Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 14 for:    sanofi pasteur | Yellow Fever

Dose-ranging Study of an Investigational Yellow Fever Candidate Vaccine in Adults (VYF01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04142086
Recruitment Status : Completed
First Posted : October 29, 2019
Last Update Posted : July 13, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE October 25, 2019
First Posted Date  ICMJE October 29, 2019
Last Update Posted Date July 13, 2021
Actual Study Start Date  ICMJE January 15, 2020
Actual Primary Completion Date June 24, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2019)
  • Number of participants with immediate adverse events [ Time Frame: 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 injection site reactions [ Time Frame: Within 7 days after vaccination ]
    Solicited injection site reactions include injection site pain, erythema and swelling
  • Number of participants with solicited systemic reactions [ Time Frame: Within 14 days after vaccination ]
    Solicited systemic reactions include fever, headache, malaise, and myalgia
  • Number of participants with unsolicited adverse events [ Time Frame: Within 28 days after vaccination ]
    Unsolicited (spontaneously reported) adverse events not fulfilling criteria for solicited adverse reactions
  • Number of participants with Grade 3 fever [ Time Frame: Within 28 days after vaccination ]
    Grade 3 fever is defined as temperature ≥ 102.1°F
  • Number of participants with serious adverse events [ Time Frame: 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 [ Time Frame: From Day 0 to Day 14 ]
    Hematology and biochemistry values that are out-of-range are assessed
  • 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 [ Time Frame: Within 28 days after vaccination ]
    Investigators are provided with guidelines for recognition and assessment of potential viscerotropic and neurotropic events
  • Number of participants with seroconversion to YF virus [ Time Frame: 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 [ Time Frame: From Day 0 to Day 180 ]
    Pre-defined threshold of 10 1/dilution
  • Geometric mean titers of neutralizing antibodies against YF virus [ Time Frame: 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
  • Number of participants with YF vaccinal viremia [ Time Frame: 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.
  • Level of YF vaccinal viremia [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-ranging Study of an Investigational Yellow Fever Candidate Vaccine in Adults
Official Title  ICMJE Safety, Tolerability, and Immunogenicity Dose-ranging Study of the Investigational Yellow Fever Vacine (vYF) Candidate Vaccine in Adults
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
An observer-blind procedure is followed for the injection of vYF or YF-VAX. Neither the observer Investigator, nor the Sponsor, nor the participants know product is administered. The "vaccinator" is in charge of preparing and administering the products and is not authorized to collect any safety data.
Primary Purpose: Prevention
Condition  ICMJE Yellow Fever (Healthy Volunteers)
Intervention  ICMJE
  • Biological: Yellow fever vaccine (produced on serum-free Vero cells), Dosage 1 vYF vaccine
    Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
  • Biological: Yellow fever vaccine (produced on serum-free Vero cells), Dosage 2 vYF vaccine
    Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
  • Biological: Yellow fever vaccine (produced on serum-free Vero cells), Dosage 3 vYF vaccine
    Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
  • Biological: Yellow fever vaccine
    Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
    Other Name: YF-VAX
Study Arms  ICMJE
  • Experimental: Group 1
    1 injection of vYF vaccine Dosage 1
    Intervention: Biological: Yellow fever vaccine (produced on serum-free Vero cells), Dosage 1 vYF vaccine
  • Experimental: Group 2
    1 injection of vYF vaccine Dosage 2
    Intervention: Biological: Yellow fever vaccine (produced on serum-free Vero cells), Dosage 2 vYF vaccine
  • Experimental: Group 3
    1 injection of vYF vaccine Dosage 3
    Intervention: Biological: Yellow fever vaccine (produced on serum-free Vero cells), Dosage 3 vYF vaccine
  • Active Comparator: Group 4
    1 injection of YF-VAX
    Intervention: Biological: Yellow fever vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2021)
73
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2019)
572
Actual Study Completion Date  ICMJE June 24, 2021
Actual Primary Completion Date June 24, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04142086
Other Study ID Numbers  ICMJE VYF01
U1111-1217-1958 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company
PRS Account Sanofi
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP