Influenza Clinical Trial
Official title:
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
Verified date | July 2012 |
Source | BiondVax Pharmaceuticals ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 55 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. - Known hypersensitivity to egg proteins (eggs or egg products), chicken proteins, or any of the vaccine components, in particular, neomycin, formaldehyde, and octoxinol 9, - Known history of drug or alcohol abuse. - Any clinically significant abnormality upon physical examination or in the clinical laboratory tests at screening visit 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. - Increased liver enzymes more than 2.5 times above the upper reference level. - Positive serology for HIV, HCV antibody or HBsAg. - Any acute medical situation (e.g. acute infection, ongoing flu symptoms) with or without fever within 48 hours of vaccination, which is considered of significance by the Principal Investigator. - Pregnant or lactating women at entry to study and those who are unwilling to agree to continue to use acceptable methods of contraception for two months after completion of the study (if applicable). - Positive blood pregnancy test on screening. - Subjects who participated in another clinical study within 30 days prior to study entry. - Subjects who are non-cooperative or unwilling to sign consent form. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Israel | Tasmc Crc | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
BiondVax Pharmaceuticals ltd. |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | To characterize the immune response | The Multimeric-001 vaccine induces both humoral and cellular immune responses, confirming previous findings in younger adults. | 21 days after second immunization with M-001 and 21 days after TIV boost | No |
Secondary | To monitor cellular immune responses | PBMC proliferation associated with IFN gamma secretion was detected after prime immunizations following in vitro exposure of the cells to M-001 or influenza viruses. | 21 days after second M-001 immunization | No |
Secondary | To obtain preliminary data on the contribution of the adjuvant | Adjuvant had an impact on anti-M-001 IgG levels but not on HAI antibody levels. | 21 days after second M-001 immunization and 21 days after TIV boost | No |
Secondary | To obtain preliminary evidence about the efficacy of M-001 as a primer | The prime-boost regimen elicits HAI immune responses, which enables assessment of an accepted surrogate marker considered to correlate with influenza vaccine activity.Priming with M-001 before a TIV boost resulted in a greater proportion of subjects seroconverted to TIV and non-TIV strains as compared to subjects given TIV alone. | 21 days after TIV boost | No |
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