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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02741128
Recruitment Status : Not yet recruiting
First Posted : April 18, 2016
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults Aged 18 to 50 Years in Brazil
Estimated Study Start Date : October 11, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue HIV/AIDS

Arm Intervention/treatment
Experimental: CYD Dengue vaccine group
Subjects will receive 3 doses of CYD dengue vaccine at 0, 6, and 12 months
Biological: CYD Dengue Vaccine
0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively

Placebo Comparator: Placebo vaccine group
Subjects will receive 3 doses of placebo (NaCl, 0.9%) vaccine at 0, 6, and 12 months
Biological: Placebo (NaCl 0.9%) vaccine group
0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).

  2. 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 ]
  3. Summary of CD4 count after each injection of CYD dengue vaccine [ Time Frame: 28 days after each injection ]
  4. Summary of HIV RNA viral load after each injection of CYD dengue vaccine [ Time Frame: 28 days after each injection ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

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.

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): NCT02741128


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com

Locations
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Brazil
BRAZIL Not yet recruiting
Nova Iguaçu, Rio De Janeiro, Brazil, 26030-380
BRAZIL Not yet recruiting
São Paulo, Brazil, 04040-002
BRAZIL Not yet recruiting
São Paulo, Brazil, 04121-000
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: NCT02741128     History of Changes
Other Study ID Numbers: CYD50
U1111-1174-4398 ( Other Identifier: WHO )
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
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/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Dengue Fever
Dengue Hemorrhagic Fever
Human Immunodeficiency Virus
CYD Dengue Vaccine
Additional relevant MeSH terms:
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Dengue
Severe Dengue
Acquired Immunodeficiency Syndrome
HIV Infections
Hemorrhagic Fevers, Viral
Immunologic Deficiency Syndromes
Fever
Immune System Diseases
Body Temperature Changes
Signs and Symptoms
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Arbovirus Infections
Flavivirus Infections
Flaviviridae Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs