Dose-ranging Study of an Investigational Yellow Fever Candidate Vaccine in Adults
- Conditions
- Yellow Fever (Healthy Volunteers)
- Interventions
- Biological: Yellow fever vaccineBiological: Yellow fever vaccine (produced on serum-free Vero cells), Dosage 1 vYF vaccineBiological: Yellow fever vaccine (produced on serum-free Vero cells), Dosage 2 vYF vaccineBiological: Yellow fever vaccine (produced on serum-free Vero cells), Dosage 3 vYF vaccine
- Registration Number
- NCT04142086
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 4 Yellow fever vaccine 1 injection of YF-VAX Group 1 Yellow fever vaccine (produced on serum-free Vero cells), Dosage 1 vYF vaccine 1 injection of vYF vaccine Dosage 1 Group 2 Yellow fever vaccine (produced on serum-free Vero cells), Dosage 2 vYF vaccine 1 injection of vYF vaccine Dosage 2 Group 3 Yellow fever vaccine (produced on serum-free Vero cells), Dosage 3 vYF vaccine 1 injection of vYF vaccine Dosage 3
- Primary Outcome Measures
Name Time Method Number of participants with serious adverse events From Day 0 to Day 180 Serious adverse events are collected throughout the study
Number of participants with hematology and biochemistry out-of-range test results From Day 0 to Day 14 Hematology and biochemistry values that are out-of-range are assessed
Number of participants with Grade 3 fever Within 28 days after vaccination Grade 3 fever is defined as temperature ≥ 102.1°F
Number of participants with immediate adverse events Within 30 minutes after vaccination Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination
Number of participants with solicited systemic reactions Within 14 days after vaccination Solicited systemic reactions include fever, headache, malaise, and myalgia
Number of participants with seroconversion to YF virus From Day 0 to Day 28 Seroconversion is defined as a fourfold increase in neutralizing antibody titers as compared to pre-vaccination value. Seroconversion is assessed from Day 0 (pre-vaccination) to Day 10, Day 14 and Day 28.
Number of participants with neutralizing antibody titers against YF virus above pre-defined threshold From Day 0 to Day 180 Pre-defined threshold of 10 1/dilution
Number of participants with YF vaccinal viremia From Day 0 to Day 14 Vaccinal viremia is measured by YF specific quantitative reverse transcription polymerase chain reaction (RT-PCR) assay in samples collected on Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, and Day 14.
Number of participants with unsolicited adverse events Within 28 days after vaccination Unsolicited (spontaneously reported) adverse events not fulfilling criteria for solicited adverse reactions
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 Within 28 days after vaccination Investigators are provided with guidelines for recognition and assessment of potential viscerotropic and neurotropic events
Number of participants with solicited injection site reactions Within 7 days after vaccination Solicited injection site reactions include injection site pain, erythema and swelling
Geometric mean titers of neutralizing antibodies against YF virus From Day 0 to Day 180 Geometric mean titer ratio Day 10/Day 0, Day 14/Day 0, Day 28/Day 0 and Day 180/Day 0
Level of YF vaccinal viremia From Day 0 to Day 14 Vaccinal viremia is measured by YF specific quantitative RT-PCR assay in samples collected on Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, and Day 14.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Investigational Site Number 8400001
🇺🇸Silver Spring, Maryland, United States