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

NCT01488890 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: CYD51U1111-1122-1892
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 7

Brief 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 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.

Conditions

Dengue; Dengue Fever; Dengue Hemorrhagic Fever; Yellow Fever

Keywords

Dengue fever; Dengue Hemorrhagic Fever; CYD dengue vaccine; Yellow Fever; Flavivirus

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  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

  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

  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

  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

  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)

  Pre Injection 1, 2 and 3 and 28 days post injection 1, 2 and 3

Study Arms (4)

CYD Dengue vaccine: Group 1

EXPERIMENTAL

Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.

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.

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.

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.

Biological: Yellow Fever

Interventions

Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus BIOLOGICAL

0.5 mL, Subcutaneous

Also known as: CYD Dengue Vaccine

CYD Dengue vaccine: Group 1

Yellow Fever BIOLOGICAL

0.5 mL, Subcutaneous

Also known as: YF VAX®

CYD Dengue and Yellow Fever vaccine: Group 3; Yellow Fever vaccine: Group 4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (7)

Unknown Facility

Alabaster, Alabama, 35007, United States

Location

Unknown Facility

Sacramento, California, 95816, United States

Location

Unknown Facility

Jacksonville, Florida, 32216, United States

Location

Unknown Facility

Silver Spring, Maryland, 20910, United States

Location

Unknown Facility

Springfield, Missouri, 65802, United States

Location

Unknown Facility

Las Vegas, Nevada, 89104, United States

Location

Unknown Facility

West Jordan, Utah, 84088, United States

Location

Related Publications (1)

• 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.

  PMID: 30241510 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Dengue; Severe Dengue; Yellow Fever

Interventions

Yellow Fever Vaccine

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

Study Officials

• Medical Director

  Sanofi Pasteur SA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 8, 2011
• Study Start: December 6, 2011
• Primary Completion: September 27, 2013
• Study Completion: September 27, 2013
• Last Updated: March 24, 2022
• Results First Posted: June 14, 2019

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (7)