Dengue FeverPhase 2NCT02741128
Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults
A Phase 2 study testing CYD Dengue Vaccine in people with Dengue Fever and Dengue Hemorrhagic Fever, run by Sanofi Pasteur, a Sanofi Company at 4 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dengue Fever, Dengue Hemorrhagic Fever, Human Immunodeficiency Virus
- What is being tested?
- CYD Dengue Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 4 sitesBrazil
- Study dates
- 6 Nov 2019to 19 Jan 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites
Investigational Site Number :0760004
Natal, Rio Grande do Norte, 59025050
Investigational Site Number :0760002
Nova Iguaçu, Rio de Janeiro, 26030-380
Investigational Site Number :0760001
São Paulo, 04040-002
Investigational Site Number :0760003
São Paulo, 04121-000
About this study
Official title: Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults Aged 18 to 50 Years in Brazil
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:
Read more
- 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.
Read the detailed description
Eligible subjects were 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 was 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 was approximately 18 months.
- Being tested
- CYD Dengue Vaccine, Placebo (NaCl 0.9%) vaccine group
- Keywords
- Dengue Fever, Dengue Hemorrhagic Fever, Human Immunodeficiency Virus, CYD Dengue Vaccine
- Medical subject headings
- Dengue, Severe Dengue, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYD Dengue VaccineBiological
0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively
Placebo (NaCl 0.9%) vaccine groupBiological
0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively
| Study group | Role | What they receive |
|---|---|---|
| CYD Dengue vaccine group | Experimental | Subjects will receive 3 doses of CYD dengue vaccine at 0, 6, and 12 months Receives: Biological: CYD Dengue Vaccine |
| Placebo vaccine group | Placebo comparator | Subjects will receive 3 doses of placebo (NaCl, 0.9%) vaccine at 0, 6, and 12 months Receives: Biological: Placebo (NaCl 0.9%) vaccine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Unsolicited Systemic Adverse Event (AE)
An AE was any untoward medical occurrence in a participant administered study vaccine and which did not necessarily have a causal relationship. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the protocol and case report form (CRF) in terms of diagnosis and/or onset window post-vaccination.
Measured: Within 30 minutes after each injection
Percentage of Participants With Solicited Injection-Site Reactions
An AE was any untoward medical occurrence in a participant administered study vaccine and which did not necessarily have a causal relationship. A solicited reaction was an expected adverse reaction (AR) observed and reported under the conditions pre-listed in the protocol and CRF and included pain, erythema, and swelling. Injection site reaction was an AR at and around the injection site. Injection site reactions were commonly inflammatory reactions.
Measured: Up to 7 days after each injection
Percentage of Participants With Solicited Systemic Reactions
A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited systemic reactions included headache, fever, localized or topical manifestations that were not associated with the vaccination or administration site.
Measured: Up to 14 days after each injection
Percentage of Participants With Unsolicited AE, Serious and Non-Serious AEs of Special Interest (AESIs)
An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the protocol and CRF in terms of diagnosis and/or onset window post-vaccination. An AESI was one of scientific and medical concern specific to the study vaccine, for which ongoing monitoring, and rapid communication by the Investigator to the Sponsor was appropriate. The following were considered as serious AESI: serious hypersensitivity/allergic reactions occurring in all participants within 7 days after vaccination; serious viscerotropic disease occurring in all participants within 30 days after vaccination; serious neurotropic disease occurring in all participants within 30 days after vaccination; serious dengue disease requiring hospitalization occurring in all participants at any time during the study. The following were considered as non-serious AESIs, hypersensitivity/allergic reactions occurring in all participants within 7 days after vaccination.
Measured: Up to 28 days after each injection
Percentage of Participants With Serious AEs (SAEs) and Hospitalized Virologically-Confirmed Dengue (VCD) Cases
An AE was any untoward medical occurrence in a participant administered study vaccine and which does not necessarily have a causal relationship. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. Hospitalized VCD cases were defined as an acute febrile illness with diagnosis of dengue requiring hospitalization. The confirmatory dengue diagnosis was performed through virological detection.
Measured: From the date of randomization until 6-month safety follow-up (approximately 38 months)
Secondary outcomes (4)
Geometric Mean Titers of Neutralizing Antibody Levels Against Each of the 4 Parental Dengue Virus Strains
Dengue neutralizing antibody levels were measured by PRNT50. Serial, 2-fold dilutions of serum to be tested (previously heat-inactivated) were mixed with a constant challenge-dose of each dengue virus serotype 1, 2, 3 or 4. The presence of dengue virus infected cells was indicated by formation of plaques. A reduction in virus infectivity due to neutralization by antibody present in serum samples was detected. The reported value represented the highest dilution of serum at which >= 50% of dengue challenge virus (in plaque counts) was neutralized when compared to the mean viral plaque count in the negative control wells which represented the 100% virus load.
Measured: Baseline (Day 0) and 28 days after each injection
Percentage of Participants With a Detected and Quantified CYD Dengue Vaccinal Viremia
The percentage of participants with detected and quantified CYD dengue vaccinal viremia, i.e above the detection level as assessed by reverse transcription-polymerase chain reaction (RT-PCR) and for each of the 4 dengue serotypes after the first CYD dengue vaccine injection has been reported. Four RT-PCRs were used to perform quantitation and serotype identification of post-vaccinal serotype-specific dengue vaccine viremia from serum samples displaying a positive yellow fever (YF) RT-PCR result. The assay was performed only for YT RT-PCR-positive samples.
Measured: At 7 and 14 days post-injection 1
Percentage of Participants With Clusters of Differentiation 4 (CD4) Count Decrease
A decrease in CD4 count greater than 30 % assessed 28 days post-injection compared to the pre-injection value, not explained by non-adherence to antiretroviral therapy (ART) and not explained by any other possible etiology, and confirmed by a second test taken 4 weeks after the first (ie, approximately 2 months post-injection) showing the same value/trend.
Measured: From Day 28 to Day 393 (28 days after each injection)
Percentage of Participants With Confirmed Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Viral Load Increase
A confirmed HIV viral load increase was defined as plasma HIV-1 RNA >1000 copies/milliliter (mL) 28 days post-injection after having been undetectable (< 50 copies/mL) pre-injection, not explained by non-adherence to ART and not explained by any other possible etiology and confirmed by a second test taken 4 weeks after the first (i.e, approximately 2 months post-injection) showing the same value/trend.
Measured: From Day 28 to Day 393 (28 days after each injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study start6 Nov 2019
- Primary completion19 Jan 2023
- Study completion19 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741128
- Sponsor's protocol ID
- CYD50
- Other IDs
- U1111-1174-4398
- Status last verified
- Jan 2024
- First submitted
- 8 Apr 2016
- Last updated
- 19 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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://vivli.org
Publications
Perroud A, Madruga JVR, Fernandes L, Luz K, Lukic N, Bouree S, Sanchez-Ruiz M, Pegoraro F, Petit C, Zambrano B, Dayan G. Safety and immunogenicity of a tetravalent dengue vaccine (CYD-TDV) in HIV-positive adults aged 18-50 years in Brazil: Results from a phase II, randomized, observer-blind, placebo-controlled trial. Hum Vaccin Immunother. 2025 Dec;21(1):2582237. doi: 10.1080/21645515.2025.2582237. Epub 2025 Nov 10.
PubMed 41213642
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults Aged 18 to 50 Years in Brazil
- ClinicalTrials.gov ID
- NCT02741128
- Acronym / sponsor ID
- CYD50
- Keywords
- Dengue Fever, Dengue Hemorrhagic Fever, Human Immunodeficiency Virus, CYD Dengue Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 19 Jan 2023 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Posted 19 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible subjects were 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 was 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 was approximately 18 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CYD Dengue vaccine group | Experimental | Biological: CYD Dengue VaccineSubjects will receive 3 doses of CYD dengue vaccine at 0, 6, and 12 months |
| Placebo vaccine group | Placebo comparator | Biological: Placebo (NaCl 0.9%) vaccine groupSubjects will receive 3 doses of placebo (NaCl, 0.9%) vaccine at 0, 6, and 12 months |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYD Dengue Vaccine0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively | Biological | CYD Dengue vaccine group |
| Placebo (NaCl 0.9%) vaccine group0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively | Biological | Placebo vaccine group |
Primary outcome
Percentage of Participants With Unsolicited Systemic Adverse Event (AE)
Time frame: Within 30 minutes after each injection
An AE was any untoward medical occurrence in a participant administered study vaccine and which did not necessarily have a causal relationship. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the protocol and case report form (CRF) in terms of diagnosis and/or onset window post-vaccination.
Percentage of Participants With Solicited Injection-Site Reactions
Time frame: Up to 7 days after each injection
An AE was any untoward medical occurrence in a participant administered study vaccine and which did not necessarily have a causal relationship. A solicited reaction was an expected adverse reaction (AR) observed and reported under the conditions pre-listed in the protocol and CRF and included pain, erythema, and swelling. Injection site reaction was an AR at and around the injection site. Injection site reactions were commonly inflammatory reactions.
Percentage of Participants With Solicited Systemic Reactions
Time frame: Up to 14 days after each injection
A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited systemic reactions included headache, fever, localized or topical manifestations that were not associated with the vaccination or administration site.
Percentage of Participants With Unsolicited AE, Serious and Non-Serious AEs of Special Interest (AESIs)
Time frame: Up to 28 days after each injection
An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the protocol and CRF in terms of diagnosis and/or onset window post-vaccination. An AESI was one of scientific and medical concern specific to the study vaccine, for which ongoing monitoring, and rapid communication by the Investigator to the Sponsor was appropriate. The following were considered as serious AESI: serious hypersensitivity/allergic reactions occurring in all participants within 7 days after vaccination; serious viscerotropic disease occurring in all participants within 30 days after vaccination; serious neurotropic disease occurring in all participants within 30 days after vaccination; serious dengue disease requiring hospitalization occurring in all participants at any time during the study. The following were considered as non-serious AESIs, hypersensitivity/allergic reactions occurring in all participants within 7 days after vaccination.
Percentage of Participants With Serious AEs (SAEs) and Hospitalized Virologically-Confirmed Dengue (VCD) Cases
Time frame: From the date of randomization until 6-month safety follow-up (approximately 38 months)
An AE was any untoward medical occurrence in a participant administered study vaccine and which does not necessarily have a causal relationship. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. Hospitalized VCD cases were defined as an acute febrile illness with diagnosis of dengue requiring hospitalization. The confirmatory dengue diagnosis was performed through virological detection.
4 secondary outcomes
Geometric Mean Titers of Neutralizing Antibody Levels Against Each of the 4 Parental Dengue Virus Strains
Time frame: Baseline (Day 0) and 28 days after each injection
Percentage of Participants With a Detected and Quantified CYD Dengue Vaccinal Viremia
Time frame: At 7 and 14 days post-injection 1
Percentage of Participants With Clusters of Differentiation 4 (CD4) Count Decrease
Time frame: From Day 28 to Day 393 (28 days after each injection)
Percentage of Participants With Confirmed Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Viral Load Increase
Time frame: From Day 28 to Day 393 (28 days after each injection)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41213642Perroud A, Madruga JVR, Fernandes L, Luz K, Lukic N, Bouree S, Sanchez-Ruiz M, Pegoraro F, Petit C, Zambrano B, Dayan G. Safety and immunogenicity of a tetravalent dengue vaccine (CYD-TDV) in HIV-positive adults aged 18-50 years in Brazil: Results from a phase II, randomized, observer-blind, placebo-controlled trial. Hum Vaccin Immunother. 2025 Dec;21(1):2582237. doi: 10.1080/21645515.2025.2582237. Epub 2025 Nov 10.
- Individual participant dataSharing planned: Yes. 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://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi Pasteur, a Sanofi Company
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CYD Dengue Vaccine in people with Dengue Fever and Dengue Hemorrhagic Fever, run by Sanofi Pasteur, a Sanofi Company at 4 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Unsolicited Systemic Adverse Event (AE) (time frame: Within 30 minutes after each injection). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02741128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.