Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent VLP Influenza Vaccine in Adults

NCT01991587 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CP-Q12VLP-004
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

A phase I/II trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a single intramuscular injection of plant-based Seasonal Quadrivalent VLP Influenza Vaccine administered to healthy adults 18-49 years of age. A total of one hundred and twenty (120) subjects will be randomized in four (4) groups of 30 subjects to receive one injection of either a low, a medium, or a high dose level of VLP of the quadrivalent VLP influenza vaccine or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80).

Conditions

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

Keywords

Influenza; Human; RNA Virus Infections; Immunologic; Immunogenic Factors; Physiological Effects of Drugs; Virus diseases; Orthomyxoviridae Infections; Infection

Outcome Measures

Primary Outcomes (3)

• Rate of solicited and unsolicited adverse events post-vaccination.

  21 days after injection

• Severity of solicited and unsolicited adverse events post-vaccination.

  21 days after injection

• Relationship to vaccination of solicited and unsolicited adverse events post-vaccination.

  21 days after injection

Secondary Outcomes (3)

• Serum HI response induced in subjects against the vaccine strains

  21 days after injection

• capacity of the quadrivalent VLP vaccine to induce specific and functional antibodies against homologous strains

  21 days after injection

• Capacity of the quadrivalent VLP vaccine to induce cross-reactive antibodies against heterologous influenza strains

  21 days after injection

Study Arms (4)

Low dose of quadrivalent VLP vaccine

EXPERIMENTAL

Biological: A single low dose of quadrivalent VLP vaccine

Biological: Low dose of quadrivalent VLP vaccine

Medium dose of quadrivalent VLP vaccine

EXPERIMENTAL

A single medium dose of quadrivalent VLP vaccine

Biological: Medium dose of quadrivalent VLP vaccine

High dose of quadrivalent VLP vaccine

EXPERIMENTAL

A single high dose of quadrivalent VLP vaccine

Biological: High dose of quadrivalent VLP vaccine

Placebo

PLACEBO COMPARATOR

A single dose of Placebo

Biological: Placebo

Interventions

Low dose of quadrivalent VLP vaccine BIOLOGICAL

A single low dose of quadrivalent VLP vaccine

Low dose of quadrivalent VLP vaccine

Medium dose of quadrivalent VLP vaccine BIOLOGICAL

A single medium dose of quadrivalent VLP vaccine

Medium dose of quadrivalent VLP vaccine

High dose of quadrivalent VLP vaccine BIOLOGICAL

A single high dose of quadrivalent VLP vaccine

High dose of quadrivalent VLP vaccine

Placebo BIOLOGICAL

A single dose of placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Male and female adults, 18 to 49 years of age, inclusive.
• Healthy as judged by the Investigator or designee and determined by medical history, complete general history/symptom-directed physical examination, vital signs, screening laboratories, and medical history conducted no more than 30 days prior to study vaccine administration.
• BMI of ≥18 and ≤32.
• Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
• Accessible by phone on a consistent basis.
• Give his/her consent to participate in this study (by signing the ICF). In the opinion of the Investigator, competence and willingness to provide written, informed consent for participation after reading the informed consent form. The subject must have adequate opportunity to discuss the study with an Investigator or qualified designee.
• If female, have a negative serum pregnancy test result prior to immunization.
• Female of childbearing potential (except subjects in a same sex relationship), must use an effective birth control for the 28 days prior to immunization and must agree to continue employing adequate birth control measures for at least 60 days post-immunization and must have no plan to become pregnant for at least 60 days post-immunization. Highly effective birth control includes hormonal contraceptives (e.g., injectable, topical \[patch\], estrogenic vaginal ring, etc.), intra-uterine device (IUD), abstinence (confirmed by Investigator), or male condom plus spermicide. Abstinent subjects should be asked what method(s) they would use, should their circumstances change, and subjects without a well-defined plan should be excluded.

You may not qualify if:

• Presence of significant acute or chronic, uncontrolled medical or neuropsychiatric illness. "Uncontrolled" is defined as:
• Requiring a new medical or surgical treatment within one month prior to study vaccine administration;
• Requiring a change in medication dosage in one month prior to study vaccine administration due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable);
• Hospitalization or an event fulfilling the definition of a serious adverse event within one month prior to study vaccine administration.
• Any medical or neuropsychiatric condition or any history of excessive alcohol use or drug abuse which, in the Investigator's opinion, would render the subject incompetent to provide informed consent or unable to provide valid safety observations and reporting.
• Any confirmed or suspected immunosuppressive condition or immunodeficiency including history of human immunodeficiency virus (HIV) infection, Hepatitis B or C, or the presence of lymphoproliferative disease.
• Presence of any febrile illness, oral temperature of \>38.0˚C within 24 hours prior to immunization. Such subjects may be re-evaluated for enrolment after resolution of illness.
• History of autoimmune disease.
• Administration of any vaccine (including any other influenza vaccine) within 30 days prior to study enrolment or planned administration within the period from the vaccination up to blood sampling at Day 21 or within 30 days prior to blood sampling at Day 201. Immunization on an emergency basis of a tetanus and diphtheria toxoids adsorbed for adult use (Td) will be allowed provided the vaccine is not administered within two weeks prior to study vaccine administration. Receipt of any other emergency immunizations (e.g., rabies) will result in a case-by-case review by the medical monitor of continued participation.
• Administration of any adjuvanted or investigational influenza vaccine other than a 'simple' seasonal Trivalent influenza vaccine (TIV) or Quadrivalent influenza vaccine (QIV) within 1 year prior to study enrolment or planned administration prior to the end of this trial (Day 201).
• Use of any investigational or non-registered product within 30 days prior to study enrolment or planned use during the study period. Subjects may not participate in any other investigational or marketed drug study while participating in this study.
• Treatment with systemic glucocorticoids at a dose exceeding 10 mg of prednisone per day, or equivalent for more than 7 consecutive days or for 10 or more days in total, within one month of study vaccine administration, any other cytotoxic or immunosuppressant drug, or any globulin preparation within 3 months of vaccination. Low doses of nasal or inhaled glucocorticoids are allowed.
• Use of high dose inhaled steroids or oral and parenteral high dose steroid medications. Nasal steroids are allowed.
• Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving prophylactic anti-platelet medications, e.g., low-dose aspirin \[≤ 325 mg/day (1 regular adult aspirin) or ≤ 81 mg/day (1 baby aspirin)\], and without a clinically apparent bleeding tendency are eligible.
• History of allergy to any of the constituents of the quadrivalent VLP study vaccine, or to the Phosphate-buffered saline (PBS) (used as placebo).

Sponsors & Collaborators

• Medicago: lead

Study Sites (1)

Miami Research Associates

Miami, Florida, 33143, United States

Location

Related Publications (1)

• Pillet S, Aubin E, Trepanier S, Bussiere D, Dargis M, Poulin JF, Yassine-Diab B, Ward BJ, Landry N. A plant-derived quadrivalent virus like particle influenza vaccine induces cross-reactive antibody and T cell response in healthy adults. Clin Immunol. 2016 Jul;168:72-87. doi: 10.1016/j.clim.2016.03.008. Epub 2016 Mar 14.

  PMID: 26987887 RESULT

MeSH Terms

Conditions

Virus Diseases; RNA Virus Infections; Respiratory Tract Diseases; Respiratory Tract Infections; Influenza, Human; Orthomyxoviridae Infections; Infections

Study Officials

• Eric Sheldon, MD

  Miami Research Associate

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: November 25, 2013
• Study Start: October 8, 2013
• Primary Completion: June 30, 2014
• Study Completion: June 30, 2014
• Last Updated: June 11, 2020

Record last verified: 2019-11

Locations

US (1)