Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000868
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Safety and Effectiveness of HIV-1 LAI gp120 an HIV Vaccine Given With or Without HIV-1 MN rgp120 Another HIV Vaccine to HIV-Negative Volunteers
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Safety and Immunogenicity Trial of Orally Administered Live Attenuated Recombinant Salmonella Typhi CVD 908 Delta-asd pW57-asd Expressing HIV-1 LAI gp120 VVG 203 and Parenterally Administered HIV-1 MN rgp120 in Alum in HIV-1-Uninfected Volunteers
Status:
COMPLETED
Status Verified Date:
2021-10
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:
The purpose of this study is to evaluate the safety and effectiveness of giving healthy volunteers a new oral HIV vaccine which has been incorporated into a bacterial cell This oral vaccine HIV-1 LAI gp120 will be given with or without a different injected HIV vaccine HIV-1 MN rgp120
Vaccines are preparations that are introduced into the body to try to prevent infection or create resistance to infection This study examines a new oral vaccine to see if it can improve the immune systems ability to fight the HIV virus when given alone or with another injected vaccine
Vaccines are preparations that are introduced into the body to try to prevent infection or create resistance to infection This study examines a new oral vaccine to see if it can improve the immune systems ability to fight the HIV virus when given alone or with another injected vaccine
Detailed Description:
Although recent advances have been made in antiviral therapy for AIDS there is no cure for HIV-1 infection or AIDS and drug therapy is too expensive for most affected populations The development of safe effective vaccines to prevent HIV-1 infection and AIDS worldwide is a global priority One promising approach in the development of HIV-1 vaccines utilizes live vaccines as vectors to express HIV-1 antigens The potential advantages of the live vector approach include the ability of live vector recombinants to induce long-lasting humoral and cell-mediated immunity particularly neutralizing antibody and CD8 cytotoxic T-cell activity and the relatively low cost of production Moreover live vector recombinant vaccines administered orally might be able to stimulate the production of secretory IgA vaccine-specific antibodies locally at relevant mucosal sites
Part I of this study is conducted as an open-label dose-escalation trial The first 5 volunteers Group A receive a single oral dose of Salmonella typhi CVD 908-HIV-1 LAI gp 120 VVG203 If no typhoid fever-like illness is seen in these volunteers during at least 14 days of follow-up the next 5 patients Group B receive a single dose of VVG203 If this higher dose is well-tolerated Phase II of the study is initiated once all Phase I volunteers have been assessed for safety for at least 21 days AS PER AMENDMENT 110797 Groups A and B are expanded to 10 patients each Part II of this study is a randomized placebo-controlled double-blind trial Nine volunteers are randomized to each of treatment groups with oral VVG203 given alone or sequentially with HIV-1 SF-2 rgp 120 in MF59 SF given intramuscularly AS PER AMENDMENT 110797 Randomization is to VVG 203 alone or sequentially with HIV-1 MN rgp120 in alum MN A total of 3 vaccinations are administered within each 9-person cohort 1 volunteer serves as a control and receives a sodium bicarbonate buffer rather than VVG203 or a vaccine placebo rather than SF Group C receives VVG at Month 0 and SF at Months 2 and 6 Group D receives VVG at Months 0 2 and 6 Group E receives SF at Months 0 and 2 and VVG at Month 6 AS PER AMENDMENT 110797 MN is given in place of SF in all Groups C D and E
Part I of this study is conducted as an open-label dose-escalation trial The first 5 volunteers Group A receive a single oral dose of Salmonella typhi CVD 908-HIV-1 LAI gp 120 VVG203 If no typhoid fever-like illness is seen in these volunteers during at least 14 days of follow-up the next 5 patients Group B receive a single dose of VVG203 If this higher dose is well-tolerated Phase II of the study is initiated once all Phase I volunteers have been assessed for safety for at least 21 days AS PER AMENDMENT 110797 Groups A and B are expanded to 10 patients each Part II of this study is a randomized placebo-controlled double-blind trial Nine volunteers are randomized to each of treatment groups with oral VVG203 given alone or sequentially with HIV-1 SF-2 rgp 120 in MF59 SF given intramuscularly AS PER AMENDMENT 110797 Randomization is to VVG 203 alone or sequentially with HIV-1 MN rgp120 in alum MN A total of 3 vaccinations are administered within each 9-person cohort 1 volunteer serves as a control and receives a sodium bicarbonate buffer rather than VVG203 or a vaccine placebo rather than SF Group C receives VVG at Month 0 and SF at Months 2 and 6 Group D receives VVG at Months 0 2 and 6 Group E receives SF at Months 0 and 2 and VVG at Month 6 AS PER AMENDMENT 110797 MN is given in place of SF in all Groups C D and E
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10578 | REGISTRY | DAIDS ES Registry Number | None |