Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001021
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase I Multicenter Study of the Safety and Immunogenicity of MN rgp120HIV-1 Vaccine Given Either Alone or in Combination With IIIB rgp120HIV-1 Vaccine in Healthy Adult Subjects NOTE Original Study Extended ONLY for Patients Previously Enrolled on VEU 009
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 Study of the Safety and Immunogenicity of MN rgp120HIV-1 Vaccine Given Either Alone or in Combination With IIIB rgp120HIV-1 Vaccine in Healthy Adult Subjects NOTE Original Study Extended ONLY for Patients Previously Enrolled on VEU 009
Status:
COMPLETED
Status Verified Date:
2002-10
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 10193 To evaluate the influence of prior immunization with an rgp120 vaccine on immune response to a subsequent immunization with a different strain of rgp120 VEU 009X extension - in patients previously enrolled on VEU 009
ORIGINAL DESIGN To evaluate the clinical and immunologic safety of MN rgp120HIV-1 vaccine MN rgp120 vaccine given alone or concurrently with the IIIB rgp120HIV-1 vaccine IIIB rgp120 vaccine in healthy HIV-1 seronegative adult subjects To compare the immune response to MN rgp120 vaccine given at 100 300 or 600 mcg To determine the immune response to 300 mcg MN rgp120 vaccine and 300 mcg IIIB rgp120 vaccine given concurrently
Recent studies suggest that immunity to the HIV-1 rgp120 protein may prevent primary infection MN rgp120 vaccine and IIIB rgp120 vaccine are both prepared by recombinant DNA technology Because the two vaccines are derived from distinct HIV-1 strains they may elicit some immunologic responses that differ Unlike IIIB rgp120 vaccine the MN rgp120 vaccine has not yet been evaluated in humans although it is expected that the MN type will result in similar safety and immunogenicity as the IIIB type
ORIGINAL DESIGN To evaluate the clinical and immunologic safety of MN rgp120HIV-1 vaccine MN rgp120 vaccine given alone or concurrently with the IIIB rgp120HIV-1 vaccine IIIB rgp120 vaccine in healthy HIV-1 seronegative adult subjects To compare the immune response to MN rgp120 vaccine given at 100 300 or 600 mcg To determine the immune response to 300 mcg MN rgp120 vaccine and 300 mcg IIIB rgp120 vaccine given concurrently
Recent studies suggest that immunity to the HIV-1 rgp120 protein may prevent primary infection MN rgp120 vaccine and IIIB rgp120 vaccine are both prepared by recombinant DNA technology Because the two vaccines are derived from distinct HIV-1 strains they may elicit some immunologic responses that differ Unlike IIIB rgp120 vaccine the MN rgp120 vaccine has not yet been evaluated in humans although it is expected that the MN type will result in similar safety and immunogenicity as the IIIB type
Detailed Description:
Recent studies suggest that immunity to the HIV-1 rgp120 protein may prevent primary infection MN rgp120 vaccine and IIIB rgp120 vaccine are both prepared by recombinant DNA technology Because the two vaccines are derived from distinct HIV-1 strains they may elicit some immunologic responses that differ Unlike IIIB rgp120 vaccine the MN rgp120 vaccine has not yet been evaluated in humans although it is expected that the MN type will result in similar safety and immunogenicity as the IIIB type
AMENDED 10193 Selected patients on VEU 009 who received four previous injections will receive three additional injections on the study extension VEU 009X administered at weeks 72 76 and 104 Patients who received 300 or 600 mcg MN rgp120 vaccine eight patients per dosage in the original portion of the study will be randomized to receive either 300 mcg MN rgp120 or 300 mcg IIIB rgp120 vaccine Eight patients who previously received the MNIIIB combination will again receive 300 mcg of both vaccines Additionally six patients who received placebo in the original portion will receive 300 mcg IIIB rgp120 vaccine There will be nine clinic visits required for the study extension
ORIGINAL DESIGN Fifty-seven adult subjects will be randomized to receive MN rgp120 vaccine at one of three dosages 100 300 or 600 mcg or 300 mcg MN rgp120 vaccine given concurrently with 300 mcg IIIB rgp120 vaccine or placebo Twelve subjects will be entered onto each of the four vaccine arms and nine subjects will be entered on the placebo arm Immunizations or placebo injections are given intramuscularly at 0 4 24 and 48 weeks Subjects are followed for 15 months after the first immunization
AMENDED 10193 Selected patients on VEU 009 who received four previous injections will receive three additional injections on the study extension VEU 009X administered at weeks 72 76 and 104 Patients who received 300 or 600 mcg MN rgp120 vaccine eight patients per dosage in the original portion of the study will be randomized to receive either 300 mcg MN rgp120 or 300 mcg IIIB rgp120 vaccine Eight patients who previously received the MNIIIB combination will again receive 300 mcg of both vaccines Additionally six patients who received placebo in the original portion will receive 300 mcg IIIB rgp120 vaccine There will be nine clinic visits required for the study extension
ORIGINAL DESIGN Fifty-seven adult subjects will be randomized to receive MN rgp120 vaccine at one of three dosages 100 300 or 600 mcg or 300 mcg MN rgp120 vaccine given concurrently with 300 mcg IIIB rgp120 vaccine or placebo Twelve subjects will be entered onto each of the four vaccine arms and nine subjects will be entered on the placebo arm Immunizations or placebo injections are given intramuscularly at 0 4 24 and 48 weeks Subjects are followed for 15 months after the first immunization
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 |
|---|---|---|---|
| V0385g | None | None | None |