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

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ClinicalTrials.gov Identifier: NCT01488890
Recruitment Status : Completed
First Posted : December 8, 2011
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 6, 2011
First Posted Date  ICMJE December 8, 2011
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 December 6, 2011
Actual Primary Completion Date September 27, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2 [ Time Frame: Pre-injection 1, 28 days and 6 months post-injection 3 ]
    GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test (PRNT).
  • Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2 [ Time Frame: Pre-injection 1, 28 days and 6 months post-injection 3 ]
    Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution).
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2011)
  • 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 ]
  • 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 ]
Change History Complete list of historical versions of study NCT01488890 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2 [ Time Frame: Pre-injection 1 and 2 and 28 days post-injection 1 and 2 ]
    GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT.
  • Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2 [ Time Frame: Pre-injection 1 and 2 and 28 days post-injection 1 and 2 ]
    Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution).
  • Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 In YF Non-Immune Participants: Group 1 and Group 2 (Pooled) and Group 3 [ Time Frame: Pre-injection 1 and 28 days post-injection 1 ]
    GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test-50 (PRNT50). Groups 1 and 2 data was reported as pooled data. YF-non immune participants were defined as participants with YF baseline titer PRNT80 < 10 (1/dilution).
  • Percentage of YF Non-Immune Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1: Group 1 and Group 2 (Pooled) and Group 3 [ Time Frame: Pre-injection 1 and 28 days post-injection 1 ]
    Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). Groups 1 and 2 data was reported as pooled data. YF-non immune participants were defined as participants with YF baseline titer dengue plaque reduction neutralization test-80 (PRNT80) <10 (1/dilution).
  • Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants) [ Time Frame: Pre Injection 1, 2 and 3 and 28 days post injection 1, 2 and 3 ]
    GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. FV immune participants were defined as participants with titer >= 10 (1/dilution) for at least 1 serotype with parental dengue virus strain (sera tested by PRNT) or with titer >= 10 (1/dilution) for YF virus (sera with PRNT80 result).
  • Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants) [ Time Frame: Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3 ]
    GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. FV non-immune participants were defined as participants with titer < 10 (1/dilution) for all serotypes with parental dengue virus strains (sera tested by PRNT) and with titer <10 (1/dilution) for YF virus (using sera with PRNT80 result).
  • Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants) [ Time Frame: Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3 ]
    Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). FV immune participants at baseline were defined as participants with titer >= 10 (1/dilution) for at least 1 serotype with parental dengue virus strain (sera tested by PRNT) or with titer >=10 (1/dilution) for YF virus (sera with PRNT80 result).
  • Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants) [ Time Frame: Pre injection 1, 2, 3 and 28 days post injection 1, 2 and 3 ]
    Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). FV non-immune participants were defined as participants with titer < 10 (1/dilution) for all serotypes with parental dengue virus strains (sera tested by PRNT) and with titer <10 (1/dilution) for YF virus (using sera with PRNT80 result).
  • Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine [ Time Frame: Within 7 days after any 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 Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine [ Time Frame: Within 14 days after any injection ]
    Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: >= 39.0°C; Headache, Malaise, Myalgia, and Asthenia: significant; prevents daily activity.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2011)
  • 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 ]
  • 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 ]
    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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Given With or Without Yellow Fever Vaccine
Official Title  ICMJE Evaluation of the Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Administered With or Without Yellow Fever Vaccine in US Adults.
Brief Summary

The aim of this study was to evaluate the administration of CYD dengue vaccine serotypes (1, 2, 3 and 4) following a compressed schedule in 3 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 Group 1 (Month [M] 13) and Group 2 (M07), irrespective of whether or not Yellow Fever (YF) vaccine has been previously administered.
  • 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 Group 1 (M18) and Group 2 (M12), irrespective of whether or not YF vaccine has been previously administered.

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 Groups 1 and 2, irrespective of whether or not YF vaccine has been previously administered.
  • To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue Dose 1 in the combined YF-participants in Group 1 (N=60) and Group 2 (N=60), and in Group 3 (N=120).
  • To describe by FV status at baseline the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each injection of CYD dengue vaccine in Groups 1, 2, and 3.
  • To describe the safety profile after each injection of CYD dengue vaccine and/or YF vaccine.
Detailed Description Participants were randomized to 4 different groups to receive either CYD dengue vaccine and/or YF vaccine. Participants who already received YF vaccine prior to enrolment were randomized to one of the 2 groups receiving CYD dengue vaccine alone. Participants were evaluated for immunogenicity, antibody persistence, reactogenicity and safety.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Dengue
  • Dengue Fever
  • Dengue Hemorrhagic Fever
  • Yellow Fever
Intervention  ICMJE
  • 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®
Study Arms  ICMJE
  • Experimental: CYD Dengue vaccine: Group 1
    Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
    Intervention: Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus
  • Experimental: CYD Dengue vaccine: Group 2
    Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
    Intervention: Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus
  • Experimental: CYD Dengue and Yellow Fever vaccine: Group 3
    Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
    Interventions:
    • Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus
    • Biological: Yellow Fever
  • Active Comparator: Yellow Fever vaccine: Group 4
    Participants received single dose of YF vaccine at Day 0.
    Intervention: Biological: Yellow Fever
Publications * Kirstein J, Douglas W, Thakur M, Boaz M, Papa T, Skipetrova A, Plennevaux E. Immunogenicity of the CYD tetravalent dengue vaccine using an accelerated schedule: randomised phase II study in US adults. BMC Infect Dis. 2018 Sep 21;18(1):475. doi: 10.1186/s12879-018-3389-x.

*   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: December 7, 2011)
390
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 27, 2013
Actual Primary Completion Date September 27, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged >= 18 to <= 45 years on the day of inclusion
  • Informed consent form had been signed and dated
  • Able to attend all scheduled visits and complied with all trial procedures
  • For participants classified as YF positive (+) to be included in Groups 1 and 2, previous vaccination (3 months to 10 years) with YF vaccine confirmed by acceptable documentation.

Exclusion Criteria:

  • Participant was 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 participants classified as YF negative (-), any previous vaccination against Flavivirus (FV) diseases (including Japanese Encephalitis [JE], tick-borne encephalitis, and YF)
  • For participants classified as YF+, previous vaccination against FV diseases except YF (including JE and tick-borne encephalitis)
  • For all participants, 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 participant 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01488890
Other Study ID Numbers  ICMJE CYD51
U1111-1122-1892 ( Other Identifier: WHO )
Has Data Monitoring Committee Yes
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 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.
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 SA
PRS Account Sanofi
Verification Date October 2016

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