Investigation of the Safety of an HIV-1 Vaccine Given Intra-muscularly and Intra-nasally to Healthy Female Subjects
|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).
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|