Investigation of the Safety of an HIV-1 Vaccine Given Intra-muscularly and Intra-nasally to Healthy Female Subjects
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|ClinicalTrials.gov Identifier: NCT01084343|
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : July 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|HIV-1||Biological: MYM-V101||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Dose Escalating Phase I Study, Double-blind, Randomized, Placebo-controlled for Examining the Safety and Tolerability to a Prophylactic HIV-1 Vaccine Called MYM-V101, Administered i.m. in Combination With i.n. Administrations to Healthy Female Subjects.|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
Active Comparator: Panel 1
Subjects in this panel receive the low dose of vaccine (10 microgram of peptides). Twelve subjects are included in this panel, 8 of them receive the active vaccine and 4 receive the carrier only (placebo).
Active Comparator: Panel 2
Subjects in this panel receive the high dose of vaccine (50 microgram of peptides). Twelve subjects are included in this panel, 8 of them receive the active vaccine and 4 receive the carrier only (placebo).
- Adverse events (local and systemic) [ Time Frame: 24 weeks ]Adverse events will be collected in the CRF by the investigator. In addition, the subjects will keep a diary card in order to collect adverse events at home.
- Humoral immune response (in blood) [ Time Frame: 24 weeks ]Quantification of blood antibodies (IgG and IgA).
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): NCT01084343
|Ghent, Belgium, 9000|
|Principal Investigator:||Geert Leroux-Roels, Prof. Dr.||CEVAC, University of Ghent, Belgium|
|Study Chair:||Sylvain Fleury, PhD||Mymetics Corporation|