Phase 2
N=133
Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults
Dengue Fever · Dengue Hemorrhagic Fever · Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT02741128 ↗Enrolled (actual)
133
Serious AEs
14.4%
Results posted
Jul 2024
Primary outcome: Primary: Percentage of Participants With Unsolicited Systemic Adverse Event (AE) — 0; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CYD Dengue Vaccine (Biological); Placebo (NaCl 0.9%) vaccine group (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Unsolicited Systemic Adverse Event (AE) |
0; 0 | — |
| PRIMARY Percentage of Participants With Solicited Injection-Site Reactions |
19.5; 29.5 | — |
| PRIMARY Percentage of Participants With Solicited Systemic Reactions |
61.4; 72.7 | — |
| PRIMARY Percentage of Participants With Unsolicited AE, Serious and Non-Serious AEs of Special Interest (AESIs) |
55.7; 65.9; 0; 0; 4.5; 2.3 | — |
| PRIMARY Percentage of Participants With Serious AEs (SAEs) and Hospitalized Virologically-Confirmed Dengue (VCD) Cases |
13.6; 15.9; 0; 0 | — |
| SECONDARY Geometric Mean Titers of Neutralizing Antibody Levels Against Each of the 4 Parental Dengue Virus Strains |
176; 256; 589; 227; 508; 260 | — |
| SECONDARY Percentage of Participants With a Detected and Quantified CYD Dengue Vaccinal Viremia |
8.3; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Clusters of Differentiation 4 (CD4) Count Decrease |
6.9; 2.3 | — |
| SECONDARY Percentage of Participants With Confirmed Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Viral Load Increase |
0; 0 | — |
Summary
The aim of the study was 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.
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 [ 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.
Data sourced from ClinicalTrials.gov (NCT02741128). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.