Clinical trial NCT04144179: Recombinant Influenza Vaccine Containing Different H3 Antigens in Healthy Adults 18 to 30 Years of Age
Official title: Safety and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Formulations Containing Different H3 Hemagglutinin Antigens in Healthy Adult Subjects 18 to 30 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2019-10-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objectives of the study are:

* To describe the safety profile of the different quadrivalent recombinant influenza vaccine (RIV) formulations.
* To describe the hemagglutination inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (HA) (H1, H3, B/Victoria, and B/Yamagata) antigens present in the control vaccine in all groups at all timepoints.

The secondary objectives of the study are:

* To describe antigenic coverage in each group by assessing the HAI and SN antibody responses against a panel of H3 antigens (not present in any of the vaccine formulations).
* To describe HAI and SN antibody responses in each group against each of the H3 antigens.
* To compare the HAI and SN antibody responses for the groups with different H3 antigens to the control group.

Detailed description: Study duration per participant is approximately 90 days.

Eligibility criteria: Inclusion criteria :

* Aged 18 to 30 years on the day of inclusion
* Informed consent form has been signed and dated
* Able to attend all scheduled visits and to comply with all study procedures

Exclusion criteria:

* Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 12 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile
* Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
* Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following study vaccination
* Previous vaccination against influenza in the previous influenza season (2018-2019) with any licensed or investigational influenza vaccine
* Previous vaccination against influenza in the 2019-2020 season with any licensed influenza vaccine
* Receipt of immune globulins, blood or blood-derived products in the past 3 months
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Have known active or recently active (12 months) neoplastic disease or a history of any hematologic malignancy
* History of influenza infection during the 2018-2019 or 2019-2020 influenza season, confirmed by laboratory tests (including rapid tests)
* Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances
* Thrombocytopenia or bleeding disorder, contraindicating intramuscular vaccination based on Investigator's judgement
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
* Alcohol abuse or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion or predispose to complications associated with influenza infection
* Have any diagnosis, current or past, of chronic pulmonary diseases including asthma, cystic fibrosis and chronic pulmonary obstructive disease
* Have taken high-dose inhaled corticosteroids within 6 months prior to study vaccination
* Body Mass Index of 40 or higher
* History of cardiac disease such as congenital heart disease, heart failure, coronary artery disease (except isolated hypertension)
* Health care personnel in inpatient and outpatient care settings, medical emergency-response workers, employees of nursing home and long-term care facilities who have contact with patients or residents and students in these professions who will have contact with patients
* Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4 F \[≥ 38.0 C\]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
* Personal or family history of Guillain-Barré syndrome

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Number of participants with immediate adverse events
timeFrame: Within 30 minutes after vaccination
measure: Number of participants with solicited injection site or systemic reactions
timeFrame: From Day 0 to Day 7
measure: Number of participants with unsolicited adverse events
timeFrame: From Day 0 to Day 28
measure: Number of participants with serious adverse events
timeFrame: From Day 0 to Day 90
measure: Number of participants with adverse events of special interest
timeFrame: From Day 0 to Day 90
measure: HAI antibody titers against HA influenza antigens in quadrivalent RIV control group
timeFrame: From Day 0 to Day 90
measure: Individual ratio of HAI titers against HA influenza antigens in quadrivalent RIV control group
timeFrame: From Day 0 to Day 90
measure: Number of participants with seroconversion to HA influenza antigens in quadrivalent RIV control group
timeFrame: Day 28
measure: Number of participants with HAI antibody titer ≥ 40 [1/dil] against HA influenza antigens in quadrivalent RIV control group
timeFrame: From Day 0 to Day 90
Secondary outcomes:
measure: 2-fold and 4-fold increase in SN antibody titers against HA influenza antigens in quadrivalent RIV control group
timeFrame: From Day 0 to Day 90
measure: HAI and SN antibody titers against influenza H3 antigens
timeFrame: From Day 0 to Day 90
measure: Individual ratio of HAI and SN titers against influenza H3 antigens
timeFrame: From Day 0 to Day 90
measure: Number of participants with seroconversion to influenza H3 antigens
timeFrame: Day 28
measure: Number of participants with HAI antibody titer ≥ 40 [1/dil] against influenza H3 antigens
timeFrame: From Day 0 to Day 90
measure: 2-fold and 4-fold increase in SN antibody titers against influenza H3 antigens
timeFrame: From Day 0 to Day 90
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Investigational Site Number 8400002
state: Florida
city: Rochester
country: United States
facility: Investigational Site Number 8400001
state: New York
city: Mount Pleasant
country: United States
facility: Investigational Site Number 8400003
state: South Carolina
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: