Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001043
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase I Multicenter Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein rgp160 of Human Immunodeficiency Virus at Two Different Vaccination Schedules
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 Multicenter Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein rgp160 of Human Immunodeficiency Virus at Two Different Vaccination Schedules
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:
AMENDED 894 To expand the safety and immunogenicity profile of MN rgp160 vaccine Immuno-AG by administering a higher dose 800 mcg at 0 1 6 and 12 months and 0 2 8 and 14 months these two schedules were compared in VEU 013A using a dose of 200 mcg To obtain plasma following the fourth immunization To evaluate skin test reactivity
ORIGINAL replaced To determine in healthy volunteers the safety and immunogenicity of two immunizations of MN rgp160 vaccine Immuno-AG in combination with a live recombinant vaccinia virus LAV HIV-1 gp160 vaccine HIVAC-1e versus DryVax the standard smallpox vaccine that was used for many years control in combination with placebo
ORIGINAL replaced A gp160 vaccine derived from the MN strain the most prevalent strain of HIV-1 in the United States has been developed A previous study showed that a combination vaccine strategy consisting of priming with HIVAC-1e followed by boosting with a gp160 subunit vaccine resulted in humoral and cellular immune responses of greater and longer duration than either vaccine alone Thus a live vectorsubunit boost approach using the MN rgp160 vaccine merits investigation
ORIGINAL replaced To determine in healthy volunteers the safety and immunogenicity of two immunizations of MN rgp160 vaccine Immuno-AG in combination with a live recombinant vaccinia virus LAV HIV-1 gp160 vaccine HIVAC-1e versus DryVax the standard smallpox vaccine that was used for many years control in combination with placebo
ORIGINAL replaced A gp160 vaccine derived from the MN strain the most prevalent strain of HIV-1 in the United States has been developed A previous study showed that a combination vaccine strategy consisting of priming with HIVAC-1e followed by boosting with a gp160 subunit vaccine resulted in humoral and cellular immune responses of greater and longer duration than either vaccine alone Thus a live vectorsubunit boost approach using the MN rgp160 vaccine merits investigation
Detailed Description:
ORIGINAL replaced A gp160 vaccine derived from the MN strain the most prevalent strain of HIV-1 in the United States has been developed A previous study showed that a combination vaccine strategy consisting of priming with HIVAC-1e followed by boosting with a gp160 subunit vaccine resulted in humoral and cellular immune responses of greater and longer duration than either vaccine alone Thus a live vectorsubunit boost approach using the MN rgp160 vaccine merits investigation
AMENDED 894 Volunteers are randomized to receive 800 mcg MN rgp160 vaccine Immuno-AG or adjuvant control placebo on one of two dosing schedules Sixteen volunteers receive candidate vaccine and four volunteers receive placebo
ORIGINAL replaced Volunteers are randomized to receive either HIVAC-1e on days 0 and 56 followed by immunization with MN rgp160 vaccine on days 224 and 364 or DryVax control on days 0 and 56 followed by placebo on days 224 and 364 Ten volunteers are entered on the MN rgp160 vaccine arm and two volunteers on the placebo arm
PER AMENDMENT 796 Two additional booster immunizations of 600 mcg of MN rgp 120HIV-1 vaccine given at study months 22 and 24 to consenting St Louis University volunteers
AMENDED 894 Volunteers are randomized to receive 800 mcg MN rgp160 vaccine Immuno-AG or adjuvant control placebo on one of two dosing schedules Sixteen volunteers receive candidate vaccine and four volunteers receive placebo
ORIGINAL replaced Volunteers are randomized to receive either HIVAC-1e on days 0 and 56 followed by immunization with MN rgp160 vaccine on days 224 and 364 or DryVax control on days 0 and 56 followed by placebo on days 224 and 364 Ten volunteers are entered on the MN rgp160 vaccine arm and two volunteers on the placebo arm
PER AMENDMENT 796 Two additional booster immunizations of 600 mcg of MN rgp 120HIV-1 vaccine given at study months 22 and 24 to consenting St Louis University volunteers
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10560 | REGISTRY | DAIDS ES Registry Number | None |