Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097838
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
2004-11-30
Brief Title:
Safety of and Immune Response to an HIV-1 Subtype C Vaccine AVX101 in HIV Uninfected Adults
Sponsor:
AlphaVax Inc
Organization:
AlphaVax Inc
Study Overview
Official Title:
A Phase I Dose Escalation Safety and Immunogenicity Trial of an Alphavirus Replicon HIV-1 Subtype C Gag Vaccine AVX101 in Healthy HIV-1 Uninfected Adult Participants
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 evaluate the safety of and immune response to an alphavirus replicon HIV-1 subtype C gag vaccine AVX101 in HIV uninfected adults in the United States South Africa and Botswana
Detailed Description:
HIV-1 subtype C is the prevailing subtype of HIV found in sub-Saharan Africa and is primarily responsible for the HIVAIDS epidemic in southern Africa Thus development of a preventive subtype C vaccine is critically important in controlling the spread of HIV in this part of the world This study will determine the safety and immunogenicity of an alphavirus replicon HIV-1 subtype C gag vaccine AVX101 in HIV uninfected adults 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 Participants will be recruited in the United States South Africa and Botswana
The study will last for 1 year Participants will be enrolled sequentially from lowest to highest dose of vaccine into one of four groups Groups will begin enrollment only following safety review of the previous group Participants will be randomly assigned to receive active vaccine or placebo During the study participants will receive either 3 injections of one of four possible doses of the vaccine or 3 injections of placebo Injections will be given at study entry and at Days 28 and 84 At screening participants will undergo medical history assessment a complete physical HIV testing and counseling and blood and urine collection they will also be interviewed and asked to complete a questionnaire After screening there will be 8 study visits the visits will occur at Days 14 28 42 84 98 168 273 and 364 Participants will be interviewed and asked to fill out a questionnaire at each study visit participants will undergo a physical additional HIV testing and counseling and blood and urine collection at selected visits
The study will last for 1 year Participants will be enrolled sequentially from lowest to highest dose of vaccine into one of four groups Groups will begin enrollment only following safety review of the previous group Participants will be randomly assigned to receive active vaccine or placebo During the study participants will receive either 3 injections of one of four possible doses of the vaccine or 3 injections of placebo Injections will be given at study entry and at Days 28 and 84 At screening participants will undergo medical history assessment a complete physical HIV testing and counseling and blood and urine collection they will also be interviewed and asked to complete a questionnaire After screening there will be 8 study visits the visits will occur at Days 14 28 42 84 98 168 273 and 364 Participants will be interviewed and asked to fill out a questionnaire at each study visit participants will undergo a physical additional HIV testing and counseling and blood and urine collection at selected visits
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