Safety and Immunogenicity of TBC-M4, a MVA HIV Vaccine Alone or in a Prime-Boost Regimen With ADVAX DNA HIV Vaccine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00902824|
Recruitment Status : Completed
First Posted : May 15, 2009
Last Update Posted : February 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Biological: ADVAX Biological: TBC-M4 Other: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase I Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of TBC-M4 (MVA Based HIV Vaccine) Alone or in a Prime-Boost Regimen With ADVAX, DNA HIV Vaccine|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Active Comparator: Group A
ADVAX at 0,1 and 2 months followed by TBC-M4 at 6 months
Number of volunteers: 12
Receive 4mg ADVAX at Months 0, 1, and 2 (Biojector), and receive boost of 5x10^7 pfu TBC-M4 (IM)
Active Comparator: Group B
TBC-M4 at 0,1,6 months
Number of volunteers: 12
Receive 5x10^7 pfu TBC-M4 (IM) at Months 0, 1, and 6.
Placebo Comparator: Placebo
Both Groups A and B will have 4 volunteers each (8 total) that will receive a placebo.
Group A (n=4) will receive the ADVAX placebo (formulation buffer) via Biojector.
Group B (n=4) will receive the TBC-M4 placebo (formulation buffer) via IM.
- Safety of TBC-M4 alone or in a prime-boost regimen with ADVAX [ Time Frame: 12 months ]Safety and tolerability of TBC-M4 alone (given im) or in a prime-boost regimen with ADVAX (administered by Biojector)
- Immunogenicity of TBM-M4 alone or in a prime-boost regimen with ADVAX [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902824
|St Stephen's Centre Chelsea and Westminster Hospital|
|London, United Kingdom, SW10 9NH|
|Principal Investigator:||Brian Gazzard, MD||St. Stephen's Centre|