Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000972
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase I Clinical Trial to Evaluate Part A The Safety of MTP-PEMF59 Adjuvant Emulsion Part B The Safety and Immunogenicity of Env 2-3 a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1 in Combination With MTP-PEMF59
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 Evaluate Part A The Safety of MTP-PEMF59 Adjuvant Emulsion Part B The Safety and Immunogenicity of Env 2-3 a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1 in Combination With MTP-PEMF59
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:
To evaluate the safety of a fixed antigen dose with an increasing dose of adjuvant MTP-PEMF59 a substance to enhance the immune response to vaccine in volunteers To evaluate local and systemic reactions Part A To determine the safety and immunogenicity of Env 2-3 in combination with MTP-PEMF59 in volunteers Part B The vaccine Env 2-3 is created from one of the viral proteins that make up HIV called envelope glycoprotein gp120 A problem with many immunogens including candidate HIV vaccines is that they may evoke relatively weak immune responses particularly in humans and in nonhuman primates Thus there is considerable interest in the development of adjuvants substances that augment immune responses to vaccines MTP-PEMF59 is an adjuvant that appears to be particularly promising and is selected for the studies with this HIV vaccine candidate
Detailed Description:
The vaccine Env 2-3 is created from one of the viral proteins that make up HIV called envelope glycoprotein gp120 A problem with many immunogens including candidate HIV vaccines is that they may evoke relatively weak immune responses particularly in humans and in nonhuman primates Thus there is considerable interest in the development of adjuvants substances that augment immune responses to vaccines MTP-PEMF59 is an adjuvant that appears to be particularly promising and is selected for the studies with this HIV vaccine candidate
This study is being conducted in two parts Part A examines the safety of the adjuvant MTP-PEMF59 alone Part B examines the safety and immunogenicity of Env 2-3 in combination with MTP-PEMF59 In Part A three volunteers receive MTP-PEMF59 and one volunteer receives emulsion alone at each dose level Initiation of each dose level is separated by at least 72 hours Doses of adjuvant emulsion are administered at day 0 and day 30 for the highest tolerated dose If significant reactions are encountered additional subjects may be studied at lower doses In Part B six doses of MTP-PE adjuvant 0 5 10 25 50 or 100 mcg in the MF59 emulsion are studied Six volunteers receive Env 2-3MTP-PEMF59 and two receive MTP-PEMF59 alone at each dose level There is a minimum 1-week interval between dose escalations Per amendment volunteers may receive an additional dose of Env 2-3 or placebo in MF59 emulsion only administered 12-18 months post initial inoculation
This study is being conducted in two parts Part A examines the safety of the adjuvant MTP-PEMF59 alone Part B examines the safety and immunogenicity of Env 2-3 in combination with MTP-PEMF59 In Part A three volunteers receive MTP-PEMF59 and one volunteer receives emulsion alone at each dose level Initiation of each dose level is separated by at least 72 hours Doses of adjuvant emulsion are administered at day 0 and day 30 for the highest tolerated dose If significant reactions are encountered additional subjects may be studied at lower doses In Part B six doses of MTP-PE adjuvant 0 5 10 25 50 or 100 mcg in the MF59 emulsion are studied Six volunteers receive Env 2-3MTP-PEMF59 and two receive MTP-PEMF59 alone at each dose level There is a minimum 1-week interval between dose escalations Per amendment volunteers may receive an additional dose of Env 2-3 or placebo in MF59 emulsion only administered 12-18 months post initial inoculation
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 |
|---|---|---|---|
| 10547 | REGISTRY | DAIDS ES Registry Number | None |
| 10546 | REGISTRY | None | None |