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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 : Completed
First Posted : December 8, 2015
Results First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE December 3, 2015
First Posted Date  ICMJE December 8, 2015
Results First Submitted Date  ICMJE May 24, 2019
Results First Posted Date  ICMJE June 14, 2019
Last Update Posted Date June 14, 2019
Actual Study Start Date  ICMJE April 14, 2016
Actual Primary Completion Date November 23, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group [ Time Frame: 28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64 ]
Geometric Mean Titers (GMTs) of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the plaque reduction neutralization test (PRNT).
Original Primary Outcome Measures  ICMJE
 (submitted: December 3, 2015)
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).
Change History Complete list of historical versions of study NCT02623725 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group [ Time Frame: 28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64 ]
    GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT.
  • GMTs of Antibodies Against Each Dengue Virus Serotype Before And Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo [ Time Frame: Pre-booster injection (Day 0) and 28 days post-booster injection ]
    GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT.
  • GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo [ Time Frame: Pre-booster injection (Day 0) and 28 days post-booster injection ]
    GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT.
  • Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo [ Time Frame: 28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64 ]
    Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titers >=10 (1/dilution).
  • Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo [ Time Frame: Pre-booster injection (Day 0) and 28 days post-booster injection ]
    Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing Antibody titers >=10 (1/dilution).
  • Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo [ Time Frame: 28 days post-booster injection ]
    Seroconversion for each serotype was defined as the percentage of participants with either a pre-booster titer < 10 (1/dilution) and a post-booster titer >= 40 (1/dilution), or a pre-booster titer >=10 (1/dilution) and a >= 4-fold increase in post-booster titer as determined by PRNT.
  • GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo [ Time Frame: 28 days post-dose 3 in CYD13 or CYD30 and pre-booster injection (Day 0) in CYD64 ]
    GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the PRNT.
  • GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo [ Time Frame: 28 days post-dose 3 in CYD13 or CYD30 and pre-booster injection (Day 0) in CYD64 ]
    GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the PRNT.
  • Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo [ Time Frame: Within 7 days after booster injection ]
    Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 reactions: Pain: significant; prevents daily activity; Erythema and Swelling: > 100 mm.
  • Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo [ Time Frame: Within 14 days after booster injection ]
    Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: >= 39°C; Headache, Malaise, Myalgia, and Asthenia: significant, prevents daily activity.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2015)
  • 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).
  • 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).
  • 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).
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Booster Dose of a Tetravalent Dengue Vaccine in Subjects Who Previously Completed the 3-dose Schedule
Official Title  ICMJE 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
Brief Summary

The aim of the study was 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 participants from CYD13 and CYD30 trials (participants from group 1 only).

Secondary Objectives:

  • If the primary objective of non-inferiority was achieved: To demonstrate the superiority, in terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD13 and CYD30 trials.
  • To describe the immune responses elicited by a CYD dengue vaccine booster and placebo injection in participants who received 3 doses of the CYD dengue vaccine in the CYD13 and CYD30 trials in all participants.
  • To describe the neutralizing antibody levels of each dengue serotype post-dose 3 (CYD13 and CYD30 participants) and immediately prior to booster or placebo injection in all participants.
  • To describe the neutralizing antibody persistence 6 months, 1 year, and 2 years post booster or placebo injection in all participants.
  • To evaluate the safety of booster vaccination with the CYD dengue vaccine in all participants.
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) received either a booster dose CYD dengue vaccine or a placebo on Day 0. They were evaluated for safety and antibody persistence of the booster injection up to 2 years post-vaccination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
An observer-blind procedure was followed for the injection of the CYD Dengue Vaccine booster or placebo. Neither the observer Investigator, nor the Sponsor, nor the participant/participants' parent(s)/legally acceptable representative(s) knew which product was administered.
Primary Purpose: Prevention
Condition  ICMJE
  • Dengue Fever
  • Dengue Hemorrhagic Fever
Intervention  ICMJE
  • Biological: CYD Dengue Vaccine (5-dose formulation)
    0.5 mL, Subcutaneous
  • Biological: Placebo, NaCl 0.9%
    0.5 mL, Subcutaneous
Study Arms  ICMJE
  • Experimental: CYD Dengue Vaccine Booster Group
    Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
    Intervention: Biological: CYD Dengue Vaccine (5-dose formulation)
  • Experimental: Placebo Group
    Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).
    Intervention: Biological: Placebo, NaCl 0.9%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2019)
251
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2015)
372
Actual Study Completion Date  ICMJE October 28, 2018
Actual Primary Completion Date November 23, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Had been identified as a potential participant 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]).
  • Participants were in good health, based on medical history and physical examination.
  • Assent form or informed consent form (ICF) had been signed and dated by the participant (based on local regulations), and ICF had been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations).
  • Participant and parent(s)/legally acceptable representative(s) attended all scheduled visits and complied with all trial procedures.

Exclusion Criteria:

  • Participant who received any other dengue vaccination that was not part of the CYD13 or CYD30 trials.
  • Participant was 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, was 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 participant should not be included in the study until the condition had resolved or the febrile event had 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 22 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Colombia,   Honduras,   Mexico,   Puerto Rico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02623725
Other Study ID Numbers  ICMJE CYD64
U1111-1161-2855 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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 the investigators continue to protect the privacy of the participants in their 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".
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP