Safety Study of an Additional MVA Vaccine in Volunteers Who Received 3 DNA Vaccines Followed by 2 MVA Vaccines (HIVIS06)
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|ClinicalTrials.gov Identifier: NCT01461447|
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : May 24, 2012
The purpose of the study is to determine the safety and immunogenecity of a third MVA in the HIVIS 03 volunteers who have received 3 HIVIS DNA vaccines followed by boosting with 2 MVA vaccines.
The investigators postulate that the Immune responses that were observed in the HIVIS 03 trial are likely to wane over time. To date it is unknown how these responses should best be maintained. In this study the investigators seek to boost immune responses, especially the antibody responses induced by the second MVA boost.
Since the HIV specific antibodies were induced only after the second MVA injection, it is hypothesized that a 3rd MVA will give rise to even higher and sustained antibody titers.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Biological: Modified Vaccinia Ankara||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Immunogenicity Following Further Boosting With HIV-1 MVA-CMDR Vaccine to HIVIS03 Volunteers Who Were Primed With HIV-1 DNA Low Dose Intradermally or 'Standard' Dose Intramuscularly and Boosted With MVA-CMDR Vaccine|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Volunteers who were primed with 3 HIVIS DNA and further boosted with 2 MVA vaccine will receive a third MVA there shall not be an comparator for this study.
Biological: Modified Vaccinia Ankara
Healthy volunteers will receive intramuscularly 1 injection of MVA-CMDR 1ml (Total 10 power 8 pfu) boost injection in the left deltoid muscle.
- Proportion of volunteers with humoral and cellular immune responses elicited by 2 different immunization schedules (id or im DNA priming) prior to MVA boosting [ Time Frame: 1 month after vaccination ]
- Safety assessed by the number of solicited and non solicited adverse events following immunization [ Time Frame: 1 month after vaccination ]
- Number of staff trained and able to conduct HIV-related vaccine studies at MUHAS. [ Time Frame: Two 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): NCT01461447
|Muhimbili University of Health and Allied Sciences|
|Dar es Salaam, Tanzania|