A Pivotal Trial to Assess the Safety and Clinical Efficacy of the M-001 as a Standalone Universal Flu Vaccine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03450915|
Recruitment Status : Active, not recruiting
First Posted : March 1, 2018
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: M-001 Biological: Saline||Phase 3|
The placebo-controlled pivotal clinical efficacy Phase 3 trial plans to enroll a total of approximately 12,460 participants over two years. Participants will be immunized twice with the M-001 influenza vaccine candidate or placebo. Influenza incidence and illness severity will be evaluated throughout the follow-up period of up to two years. Participants will be 50 years and older, with at least half over 65 years of age.
The trial is expected to take place in eastern European countries and begin prior to the 2018/19 Northern Hemisphere flu season.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12463 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Experimental group: 2 immunizations with M-001 Control group: 2 injection of saline (placebo)|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||All parties are blinded except for the person who prepares the syringe for injection. The M-001 is cloudy white and its appearance is different from the transparent saline that is used for placebo. The person prepares the syringe with an opaque sticker that fully covers the syringe contents. People administering the syringe are not involved or present during syringe preparation, and are thus fully blinded.|
|Official Title:||A Pivotal Multi-center, Randomized, Modified Double-blind, Placebo-controlled Phase 3 Trial to Assess the Safety and Clinical Efficacy of M-001 Influenza Vaccine Administered Intra-muscularly Twice in Older Adults and Elderly (≥50 Years).|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||December 2020|
Participants will be vaccinated with 1mg dose of M-001 twice: Once at Day 0, and once at Day 21.
A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses.
Other Name: Multimeric-001
Placebo Comparator: Saline
Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.
0.9% sodium chloride (NaCl)
- Clinical Efficacy: PCR and Culture Confirmed Influenza [ Time Frame: Up to 2 flu seasons (approximately 1.5 years) ]If a participant presents with ILI, then we will run Polymerase chain reaction (PCR). If the PCR is positive, then we will culture confirm. Outcome measure is percentage of PCR and culture confirmed influenza cases in the M-001 experimental group vs. placebo caused by any influenza A or B virus in association with Influenza-like illness (ILI) symptoms.
- Safety: Occurrence of vaccine-related serious adverse events (SAEs) [ Time Frame: 6 months ]Occurrence of vaccine-related serious adverse events (SAEs) such as solicited and unsolicited injection site and systemic reactogenicity events.
- Clinical Efficacy: PCR Confirmed Influenza [ Time Frame: Up to 2 flu seasons (approximately 1.5 years) ]Percentage of PCR confirmed influenza cases in the M-001 experimental group vs. placebo
- Lot consistency [ Time Frame: 42 days ]Frequency of T-cell subsets from participants in the experimental group, expressing interferon gamma (IFN-g) in cluster of differentiation 4 (CD4+) peripheral blood mononuclear cells (PBMCs) after stimulation with M-001 16 days after the second dose of M-001 as compared to baseline.
- Reduced severity of illness [ Time Frame: Up to 2 flu seasons (approximately 1.5 years) ]Average time to alleviation of each influenza symptom
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450915
|Jagiellońskie Centrum Innowacji Sp.z o.o.|
|Kraków, Ul. Bobrzyńskiego 14,, Poland, 30-348|
|Jagiellońskie Centrum Innowacji Sp.z o.o.|
|Kraków, Poland, 30348|
|Study Director:||Tamar Ben-Yedidia, PhD||BiondVax Pharmaceuticals ltd.|