Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000866
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
A Multicenter Randomized Placebo-Controlled Double-Blind Trial to Evaluate the Safety and Immunogenicity of the Therion Recombinant Vaccinia-HIV-1 IIIB ENVGAGPOL Vaccine TCB-3B and MN RGP 120HIV-1 In Alum
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Randomized Placebo-Controlled Double-Blind Trial to Evaluate the Safety and Immunogenicity of the Therion Recombinant Vaccinia-HIV-1 IIIB ENVGAGPOL Vaccine TCB-3B and MN RGP 120HIV-1 In Alum
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 administering Therion Recombinant Vaccinia-HIV-1 IIIB envgagpol Vaccine TBC-3B vaccinations to vaccinia-naive individuals To evaluate the immunogenicity of priming with TBC-3B by the scarification intradermal and subcutaneous routes followed by booster immunization of MN rgp120 HIV-1 To compare the immunogenicity of priming with TBC-3B in vaccinia-naive individuals to vaccinia-immune individuals
In prior trials evaluating alternative methods of vaccine administration scarification has been found to be an imprecise method of administration and allows only 10 - 25 microliters of immunogen to be given Since it is not feasible to produce vaccine at concentrations higher than 10 to the 10th pfuml this method limits the maximum deliverable dose Intradermal and subcutaneous injection routes allow larger volumes of vaccinia to be given ie up to 200 microliters intradermally and up to 100 ml subcutaneously In the present study the initial priming dose will be the same administered by all 3 methods however the second priming dose administered at 2 months intradermally and subcutaneously will be 2 logs higher in order to achieve boosting of immune responses particularly to gag and pol components of TBC-3B
In prior trials evaluating alternative methods of vaccine administration scarification has been found to be an imprecise method of administration and allows only 10 - 25 microliters of immunogen to be given Since it is not feasible to produce vaccine at concentrations higher than 10 to the 10th pfuml this method limits the maximum deliverable dose Intradermal and subcutaneous injection routes allow larger volumes of vaccinia to be given ie up to 200 microliters intradermally and up to 100 ml subcutaneously In the present study the initial priming dose will be the same administered by all 3 methods however the second priming dose administered at 2 months intradermally and subcutaneously will be 2 logs higher in order to achieve boosting of immune responses particularly to gag and pol components of TBC-3B
Detailed Description:
In prior trials evaluating alternative methods of vaccine administration scarification has been found to be an imprecise method of administration and allows only 10 - 25 microliters of immunogen to be given Since it is not feasible to produce vaccine at concentrations higher than 10 to the 10th pfuml this method limits the maximum deliverable dose Intradermal and subcutaneous injection routes allow larger volumes of vaccinia to be given ie up to 200 microliters intradermally and up to 100 ml subcutaneously In the present study the initial priming dose will be the same administered by all 3 methods however the second priming dose administered at 2 months intradermally and subcutaneously will be 2 logs higher in order to achieve boosting of immune responses particularly to gag and pol components of TBC-3B
After volunteers are recruited screened and enrolled in the study they will be randomized to group C D or E Each group will enroll 10 patients and 2 controls The placebo control for TBC-3B will be standard vaccinia vaccination administered at doses no higher than that administered by scarification the placebo control for MN rgp120 will be alum Group C will receive undiluted TBC-3B by scarification at months 0 and 2 Group D will receive diluted TBC-3B intradermally at month 0 and undiluted TBC-3B at month 2 Group E will receive diluted TBC-3B subcutaneously at month 0 and undiluted TBC-3B at month 2 At months 8 and 12 all groups will receive MN rgp 120HIV-1 in alum intramuscularly
After volunteers are recruited screened and enrolled in the study they will be randomized to group C D or E Each group will enroll 10 patients and 2 controls The placebo control for TBC-3B will be standard vaccinia vaccination administered at doses no higher than that administered by scarification the placebo control for MN rgp120 will be alum Group C will receive undiluted TBC-3B by scarification at months 0 and 2 Group D will receive diluted TBC-3B intradermally at month 0 and undiluted TBC-3B at month 2 Group E will receive diluted TBC-3B subcutaneously at month 0 and undiluted TBC-3B at month 2 At months 8 and 12 all groups will receive MN rgp 120HIV-1 in alum intramuscularly
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 |
|---|---|---|---|
| 10562 | REGISTRY | DAIDS ES Registry Number | None |