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Immunogenicity and Safety of Different Vaccination Schedules of Tetravalent Dengue Vaccine in Healthy Subjects 9 to 50 Years of Age

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ClinicalTrials.gov Identifier: NCT02628444
Recruitment Status : Active, not recruiting
First Posted : December 11, 2015
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The aim of the study is to assess the immune response and the safety of different vaccination schedules of CYD dengue vaccine.

The primary objectives of the study are:

  • To demonstrate the non-inferiority of the immune response elicited against each dengue serotype by CYD dengue vaccine given as a 2-dose schedule compared to the immune response elicited by CYD dengue vaccine given as a 3-dose schedule, in previously dengue exposed participants 28 days after the last injection.
  • To demonstrate the non-inferiority of the immune response elicited against each dengue serotype by CYD dengue vaccine given as a 2-dose schedule compared to the immune response elicited by CYD vaccine given as a 3-dose schedule in previously dengue exposed participants, 1 year after the last injection.
  • To demonstrate the non-inferiority of the immune response elicited against each dengue serotype elicited by a booster dose of CYD dengue vaccine one year or two years after the last injection in the primary series in previously dengue exposed participants.

The secondary objectives of the study are:

  • To demonstrate the superiority of the immune response elicited by CYD dengue vaccine given as a 2-dose schedule compared to the immune response elicited by CYD dengue vaccine given as a 3-dose schedule, in previously dengue exposed participants 28 days after the last injection.
  • To demonstrate the superiority of the immune response elicited by CYD dengue vaccine given as a 2-dose schedule compared to the immune response elicited by CYD dengue vaccine given as a 3-dose schedule, in previously dengue exposed participants, one year after the last injection.
  • To describe the neutralizing antibody levels of each dengue serotype at 28 days post-injection 3 to the antibody levels immediately before receiving a booster dose, by baseline dengue serostatus.
  • To describe the neutralizing antibody levels of each dengue serotype at 28 days post-injection 2 and 28 days post-injection 3 from Group 1 in a primary series schedule by baseline dengue serostatus.
  • To demonstrate the superiority of the immune response elicited against each dengue serotype 28 days after administration of a booster dose of CYD dengue vaccine, in previously dengue exposed participants, at One year or two years after last injection in the primary series.
  • To describe the seroconversion rate 28 days post-booster injection in all 3 groups.
  • To describe all hospitalized virologically confirmed dengue (VCD) cases during the study.
  • To evaluate the safety profile of CYD after each and any injection during the trial. Safety assessments include solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period.

Condition or disease Intervention/treatment Phase
Dengue Fever Dengue Hemorrhagic Fever Biological: CYD Dengue Vaccine Biological: Placebo (NaCl 0.9%) Phase 2

Detailed Description:
Healthy participants aged between 9 and 50 year receive CYD dengue vaccine in various schedules, in two sequential stages. In the first stage, participants receive 1, 2 or 3 injections of CYD dengue vaccine over a 12-month period. In the second stage, participants are randomized to receive a booster dose of CYD dengue vaccine at either 12 months or 24 months after the third injection of study vaccine. Only participants who were previously dengue exposed at baseline (dengue seropositive) are eligible to receive the booster dose.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Tetravalent Dengue Vaccine Given in 1 , 2 , or 3 Dose Schedules (STAGE I) Followed by a Single Booster Injection of the Same Vaccine (STAGE II) 1 or 2 Years After the Last Primary Dose in Healthy Subjects 9 to 50 Years of Age in Colombia and the Philippines
Actual Study Start Date : May 2, 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever

Arm Intervention/treatment
Experimental: Group 1
3 injections of CYD dengue vaccine at Day 0, Day 0 + 6 months, and Day 0 + 12 months. Booster injection of CYD dengue vaccine 1 year or 2 years after third injection among previously dengue exposed participants only.
Biological: CYD Dengue Vaccine
0.5 mL, Subcutaneous

Experimental: Group 2
1 injection of placebo (NaCl 0.9%) followed by 2 injections of CYD dengue vaccine at Day 0, Day 0 + 6 months, and Day 0 + 12 months. Booster injection of CYD dengue vaccine 1 year or 2 years after third injection among previously dengue exposed participants only.
Biological: CYD Dengue Vaccine
0.5 mL, Subcutaneous

Biological: Placebo (NaCl 0.9%)
0.5 mL, Subcutaneous

Experimental: Group 3
2 injections of placebo (NaCl 0.9%) followed by 1 injection of CYD dengue vaccine at Day 0, Day 0 + 6 months, and Day 0 + 12 months. Booster injection of CYD dengue vaccine 1 year or 2 years after third injection among previously dengue exposed participants only.
Biological: CYD Dengue Vaccine
0.5 mL, Subcutaneous

Biological: Placebo (NaCl 0.9%)
0.5 mL, Subcutaneous




Primary Outcome Measures :
  1. Neutralizing antibody titers against each dengue virus serotype 28 days after the last CYD dengue injection in the Group 1 and Group 2 primary series [ Time Frame: 28 days after the last CYD dengue vaccine injection in primary series ]
    Neutralizing antibody levels are measured using dengue plaque reduction neutralization test (PRNT).

  2. Neutralizing antibody titers against each dengue virus serotype 1 year after the last injection in the Group 1 and Group 2 primary series [ Time Frame: 1 year after the last CYD dengue vaccine injection in the primary series ]
    Neutralizing antibody levels are measured using dengue PRNT.

  3. Neutralizing antibody titers against each dengue virus serotype 28 days after the booster dose at 1 year or 2 years after the last CYD dengue vaccine injection in the primary series [ Time Frame: 28 days after the booster dose ]
    Neutralizing antibody levels are measured using dengue PRNT.


Secondary Outcome Measures :
  1. Neutralizing antibody titers against each dengue virus serotype 28 days post-injection 2 in Group 1, 28 days post-injection 3, and 1 year post-injection 3 in all 3 groups [ Time Frame: : 28 days and 1 year post-injection 3 ]
    Neutralizing antibody levels are measured using dengue PRNT. The level of antibodies are assessed after the second injection of CYD dengue vaccine in Group 1, 28 days post-injection 3 and 1 year post-injection 3 in all 3 groups.

  2. Neutralizing antibody titers against each dengue virus serotype before the booster dose [ Time Frame: Immediately before administration of the booster dose (1 year or 2 years after last CYD dengue vaccine injection) ]
    Neutralizing antibody levels are measured using dengue PRNT.

  3. Percentage of participants with seroconversion against each dengue virus serotype [ Time Frame: Immediately prior to and 28 days after the booster dose ]
    Seroconversion is assessed as percentages of participants with either a pre-booster titer < 10 (1/dil) and a post-booster titer ≥ 40 (1/dil), or a pre-booster titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post-booster titer.

  4. Number of Participants With Solicited Injection Site Reactions [ Time Frame: Within 7 days after vaccination ]
    Solicited injection site reactions: Pain, Erythema, and Swelling.

  5. Number of Participants With Solicited Systemic Reactions [ Time Frame: Within 14 days after vaccination ]
    Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Asthenia

  6. Number of hospitalized VCD cases [ Time Frame: From Day 0 to end of study (6 months after last vaccination) ]
    Hospitalized suspected dengue disease is defined as an acute febrile illness with diagnosis of dengue requiring hospitalization (with bed attribution). In such cases, 1 unplanned blood sample is collected for virological confirmation: an acute sample (within the first 5 days after fever onset ). A suspected hospitalized dengue case is considered a VCD case if there is a detection of wild-type dengue virus by non-structural 1 (NS1) antigen enzyme-linked immunosorbent assay and/or wild-type dengue reverse transcription polymerase chain reaction.



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 9 to 50 years on the day of enrollment
  • Subject in good health, based on medical history and physical examination
  • Assent form or informed consent form (ICF) has been signed and dated by the subject (based on local regulations), and ICF has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations)
  • Subject and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

  • Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination)
  • Participation at the time of study enrollment (or 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
  • Self-reported 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 systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
  • Planned receipt of any vaccine in the 4 weeks following any trial vaccination
  • Previous vaccination against dengue disease with either the trial vaccine or another vaccine
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Current alcohol abuse or drug addiction that, based on investigator's judgment, may interfere with the subject´s ability to comply with trial procedures.
  • Identified as a site employee of the Investigator, 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 employees or the Investigator
  • A prospective subject must not be included in the study until the following conditions and/or symptoms are resolved:

    • Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection (according to Investigator's judgment) on the day of vaccination.
    • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.

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): NCT02628444


Locations
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Colombia
Investigational Site 102
Barranquilla, Colombia
Investigational Site 101
Cali, Colombia
Investigational Site 103
Medellin, Colombia
Philippines
Investigational Site 203
Manila, Philippines
Investigational Site 204
Manila, Philippines
Investigational Site 201
Muntinlupa, Philippines
Investigational Site 202
San Pablo, Philippines
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: NCT02628444     History of Changes
Other Study ID Numbers: CYD65
U1111-1161-3242 ( Other Identifier: WHO )
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at www.clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: Clinicalstudydatarequest.com/Sanofi.

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Dengue Fever
Dengue virus
Dengue Hemorrhagic Fever
CYD Dengue Vaccine

Additional relevant MeSH terms:
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Fever
Dengue
Hemorrhagic Fevers, Viral
Severe Dengue
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs