Evaluation of the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix M-1 Adjuvant (NanoFlu)

NCT03293498 | Completed Phase 1 Results FDA Drug

• 1 other identifier: tNIV-E-101
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 3

Brief Summary

This was a Phase 1/2, randomized, observer-blinded, active-controlled trial to assess the Safety and Tolerability of a Recombinant Trivalent Nanoparticle Influenza Vaccine (Tri-NIV) with Matrix M1™ Adjuvant in Healthy Older Adults ≥ 60 Years of Age

Conditions

Influenza

Outcome Measures

Primary Outcomes (6)

• Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs).

  Number of participants that reported all adverse event (AE) profile (including adverse changes in clinical laboratory parameters) ; medically-attended adverse event (MAE), serious adverse event (SAE), and significant new medical condition (SNMC) post dosing.

  Day 0 - Day 21 post dosing

• Number of Participants With Solicited Local and Systemic AEs

  Number of participants with solicited local and systemic adverse events over the 7 days post-injection

  Day 0 - Day 6 post-dosing

• Geometric Mean Titers (GMT) Specific for the Hemagglutinin (HA) Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the Hemagglutination Inhibition (HAI) Assay.

  The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as GMTs.

  Day 0 - Day 21 post dosing

• Geometric Mean Ratio (GMR) Specific for the HA Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the HAI Assay.

  The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as GMR.

  Day 0 - Day 21 post dosing

• Seroconversion Rate (SCR) Specific for the HA Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the HAI Assay.

  The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as SCRs.

  Day 0 - Day 21 post dosing

• Number of Participants With Seroprotection Specific for the HA Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the HAI Assay.

  The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as SPRs. Seroprotection rate (SPR) - defined as the number of subjects with an HAI titer ≥ 1:40.

  Day 0 - Day 21 post dosing

Secondary Outcomes (7)

• Geometric Mean Titers (GMT) Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay

  Day 0 - Day 21

• Geometric Mean Ratio (GMR) Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay

  Day 0 - Day 21

• Seroconversion Rate (SCR) Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay

  Day 0 - Day 21

• Number of Participants With Seroprotection Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay

  Day 0 - Day 21

• Geometric Mean Titers (GMT) for Neutralizing Antibody Titers Specific for the Virus Strains Included in NanoFlu and the Fluzone HD Comparator, as Well as Selected Historical A Strains, as Measured by a Microneutralization Assay.

  Day 0 - Day 21 post dosing

Study Arms (3)

Group A

EXPERIMENTAL

Low dose NanoFlu - Day 0; Fluzone HD - Day 21

Biological: NanoFlu; Biological: Fluzone HD - Day 21

Group B

EXPERIMENTAL

High dose NanoFlu - Day 0; Fluzone HD - Day 21

Biological: NanoFlu; Biological: Fluzone HD - Day 21

Group C

ACTIVE COMPARATOR

Fluzone HD - Day 0; Saline - Day 21

Biological: Fluzone HD - Day 0; Other: Saline - Day 21

Interventions

NanoFlu BIOLOGICAL

Vaccine

Group A; Group B

Fluzone HD - Day 0 BIOLOGICAL

Vaccine

Group C

Fluzone HD - Day 21 BIOLOGICAL

Vaccine

Group A; Group B

Saline - Day 21 OTHER

Placebo

Group C

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy older adults, male or female,
• Willing and able to give informed consent prior to trial enrollment, and
• Able to attend trial visits, comply with trial requirements, and provide reliable and complete reports of adverse events.

You may not qualify if:

• Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care.
• Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first injection.
• History of a serious reaction to prior influenza vaccination, or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80.
• History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
• Receipt of any vaccine in the 4 weeks preceding the trial vaccination and any influenza vaccine within 6 months preceding the trial vaccination.
• Any known or suspected immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination.
• Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the trial vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the trial vaccine or during the trial.
• Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature \> 38.0°C, on the planned day of vaccine administration).
• Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of trial results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
• Known disturbance of coagulation.
• Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.

Sponsors & Collaborators

• Novavax: lead

Study Sites (3)

Research Site US108

Raleigh, North Carolina, 27609, United States

Location

Research Site US106

Rocky Mount, North Carolina, 27804, United States

Location

Research Site US132

Statesville, North Carolina, 28625, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Novavax Customer Service Center
• Organization: Novavax Inc.

Clinicaltrials@novavax.com

1-844-Novavax (668-2829)

Study Officials

• Clinical Development

  Novavax

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 26, 2017
• Study Start: September 18, 2017
• Primary Completion: March 14, 2018
• Study Completion: October 29, 2018
• Last Updated: December 21, 2022
• Results First Posted: December 21, 2022

Record last verified: 2022-11

Locations

US (3)