Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults

NCT03321968 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CP-PRO-QVLP-011
• Study Type: interventional
• Target: 1,202
• Locations: 1 country
• Sites: 10

Brief Summary

This Phase 3 study is intended to assess the clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three consecutively manufactured lots of the Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine, during the 2016-2017 influenza season, in healthy adults 18-49 years of age. A single dose of one of three consecutive lots of Quadrivalent VLP Influenza Vaccine (30 µg/strain) will be administered to 1,200 participants.

Conditions

Virus Diseases; RNA Virus Infections; Respiratory Tract Infections; Respiratory Tract Disease; Influenza

Keywords

Influenza; Human; RNA Virus Infections; Lot Consistency; Immunologic; Orthomyxoviridae Infections; Infection; Virus Diseases; Vaccine; Safety; Plant-made; Virus-like particle; Hemagglutinin

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain

  The GMTs were measured using a HI assay for the homologous strains: A/California/7/2009 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008 (Victoria lineage), and B/Phuket/3073/2013 (Yamagata lineage). Lot-to-lot consistency was based on adjusted GMT ratio for pairwise comparisons of the lots (Lot 1 / Lot 2, Lot 1 / Lot 3, and Lot 2 / Lot 3).

  Day 21 (post-vaccination)

Secondary Outcomes (14)

• Percentage of Participants With Seroconversion (SC) Measured by HI Antibody Response for Each Homologous Influenza Strain

  Day 0 (pre-vaccination) to Day 21

• Percentage of Participants With Seroprotection (SP) Measured by HI Antibody Response of for Each Homologous Influenza Strain

  Day 0 (pre-vaccination), Day 21

• Geometric Mean of the Ratio of GMTs (Geometric Mean Fold Rise [GMFR]) of HI Antibody Response for Each Homologous Influenza Strain

  Day 0 (pre-vaccination), Day 21

• Number of Participants With at Least One Immediate Complaint

  15 minutes post-vaccination

• Number of Participants With at Least One Solicited Local and/or Systemic Reactions

  Day 0 (post-vaccination) up to Day 7

Study Arms (3)

Quadrivalent VLP Influenza Vaccine - Lot 1

EXPERIMENTAL

Participants received one intramuscular (IM) injection of 0.5 mL of their assigned vaccine lot of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.

Biological: Quadrivalent VLP Influenza Vaccine

Quadrivalent VLP Influenza Vaccine - Lot 2

EXPERIMENTAL

Participants received one IM injection of 0.5 mL of their assigned vaccine lot of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.

Biological: Quadrivalent VLP Influenza Vaccine

Quadrivalent VLP Influenza Vaccine - Lot 3

EXPERIMENTAL

Participants received one IM injection of 0.5 mL of their assigned vaccine lot of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.

Biological: Quadrivalent VLP Influenza Vaccine

Interventions

Quadrivalent VLP Influenza Vaccine BIOLOGICAL

Single dose of 30 µg/strain Quadrivalent VLP Influenza Vaccine

Quadrivalent VLP Influenza Vaccine - Lot 1; Quadrivalent VLP Influenza Vaccine - Lot 2; Quadrivalent VLP Influenza Vaccine - Lot 3

Eligibility Criteria

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

You may qualify if:

• Participants must be considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study;
• Participants have a body mass index (BMI) ≤ 40.0 kg/m\^2 on Day 0 (pre-vaccination);
• Participants must be in good general health prior to study participation with no clinically relevant abnormalities that could jeopardize participant safety or interfere with study assessments as assessed by the Principal Investigator or sub-Investigator (thereafter referred as Investigator) and determined by medical history, physical examination, and vital signs; Note: Participants with a pre-existing chronic disease will be allowed to participate if the disease is stable and, according to the Investigator's judgment, the condition is unlikely to confound the results of the study or pose additional risk to the participant by participating in the study. Stable disease is generally defined as no new onset or exacerbation of pre-existing chronic disease six months prior to vaccination. Based on the Investigator's judgment, a participant with a more recent stabilization of a disease could also be eligible.
• Female participants must have a negative urine pregnancy test result at the Screening/Vaccination visit (Visit 1);
• Female participants of childbearing potential must use an effective method of contraception for one month prior to vaccination and agree to continue employing adequate birth control measures for the duration of the study. Abstinent participants should be asked what method(s) they would use, should their circumstances change, and participants without a well-defined plan should be excluded. The following relationship or methods of contraception are considered to be effective:
• Hormonal contraceptives (e.g. oral, injectable, topical \[patch\], or estrogenic vaginal ring);
• Intra-uterine device with or without hormonal release;
• Male partner using a condom plus spermicide or a sterilized partner (at least one year prior to vaccination);
• Credible self-reported history of heterosexual vaginal intercourse abstinence until at least the Day 21 visit;
• Female partner.
• Non-childbearing females are defined as:
• Surgically-sterile (defined as bilateral tubal ligation, hysterectomy, or bilateral oophorectomy performed more than one month prior to vaccination); or
• Post-menopausal (absence of menses for 24 consecutive months and age consistent with natural cessation of ovulation).

You may not qualify if:

• Participants who meet any of the following criteria will be excluded from participating in this study; no protocol waivers are allowed:
• According to the Investigator's opinion, history of significant acute or chronic, uncontrolled medical or neuropsychiatric illness. 'Uncontrolled' is defined as:
• Any medical or neuropsychiatric condition or any history of excessive alcohol use or drug abuse which, in the Investigator's opinion, would render the participant unable to provide informed consent or unable to provide valid safety observations and reporting;
• Any autoimmune disease other than hypothyroidism with stable replacement therapy; or any confirmed or suspected immunosuppressive condition or immunodeficiency including known or suspected human immunodeficiency virus (HIV), hepatitis B or C infection, or the presence of lymphoproliferative disease;
• Administration or planned administration of any non-influenza vaccine within 30 days prior to randomization and up to blood sampling on Day 21. Immunization on an emergency basis will be evaluated case-by-case by the Investigator;
• Administration of any adjuvanted or investigational influenza vaccine within 24 months prior to randomization or planned administration prior to the completion of Day 21;
• Administration of any "standard", non-adjuvanted influenza vaccine (e.g. live attenuated trivalent/quadrivalent inactivated influenza vaccine intranasal or split trivalent/quadrivalent inactivated influenza vaccine by either intradermal or IM route) within 24 months prior to randomization and up to completion of the Day 21 visit;
• Use of any investigational or non-registered product within 30 days prior to randomization or planned use during the study period. Participants may not participate in any other investigational or marketed drug study while participating in this study until the Day 21 visit. Participation in observational studies is permitted;
• Treatment with systemic glucocorticoids at a dose exceeding 10 milligrams (mg) of prednisone (or the equivalent) per day for more than seven consecutive days or for ten or more days in total, within one month of study vaccine administration; or any other cytotoxic or immunosuppressant drug, or any immunoglobulin preparation within three months of vaccination and until the completion of the Day 21 visit. Low doses of nasal or inhaled glucocorticoids and topical steroids are permitted;
• Any significant disorder of coagulation including, but not limited to, treatment with warfarin derivatives or heparin. Persons receiving prophylactic anti-platelet medications (e.g. low-dose aspirin \[no more than 325 mg/day\]) and without a clinically apparent bleeding tendency are eligible. Participants treated with new generation drugs that do not increase the risk of IM bleeding (e.g. clopidogrel) are also eligible.
• History of allergy to any of the constituents of the Quadrivalent VLP Influenza Vaccine or a tobacco allergy;
• History of anaphylactic allergic reactions to plants or plants components;
• Any history of serious asthma (e.g. status asthmaticus, hospitalization for asthma control) in the last three years;
• Use of antihistamines 48 hours prior to study vaccination;
• The use of prophylactic medications (e.g. acetaminophen/paracetamol, aspirin, naproxen, or ibuprofen) within 24 hours of randomization to prevent or pre-empt symptoms due to vaccination. Participant discovered to have taken a prophylactic medication to prevent or pre empt symptoms due to vaccination within the 24 hours prior to planned randomization must be delayed until at least the 24-hour period is met;

Sponsors & Collaborators

• Medicago: lead

Study Sites (10)

Site 205

Halifax, Nova Scotia, Canada

Location

Site 208

Burlington, Ontario, Canada

Location

Site 207

Guelph, Ontario, Canada

Location

Site 202

Toronto, Ontario, Canada

Location

Site 204

Chicoutimi, Quebec, Canada

Location

Site 203

Gatineau, Quebec, Canada

Location

Site 201

Lévis, Quebec, Canada

Location

Site 209

Pointe-Claire, Quebec, Canada

Location

Site 206

Toronto, Quebec, Canada

Location

Site 210

Victoriaville, Quebec, Canada

Location

Related Publications (1)

• Ward BJ, Seguin A, Couillard J, Trepanier S, Landry N. Phase III: Randomized observer-blind trial to evaluate lot-to-lot consistency of a new plant-derived quadrivalent virus like particle influenza vaccine in adults 18-49 years of age. Vaccine. 2021 Mar 5;39(10):1528-1533. doi: 10.1016/j.vaccine.2021.01.004. Epub 2021 Feb 10.

  PMID: 33581920 RESULT

MeSH Terms

Conditions

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

Results Point of Contact

• Title: Medical Director
• Organization: Medicago

clinicaltrialinquiries@medicago.com

+1 418-658-9393

Study Officials

• Medical Director

  Medicago

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Observer-blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 26, 2017
• Study Start: September 29, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 4, 2023
• Results First Posted: August 4, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10)