DenguePhase 2NCT01488890

Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Given With or Without Yellow Fever Vaccine

A Phase 2 study testing Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus and Yellow Fever in people with Dengue and Dengue Fever, run by Sanofi Pasteur, a Sanofi Company at 7 sites 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 this study was to evaluate the administration of CYD dengue vaccine serotypes (1, 2, 3 and 4) following a compressed schedule in 3 different populations. Primary Objectives: To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue… 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?: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus and Yellow Fever
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 390 participants
Where: 7 sitesUnited States
Study dates: 6 Dec 2011to 27 Sep 2013
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 >= 18 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
For participants classified as YF positive (+) to be included in Groups 1 and 2, previous vaccination (3 months to 10 years) with YF vaccine confirmed by acceptable documentation.

Who cannot join

Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be 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 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 of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following each trial vaccination
For all participants classified as YF negative (-), any previous vaccination against Flavivirus (FV) diseases (including Japanese Encephalitis [JE], tick-borne encephalitis, and YF)
For participants classified as YF+, previous vaccination against FV diseases except YF (including JE and tick-borne encephalitis)
For all participants, any FV vaccination planned during the trial period outside the study protocol

Show all 18Show fewer

Receipt of immune globulins, blood or blood-derived products in the past 3 months
Known or suspected congenital or acquired immunodeficiency; 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)
Self-reported seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
Self-reported history of FV infection (e.g., JE, Dengue, YF, West Nile), confirmed either clinically or serologically
Known systemic hypersensitivity to any of the vaccine components, 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
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
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
Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature >= 38.0°C [>=100.4°F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
Previous residence (> 12 months) in, or travel in the last 30 days to FV endemic regions
History of thymic pathology (thymoma), thymectomy, or myasthenia.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Study site
Alabaster, Alabama, 35007
Study site
Jacksonville, Florida, 32216
Study site
Las Vegas, Nevada, 89104
Study site
Sacramento, California, 95816
Study site
Silver Spring, Maryland, 20910
Study site
Springfield, Missouri, 65802
Study site
West Jordan, Utah, 84088

Other trials in United States

About this study

Official title: Evaluation of the Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Administered With or Without Yellow Fever Vaccine in US Adults.

The aim of this study was to evaluate the administration of CYD dengue vaccine serotypes (1, 2, 3 and 4) following a compressed schedule in 3 different populations.

Primary Objectives:

To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue vaccine Dose 3 in Group 1 (Month [M] 13) and Group 2 (M07), irrespective of whether or not Yellow Fever (YF) vaccine has been previously administered.
To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes 6 months after CYD dengue vaccine Dose 3 in Group 1 (M18) and Group 2 (M12), irrespective of whether or not YF vaccine has been previously administered.

Secondary Objective:

To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue vaccine Dose 1 and Dose 2 in Groups 1 and 2, irrespective of whether or not YF vaccine has been previously administered.
To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue Dose 1 in the combined YF-participants in Group 1 (N=60) and Group 2 (N=60), and in Group 3 (N=120).
To describe by FV status at baseline the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each injection of CYD dengue vaccine in Groups 1, 2, and 3.
To describe the safety profile after each injection of CYD dengue vaccine and/or YF vaccine.

Read the detailed description

Participants were randomized to 4 different groups to receive either CYD dengue vaccine and/or YF vaccine. Participants who already received YF vaccine prior to enrolment were randomized to one of the 2 groups receiving CYD dengue vaccine alone. Participants were evaluated for immunogenicity, antibody persistence, reactogenicity and safety.

Conditions: Dengue, Dengue Fever, Dengue Hemorrhagic Fever, Yellow Fever
Being tested: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus, Yellow Fever
Keywords: Dengue fever, Dengue Hemorrhagic Fever, CYD dengue vaccine, Yellow Fever, Flavivirus
Medical subject headings: Dengue, Severe Dengue, Yellow Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virusBiological
Also called CYD Dengue Vaccine
0.5 mL, Subcutaneous
Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virusBiological
Also called CYD Dengue Vaccine
0.5 mL, Subcutaneous
Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virusBiological
Also called CYD Dengue Vaccine
0.5 mL, Subcutaneous
Yellow FeverBiological
Also called YF VAX®
0.5 mL, Subcutaneous

Study groups in NCT01488890
Study group	Role	What they receive
CYD Dengue vaccine: Group 1	Experimental	Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. Receives: Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus
CYD Dengue vaccine: Group 2	Experimental	Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. Receives: Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus
CYD Dengue and Yellow Fever vaccine: Group 3	Experimental	Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. Receives: Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus; Biological: Yellow Fever
Yellow Fever vaccine: Group 4	Active comparator	Participants received single dose of YF vaccine at Day 0. Receives: Biological: Yellow Fever

What is being measured

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

Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test (PRNT).
Measured: Pre-injection 1, 28 days and 6 months post-injection 3
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution).
Measured: Pre-injection 1, 28 days and 6 months post-injection 3

Secondary outcomes (10)

Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT.
Measured: Pre-injection 1 and 2 and 28 days post-injection 1 and 2
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution).
Measured: Pre-injection 1 and 2 and 28 days post-injection 1 and 2
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 In YF Non-Immune Participants: Group 1 and Group 2 (Pooled) and Group 3
GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test-50 (PRNT50). Groups 1 and 2 data was reported as pooled data. YF-non immune participants were defined as participants with YF baseline titer PRNT80 < 10 (1/dilution).
Measured: Pre-injection 1 and 28 days post-injection 1
Percentage of YF Non-Immune Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1: Group 1 and Group 2 (Pooled) and Group 3
Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). Groups 1 and 2 data was reported as pooled data. YF-non immune participants were defined as participants with YF baseline titer dengue plaque reduction neutralization test-80 (PRNT80) <10 (1/dilution).
Measured: Pre-injection 1 and 28 days post-injection 1
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. FV immune participants were defined as participants with titer >= 10 (1/dilution) for at least 1 serotype with parental dengue virus strain (sera tested by PRNT) or with titer >= 10 (1/dilution) for YF virus (sera with PRNT80 result).
Measured: Pre Injection 1, 2 and 3 and 28 days post injection 1, 2 and 3
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. FV non-immune participants were defined as participants with titer < 10 (1/dilution) for all serotypes with parental dengue virus strains (sera tested by PRNT) and with titer <10 (1/dilution) for YF virus (using sera with PRNT80 result).
Measured: Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). FV immune participants at baseline were defined as participants with titer >= 10 (1/dilution) for at least 1 serotype with parental dengue virus strain (sera tested by PRNT) or with titer >=10 (1/dilution) for YF virus (sera with PRNT80 result).
Measured: Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). FV non-immune participants were defined as participants with titer < 10 (1/dilution) for all serotypes with parental dengue virus strains (sera tested by PRNT) and with titer <10 (1/dilution) for YF virus (using sera with PRNT80 result).
Measured: Pre injection 1, 2, 3 and 28 days post injection 1, 2 and 3
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 reactions: Pain: significant; prevents daily activity; Erythema and Swelling: >100 mm.
Measured: Within 7 days after any injection
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: >= 39.0°C; Headache, Malaise, Myalgia, and Asthenia: significant; prevents daily activity.
Measured: Within 14 days after any injection

Timeline

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

6 Dec 201127 Sep 2013

First posted8 Dec 2011 (estimated)
Study start6 Dec 2011
Primary completion27 Sep 2013
Study completion27 Sep 2013

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 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: 390 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01488890
Sponsor's protocol ID: CYD51
Other IDs: U1111-1122-1892
Status last verified: Mar 2022
First submitted: 6 Dec 2011
Last updated: 24 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
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

Kirstein J, Douglas W, Thakur M, Boaz M, Papa T, Skipetrova A, Plennevaux E. Immunogenicity of the CYD tetravalent dengue vaccine using an accelerated schedule: randomised phase II study in US adults. BMC Infect Dis. 2018 Sep 21;18(1):475. doi: 10.1186/s12879-018-3389-x.
PubMed 30241510

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

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A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
Healthy
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Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
Healthy Volunteers, Dengue
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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
Dengue, Antiviral Drugs

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: Evaluation of the Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Administered With or Without Yellow Fever Vaccine in US Adults.
ClinicalTrials.gov ID: NCT01488890
Acronym / sponsor ID: CYD51
Conditions: Dengue, Dengue Fever, Dengue Hemorrhagic Fever, Yellow Fever
Keywords: Dengue fever, Dengue Hemorrhagic Fever, CYD dengue vaccine, Yellow Fever, Flavivirus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 390 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 6 Dec 2011 (actual)
Primary completion: 27 Sep 2013 (actual)
Study completion: 27 Sep 2013 (actual)
First posted: 8 Dec 2011 (estimated)
Results: Posted 14 Jun 2019

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 this study was to evaluate the administration of CYD dengue vaccine serotypes (1, 2, 3 and 4) following a compressed schedule in 3 different populations.

Primary Objectives:

To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue vaccine Dose 3 in Group 1 (Month [M] 13) and Group 2 (M07), irrespective of whether or not Yellow Fever (YF) vaccine has been previously administered.
To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes 6 months after CYD dengue vaccine Dose 3 in Group 1 (M18) and Group 2 (M12), irrespective of whether or not YF vaccine has been previously administered.

Secondary Objective:

To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue vaccine Dose 1 and Dose 2 in Groups 1 and 2, irrespective of whether or not YF vaccine has been previously administered.
To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue Dose 1 in the combined YF-participants in Group 1 (N=60) and Group 2 (N=60), and in Group 3 (N=120).
To describe by FV status at baseline the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each injection of CYD dengue vaccine in Groups 1, 2, and 3.
To describe the safety profile after each injection of CYD dengue vaccine and/or YF vaccine.

Detailed description

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: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virusParticipants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
CYD Dengue vaccine: Group 2	Experimental	Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virusParticipants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
CYD Dengue and Yellow Fever vaccine: Group 3	Experimental	Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus, Biological: Yellow FeverParticipants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
Yellow Fever vaccine: Group 4	Active comparator	Biological: Yellow FeverParticipants received single dose of YF vaccine at Day 0.

Who may qualify

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

Key inclusion criteria (4 listed)

Aged >= 18 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
For participants classified as YF positive (+) to be included in Groups 1 and 2, previous vaccination (3 months to 10 years) with YF vaccine confirmed by acceptable documentation.

Key exclusion criteria (18 listed)

Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be 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 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 of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following each trial vaccination
For all participants classified as YF negative (-), any previous vaccination against Flavivirus (FV) diseases (including Japanese Encephalitis [JE], tick-borne encephalitis, and YF)
For participants classified as YF+, previous vaccination against FV diseases except YF (including JE and tick-borne encephalitis)

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
Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virusAlso: CYD Dengue Vaccine0.5 mL, Subcutaneous	Biological	CYD Dengue vaccine: Group 1
Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virusAlso: CYD Dengue Vaccine0.5 mL, Subcutaneous	Biological	CYD Dengue vaccine: Group 2
Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virusAlso: CYD Dengue Vaccine0.5 mL, Subcutaneous	Biological	CYD Dengue and Yellow Fever vaccine: Group 3
Yellow FeverAlso: YF VAX®0.5 mL, Subcutaneous	Biological	CYD Dengue and Yellow Fever vaccine: Group 3, Yellow Fever vaccine: Group 4

Primary outcome

Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Time frame: Pre-injection 1, 28 days and 6 months post-injection 3
GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test (PRNT).
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Time frame: Pre-injection 1, 28 days and 6 months post-injection 3
Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution).

10 secondary outcomes

Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Time frame: Pre-injection 1 and 2 and 28 days post-injection 1 and 2
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Time frame: Pre-injection 1 and 2 and 28 days post-injection 1 and 2
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 In YF Non-Immune Participants: Group 1 and Group 2 (Pooled) and Group 3
Time frame: Pre-injection 1 and 28 days post-injection 1
Percentage of YF Non-Immune Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1: Group 1 and Group 2 (Pooled) and Group 3
Time frame: Pre-injection 1 and 28 days post-injection 1
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Time frame: Pre Injection 1, 2 and 3 and 28 days post injection 1, 2 and 3
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Time frame: Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Time frame: Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Time frame: Pre injection 1, 2, 3 and 28 days post injection 1, 2 and 3
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Time frame: Within 7 days after any injection
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Time frame: Within 14 days after any injection

Results and safety

Results posted to the registry on 14 Jun 2019, 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	120	88
CYD Dengue Vaccine: Group 2	120	100
CYD Dengue and Yellow Fever (YF) Vaccine: Group 3	120	85
Yellow Fever Vaccine: Group 4	30	25

Primary outcome: Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2

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

Measure	CYD Dengue Vaccine: Group 1 n = 117	CYD Dengue Vaccine: Group 2 n = 119
Dengue Virus Serotype 1: Pre-injection 1	5.38 (4.85 to 5.96)	5.13 (4.98 to 5.28)
Dengue Virus Serotype 1: 28 days Post-injection 3	14.8 (11.3 to 19.4)	15.9 (12.6 to 20.0)
Dengue Virus Serotype 1: 6 months Post-injection 3	13.3 (10.2 to 17.4)	9.01 (7.54 to 10.8)
Dengue Virus Serotype 2: Pre-injection 1	5.19 (4.82 to 5.58)	5.22 (4.96 to 5.50)
Dengue Virus Serotype 2: 28 days Post-injection 3	51.2 (38.2 to 68.6)	59.9 (45.8 to 78.4)
Dengue Virus Serotype 2: 6 months Post-injection 3	45.6 (31.6 to 65.6)	38.7 (29.5 to 50.8)
Dengue Virus Serotype 3: Pre-injection	5.32 (4.94 to 5.73)	5.28 (5.03 to 5.55)
Dengue Virus Serotype 3: 28 days Post-injection 3	45.7 (35.0 to 59.8)	59.3 (47.0 to 74.7)

Population analysed: Full Analysis Set included participants who received at least 1 Inj. of CYD dengue or/ YF vaccine, had at least 1 blood sample drawn and valid post-Inj. serology result. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 3 and 4.

Primary outcome: Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2

Time frame: Pre-injection 1, 28 days and 6 months post-injection 3. Number. Unit: percentage of participants

Measure	CYD Dengue Vaccine: Group 1 n = 117	CYD Dengue Vaccine: Group 2 n = 119
Dengue Virus Serotype 1: Pre-injection 1	1.7	2.5
Dengue Virus Serotype 1: 28 days Post-injection 3	52.7	56.5
Dengue Virus Serotype 1: 6 months Post-injection 3	47.7	32.7
Dengue Virus Serotype 2: Pre-injection 1	0.9	2.5
Dengue Virus Serotype 2: 28 days Post-injection 3	84.0	88.0
Dengue Virus Serotype 2: 6 months Post-injection 3	75.0	80.8
Dengue Virus Serotype 3: Pre-injection 1	2.6	4.2
Dengue Virus Serotype 3: 28 days Post-injection 3	85.1	90.7

Population analysed: Analysis was performed on Full Analysis Set. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 3 and 4.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF 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 after the first injection).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CYD Dengue Vaccine: Group 1	4 of 120 (3.3%)	91 of 120 (75.8%)	0 of 120
CYD Dengue Vaccine: Group 2	4 of 120 (3.3%)	92 of 120 (76.7%)	0 of 120
CYD Dengue and Yellow Fever Vaccine: Group 3	5 of 119 (4.2%)	92 of 119 (77.3%)	0 of 119
Yellow Fever Vaccine: Group 4	0 of 30 (0%)	17 of 30 (56.7%)	0 of 30

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.
Derived from this study: PubMed 30241510Kirstein J, Douglas W, Thakur M, Boaz M, Papa T, Skipetrova A, Plennevaux E. Immunogenicity of the CYD tetravalent dengue vaccine using an accelerated schedule: randomised phase II study in US adults. BMC Infect Dis. 2018 Sep 21;18(1):475. doi: 10.1186/s12879-018-3389-x.
Related InfoLink provided by the sponsor.
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

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 18 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 7 sites 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 14 Jun 2019). 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 Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2 (time frame: Pre-injection 1, 28 days 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 NCT01488890, 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 24 Mar 2022.