Clinical trial NCT01146119: Further Investigation of an Intramuscular Influenza Vaccine (Multimeric-001)
Official title: A Phase II, Randomized, Two Stage, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of an Intramuscular Influenza Vaccine (Multimeric-001) Injected to Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: HAI
Influenza
prime
boost
immune response
seroconversion
universal
vaccine
Lead sponsor: BiondVax Pharmaceuticals ltd.
Sponsor class: INDUSTRY
First posted: 2010-06-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, two stage, double-blind, placebo-controlled administration study comprising 200 healthy participants.

Detailed description: This is a Phase II multi-center, randomized, two stage, double-blind, placebo-controlled study comprising 200 participants. Eligible subjects will be randomized to receive one of the following administrations (as two single IM injections with an interval of 21 days between each injection Administration A: Prime twice with Adjuvanted Multimeric-001 500 mcg - 64 subjects.

Administration B: PBS (Placebo) twice - 32 subjects. Administration C: Adjuvanted PBS (Placebo)twice - 32 subjects. Participants from administrations A and B will be further immunized with a 15% dose of commercial seasonal trivalent vaccine for 2011 on day 81.

Administration D: Adjuvanted Multimeric-001 500 mcg coadministered once with 15% of TIV dose - 24 subjects. Administration E: Adjuvanted Multimeric-001 500 mcg coadministered once with 50% of TIV dose - 24 subjects Administration group F: PBS (Placebo) co-administered once with 50% of TIV dose - 24 subjects

Eligibility criteria: Inclusion Criteria:

* Healthy males and females between the age of 18 and 49 years (inclusive).
* 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 (until termination visit) if female partner is not using an effective contraceptive method.
* Subjects who are seronegative to at least one of the strains included in the seasonal vaccine against influenza for 2011.

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.
* Subjects with known Guillain Barré Syndrome in the past.
* Two or more hospitalizations within the last year prior to screening visit.
* Known 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.
* 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 any clinical study within 30 days prior to study entry
* Subjects who are non-cooperative or unwilling to sign consent form.

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: From day 0 until day 221
measure: Anti Multimeric-001 antibodies
timeFrame: 21 days after second immunization with M-001
Secondary outcomes:
measure: Hemagglutination Inhibition (HAI) test for anti influenza antibodies
timeFrame: 21 days post co administration of M-001 and TIV 50%
Other outcomes:
measure: Cellular Immunogenicity
timeFrame: 21 days after co administration of M-001 and TIV 50%
Locations:
city: Jerusalem
country: Israel
facility: Clinical Research Center, Hadassah Medical Center
city: Tel-Aviv
country: Israel
facility: Clinical Research Center, Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: Clinical Research Center, Tel-Aviv Sourasky Medical Center
name: Jacob Atsmon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Center, Hadassah Medical Center, Jerusalem
name: Yosef Caraco, Phd
role: PRINCIPAL_INVESTIGATOR
References: