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

Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults Aged 18 to 50 Years in Brazil

Sponsors

Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Source Sanofi
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.

Overall Status Active, not recruiting
Start Date 2019-10-28
Completion Date 2022-12-01
Primary Completion Date 2022-12-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
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 Day 0 up to 18 Months post vaccination
Secondary Outcome
Measure Time Frame
Summary of Neutralizing antibody levels against each dengue virus serotype at baseline and 28 days after each injection in each group Baseline and 28 days after each injection
Summary of CYD dengue vaccinal viremia following first vaccination with CYD dengue vaccine or placebo injection 7 and 14 days post injection 1
Summary of CD4 count after each injection of CYD dengue vaccine 28 days after each injection
Summary of HIV RNA viral load after each injection of CYD dengue vaccine 28 days after each injection
Enrollment 150
Condition
Intervention

Intervention Type: Biological

Intervention Name: CYD Dengue Vaccine

Description: 0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively

Arm Group Label: CYD Dengue vaccine group

Intervention Type: Biological

Intervention Name: Placebo (NaCl 0.9%) vaccine group

Description: 0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively

Arm Group Label: Placebo vaccine group

Eligibility

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) 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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

50 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Clinical Sciences & Operations Study Director Sanofi Pasteur, a Sanofi Company
Location
Facility:
Investigational Site Number 0760002 | Nova Iguaçu, Rio De Janeiro, 26030-380, Brazil
Investigational Site Number 0760001 | São Paulo, 04040-002, Brazil
Investigational Site Number 0760003 | São Paulo, 04121-000, Brazil
Location Countries

Brazil

Verification Date

2021-02-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: CYD Dengue vaccine group

Type: Experimental

Description: Subjects will receive 3 doses of CYD dengue vaccine at 0, 6, and 12 months

Label: Placebo vaccine group

Type: Placebo Comparator

Description: Subjects will receive 3 doses of placebo (NaCl, 0.9%) vaccine at 0, 6, and 12 months

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Outcomes Assessor)

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