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
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Prevention
|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.|
- Humoral- ELISA and Western Blot antibodies to HIV-1 subtype B gag p24.
- Cellular- Cytotoxic T-lymphocyte (CTL) responses against subtype B gag antigen target expressed in Epstein Barr Virus (EBV) transformed autologous B cell lines.
- IFN - ELISPOT assay against HIV-gag antigen.
- IFN- ICS assay against HIV-gag antigen.
- Lymphocyte proliferative responses to HIV-1 subtype B gag
- Humoral- Binding antibodies to LFn
- Neutralizing antibodies to Lfn
- Cellular: -Lymphoproliferation to LFn
|Study Start Date:||August 2004|
|Estimated Study Completion Date:||November 2006|
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 D.C. area.
The study’s 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 visits.renee
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.
Group Subjects 0 4th Week 16th Week I *6 150g LFn-p24 Alhydrogel 150g LFn-p24 Alhydrogel 150g LFn-p24 Alhydrogel II *6 300g LFn-p24 Alhydrogel 300g LFn-p24 Alhydrogel 300g LFn-p24 Alhydrogel III *6 450µg LFn-p24 Alhydrogel 450µg LFn-p24 Alhydrogel 450µg LFn-p24 Alhydrogel
*Six subjects per group includes 4 vaccinees and 2 placebos.
|United States, Maryland|
|Vaccine Clinical Research Center|
|Rockville, Maryland, United States, 20850|
|Principal Investigator:||CDR Shirley Lee-Lecher, MD||Walter Reed Army Institute of Research (WRAIR)|