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Trial record 3 of 14 for:    sanofi pasteur | Yellow Fever

Study on an Investigational Yellow Fever Vaccine Compared With YF-VAX in Adults in the USA (VYF02)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04942210
Recruitment Status : Recruiting
First Posted : June 28, 2021
Last Update Posted : November 17, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The primary objective of the study is to demonstrate the non-inferiority of the antibody response in terms of seroconversion rate 28 days after vaccine administration of one dose of yellow fever vaccine (vYF) compared to the antibody response after one dose of the YF-VAX control vaccine in yellow fever naïve participants.

The secondary objectives of the study are:

  • To describe the immune response to yellow fever in both vaccine groups before and after vYF or YF-VAX administration.
  • To describe the safety profile of vYF vaccine in comparison to the safety profile of the control YF-VAX.
  • To describe the biosafety profile of vYF in comparison to the biosafety profile of the control YF-VAX.

Condition or disease Intervention/treatment Phase
Yellow Fever (Healthy Volunteers) Biological: Yellow fever vaccine (produced on serum-free Vero cells) Biological: Yellow fever vaccine Phase 2

Detailed Description:
The duration of each participant's participation will be approximately 5 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The study will be performed in a modified double-blind fashion: Investigators, Sponsor, and study staff who conduct the safety assessment and the participant will not know which vaccine is administered.
Primary Purpose: Prevention
Official Title: Controlled Study of Immunogenicity and Safety of the Investigational vYF Candidate Vaccine in Comparison to YF-VAX in Adults
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : December 2, 2021
Estimated Study Completion Date : December 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Vaccines

Arm Intervention/treatment
Experimental: vYF
1 injection of vYF at Day 1
Biological: Yellow fever vaccine (produced on serum-free Vero cells)
Powder and diluent for suspension for injection Subcutaneous injection

Active Comparator: YF-VAX
1 injection of YF-VAX at Day 1
Biological: Yellow fever vaccine
Powder and diluent for suspension for injection Subcutaneous injection
Other Name: YF-VAX




Primary Outcome Measures :
  1. Percentage of participants with seroconversion to YF virus at Day 29 [ Time Frame: Day 29 ]
    Seroconversion is defined as a 4-fold increase in neutralizing antibody titers as compared to the pre-vaccination value.


Secondary Outcome Measures :
  1. Percentage of participants with seroconversion to YF virus [ Time Frame: Day 1, Day 11, Day 29, Month 6, Year 1, Year 2, Year 3, Year 4, and Year 5 ]
    Seroconversion is defined as a 4-fold increase in neutralizing antibody titers as compared to the pre-vaccination value (up to Month 6) or compared to the values at the preceding time point (from Year 1 onwards).

  2. Percentage of participants with seroprotection to YF virus [ Time Frame: Day 1, Day 11, Day 29, Month 6, Year 1, Year 2, Year 3, Year 4, and Year 5 ]
    Seroprotection is defined as neutralizing antibody titers ≥ threshold of 10 (1/dil).

  3. 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.

  4. 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.

  5. Number of participants with solicited systemic reactions [ Time Frame: Within 14 days after vaccination ]
    Solicited systemic reactions include fever, headache, malaise and myalgia.

  6. 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, including medically attended adverse events.

  7. Number of participants with adverse events of special interest [ Time Frame: Within 6 months after vaccination ]
  8. Number of participants with serious adverse events [ Time Frame: From Day 1 to Month 6 ]
    Serious adverse events include medically attended adverse events.

  9. Number of participants with related serious adverse events and deaths [ Time Frame: From Day 1 to Year 5 ]
    Related serious adverse events include medically attended adverse events.

  10. Number of participants with out-of-range biochemistry and hematology test results [ Time Frame: Day 1 and Day 11 ]
    Participants with biochemistry and hematology values out of normal range (as per the laboratory performing the test) are considered.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18 years to 60 years on the day of inclusion.
  • A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:

Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile.

OR Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) before any dose of study intervention on Day 1 and will be repeated on Day 29 to confirm the participant is still not pregnant within the 28 days of vaccine administration.

  • Informed consent form has been signed and dated.
  • Able to attend all scheduled visits and to comply with all study procedures.

Exclusion Criteria:

  • 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 study 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 or family history of thymic pathology (thymoma, thymectomy, or myasthenia).
  • 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
  • Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following the study vaccination except for influenza vaccination, which may be received at least 2 weeks before study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
  • Previous vaccination against a flavivirus disease at any time including YF with either the study vaccine or another vaccine.
  • Receipt of immune globulins, blood, or blood-derived products in the past 6 months.
  • Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the first 2 years of the 5-year follow-up in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Enrollment in another study after the first 2 years is permitted, assuming it does not exclude participation in this study
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
  • Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04942210


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
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United States, Georgia
Investigational Site Number :8400005 Recruiting
Decatur, Georgia, United States, 30030
United States, Louisiana
Investigational Site Number :8400008 Recruiting
Metairie, Louisiana, United States, 70006
United States, Maryland
Investigational Site Number :8400004 Recruiting
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Investigational Site Number :8400002 Recruiting
Boston, Massachusetts, United States, 02115
United States, Missouri
Investigational Site Number :8400003 Recruiting
Saint Louis, Missouri, United States, 63104
United States, New York
Investigational Site Number :8400013 Recruiting
New York, New York, United States, 10016
Investigational Site Number :8400010 Recruiting
Rochester, New York, United States, 14609
Investigational Site Number :8400006 Recruiting
Syracuse, New York, United States, 13210
United States, Utah
Investigational Site Number :8400012 Recruiting
Salt Lake City, Utah, United States, 84109
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT04942210    
Other Study ID Numbers: VYF02
U1111-1261-5612 ( Registry Identifier: ICTRP )
First Posted: June 28, 2021    Key Record Dates
Last Update Posted: November 17, 2021
Last Verified: November 16, 2021
Individual Participant Data (IPD) Sharing Statement:
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/

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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
Additional relevant MeSH terms:
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Yellow Fever
Fever
Hemorrhagic Fevers, Viral
Body Temperature Changes
Arbovirus Infections
Vector Borne Diseases
Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs