Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000853
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase I Multicenter Randomized Double-Blind Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of Low Dose MN rsgp120HIV-1 Genentech in Combination With QS21 Adjuvant or Alum in Healthy Adults
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 Double-Blind Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of Low Dose MN rsgp120HIV-1 Genentech in Combination With QS21 Adjuvant or Alum in Healthy Adults
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 expand the safety information regarding MN rsgp 120HIV-1 formulated with QS21 or alum To evaluate the immunogenicity of low doses of MN rsgp 120HIV-1 formulated with QS21 or alum
Studies to date indicate that there may be a dose-sparing effect with the use of QS21 In animal studies when QS21 has been employed as an adjuvant it shifted both the dose response curve and allowed less antigen to elicit equivalent binding antibody titers to the rgp120 protein There may also be an acceleration in the course of antibody response after both the first and the second immunizations Although the final titers in response to vaccine given in both alum and QS21 appear similar after 3 doses in humans this plateau may be reached more readily and with a lower antigen dose when using QS21 as an adjuvant In addition it has been established that using a lower dose of antigen may elicit an immune response which is characterized by lymphoproliferation and production of TH1-like cytokines such as INF-gamma interleukin-2 interleukin-4 interleukin-5 and interleukin-10
Studies to date indicate that there may be a dose-sparing effect with the use of QS21 In animal studies when QS21 has been employed as an adjuvant it shifted both the dose response curve and allowed less antigen to elicit equivalent binding antibody titers to the rgp120 protein There may also be an acceleration in the course of antibody response after both the first and the second immunizations Although the final titers in response to vaccine given in both alum and QS21 appear similar after 3 doses in humans this plateau may be reached more readily and with a lower antigen dose when using QS21 as an adjuvant In addition it has been established that using a lower dose of antigen may elicit an immune response which is characterized by lymphoproliferation and production of TH1-like cytokines such as INF-gamma interleukin-2 interleukin-4 interleukin-5 and interleukin-10
Detailed Description:
Studies to date indicate that there may be a dose-sparing effect with the use of QS21 In animal studies when QS21 has been employed as an adjuvant it shifted both the dose response curve and allowed less antigen to elicit equivalent binding antibody titers to the rgp120 protein There may also be an acceleration in the course of antibody response after both the first and the second immunizations Although the final titers in response to vaccine given in both alum and QS21 appear similar after 3 doses in humans this plateau may be reached more readily and with a lower antigen dose when using QS21 as an adjuvant In addition it has been established that using a lower dose of antigen may elicit an immune response which is characterized by lymphoproliferation and production of TH1-like cytokines such as INF-gamma interleukin-2 interleukin-4 interleukin-5 and interleukin-10
Patients will be recruited and screened and those determined as eligible will be enrolled in the study Initially 5 patients will be randomized into each combination of MN rsgp 120HIV-1 dose and adjuvant QS21 or alum along with 2 controls for each adjuvant group An additional 10 patients will be randomized equally between the QS21 and alum arms to the lowest dose group having 2 or more responders defined as an MN Vital Dye neutralization titer greater than or equal to 10 measured at 2 weeks after the second vaccination 1 additional control will also be randomized to each adjuvant group If neither dose has 2 or more responders no additional patients will be enrolled Patients will receive their randomly assigned injections at months 0 1 and 6 Patients will be tested for DTH to MN rsgp 120 at 12 months
Patients will be recruited and screened and those determined as eligible will be enrolled in the study Initially 5 patients will be randomized into each combination of MN rsgp 120HIV-1 dose and adjuvant QS21 or alum along with 2 controls for each adjuvant group An additional 10 patients will be randomized equally between the QS21 and alum arms to the lowest dose group having 2 or more responders defined as an MN Vital Dye neutralization titer greater than or equal to 10 measured at 2 weeks after the second vaccination 1 additional control will also be randomized to each adjuvant group If neither dose has 2 or more responders no additional patients will be enrolled Patients will receive their randomly assigned injections at months 0 1 and 6 Patients will be tested for DTH to MN rsgp 120 at 12 months
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 |
|---|---|---|---|
| 10566 | REGISTRY | DAIDS ES Registry Number | None |