Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03301051
• Date of registration: 21/09/2017
• Prospective Registration: No
• Primary sponsor: Medicago
• Public title: Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Adults
• Scientific title: A Randomized, Observer-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Adults 18-64 Years of Age
• Date of first enrolment: August 31, 2017
• Target sample size: 10137
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03301051
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Canada, Finland, Germany, Philippines, Thailand, United Kingdom, United States

Contacts

• Name: Brian J Ward, MD
• Affiliation: Medicago

Key inclusion & exclusion criteria

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation
in this study; no protocol waivers are allowed:

1. Subjects must be able to read, understand, and sign the informed consent form (ICF);
complete study-related procedures; and communicate with the study staff at visits and
by phone;

2. Subject must have a body mass index (BMI) below 40 kg/m2;

3. Subjects are considered by the Investigator to be reliable and likely to cooperate
with the assessment procedures and be available for the duration of the study;

4. Male and female subjects must be 18 to 64 (has not yet had his/her 65th birthday)
years of age, inclusive, at the Screening/Vaccination visit (Visit 1);

5. Subjects must be in good general health prior to study participation, with no
clinically relevant abnormalities that could jeopardize subject 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: Subjects 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 subject by participating in the study. Stable
disease is generally defined as no new onset or exacerbation of pre-existing chronic
disease three months prior to vaccination. Based on the Investigator's judgment, a
subject with more recent stabilization of a disease could also be eligible.

6. Female subjects must have a negative urine pregnancy test result at the
Screening/Vaccination visit (Visit 1);

7. Female subjects 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 at least 60 days post-vaccination. Moreover,
female subjects must have no plan to become pregnant for at least two months
post-vaccination. 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. 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 sterilized partner (at least one
year prior to vaccination);

- Credible self-reported history of heterosexual vaginal intercourse abstinence
until at least 60 days post-vaccination;

- Female partner;

8. 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).

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from participating in this
study; no protocol waivers are allowed:

1. Any subject whose medical condition(s) is sufficiently severe that annual influenza
vaccination would be routinely recommended in the jurisdiction of recruitment, as per
the Investigator's judgement;

2. According to the Investigator's opinion, history of significant acute or chronic,
uncontrolled medical or neuropsychiatric illness. 'Uncontrolled' is defined as:

- Requiring a new medical or surgical treatment during the three months prior to
study vaccine administration unless the criteria outlined in inclusion criterion
no. 5 can be met (i.e. the Investigator can justify inclusion based upon the
innocuous nature of medical/surgical events and/or treatments);

- Requiring any significant change in a chronic medication (i.e. drug, dose,
frequency) during the three months prior to study vaccine administration due to
uncontrolled symptoms or drug toxicity unless the innocuous nature of the
medication change meets the criteria outlined in inclusion criterion no. 5 and is
appropriately justified by the Investigator.

3. 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 unable to
provide informed consent or unable to provide valid safety observations and reporting;

4. Any autoimmune disease other than hypothyroidism on stable replacement therapy
(including, but not limited to rheumatoid arthritis, systemic lupus erythematosus,
Crohn's disease, and inflammatory bowel disease) or any confirmed or suspected
immunosuppressive condition or immunodeficiency including known or suspected human
immunodeficiency virus (HIV), Hepatitis B or C infection, the presence of
lymphoproliferative disease;

5. History of chronic pulmonary (including asthma, bronchopulmonary dysplasia, and cystic
fibrosis) or cardiovascular (except isolated hypertension), renal, hepatic,
neurologic, hematologic (including anemia and hemoglobinopathy), or metabolic
disorders (including diabetes mellitus);

6. Because this is a placebo-controlled study, any subjects in close contact with
individuals considered to be at high risk for developing influenza-related
complications (individuals considered at high risk for complications include adults
and children who have chronic pulmonary or cardiovascular [except isolated
hypertension], renal, hepatic, neurologic, hematologic, or metabolic disorders
[including diabetes mellitus]), ;

7. Administration or planned administration of any non-influenza vaccine within 30 days
prior to randomization up to blood sampling on Day 21. Immunization on an emergency
basis will be evaluated case-by-case by the Investigator;

8. Administration of any adjuvanted or investigational influenza vaccine within one year
prior to randomization or planned administration prior to the completion of the study;

9. Administration of any 'standard', non-adjuvanted influenza vaccine (e.g. live
attenuated trivalent/quadrivalent inactivated influenza vaccine or split
trivalent/quadrivalent inactivated influenza vaccine administered by intranasal,
intradermal, or intramuscular route) within six mon


Age minimum: 18 Years
Age maximum: 64 Years
Gender: All

Health Condition(s) or Problem(s) studied

Respiratory Tract Diseases

Virus Diseases

Respiratory Tract Infections

RNA Virus Infections

Intervention(s)

Biological: Quadrivalent VLP Vaccine

Biological: Placebo

Primary Outcome(s)

Time of occurence of protocol-defined respiratory illness due to laboratory-confirmed influenza caused by vaccine matched strains. [Time Frame: 8 months]

Secondary Outcome(s)

Time of occurence of protocol-defined respiratory illness due to any laboratory-confirmed influenza strains. [Time Frame: 8 months]

Number of subjects with solicited local and systemic reactions, unsolicited adverse events, serious adverse events and New Onset Chronic Diseases. [Time Frame: 8 months]

Immunogenicity evaluated by the humoral immune response (HI, MN, and SRH assays) and the CMI response [Time Frame: 21 days after injection]

Secondary ID(s)

CP-PRO-QVLP-012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors