A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001) Injected to Elderly Volunteers
A Phase I/II, Randomized, Single-Blind, Placebo-Controlled Escalating Double-Dose, Safety and Priming Potential Study of an Intramuscular Influenza Vaccine (Multimeric-001) Injected to Elderly Volunteers
1 other identifier
interventional
60
1 country
1
Brief Summary
This is a phase I/II, randomized, single-blind, placebo-controlled escalating double-dose study of the safety and priming potential of an intramuscular Influenza vaccine (Multimeric-001) injected to elderly volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 18, 2009
CompletedFirst Posted
Study publicly available on registry
November 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedJuly 31, 2012
July 1, 2012
6 months
October 18, 2009
July 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety, local and systemic tolerability and reactogenicity of Multimeric-001 vaccine when administered intramuscularly twice to elderly male and female subjects, using chemistry, CBC, fibrinogen, and urinalysis measurements.
The Multimeric-001 vaccine exhibits a positive safety profile. The number of subjects reporting adverse events (AEs) after treatment with active vaccines was similar to respective placebo cohorts. Overall AE frequencies for each active group were similar to those of placebo counterparts.
From day 0 until termination visit
Secondary Outcomes (4)
To characterize the immune response
21 days after second immunization with M-001 and 21 days after TIV boost
To monitor cellular immune responses
21 days after second M-001 immunization
To obtain preliminary data on the contribution of the adjuvant
21 days after second M-001 immunization and 21 days after TIV boost
To obtain preliminary evidence about the efficacy of M-001 as a primer
21 days after TIV boost
Study Arms (6)
Multimeric-001 250 mcg
EXPERIMENTAL250mcg of Multimeric-001 was administered twice at an interval of 19-23 days via the IM route to 10 participants as a primer and then a TIV boost was administered.
Adjuvant: Montonide isa 51 VG
ACTIVE COMPARATORAdjuvanted PBS was administered twice with a 19-23 day interval via the IM route to 10 participants and then a TIV boost was administered.
Placebo
ACTIVE COMPARATORPBS was administered twice with a 19-23 day interval via the IM route to 10 participants and then a TIV boost was administered.
Multimeric-001 500 mcg
EXPERIMENTAL500mcg of M-001 was administered twice with an interval of 19-23 days via the IM route to 10 participants as a primer and then a TIV boost was administered.
Adjuvanted Multimeric-001 500mcg
EXPERIMENTAL5000mcg of Adjuvanted M-001 was administered twice with an interval of 19-23 days via the IM route to 10 participants as a primer and then a TIV boost was administered.
Adjuvanted Multimeric-001 250mcg
EXPERIMENTAL250mcg of Adjuvanted M-001 was administered twice with an interval of 19-23 days via the IM route to 10 participants as a primer and then a TIV boost was administered.
Interventions
Multimeric-001 (M-001) was administered twice at a dose of 250mcg via the IM route to 10 participants as a primer, followed by TIV boost immunization. in 19-23 days interval between them.
Injection of Multimeric-001 250 mcg with Adjuvant Montonide isa 51 VG, 2 doses with interval of 19-23 days between them
Placebo injected with PBS (Phosphate Buffered Saline), 2 injections with the interval of 19-23 days between them.
Injection of Placebo with Adjuvant Montonide isa 51 VG, 2 injections with the interval of 19-23 days between them.
Injection of Multimeric-001 with PBS, 2 injections with the interval of 19-23 days between them.
Injection of Multimeric-001 500 mcg with Adjuvant Montonide isa 51 VG, 2 doses with the interval of 19-23 days between them
Injection of the conventional flu vaccine: Vaxigrip to all study participants.
Eligibility Criteria
You may qualify if:
- Males and females between the age of 55 and 75 years (inclusive):
- Healthy or treated for any or all of the following conditions:
- Hypertension, under control with standard medications
- Hyperlipidemia, medically treated
- Subjects who provide written informed consent to participate in the study.
- Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Haematology, chemistry and urinalysis values with no clinical significance or do not reflect a medical condition which, according to the physician's judgment, might confound the results of the study or pose additional risk to the subject by participation in the study.
- Female of childbearing age must agree to use an acceptable method of contraception and male subjects should use a condom throughout the study period (including the follow up- where applicable) if female partner is not using an effective contraceptive method.
You may not qualify if:
- Known history of significant medical disorder, which in the investigator's judgment, might confound the results of the study or pose additional risk to the subject by participation in the study.
- Renal dysfunction.
- COPD.
- Chronic cardiovascular system disorders (except hypertension adequately controlled by standard medications).
- Asthma
- Diabetes mellitus.
- Subjects with known Guillain Barré Syndrome in the past.
- Two or more hospitalizations within the last year prior to screening visit.
- Bleeding disorders including hemophilia or thrombocytopenia, or treatment with anticoagulant therapy (risk of bleeding with intramuscular injection).
- Immunocompromised patients and those receiving concomitant immunosuppressive therapy; or other immune modulating drugs including chronic steroid treatment.
- Subjects who have been immunized with anti-influenza vaccine or infected by influenza virus within eight months prior to the screening visit.
- Administration of any vaccine 30 days before the screening visit.
- Known hypersensitivity to previous influenza vaccination.
- Use of an influenza antiviral medication within 4 weeks of vaccination.
- Known hypersensitivity and/or allergy to any drug or vaccine.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tasmc Crc
Tel Aviv, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacob Atsmon, MD
CRC, Sourascky MC, Israel
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2009
First Posted
November 10, 2009
Study Start
September 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
July 31, 2012
Record last verified: 2012-07