A Phase 2 interventional study of M-001 and TIV in Influenza, sponsored by BiondVax Pharmaceuticals ltd.. Completed at 1 site in Israel. Open to participants aged 50 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-23.
Sponsored by BiondVax Pharmaceuticals ltd. · Phase 2, Interventional, and Prevention
This is a single-site, randomized, double-blind, placebo-controlled study of Multimeric-001 in thirty six (36) volunteers 50-65 years of age.
All subjects will receive an intramuscular (IM) injection, in each one of three visits, with a 21±2 days interval between treatments.
Subjects will undergo screening procedures within 30 days prior to first vaccination which will include medical history, vital signs, ECG, physical examination and safety blood and urine lab tests.
On the first treatment visit, eligible subjects will undergo pre-dose physical examination and vital signs, and a blood sample will be drawn for baseline cellular immunogenicity and circulating Interferon gamma (IFN-g). They will then receive an IM injection of either vaccine or placebo, according to the above treatment assignment, into the deltoid muscle preferably of the same arm. The subjects will remain under medical supervision for 2 hrs (± 15 min) at which time they will be released from the Clinical research center.
The second treatment will take place 21 (±2) days after the first vaccination. Procedures will be the same as that of Visit 2 Additional two follow-up visits will take place at approximately 24 hrs and 48h The third treatment will take place 21 (±2) days after the second vaccination. Procedures will be the same as that of Visit 2 21 days later, each subject will be immunized with the seasonal influenza vaccine approved for 2014/15 year.
A Study Termination visit will take place at 21 (±2) days after last vaccination. Adverse events (AEs) and changes in concomitant medications will be recorded, vital signs will be measured and the subjects will undergo physical examination and ECG. Blood and urine samples will be collected for safety.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 37 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →BiondVax Pharmaceuticals ltd. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
M-001 (0.5mg) administered intramuscular 3 times at 21 days intervals followed by vaccination with Trivalent Influenza Vaccine (TIV)
Biological: M-001 · Drug: TIV
M-001 (1.0mg) administered intramuscular 3 times at 21 days intervals followed by vaccination with Trivalent Influenza Vaccine (TIV)
Biological: M-001 · Drug: TIV
0.3ml Saline administered Intramuscular 3 times at 21 days intervals followed by vaccination with Trivalent Influenza Vaccine (TIV)
Drug: TIV · Other: Saline
A recombinant epitope based universal vaccine against seasonal and pandemic influenza
Also known as: Multimeric-001
HA based seasonal influenza vaccine, for 2014/15 seson
Placebo
Number of participants with adverse events in treatment vs control group
Number of Participants with Adverse Events as a Measure of Safety and Tolerability will be measured in the experimental and control group, both local and systemic adverse events will be followed.
Time frame: 3 months (from first visit to termination visit for each subject)
Immunity induced by priming and boosting, measured by HAI (Hemagglutination Inhibition)
To characterize humoral immunity, Hemagglutination Inhibition (HAI) test for anti influenza antibodies to TIV strains will be measured after boosting with TIV, proportion of participants achieving seroconversion in the groups primed with M-001 and boosted with TIV, will be compared to participants given TIV alone.
Time frame: Day 84 (21 days after TIV injection)
Number of participants with cell mediated immune response in treatment vs control group
To characterize the cell mediated immune response, Fluorescence activated cell sorter (FACS) analysis for CD4/CD8 lymphocytes will be performed after 3 immunizations with M-001 as compared to the control group (injected 3 times with saline)
Time frame: Day 63 (21 days after immunization with M-001)
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
BiondVax Pharmaceuticals ltd.