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Trial record 3 of 183 for:    dengue

Study of a Booster Dose of a Tetravalent Dengue Vaccine in Subjects Who Previously Completed the 3-dose Schedule

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ClinicalTrials.gov Identifier: NCT02623725
Recruitment Status : Active, not recruiting
First Posted : December 8, 2015
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The aim of the study is to assess and describe the booster effect of a CYD dengue vaccine dose administered 4 to 5 years after the completion of a 3-dose vaccination schedule.

Primary Objective

- To demonstrate the non-inferiority, in terms of geometric mean of titer ratios (GMTRs), of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in subjects from previous CYD dengue vaccine trials.

Secondary Objectives:

  • If the primary objective of non-inferiority is achieved: To demonstrate the superiority, in terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in subjects from previous CYD dengue vaccine trials.
  • To describe the immune responses elicited by a CYD dengue vaccine booster and placebo injection in subjects who received 3 doses of the CYD dengue vaccine in previous CYD dengue vaccine trials.
  • To describe the neutralizing Ab levels of each dengue serotype post-dose 3 (previous CYD dengue vaccine trials' subjects) and immediately prior to booster or placebo injection in all subjects.
  • To describe the neutralizing Ab persistence 6 months, 1 year, and 2 years post booster or placebo injection in all subjects.
  • To evaluate the safety of booster vaccination with the CYD dengue vaccine in all subjects.

Condition or disease Intervention/treatment Phase
Dengue Fever Dengue Hemorrhagic Fever Biological: CYD Dengue Vaccine (5-dose formulation) Biological: Placebo, NaCl 0.9% Phase 2

Detailed Description:
Healthy adolescents and adults who received 3 doses of the tetravalent dengue vaccine 4 to 5 years earlier in previous CYD dengue vaccine trials (CYD13 - NCT00993447 and CYD30 - NCT01187433) will receive either a booster dose CYD dengue vaccine or a placebo vaccine. They will be evaluated for safety and antibody persistence of the booster injection up to 2 years post-vaccination.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of a Tetravalent Dengue Vaccine Given as a Booster Injection in Adolescents and Adults Who Previously Completed the 3-dose Schedule in a Study Conducted in Latin America
Actual Study Start Date : April 14, 2016
Actual Primary Completion Date : November 23, 2016
Estimated Study Completion Date : October 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever

Arm Intervention/treatment
Experimental: CYD Dengue Vaccine Booster
Participants from a previous CYD dengue vaccine study randomized to receive CYD dengue vaccine booster
Biological: CYD Dengue Vaccine (5-dose formulation)
0.5 mL, Subcutaneous

Experimental: Placebo Vaccine Group
Participants from a previous CYD dengue vaccine study randomized to receive a placebo vaccine
Biological: Placebo, NaCl 0.9%
0.5 mL, Subcutaneous




Primary Outcome Measures :
  1. Neutralizing antibody levels against each dengue virus serotype measured 28 days after the third CYD dengue vaccine injection and 28 days after the booster injection in the study group [ Time Frame: Day 28 post booster vaccination ]
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT).


Secondary Outcome Measures :
  1. Neutralizing antibody levels against each of the 4 parental dengue virus strains of the CYD dengue vaccine immediately prior and 28 days post booster or placebo injection [ Time Frame: Before and Day 28 post booster vaccination ]
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT).

  2. Percentages of subjects with seroconversion 28 days after the booster injection for each of the four parental dengue virus strain of CYD dengue vaccine immediately prior and 28 days post booster or placebo injection [ Time Frame: Before and Day 28 post booster vaccination ]
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT).

  3. Neutralizing antibody levels against each of the 4 parental dengue virus strains at 6 months, 1 year, and 2 years post booster or placebo injection [ Time Frame: 6 months up to 2 years post booster vaccination ]
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT).

  4. Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during trial [ Time Frame: Day 0 up to 2 years post vaccination ]
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Asthenia



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Ages Eligible for Study:   13 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Has been identified as a potential subject by the Sponsor and is included in the list provided to the Investigator (i.e., aged 9 to 16 years on the day of first vaccination of CYD dengue vaccine in CYD13/CYD30 and has a post-dose 3 serum sample available [at least 400 µL of serum])
  • Presently 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 who received any other dengue vaccination that was not part of the CYD13 and CYD30 trials.
  • Subject is pregnant, or lactating, or of childbearing potential (to be considered of non childbearing potential, a female must be pre-menarche or 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 vaccination until at least 4 weeks after vaccination)
  • 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
  • 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)
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines 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
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Current alcohol abuse or drug addiction
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
  • 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 (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

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): NCT02623725


Locations
Brazil
Vitória, Brazil, 29047-105
Colombia
Bucaramanga, Colombia
Honduras
Tegucigalpa, Municipalo Del Distrito Central, Honduras
Mexico
Mexico City, Mexico, 04530
Puerto Rico
Carolina, Puerto Rico, 00984
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02623725     History of Changes
Other Study ID Numbers: CYD64
U1111-1161-2855 ( Other Identifier: WHO )
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

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