Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Given With or Without Yellow Fever Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01488890
First received: December 6, 2011
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

The aim of this study is to evaluate the administration of CYD dengue vaccine following a compressed schedule in different populations.

Primary Objectives:

  • To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue vaccine Dose 3 in defined study groups.
  • 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 in defined study groups.

Secondary Objective:

  • To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue vaccine Dose 1 and Dose 2 in defined study groups, irrespective of whether or not Yellow fever (YF) vaccine has been previously administered.
  • To describe the YF humoral immune response at baseline and 1, 3, and 7 months after injection of the YF vaccine at Month 0 in Groups 3 and 4.
  • To describe the safety profile in terms of solicited injection site and systemic events, unsolicited adverse events and serious adverse events after each injection of CYD dengue vaccine and/or YF vaccine.

Condition Intervention Phase
Dengue
Dengue Fever
Dengue Hemorrhagic Fever
Yellow Fever
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus
Biological: Yellow Fever
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: Evaluation of the Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Administered With or Without Yellow Fever Vaccine in US Adults.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Neutralizing antibody levels (measured by a dengue plaque reduction neutralization test [PRNT]) against each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue vaccine Dose 3 in Groups 1 and 2. [ Time Frame: 28 Days post-dose 3 ] [ Designated as safety issue: No ]
  • Neutralizing antibody levels (measured by a dengue PRNT) against each of the 4 parental dengue virus serotypes at 6 months after CYD dengue vaccine Dose 3 in Groups 1 and 2. [ Time Frame: 6 Months post-dose 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neutralizing antibody levels (measured by dengue PRNT) against each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue vaccine Dose 1 and Dose 2 in Groups 1 and 2 [ Time Frame: 28 days post-dose 1 and 2 ] [ Designated as safety issue: No ]
  • 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 vaccine [ Time Frame: Day 0 to up to 18 months post-dose 3 ] [ Designated as safety issue: No ]
    Solicited injection site: Pain, Redness, and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia.

  • Neutralizing antibody levels (measured by Yellow fever [YF] PRNT) against YF at baseline and 1, 3, and 7 months after injection of the YF vaccine at Month 0 in Groups 3 and 4. [ Time Frame: Day 0 and up to 7 Months post-vaccination ] [ Designated as safety issue: No ]

Enrollment: 390
Study Start Date: December 2011
Study Completion Date: April 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CYD Dengue vaccine Group 1
Participants will receive a dose of CYD dengue vaccine at Day 0, Month 6 and 12, respectively.
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus
0.5 mL, Subcutaneous
Other Name: CYD Dengue Vaccine
Experimental: CYD Dengue vaccine Group 2
Participants will receive a dose of CYD dengue vaccine at Day 0, Month 2 and 6, respectively.
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus
0.5 mL, Subcutaneous
Other Name: CYD Dengue Vaccine
Experimental: CYD Dengue and Yellow Fever vaccine Group
Participants will receive a dose of Yellow Fever and CYD Dengue vaccine at Day 0, and CYD Dengue vaccine at Month 2 and 6, respectively.
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus
0.5 mL, Subcutaneous
Other Name: CYD Dengue Vaccine
Biological: Yellow Fever
0.5 mL, Subcutaneous
Other Name: YF VAX®
Active Comparator: Yellow Fever vaccine Group
Participants will receive a dose of Yellow Fever vaccine at Day 0.
Biological: Yellow Fever
0.5 mL, Subcutaneous
Other Name: YF VAX®

Detailed Description:

Study participants will be randomized to receive CYD Dengue alone, or CYD Dengue and/or Yellow fever (YF) vaccine. Participants who already received YF vaccine prior to enrolment will be randomized to one of the groups receiving CYD Dengue alone. Flavivirus status will be determined at baseline (before the first dose) and the vaccine immunogenicity assessment will be at 28 days after each vaccination. Reactogenicity data will be collected in all subjects after each dose. Serious adverse events and adverse events of special interest will be collected throughout the study.

The expected duration of participation in the trial will be 18 months or 7 months for participants receiving only YF vaccine.

  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
  • For subjects classified as Yellow Fever (YF) + to be included in Groups 1 and 2, previous vaccination (3 months to 10 years) with YF vaccine confirmed by acceptable documentation.

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 of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following each trial vaccination
  • For all subjects classified as YF-, any previous vaccination against Flavivirus (FV) diseases (including Japanese Encephalitis, tick-borne encephalitis, and YF)
  • For subjects classified as YF+, previous vaccination against FV diseases except YF (including Japanese Encephalitis and tick-borne encephalitis)
  • For all subjects, any FV vaccination planned during the trial period outside the study protocol
  • Receipt of immune globulins, blood or blood-derived products in the past 3 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)
  • Self-reported seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Self-reported history of FV infection (e.g., JE, Dengue, YF, West Nile), confirmed either clinically or serologically
  • Known systemic hypersensitivity to any of the vaccine components, 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
  • 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
  • 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
  • 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
  • Previous residence (> 12 months) in, or travel in the last 30 days to FV endemic regions
  • History of thymic pathology (thymoma), thymectomy, or myasthenia.
  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: NCT01488890

Locations
United States, Alabama
Alabaster, Alabama, United States, 35007
United States, California
Sacramento, California, United States, 95816
United States, Florida
Jacksonville, Florida, United States, 32216
United States, Maryland
Silver Spring, Maryland, United States, 20910
United States, Missouri
Springfield, Missouri, United States, 65802
United States, Nevada
Las Vegas, Nevada, United States, 89104
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: NCT01488890     History of Changes
Other Study ID Numbers: CYD51, U1111-1122-1892
Study First Received: December 6, 2011
Last Updated: May 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Dengue fever
Dengue Hemorrhagic Fever
CYD dengue vaccine
Yellow Fever
Flavivirus

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

ClinicalTrials.gov processed this record on August 18, 2014