Further Investigation of an Intramuscular Influenza Vaccine (Multimeric-001)

NCT01146119 | Completed Phase 2

• 1 other identifier: BVX-004
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Influenza

Keywords

HAI; Influenza; prime; boost; immune response; seroconversion; universal; vaccine

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  Number of Participants with Adverse Events possible/probably related to the study drug in each group were similar in the experimental and control groups.

  From day 0 until day 221

• Anti Multimeric-001 antibodies

  Direct Elisa assay to test the titer of human antibodies that recognize the Multimeric-001 protein. Humoral immunity was manifested 21 and 60 days post immunization by significantly elevated anti-M-001 IgG levels among subjects administered twice with adjuvanted M-001

  21 days after second immunization with M-001

Secondary Outcomes (1)

• Hemagglutination Inhibition (HAI) test for anti influenza antibodies

  21 days post co administration of M-001 and TIV 50%

Other Outcomes (1)

• Cellular Immunogenicity

  21 days after co administration of M-001 and TIV 50%

Study Arms (6)

Multimeric-001, Adjuvanted

EXPERIMENTAL

64 subjects received 2 injections of Adjuvanted Multimeric-001, 500 mcg with an interval of 21 days and then 60 days later were further immunized with a 15% dose of commercial seasonal trivalent vaccine (season 2011).

Biological: Multimeric-001, 500 mcg

PBS and TIV 15%

ACTIVE COMPARATOR

32 subjects received 2 injections of PBS (Phosphate Buffered Saline) with an interval of 21 days and then were further immunized 60 days later with a 15% dose of commercial seasonal trivalent vaccine (season 2011).

Biological: PBS and TIV 15%

Placebo, Adjuvanted

PLACEBO COMPARATOR

32 subjects received Adjuvanted PBS (Placebo) with an interval of 21 days.

Biological: Adjuvanted PBS

Co-administration M-001 and TIV 15%

EXPERIMENTAL

24 subjects received 2 injections on the same day, one injection containing Adjuvanted Multimeric-001 500 mcg and the other containing TIV 15%.

Biological: Multimeric-001, 500 mcg

Co administration of M-001 and TIV 50%

EXPERIMENTAL

24 subjects received 2 injections on the same day, one injection containing Adjuvanted Multimeric-001 500 mcg and the other containing TIV 50%.

Biological: Multimeric-001, 500 mcg

Co administration of PBS and TIV 50%

ACTIVE COMPARATOR

24 subjects received 2 injections on the same day, one injection containing PBS and the other containing TIV 50%.

Biological: PBS and TIV 50%

Interventions

Multimeric-001, 500 mcg BIOLOGICAL

Adjuvanted Multimeric-001 was administered twice with an interval of 19-23 days.

Co administration of M-001 and TIV 50%; Co-administration M-001 and TIV 15%; Multimeric-001, Adjuvanted

Adjuvanted PBS BIOLOGICAL

Adjuvanted PBS was administered twice with an interval of 19-23 days.

Also known as: placebo

Placebo, Adjuvanted

PBS and TIV 15% BIOLOGICAL

PBS (Phosphate Buffered Saline) was administered twice with an interval of 19-23 days and then 60 days later a 15% dose of commercial seasonal trivalent vaccine (season 2011) was administered.

PBS and TIV 15%

PBS and TIV 50% BIOLOGICAL

PBS (Phosphate Buffered Saline) was administered twice with an interval of 19-23 days and then 60 days later a 50% dose of commercial seasonal trivalent vaccine (season 2011) was administered.

Co administration of PBS and TIV 50%

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

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.
• 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.

Sponsors & Collaborators

• BiondVax Pharmaceuticals ltd.: lead

Study Sites (2)

Clinical Research Center, Hadassah Medical Center

Jerusalem, Israel

Location

Clinical Research Center, Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Influenza, Human; HIV Seropositivity

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jacob Atsmon, MD

  Clinical Research Center, Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

• Yosef Caraco, Phd

  Clinical Research Center, Hadassah Medical Center, Jerusalem

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2010
• First Posted: June 17, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 31, 2012

Record last verified: 2012-07

Locations

IL (2)