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Dengue Virus clinical trials

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NCT ID: NCT05507450 Completed - Dengue Virus Clinical Trials

Safety and Immunogenicity of Three V181 Dengue Vaccine Potencies in Adults (V181-003)

Start date: September 7, 2022
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to compare the dengue virus-neutralizing antibody geometric mean titers (GMTs) for each of the 4 dengue serotypes (DENV1, DENV2, DENV3, and DENV4) at Day 28 post-vaccination for participants administered the V181 Low-Potency Level vaccine versus the V181 Mid-Potency Level vaccine. This study will also evaluate the safety and tolerability of 3 different V181 potency level vaccines. The primary hypothesis of the study is that the V181 Low-Potency Level vaccine is non-inferior to the V181 Mid-Potency Level vaccine for each of the 4 dengue serotypes based on GMTs at Day 28 post-vaccination.

NCT ID: NCT02794181 Completed - Zika Virus Clinical Trials

Zika Virus and Related Arbovirus Infections in Deferred Blood Donors (ZVADD)

Start date: June 8, 2016
Phase:
Study type: Observational

Background: Zika virus is mostly passed on by the bite of an infected mosquito. It usually causes mild illness. But in pregnant women it can cause serious birth defects to the baby. The virus can also spread by blood transfusion and sexual intercourse. This is why the U.S. Food & Drug Administration (FDA) recommended that people should not give blood if possibly exposed to Zika virus. Dengue virus and chikungunya virus are passed by the same mosquitoes as Zika virus. These can cause severe reactions if passed through transfused blood. Donated blood is usually not tested for these three viruses. Researchers want to count the infections in people who have been exposed because of travel or sexual exposure. They want to learn the risk these viruses might pose to the U.S. blood supply. They also want to study the natural history of these viruses by following infected people over time. Objective: To study the risk of Zika, dengue, and chikungunya viruses to the U.S. blood supply. Eligibility: Adults age 18 or older who were turned down for donating blood because of possible exposure to certain viruses. Design: Participants will have blood and urine tests. They will answer questions about their travel. They will be called in about a week with virus test results. Participants with negative results do not have any more study visits. Participants with positive results will be asked to stay in the study for 6 months. They will have weekly clinic visits and tests until results are negative for 2 straight weeks. Once test results are negative, they will have monthly visits. Visits will include physical exams, blood and urine samples, and optional semen samples from men. Most people will have 3-4 weekly visits and 5 monthly visits.

NCT ID: NCT02305732 Completed - Dengue Virus Clinical Trials

A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components

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Start date: March 2015
Phase:
Study type: Observational

The rationale for a Treatment Use Investigational Device Exemption (IDE) of INTERCEPT PCs is to address current gaps in platelet transfusion safety in selected geographic regions. The objective is to provide access to INTERCEPT PCs for patients who might be at risk of transfusion-transmitted infection (TTI) due to Chikungunya virus (CHIKV) and Dengue virus (DENV) in regions in which a substantial proportion of the population has been infected or is at risk of infection by these pathogens (Petersen 2014); and the risk of asymptomatic infection among qualified blood donors is recognized (Stramer 2012, Adda 2014). The study is designed as a prospective, open label, multi-center, observational study to evaluate the safety and efficacy of INTERCEPT platelet components.

NCT ID: NCT01084291 Completed - Dengue Virus Clinical Trials

Evaluation of the Safety and Immune Response to an Investigational Dengue Type 1 Vaccine

Start date: April 2010
Phase: Phase 1
Study type: Interventional

Dengue viruses can cause dengue fever and other serious health conditions, primarily affecting people living in tropical regions of the world. There are four types of dengue virus, and infection with one does not offer protection against the others. This study will test whether a vaccine developed to prevent infection with dengue virus type 1 (DEN1) causes a response in people's immune system and is safe.

NCT ID: NCT01073306 Completed - Dengue Virus Clinical Trials

Safety and Immune Response to an Investigational Dengue Type 2 Vaccine

Start date: February 2010
Phase: Phase 1
Study type: Interventional

Dengue viruses can cause dengue fever and other serious health conditions, primarily affecting people living in tropical regions of the world. This study will test whether a vaccine developed to prevent infection with dengue virus type 2 causes a response in people's immune system and is safe.

NCT ID: NCT00993447 Completed - Dengue Clinical Trials

Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America

Start date: October 2009
Phase: Phase 2
Study type: Interventional

Primary objectives: - To describe the immune response to each dengue serotype before and after each vaccination with sanofi pasteur's CYD dengue vaccine. - To evaluate the safety of each vaccination with sanofi pasteur's CYD dengue vaccine.

NCT ID: NCT00880893 Completed - Dengue Fever Clinical Trials

Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore

Start date: April 7, 2009
Phase: Phase 2
Study type: Interventional

Primary Objectives: - To evaluate safety after each CYD Dengue vaccination in terms of injection site and systemic reactogenicity. - To evaluate the occurrence of Serious Adverse Events (SAEs) throughout the trial period. - To evaluate the humoral immune response to each CYD Dengue serotype after each vaccination in a subset of participants. Secondary Objectives: - To evaluate the persistence of the humoral immune response during 4 years after the last vaccination in a subset of participants.

NCT ID: NCT00875524 Completed - Dengue Fever Clinical Trials

Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects

Start date: March 2009
Phase: Phase 2
Study type: Interventional

This trial evaluated the use of a tetravalent vaccine against dengue. Primary objectives: - To describe the humoral immune response to dengue before and after each vaccination with tetravalent dengue vaccine in adults, adolescents, and children. - To evaluate the safety of each vaccination with tetravalent dengue vaccine in the 4 age cohorts. - To evaluate the persistence of antibodies against dengue during 5 years after the first vaccination with tetravalent dengue vaccine in the 4 age cohorts.

NCT ID: NCT00842530 Completed - Dengue Fever Clinical Trials

Efficacy and Safety of Dengue Vaccine in Healthy Children

Start date: February 2009
Phase: Phase 2
Study type: Interventional

The primary objective of the study was to assess the efficacy of CYD dengue vaccine after three injections in preventing symptomatic virologically-confirmed dengue (VCD) cases, regardless of the severity, due to any of the four serotypes in children aged 4 to 11 years at the time of inclusion. Secondary objectives included to assess: - Vaccine efficacy against severe VCD cases - Vaccine efficacy against VCD cases following at least two injections with CYD dengue vaccine - Immune response to CYD dengue vaccine - Safety profile of CYD dengue vaccine. Safety assessments include solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period. Other objectives included: - Vaccine efficacy against VCD cases following at least one injection with CYD dengue vaccine - Vaccine efficacy against VCD cases due to each serotype - Participants with clinical signs and symptoms for VCD

NCT ID: NCT00788151 Completed - Dengue Fever Clinical Trials

Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years

Start date: September 26, 2008
Phase: Phase 2
Study type: Interventional

The aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease. Primary Objectives: - To describe the humoral immune response to dengue before and after each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years) previously vaccinated with yellow fever (YF) vaccine. - To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years). - To describe viremia after the first and second vaccinations with dengue vaccine in a subgroup of 130 randomized participants (100 participants in Dengue Vaccine Group and 30 participants in Control Group) in two age cohorts of children (6 to 11 years and 2 to 5 years).