Immunologic Mechanisms of Immune Interference and/or Cross-Neutralizing Immunity After CYD Tetravalent Dengue Vaccine

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Sanofi
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01943825
First received: September 12, 2013
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

The aim of the study is to evaluate a compressed dosing schedule and the immunologic effects of co-administration of a flavivirus with JE vaccine.

Primary Objectives:

  • To describe and compare the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each CYD dengue vaccine dose.
  • To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes 6 months after CYD dengue vaccine Dose 3, irrespective of whether or not JE vaccine has been previously administered.

Secondary Objectives:

  • To describe the safety profile after each injection of CYD dengue vaccine.
  • To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each CYD dengue vaccine dose when administered with or after JE virus vaccine.
  • To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes at six months post-Dose 3 in all four groups and at 12 months post dose 3 in Groups 1 and 3 with the compressed schedule.
  • To describe the JE humoral immune response 28 days after each injection of CYD dengue vaccine.

Condition Intervention Phase
Dengue
Dengue Fever
Dengue Hemorrhagic Fever
Biological: CYD Dengue Vaccine
Biological: CYD Dengue and Japanese Encephalitis Vaccines
Biological: Japanese Encephalitis and CYD Dengue Vaccines
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Exploration of Immunologic Mechanisms of Immune Interference and/or Cross-Neutralizing Immunity Following Various Administration Schedules With CYD Tetravalent Dengue Vaccine

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Neutralizing antibody levels by microneutralization assay and/or plaque reduction neutralization test (PRNT) against each of the 4 parental dengue virus serotypes at baseline and 28 days after each CYD dengue vaccine dose in all four groups [ Time Frame: 28 days post CYD dengue vaccination ] [ Designated as safety issue: No ]
  • Neutralizing antibody levels by microneutralization assay and/or PRNT against each of the 4 parental dengue virus serotypes 6 and/or 12 months after CYD dengue vaccine Dose 3 in all four groups [ Time Frame: 6 and 12 months post CYD dengue vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Description of the Safety profile in terms of solicited injection site and systemic reaction, unsolicited adverse events and serious adverse events after each vaccination with CYD dengue and/or JE vaccines [ Time Frame: Day 0 up to 6 months post last vaccination ] [ Designated as safety issue: No ]
  • Neutralizing antibody levels, measured by microneutralization assay and/or PRNT, against each of the four parental dengue virus serotypes at baseline and 28 days after each CYD dengue vaccine dose in Groups 3 and 4. [ Time Frame: 28 days post CYD dengue vaccination ] [ Designated as safety issue: No ]
  • Neutralizing antibody levels, measured by microneutralization assay and/or PRNT, against each of the four parental dengue virus serotypes at 6 months post Dose 3 in all subjects and at 12 months post Dose 3 in Groups 1 and 3 [ Time Frame: 6 and 12 months post dose 3 CYD dengue vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: September 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: CYD dengue vaccine
Participants will receive a dose on CYD dengue vaccine at Day 0, and month 2 and 6, respectively
Biological: CYD Dengue Vaccine
0.5 mL, Subcutaneous
Experimental: Group 2: CYD dengue vaccine
Participants will receive a dose on CYD dengue vaccine at Day 0, and month 6 and 12, respectively
Biological: CYD Dengue Vaccine
0.5 mL, Subcutaneous
Experimental: Group 3: CYD dengue and IXIARO vaccines
Participants will receive a dose on CYD dengue and IXIARO (JE) vaccines at Day 0, JE at month 1, and CYD dengue at month 2 and 6 and 12, respectively
Biological: CYD Dengue and Japanese Encephalitis Vaccines
0.5 mL, Subcutaneous (CYD) Intramuscular (JE)
Other Name: IXIARO Japanese Encephalitis Vaccine
Experimental: Group 4: IXIARO (JE) vaccine
Participants will receive a dose of IXIARO (JE) vaccines at Day 0 and at month 1; and CYD dengue at months 7, 9 and 13, respectively
Biological: Japanese Encephalitis and CYD Dengue Vaccines
0.5 mL, Intramuscular (JE), Subcutaneous (CYD)
Other Name: IXIARO Japanese Encephalitis Vaccine

Detailed Description:

Study participants will be randomly assigned to one of the four groups to receive assigned study vaccine and will be evaluated neutralizing antibody (Ab) titers; markers of cell-mediated immunity (CMI)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged ≥ 18 to ≤ 45 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 trial procedures
  • Subject in good health, based on medical history and physical examination.

Exclusion Criteria:

  • Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post- menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination)
  • Participation in the 4 weeks preceding the first trial vaccination, or planned participation during the present trial period, in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
  • Receipt or planned receipt of any vaccine, outside the study protocol in the 4 weeks preceding or following trial vaccinations. (If influenza activity warrants vaccination of healthy young adults, influenza vaccination will be encouraged and will not lead to study exclusion.)
  • Any history of flavivirus (FV) vaccination, or planned FV vaccination during the trial period.
  • Previous residence (>12 months) in, or travel in the last 30 days to dengue endemic regions.
  • Receipt of immune globulins, blood or blood-derived products in the 3 months prior to first vaccination or planned use during the study period
  • 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 systemic hypersensitivity to any of the vaccine components (including protamine sulfate), or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances, including dry natural latex
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Excessive alcohol consumption 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
  • Identified as an employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employee or the Investigator
  • Temporary Exclusion Criteria: Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided. If the delay for the febrile illness exceeds the window between screening and vaccination, or if deemed necessary by the Investigator, a prospective subject may be re-screened once the fever has resolved.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01943825

Contacts
Contact: Public Registry Sanofi Pasteur RegistryContactUs@sanofipasteur.com

Locations
United States, New York
Recruiting
Syracuse, New York, United States, 13210
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur SA
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01943825     History of Changes
Other Study ID Numbers: CYD56, U1111-1143-8391
Study First Received: September 12, 2013
Last Updated: March 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Dengue
Dengue fever
CYD dengue vaccine
IXIARO JE vaccine
Flavivirus

Additional relevant MeSH terms:
Dengue Hemorrhagic Fever
Hemorrhagic Fevers, Viral
Dengue
Fever
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014