Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002261
Status:
COMPLETED
Last Update Posted:
2007-09-26
First Post:
1999-11-02
Brief Title:
A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox Vaccinia Vaccines in Previously Vaccinia Vaccinated and Unvaccinated Volunteers
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox Vaccinia Vaccines in Previously Vaccinia Vaccinated and Unvaccinated Volunteers
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the physiological and immunological responses in healthy HIV seronegative adult volunteers vaccinated with a the HIVAC-1e vaccinia-HIV vaccine expressing the envelope glycoproteins of HIV and b the Wyeth smallpox vaccine The parameters to be studied will include
1 The course of physiological responses to vaccination including a lesion development progression and resolution b physiological changes such as temperature malaise itching at the site etc and c any observable AE
2 The appearance identity quantity and duration of humoral antibodies against HIV and vaccinia virus
3 The appearance identity quantity and duration of cell-mediated immunity against HIV and vaccinia virus
4 The adequacy of a procedure using a special dressing to contain viral shedding from the vaccination site
5 The safety humoral and cellular immune responses of a booster injection of the recombinant subunit gp160 vaccine MicroGeneSys in HIVAC-1e recipients
1 The course of physiological responses to vaccination including a lesion development progression and resolution b physiological changes such as temperature malaise itching at the site etc and c any observable AE
2 The appearance identity quantity and duration of humoral antibodies against HIV and vaccinia virus
3 The appearance identity quantity and duration of cell-mediated immunity against HIV and vaccinia virus
4 The adequacy of a procedure using a special dressing to contain viral shedding from the vaccination site
5 The safety humoral and cellular immune responses of a booster injection of the recombinant subunit gp160 vaccine MicroGeneSys in HIVAC-1e recipients
Detailed Description:
None
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 |
|---|---|---|---|
| AI452-003001 | None | None | None |