Clinical trial NCT04142086: Dose-ranging Study of an Investigational Yellow Fever Candidate Vaccine in Adults
Official title: Safety, Tolerability, and Immunogenicity Dose-ranging Study of the Investigational Yellow Fever Vacine (vYF) Candidate Vaccine in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Yellow Fever (Healthy Volunteers)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2019-10-29
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
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 each of the 3 dosages of vYF and of YF-VAX® within the 28 days post-vaccination and up to the 6 months (Day 180) post-vaccination visit
* To describe the antibody responses elicited by each of the 3 dosages of vYF and by YF-VAX on Day 0 pre-vaccination and then on Day 10, Day 14, Day 28 and 6 months (Day 180) post-vaccination overall and by baseline flavivirus serostatus
* To quantify the detectable yellow fever (YF) vaccinal viremia in each vaccine groups (vYF and YF-VAX) in a subset of subjects on Day 0 visit, Day 1 visit, Day 3 visit, Day 5 visit, Day 7 visit, Day 10 visit, and Day 14 visit.

Detailed description: Study duration per participant is approximately 6 months.

Eligibility criteria: Inclusion criteria :

* Aged 18 years up to 60 years on the day of inclusion
* Able to read and understand the Informed Consent Form which has been signed and dated
* Able to attend all scheduled visits and to comply with all trial 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 4 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 trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
* Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination
* Previous vaccination against a flavivirus disease including YF with either the trial vaccine or another vaccine
* Receipt of immune globulins, blood, or blood-derived products in the past 6 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)
* Known history of flavivirus infection
* Known systemic hypersensitivity to any of the vaccine components, eggs, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
* Known history or laboratory evidence of human immunodeficiency virus infection
* Known history of hepatitis B or hepatitis C seropositivity
* Personal of family history of thymic pathology (thymoma, thymectomy, or myasthenia)
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
* Current alcohol abuse or drug addiction
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion, including malignancy, such as leukemia or lymphoma
* Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4 F). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
* Administration of any anti-viral within 2 months preceding the vaccination and up to the 6 weeks following the vaccination
* 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
* Planned travel in a YF endemic country within 6 months of investigational or control vaccine administration

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 reactions
timeFrame: Within 7 days after vaccination
measure: Number of participants with solicited systemic reactions
timeFrame: Within 14 days after vaccination
measure: Number of participants with unsolicited adverse events
timeFrame: Within 28 days after vaccination
measure: Number of participants with Grade 3 fever
timeFrame: Within 28 days after vaccination
measure: Number of participants with serious adverse events
timeFrame: From Day 0 to Day 180
measure: Number of participants with hematology and biochemistry out-of-range test results
timeFrame: From Day 0 to Day 14
measure: Number of participants with YF and flavivirus viremia and out-of-normal-range biological test results in the event of severe fever, or suspicion of neurotropic disease or acute viscerotropic diseases
timeFrame: Within 28 days after vaccination
measure: Number of participants with seroconversion to YF virus
timeFrame: From Day 0 to Day 28
measure: Number of participants with neutralizing antibody titers against YF virus above pre-defined threshold
timeFrame: From Day 0 to Day 180
measure: Geometric mean titers of neutralizing antibodies against YF virus
timeFrame: From Day 0 to Day 180
measure: Number of participants with YF vaccinal viremia
timeFrame: From Day 0 to Day 14
measure: Level of YF vaccinal viremia
timeFrame: From Day 0 to Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: Investigational Site Number 8400001
state: Maryland
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: