Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults (NCT02741128) | Clinical Trial Compass
CompletedPhase 2
Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults
Brazil133 participantsStarted 2019-11-06
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With Unsolicited Systemic Adverse Event (AE)
Timeframe: Within 30 minutes after each injection
2
Percentage of Participants With Solicited Injection-Site Reactions
Timeframe: Up to 7 days after each injection
3
Percentage of Participants With Solicited Systemic Reactions
Timeframe: Up to 14 days after each injection
4
Percentage of Participants With Unsolicited AE, Serious and Non-Serious AEs of Special Interest (AESIs)
Timeframe: Up to 28 days after each injection
5
Percentage of Participants With Serious AEs (SAEs) and Hospitalized Virologically-Confirmed Dengue (VCD) Cases
Timeframe: From the date of randomization until 6-month safety follow-up (approximately 38 months)