Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001019
Status:
COMPLETED
Last Update Posted:
2012-10-30
First Post:
1999-11-02
Brief Title:
Safety of and Immune Response to an HIV Vaccine SF-2 gp120 With or Without MTP-PEMF59 Adjuvant
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 Clinical Trial to EvaluatePart A The Safety and Immunogenicity of Two Dose Levels of SF-2 gp120 CHO With or Without MTP-PE Adjuvant in the MF59 Emulsion Part B The Safety and Immunogenicity of Five Monthly Doses of 50 mcg gp120 Protein in MF59 Emulsion Without MTP-PE Versus the Emulsion Control
Status:
COMPLETED
Status Verified Date:
2012-10
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:
Part A To compare the safety and immunogenicity of two dose levels of gp120 CHO in MF59 emulsion alone or with MTP-PEMF59 adjuvant administered at 0 1 and 6 months
Part B To evaluate the safety and immunogenicity of gp120 in MF59 when administered in five monthly injections
One experimental AIDS vaccine is the gp120 vaccine The HIV envelope glycoprotein 120 is manufactured through recombinant DNA technology and used as an immunogen Antibodies directed against gp120 can neutralize HIV-1 and gp120 can also stimulate certain types of cell-mediated immune responses Because many immunogens including candidate HIV vaccines may evoke relatively weak immune responses the use of adjuvants or substances that augment immune responses to vaccines is of interest MTP-PEMF59 composed of the immunomodulator MTP-PE combined with MF59 emulsion appears to be a promising adjuvant and has been selected for studies with the gp120 vaccine
Part B To evaluate the safety and immunogenicity of gp120 in MF59 when administered in five monthly injections
One experimental AIDS vaccine is the gp120 vaccine The HIV envelope glycoprotein 120 is manufactured through recombinant DNA technology and used as an immunogen Antibodies directed against gp120 can neutralize HIV-1 and gp120 can also stimulate certain types of cell-mediated immune responses Because many immunogens including candidate HIV vaccines may evoke relatively weak immune responses the use of adjuvants or substances that augment immune responses to vaccines is of interest MTP-PEMF59 composed of the immunomodulator MTP-PE combined with MF59 emulsion appears to be a promising adjuvant and has been selected for studies with the gp120 vaccine
Detailed Description:
One experimental AIDS vaccine is the gp120 vaccine The HIV envelope glycoprotein 120 is manufactured through recombinant DNA technology and used as an immunogen Antibodies directed against gp120 can neutralize HIV-1 and gp120 can also stimulate certain types of cell-mediated immune responses Because many immunogens including candidate HIV vaccines may evoke relatively weak immune responses the use of adjuvants or substances that augment immune responses to vaccines is of interest MTP-PEMF59 composed of the immunomodulator MTP-PE combined with MF59 emulsion appears to be a promising adjuvant and has been selected for studies with the gp120 vaccine
In Part A 32 volunteers eight on each of four treatment arms are randomized to receive one of two doses 15 or 50 mcg of gp120 vaccine with either MTP-PEMF59 adjuvant emulsion or MF59 emulsion alone The volunteers receive three IM injections at 0 1 and 6 months In Part B 16 female volunteers eight on each of two treatment arms are randomized to receive either MF59 emulsion alone placebo or MF59 emulsion plus gp120 vaccine 50 mcg Volunteers receive five IM injections at monthly intervals
In Part A 32 volunteers eight on each of four treatment arms are randomized to receive one of two doses 15 or 50 mcg of gp120 vaccine with either MTP-PEMF59 adjuvant emulsion or MF59 emulsion alone The volunteers receive three IM injections at 0 1 and 6 months In Part B 16 female volunteers eight on each of two treatment arms are randomized to receive either MF59 emulsion alone placebo or MF59 emulsion plus gp120 vaccine 50 mcg Volunteers receive five IM injections at monthly intervals
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?: