enrolled must have 5 days Group 1 or 14 days Group 2 and Group 3 of follow-up before proceeding with further enrollments into that group
Study Duration
Subjects will be evaluated at 7 or more clinical visits during the 48 weeks after the study injection
Study Endpoints
The primary endpoint is safety and tolerability of the vaccine administered at doses of 2 x 109 2 x 1010 and 2 x 1011 virus particles VP by IM injection Secondary endpoints are immunogenicity as indicated by Ebola-specific antibody and cellular immune responses at Weeks 0 4 and 24 and Ad5 antibody titer at Weeks 0 4 and 24 Exploratory analyses of immunogenicity will also be conducted on stored samples collected at other timepoints including Weeks 2 12 and 48
This is a Phase I randomized placebo-controlled double-blinded study to examine safety tolerability and immune response of a recombinant Ebola adenovirus serotype 5 vector Ebola-rAd5 vaccine in healthy adults The hypothesis is that this vaccine will be safe and elicit immune responses to Ebola The primary objective is to evaluate the safety and tolerability of the investigational vaccine VRC-EBOADV018-00-VP in healthy subjects The secondary objectives include immunogenicity evaluations and adenovirus serotype 5 antibody titers Ad5 Ab at Weeks 0 4 and 24 Exploratory evaluations include immunogenicity evaluations at Weeks 2 12 and 48
Product Description
VRC-EBOADV018-00-VP is a recombinant product composed of two replication-deficient recombinant adenovirus serotype 5 rAd5 vectors encoding for glycoprotein GP one from the Zaire strain and one from the Sudan-Gulu strain of Ebola The final formulation buffer will be used as the diluent and as the placebo control Crucell placebo Injections will be administered intramuscularly IM by needle and syringe
Subjects
Healthy adult subjects ages 18 to 50 years old
Study Plan
Forty-eight subjects will receive a 1 mL intramuscular IM deltoid injection via needle and syringe of the study agent or placebo in a deltoid muscle as shown in the schema Dose escalation will occur about three weeks after the last injection in the preceding dose group following an interim safety data review by a Data and Safety Monitoring Board DSMB provided that there are no significant toxicities No more than one subject per day will be enrolled for the first 6 enrollments into each dosage group and the sixth subject enrolled must have 5 days Group 1 or 14 days Group 2 and Group 3 of follow-up before proceeding with further enrollments into that group
Study Duration
Subjects will be evaluated at 7 or more clinical visits during the 48 weeks after the study injection
Study Endpoints
The primary endpoint is safety and tolerability of the vaccine administered at doses of 2 x 109 2 x 1010 and 2 x 1011 virus particles VP by IM injection Secondary endpoints are immunogenicity as indicated by Ebola-specific antibody and cellular immune responses at Weeks 0 4 and 24 and Ad5 antibody titer at Weeks 0 4 and 24 Exploratory analyses of immunogenicity will also be conducted on stored samples collected at other timepoints including Weeks 2 12 and 48
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-I-0237 | None | None | None |