DenguePhase 2NCT01943825

Immunologic Mechanisms of Immune Interference and/or Cross-Neutralizing Immunity After CYD Tetravalent Dengue Vaccine

A Phase 2 study testing CYD Dengue Vaccine and Japanese Encephalitis Vaccine in people with Dengue and Dengue Fever, run by Sanofi Pasteur, a Sanofi Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of the study was to evaluate a compressed dosing schedule and the immunologic effects of co-administration of a CYD dengue vaccine with a licensed flavivirus (FV) with Japanese encephalitis (JE) vaccine. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Dengue, Dengue Fever, Dengue Hemorrhagic Fever
What is being tested?: CYD Dengue Vaccine and Japanese Encephalitis Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteUnited States
Study dates: 5 Nov 2013to 25 Nov 2015
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Aged greater than or equal to (>=)18 to less than or equal to (<=) 45 years on the day of inclusion.
Informed consent form had been signed and dated.
Able to attend all scheduled visits and complied with all trial procedures.
Participant was in good health, based on medical history and physical examination.

Who cannot join

Participant was pregnant, or lactating, or of childbearing potential (were considered of non-childbearing potential, a female had to be post- menopausal for at least 1 year, surgically sterile, or used an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination).
Participation 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 or planned receipt of any vaccine, outside the study protocol in the 4 weeks preceded or followed trial vaccinations. (If influenza activity warranted vaccination of healthy young adults, influenza vaccination was encouraged and did not lead to study exclusion).
Any history of FV vaccination, or planned FV vaccination during the trial period.
Previous residence (greater than [>]12 months) in, or travel in the last 30 days to dengue endemic regions.
Receipt of immune globulins, blood or blood-derived products in the 3 months prior to first vaccination or planned use during the study period.

Show all 13Show fewer

Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceded 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
Known systemic hypersensitivity to any of the vaccine components (including protamine sulfate), or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances, including dry natural latex.
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
Excessive alcohol consumption or drug addiction.
Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion.
Identified as an employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employee or the Investigator.
Temporary Exclusion Criteria: Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature >= 38.0 degree Celsius [>= 100.4 degree fahrenheit]). A prospective participant was not included in the study until the condition had resolved or the febrile event had subsided. If the delay for the febrile illness exceeded the window between screening and vaccination, or if deemed necessary by the Investigator, a prospective participant might be re-screened once the fever had resolved.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Syracuse, New York, 13210

Other trials in United States

About this study

Official title: Exploration of Immunologic Mechanisms of Immune Interference and/or Cross-Neutralizing Immunity Following Various Administration Schedules With CYD Tetravalent Dengue Vaccine

Primary Objectives:

To describe and compare the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each CYD dengue vaccine dose.
To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes 6 after CYD dengue vaccine Dose 3, irrespective of whether or not JE vaccine had been previously administered.

Secondary Objectives:

To describe the safety profile after each injection of CYD dengue vaccine.
To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each CYD dengue vaccine dose when administered with or after JE virus vaccine in Groups 3 and 4.
To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes at 6 months post-dose 3 in all four groups and at 12 months post-dose 3 in Groups 1 and 3 with the compressed schedule.
To determine the level of viremia on Day (D)0, D3, D5, D7 and D14 following each CYD vaccine dose administered in Groups 1-4.
To describe the JE humoral immune response at baseline and 28 days after each injection of CYD dengue vaccine in Groups 3 and 4.

Read the detailed description

Study participants were randomly assigned to one of the four groups to receive assigned study vaccine and were evaluated for neutralizing antibody titers; markers of cell-mediated immunity.

Conditions: Dengue, Dengue Fever, Dengue Hemorrhagic Fever
Being tested: CYD Dengue Vaccine, Japanese Encephalitis Vaccine
Keywords: Dengue, Dengue fever, CYD dengue vaccine, IXIARO JE vaccine, Flavivirus
Medical subject headings: Dengue, Severe Dengue

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
CYD Dengue VaccineBiological
0.5 mL, Subcutaneous
Japanese Encephalitis VaccineBiological
Also called IXIARO Japanese Encephalitis Vaccine
0.5 mL, Intramuscular
Japanese Encephalitis VaccineBiological
Also called IXIARO Japanese Encephalitis Vaccine
0.5 mL, Intramuscular

Study groups in NCT01943825
Study group	Role	What they receive
CYD Dengue Vaccine: Group 1	Experimental	Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively. Receives: Biological: CYD Dengue Vaccine
CYD Dengue Vaccine: Group 2	Experimental	Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively. Receives: Biological: CYD Dengue Vaccine
CYD Dengue and JE Vaccine: Group 3	Experimental	Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively. Receives: Biological: CYD Dengue Vaccine; Biological: Japanese Encephalitis Vaccine
CYD Dengue and JE Vaccine: Group 4	Experimental	Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively. Receives: Biological: CYD Dengue Vaccine; Biological: Japanese Encephalitis Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by plaque reduction neutralization test (PRNT). The lower limit of quantitation (LLOQ) of the assay was a titer of 10 (1/dilution).
Measured: Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Antibody titers against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT.
Measured: Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3

Secondary outcomes (7)

Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT. The LLOQ of the assay was a titer of 10 (1/dilution).
Measured: Pre-injection 1, 2 and 3, and 28 days post-injection 1, 2 and 3
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains
GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT.
Measured: 6 months and 12 months post-injection 3
Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia
Viremia was determined by reverse transcriptase (RT) polymerase chain reaction (PCR) using primer/probes specific to a non serotype-specific part of the dengue vaccine.
Measured: 3, 5, 7 and 14 days post-injection 1, 2 and 3
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Viremia was determined by RT PCR using primer/probes specific to each dengue vaccine serotypes.
Measured: 3, 5, 7 and 14 days post-injection 1; 3 and 14 days post-injection 2 and 7 days post-injection 3
Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4
GMTs of antibodies against JE were measured by JE micro neutralization assay. The LLOQ of the assay was a titer of 10 (1/dilution).
Measured: Pre-injection 1, and 28 days post-injection 1, 2 and 3
Number of Participants With Solicited Injection Site Reactions
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the electronic case report form (eCRF) and considered as related to vaccination. Solicited injection site reactions: pain, erythema, and swelling.
Measured: Within 7 days after any CYD dengue vaccine and/or JE vaccine
Number of Participants With Solicited Systemic Reactions
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited systemic reactions: fever, headache, malaise, myalgia, and asthenia.
Measured: Within 14 days after any CYD dengue vaccine and/or JE vaccine

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 201325 Nov 2015

First posted17 Sep 2013 (estimated)
Study start5 Nov 2013
Primary completion25 Nov 2015
Study completion25 Nov 2015

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.
Other trials for DengueStudies 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: None (open label)
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01943825
Sponsor's protocol ID: CYD56
Other IDs: U1111-1143-8391
Status last verified: Mar 2022
First submitted: 12 Sep 2013
Last updated: 24 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
Healthy
RecruitingPhase 1
Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
Healthy Volunteers, Dengue
Active, not recruiting
A Controlled Human Infection Model of Dengue
Dengue
RecruitingPhase 2/3
Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative)
Dengue
RecruitingPhase 2
Adaptive Dengue Antiviral Platform Trial
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All Dengue trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploration of Immunologic Mechanisms of Immune Interference and/or Cross-Neutralizing Immunity Following Various Administration Schedules With CYD Tetravalent Dengue Vaccine
ClinicalTrials.gov ID: NCT01943825
Acronym / sponsor ID: CYD56
Conditions: Dengue, Dengue Fever, Dengue Hemorrhagic Fever
Keywords: Dengue, Dengue fever, CYD dengue vaccine, IXIARO JE vaccine, Flavivirus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Collaborators: United States Department of Defense
Study start: 5 Nov 2013 (actual)
Primary completion: 25 Nov 2015 (actual)
Study completion: 25 Nov 2015 (actual)
First posted: 17 Sep 2013 (estimated)
Results: Posted 5 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary Objectives:

To describe and compare the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each CYD dengue vaccine dose.
To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes 6 after CYD dengue vaccine Dose 3, irrespective of whether or not JE vaccine had been previously administered.

Secondary Objectives:

To describe the safety profile after each injection of CYD dengue vaccine.
To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each CYD dengue vaccine dose when administered with or after JE virus vaccine in Groups 3 and 4.
To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes at 6 months post-dose 3 in all four groups and at 12 months post-dose 3 in Groups 1 and 3 with the compressed schedule.
To determine the level of viremia on Day (D)0, D3, D5, D7 and D14 following each CYD vaccine dose administered in Groups 1-4.
To describe the JE humoral immune response at baseline and 28 days after each injection of CYD dengue vaccine in Groups 3 and 4.

Detailed description

Study participants were randomly assigned to one of the four groups to receive assigned study vaccine and were evaluated for neutralizing antibody titers; markers of cell-mediated immunity.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
CYD Dengue Vaccine: Group 1	Experimental	Biological: CYD Dengue VaccineParticipants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
CYD Dengue Vaccine: Group 2	Experimental	Biological: CYD Dengue VaccineParticipants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
CYD Dengue and JE Vaccine: Group 3	Experimental	Biological: CYD Dengue Vaccine, Biological: Japanese Encephalitis VaccineParticipants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
CYD Dengue and JE Vaccine: Group 4	Experimental	Biological: CYD Dengue Vaccine, Biological: Japanese Encephalitis VaccineParticipants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Aged greater than or equal to (>=)18 to less than or equal to (<=) 45 years on the day of inclusion.
Informed consent form had been signed and dated.
Able to attend all scheduled visits and complied with all trial procedures.
Participant was in good health, based on medical history and physical examination.

Key exclusion criteria (13 listed)

Participant was pregnant, or lactating, or of childbearing potential (were considered of non-childbearing potential, a female had to be post- menopausal for at least 1 year, surgically sterile, or used an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination).
Participation 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 or planned receipt of any vaccine, outside the study protocol in the 4 weeks preceded or followed trial vaccinations. (If influenza activity warranted vaccination of healthy young adults, influenza vaccination was encouraged and did not lead to study exclusion).
Any history of FV vaccination, or planned FV vaccination during the trial period.
Previous residence (greater than [>]12 months) in, or travel in the last 30 days to dengue endemic regions.

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	Biological	CYD Dengue Vaccine: Group 1, CYD Dengue and JE Vaccine: Group 3, CYD Dengue and JE Vaccine: Group 4
CYD Dengue Vaccine0.5 mL, Subcutaneous	Biological	CYD Dengue Vaccine: Group 2
Japanese Encephalitis VaccineAlso: IXIARO Japanese Encephalitis Vaccine0.5 mL, Intramuscular	Biological	CYD Dengue and JE Vaccine: Group 3
Japanese Encephalitis VaccineAlso: IXIARO Japanese Encephalitis Vaccine0.5 mL, Intramuscular	Biological	CYD Dengue and JE Vaccine: Group 4

Primary outcome

Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Time frame: Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3
GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by plaque reduction neutralization test (PRNT). The lower limit of quantitation (LLOQ) of the assay was a titer of 10 (1/dilution).
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Time frame: Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3
Antibody titers against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT.

7 secondary outcomes

Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Time frame: Pre-injection 1, 2 and 3, and 28 days post-injection 1, 2 and 3
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains
Time frame: 6 months and 12 months post-injection 3
Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia
Time frame: 3, 5, 7 and 14 days post-injection 1, 2 and 3
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Time frame: 3, 5, 7 and 14 days post-injection 1; 3 and 14 days post-injection 2 and 7 days post-injection 3
Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4
Time frame: Pre-injection 1, and 28 days post-injection 1, 2 and 3
Number of Participants With Solicited Injection Site Reactions
Time frame: Within 7 days after any CYD dengue vaccine and/or JE vaccine
Number of Participants With Solicited Systemic Reactions
Time frame: Within 14 days after any CYD dengue vaccine and/or JE vaccine

Results and safety

Results posted to the registry on 5 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CYD Dengue Vaccine: Group 1	25	15
CYD Dengue Vaccine: Group 2	15	11
CYD Dengue and Japanese Encephalitis (JE) Vaccine : Group 3	25	10
CYD Dengue and JE Vaccine: Group 4	25	14

Primary outcome: Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains

Time frame: Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3. Geometric mean (95% Confidence Interval). Unit: titers (1/dilution)

Measure	CYD Dengue Vaccine: Group 1 n = 25	CYD Dengue Vaccine: Group 2 n = 15	CYD Dengue and JE Vaccine : Group 3 n = 25	CYD Dengue and JE Vaccine: Group 4 n = 25
Serotype 1: Pre-injection 1	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)
Serotype 1: 28 days Post-injection 1	6.1 (4.8 to 7.8)	5.5 (4.5 to 6.8)	6.8 (4.7 to 10.0)	7.4 (5.3 to 10.2)
Serotype 1: Pre-injection 2	6.5 (4.7 to 8.9)	5.4 (4.6 to 6.4)	6.7 (4.3 to 10.6)	7.2 (5.0 to 10.2)
Serotype 1: 28 days Post-injection 2	8.5 (5.5 to 13.1)	6.2 (4.5 to 8.4)	10.8 (5.4 to 21.8)	10.8 (6.6 to 17.7)
Serotype 1: Pre-injection 3	7.1 (4.7 to 10.8)	6.3 (4.4 to 9.0)	8.3 (4.6 to 15.1)	6.5 (4.7 to 9.1)
Serotype 1: 28 days Post-injection 3	9.1 (5.5 to 15.0)	9.9 (6.0 to 16.6)	12.0 (5.4 to 26.7)	12.9 (7.6 to 21.9)
Serotype 1: 6 months Post-injection 3	5.8 (4.7 to 7.3)	6.6 (4.3 to 9.9)	8.6 (3.5 to 21.1)	7.3 (5.0 to 10.9)
Serotype 2: Pre-injection 1	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)

Population analysed: Analysis was performed on full analysis set which included participants who received at least one injection of CYD dengue vaccine or JE vaccine and had at least one blood sample drawn and valid post-injection serology result. Here, 'Number analyzed' = participants with available data for each specified category.

Primary outcome: Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains

Time frame: Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3. Count of participants. Unit: Participants

Measure	CYD Dengue Vaccine: Group 1 n = 25	CYD Dengue Vaccine: Group 2 n = 15	CYD Dengue and JE Vaccine : Group 3 n = 25	CYD Dengue and JE Vaccine: Group 4 n = 25
Serotype 1: Pre-injection 1	0	0	0	0
Serotype 1: 28 days Post-injection 1	3	1	3	6
Serotype 1: Pre-injection 2	3	1	2	4
Serotype 1: 28 days Post-injection 2	6	2	5	8
Serotype 1: Pre-injection 3	3	2	3	3
Serotype 1: 28 days Post-injection 3	5	6	5	9
Serotype 1: 6 months Post-injection 3	2	2	2	4
Serotype 2: Pre-injection 1	0	0	0	0

Population analysed: Analysis was performed on full analysis set. Here, 'Number analyzed' = participants with available data for each specified category.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CYD Dengue Vaccine: Group 1	3 of 25 (12%)	18 of 25 (72%)	0 of 25
CYD Dengue Vaccine: Group 2	0 of 15 (0%)	15 of 15 (100%)	0 of 15
CYD Dengue and JE Vaccine : Group 3	0 of 25 (0%)	17 of 25 (68%)	0 of 25
CYD Dengue and JE Vaccine: Group 4	1 of 25 (4%)	20 of 25 (80%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Medical Director study director

Sanofi Pasteur SA

1 site 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 and Japanese Encephalitis Vaccine in people with Dengue and Dengue Fever, run by Sanofi Pasteur, a Sanofi Company at 1 site in United States.

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 4 inclusion and 13 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 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. 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 5 Feb 2020). 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?

Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains (time frame: Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3). The study lists 2 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 NCT01943825.

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 24 Mar 2022.