Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412477
Status:
COMPLETED
Last Update Posted:
2018-10-10
First Post:
2006-12-15
Brief Title:
A Phase I Study of Safety and Immunogenicity of the WRAIR HIV-1 Vaccine
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
Official Title:
RV 151 A Phase I Study of Safety and Immunogenicity of the WRAIR HIV-1 Vaccine LFn-p24 Administered by the Intramuscular IM Route in Healthy Adults WRAIR 984 HSRRB Log A-11905
Status:
COMPLETED
Status Verified Date:
2018-10
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:
To evaluate the safety of LFn-p24 administered at three different doses with Alhydrogel given intramuscularly
To evaluate immune responses to LFn-p24 with Alhydrogel at three different doses given intramuscularly
To evaluate immune responses to LFn-p24 with Alhydrogel at three different doses given intramuscularly
Detailed Description:
The study seeks to enroll healthy vaccine naïve volunteers 18 through 45 years old Recruitment consists of using flyers newspaper advertising radio and direct mailing at local military installations targeting the general population of the greater Washington DC area
The studys primary objective is the safety and tolerability of Lfn-p24 given IM
Volunteers will be screened visit 1 and enrolled within 2 to 12 weeks prior to the first vaccination Study volunteers will receive a briefing from the Principal Investigator PI or a sub investigator The briefing is followed by an opportunity for questions from the volunteers The PI or designee will then review the consent form with potential volunteers visit 1 and answer any questions After review an Informed Consent will be signed and a Test of Understanding will be completed by all volunteers prior to enrollment in the study A second pre-screening visit visit 2 will occur 3 - 30 days prior to the first vaccination visit 3 to confirm eligibility for vaccination During this visit each volunteer will have an opportunity to ask questions about the study
On the day of vaccination visits 3 6 and 10 volunteers will be observed for 30 minutes following injection for acute adverse experiences and will be contacted the day following injection for a brief adverse reaction interview In addition volunteers will complete diaries for 7 days following each vaccination and will be evaluated by a clinical investigator if significant symptoms are reported Adverse effects and laboratory abnormalities will be tabulated Routine measurements of hematology serum chemistry and urinalysis laboratory tests will be performed in subsequent safety and general follow up visitsrenee
LFn-p24 with Alhydrogel adjuvant will be delivered IM in the deltoid muscle at the intervals shown below Groups will be enrolled in staggered fashion beginning with the lowest dose group The subsequent groups receiving higher doses will then be enrolled by the investigator if the second injection of the immediate lower dose is shown to be safe and well tolerated grade II toxicity after the 2 week post vaccination follow-up visit
IMMUNIZATION SCHEDULE
Group I Subjects 6 0150µg LFn-p24 Alhydrogel4th Week150µg LFn-p24 Alhydrogel 16th Week150µg LFn-p24 Alhydrogel Group II Subjects 6 0300µg LFn-p24 Alhydrogel 4th Week 300µg LFn-p24 Alhydrogel 16th Week 300µg LFn-p24 Alhydrogel Group III Subjects 6 0 450µg LFn-p24 Alhydrogel 4th Week 450µg LFn-p24 Alhydrogel 16th Week 450µg LFn-p24 Alhydrogel
Six subjects per group includes 4 vaccines and 2 placebos
The studys primary objective is the safety and tolerability of Lfn-p24 given IM
Volunteers will be screened visit 1 and enrolled within 2 to 12 weeks prior to the first vaccination Study volunteers will receive a briefing from the Principal Investigator PI or a sub investigator The briefing is followed by an opportunity for questions from the volunteers The PI or designee will then review the consent form with potential volunteers visit 1 and answer any questions After review an Informed Consent will be signed and a Test of Understanding will be completed by all volunteers prior to enrollment in the study A second pre-screening visit visit 2 will occur 3 - 30 days prior to the first vaccination visit 3 to confirm eligibility for vaccination During this visit each volunteer will have an opportunity to ask questions about the study
On the day of vaccination visits 3 6 and 10 volunteers will be observed for 30 minutes following injection for acute adverse experiences and will be contacted the day following injection for a brief adverse reaction interview In addition volunteers will complete diaries for 7 days following each vaccination and will be evaluated by a clinical investigator if significant symptoms are reported Adverse effects and laboratory abnormalities will be tabulated Routine measurements of hematology serum chemistry and urinalysis laboratory tests will be performed in subsequent safety and general follow up visitsrenee
LFn-p24 with Alhydrogel adjuvant will be delivered IM in the deltoid muscle at the intervals shown below Groups will be enrolled in staggered fashion beginning with the lowest dose group The subsequent groups receiving higher doses will then be enrolled by the investigator if the second injection of the immediate lower dose is shown to be safe and well tolerated grade II toxicity after the 2 week post vaccination follow-up visit
IMMUNIZATION SCHEDULE
Group I Subjects 6 0150µg LFn-p24 Alhydrogel4th Week150µg LFn-p24 Alhydrogel 16th Week150µg LFn-p24 Alhydrogel Group II Subjects 6 0300µg LFn-p24 Alhydrogel 4th Week 300µg LFn-p24 Alhydrogel 16th Week 300µg LFn-p24 Alhydrogel Group III Subjects 6 0 450µg LFn-p24 Alhydrogel 4th Week 450µg LFn-p24 Alhydrogel 16th Week 450µg LFn-p24 Alhydrogel
Six subjects per group includes 4 vaccines and 2 placebos
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HSRRB Log A-11905 | OTHER | USAMRMC | None |