Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00063778
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
2003-07-07
Brief Title:
Safety of an HIV Vaccine AVX101 in HIV Uninfected Volunteers in the United States and South Africa
Sponsor:
AlphaVax Inc
Organization:
AlphaVax Inc
Study Overview
Official Title:
A Phase I Safety and Immunogenicity Trial of an Alphavirus Replicon HIV Subtype C Gag Vaccine AVX101 Alphavax Inc in Healthy HIV-1 Uninfected Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2012-06
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 purpose of this study is to see if different doses of an experimental HIV vaccine are safe and to study how the immune system responds to the vaccine The vaccine will be tested in healthy HIV uninfected volunteers AVX101 contains only one of the many substances that HIV needs to make more copies of itself therefore the vaccine cannot cause HIV or AIDS
Detailed Description:
This study was designed to evaluate the safety and immunogenicity of an alphavirus replicon HIV subtype C gag vaccine This vaccine utilizes a propagation-defective replicon vector system derived from an attenuated strain of Venezuelan Equine Encephalitis VEE virus The vaccine replicon expresses the gag gene from a South African subtype C isolate of HIV-1
This study evaluated the AVX101 vaccine in healthy HIV uninfected volunteers in both the United States and South Africa Participants will be randomized to receive either vaccine or placebo at study entry and again at Months 1 and 3 The study was originally designed to enroll four groups of participants in both the US and South Africa with successive groups receiving increasing doses of the vaccine but was later amended to enroll only two groups Twelve US participants US Group 1 were randomized to receive either vaccine or placebo After a review of initial safety data from this group 12 South African participants SA Group 1 were randomized to receive the same vaccine dose as US Group 1 or placebo while 12 US participants US Group 2 were randomized to receive the next higher vaccine dose or placebo Review of safety data from SA Group 1 and US Group 2 was used to inform the decision to begin enrollment into SA Group 2
Participants had nine study visits over 12 months Study visits included clinical evaluation urine and blood tests and HIV tests After each injection participants were asked to record their temperature and any symptoms each day for 7 days and report them to the clinic staff
This study evaluated the AVX101 vaccine in healthy HIV uninfected volunteers in both the United States and South Africa Participants will be randomized to receive either vaccine or placebo at study entry and again at Months 1 and 3 The study was originally designed to enroll four groups of participants in both the US and South Africa with successive groups receiving increasing doses of the vaccine but was later amended to enroll only two groups Twelve US participants US Group 1 were randomized to receive either vaccine or placebo After a review of initial safety data from this group 12 South African participants SA Group 1 were randomized to receive the same vaccine dose as US Group 1 or placebo while 12 US participants US Group 2 were randomized to receive the next higher vaccine dose or placebo Review of safety data from SA Group 1 and US Group 2 was used to inform the decision to begin enrollment into SA Group 2
Participants had nine study visits over 12 months Study visits included clinical evaluation urine and blood tests and HIV tests After each injection participants were asked to record their temperature and any symptoms each day for 7 days and report them to the clinic staff
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