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Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults

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ClinicalTrials.gov Identifier: NCT02741128
Recruitment Status : Active, not recruiting
First Posted : April 18, 2016
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE April 8, 2016
First Posted Date  ICMJE April 18, 2016
Last Update Posted Date February 16, 2021
Actual Study Start Date  ICMJE October 28, 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
Number of participants reporting unsolicited systematic AE, solicited injection site reactions, solicited systemic reactions, unsolicited AEs, serious and non-serious AEs of special interests, SAE and hospitalized virologically confirmed dengue cases [ Time Frame: Day 0 up to 18 Months post vaccination ]
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Asthenia
Original Primary Outcome Measures  ICMJE
 (submitted: April 12, 2016)
Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse events, serious adverse events and non serious adverse events of special interest and hospitalized virologically confirmed dengue cases [ Time Frame: Day 0 up to 18 Months post vaccination ]
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Asthenia
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • Summary of Neutralizing antibody levels against each dengue virus serotype at baseline and 28 days after each injection in each group [ Time Frame: Baseline and 28 days after each injection ]
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT).
  • Summary of CYD dengue vaccinal viremia following first vaccination with CYD dengue vaccine or placebo injection [ Time Frame: 7 and 14 days post injection 1 ]
  • Summary of CD4 count after each injection of CYD dengue vaccine [ Time Frame: 28 days after each injection ]
  • Summary of HIV RNA viral load after each injection of CYD dengue vaccine [ Time Frame: 28 days after each injection ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2016)
  • Summary of Neutralizing antibody titers against each dengue virus serotype at baseline and 28 days after each injection in each group [ Time Frame: Baseline and 28 days after each injection ]
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT).
  • Summary of CYD dengue vaccinal viremia following first vaccination with CYD dengue vaccine or placebo injection [ Time Frame: 7 and 14 days post injection 1 ]
  • Summary of CD4 count after each injection of CYD dengue vaccine [ Time Frame: 28 days after each injection ]
  • Summary of HIV RNA viral load after each injection of CYD dengue vaccine [ Time Frame: 28 days after each injection ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults
Official Title  ICMJE Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults Aged 18 to 50 Years in Brazil
Brief Summary

The aim of the study is to evaluate the safety and immunogenicity of the Dengue vaccine in a population of special interest, such as HIV-positive adults previously exposed to dengue.

Primary Objective:

  • To describe the safety of each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue.

Secondary Objectives:

  • To describe the humoral immune response to each dengue serotype at baseline and after each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue.
  • To detect the CYD dengue vaccinal viremia post-Inj 1 in HIV-positive adults previously exposed to dengue.
  • To describe changes in CD4 count and HIV RNA viral load after each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue.

Observational Objective:

  • To describe the FV (YF, Dengue, Zika) serological status in the study population at baseline.
Detailed Description Eligible subjects will be randomized in a 2:1 ratio into 1 of 2 groups to receive 3 injections of either CYD dengue vaccine or placebo at 0, 6, and 12 months. The enrollment of subjects will be carried out in two steps, including an early safety data review before the second step. The duration of each subject's participation in the study will be approximately 18 months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Dengue Fever
  • Dengue Hemorrhagic Fever
  • Human Immunodeficiency Virus
Intervention  ICMJE
  • Biological: CYD Dengue Vaccine
    0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively
  • Biological: Placebo (NaCl 0.9%) vaccine group
    0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively
Study Arms  ICMJE
  • Experimental: CYD Dengue vaccine group
    Subjects will receive 3 doses of CYD dengue vaccine at 0, 6, and 12 months
    Intervention: Biological: CYD Dengue Vaccine
  • Placebo Comparator: Placebo vaccine group
    Subjects will receive 3 doses of placebo (NaCl, 0.9%) vaccine at 0, 6, and 12 months
    Intervention: Biological: Placebo (NaCl 0.9%) vaccine group
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 12, 2016)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 18 to 50 years on the day of first study vaccination (study product administration) ("18 to 50" means from the day of the 18th birthday to the day before the 51th birthday)
  • Inform concent form has been signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures
  • Documented seropositivity for HIV-1 infection based on the Brazilian HIV Guidelines' laboratory criteria (i.e., two positive results obtained from different and independent determination methods) or detectable HIV-1 viral load results in the past
  • Stable HIV condition according to Brazilian HIV Guidelines (i.e., with both CD4 count > 350 cells/mm3 and sustainable and undetectable HIV viral load [< 50 copies/mL]) for at least 1 year before consent
  • Stable antiretroviral (ART) regimen based on local HIV protocol for at least 1 year before consent.
  • Previous exposure to dengue confirmed by rapid diagnostic test (RDT) or dengue IgG ELISA

Exclusion Criteria:

  • 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 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
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or 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
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • Self-reported or suspected congenital or acquired immunodeficiency, except HIV; 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)
  • Previous acquired immunodeficiency syndrome (AIDS), defined as the occurrence of opportunistic infection in the last 2 years before consent
  • 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
  • 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
  • Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C) on the day of vaccination. 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
  • Previous CD4 count < 200 cells/mm3 (nadir) since diagnosis of HIV
  • History of chronic and active hepatitis B infection or HBsAg-positive
  • History of chronic and active hepatitis C infection or HCV Ab-positive
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), urea and creatinine > 3 times the upper limit of normal range (ULN)
  • Hemoglobin (Hb) < 10 g/dL
  • White blood cell count (WBC) < 1500 cells/mm3
  • Platelets < 100,000 cells/mm3.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02741128
Other Study ID Numbers  ICMJE CYD50
U1111-1174-4398 ( Other Identifier: WHO )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company
PRS Account Sanofi
Verification Date February 2021

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