NCT02623725

Brief Summary

The aim of the study was to assess and describe the booster effect of a CYD dengue vaccine dose administered 4 to 5 years after the completion of a 3-dose vaccination schedule. Primary Objective \- To demonstrate the non-inferiority, in terms of geometric mean of titer ratios (GMTRs), of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD13 - NCT00993447 and CYD30 - NCT01187433 trials (participants from Group 1 only). Secondary Objectives:

  • If the primary objective of non-inferiority was achieved: To demonstrate the superiority, in terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD13 and CYD30 trials.
  • To describe the immune responses elicited by a CYD dengue vaccine booster and placebo injection in participants who received 3 doses of the CYD dengue vaccine in the CYD13 and CYD30 trials in all participants.
  • To describe the neutralizing antibody levels of each dengue serotype post-dose 3 (CYD13 and CYD30 participants) and immediately prior to booster or placebo injection in all participants.
  • To describe the neutralizing antibody persistence 6 months, 1 year, and 2 years post booster or placebo injection in all participants.
  • To evaluate the safety of booster vaccination with the CYD dengue vaccine in all participants.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
251

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2016

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

April 14, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2016

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2018

Completed
8 months until next milestone

Results Posted

Study results publicly available

June 14, 2019

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

December 3, 2015

Results QC Date

May 24, 2019

Last Update Submit

March 15, 2022

Conditions

Dengue FeverDengue Hemorrhagic Fever

Keywords

Dengue FeverDengue virusDengue Hemorrhagic FeverCYD Dengue Vaccine

Outcome Measures

Primary Outcomes (1)

  • Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group

    Geometric Mean Titers (GMTs) of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the plaque reduction neutralization test (PRNT).

    28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64

Secondary Outcomes (13)

  • GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group

    28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64

  • GMTs of Antibodies Against Each Dengue Virus Serotype Before And Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo

    Pre-booster injection (Day 0) and 28 days post-booster injection

  • GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo

    Pre-booster injection (Day 0) and 28 days post-booster injection

  • Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo

    Pre-booster injection (Day 0) and 28 days post-booster injection

  • Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo

    28 days post-booster injection

  • +8 more secondary outcomes

Study Arms (2)

CYD Dengue Vaccine Booster Group

EXPERIMENTAL

Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).

Biological: CYD Dengue Vaccine (5-dose formulation)

Placebo Group

EXPERIMENTAL

Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).

Biological: Placebo, NaCl 0.9%

Interventions

CYD Dengue Vaccine (5-dose formulation)BIOLOGICAL

0.5 mL, Subcutaneous

CYD Dengue Vaccine Booster Group
Placebo, NaCl 0.9%BIOLOGICAL

0.5 mL, Subcutaneous

Placebo Group

Eligibility Criteria

Age13 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Had been identified as a potential participant by the Sponsor and is included in the list provided to the Investigator (i.e., aged 9 to 16 years on the day of first vaccination of CYD dengue vaccine in CYD13/CYD30 and has a post-dose 3 serum sample available \[at least 400 microliters of serum\]).
  • Participants were in good health, based on medical history and physical examination.
  • Assent form or informed consent form (ICF) had been signed and dated by the participant (based on local regulations), and ICF had been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations).
  • Participant and parent(s)/legally acceptable representative(s) attended all scheduled visits and complied with all trial procedures.

You may not qualify if:

  • Participant who received any other dengue vaccination that was not part of the CYD13 or CYD30 trials.
  • Participant was 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 vaccination until at least 4 weeks after vaccination).
  • Participation at the time of study enrollment (or in the 4 weeks preceding the 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 trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination.
  • 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).
  • 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.
  • Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion.
  • Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response.
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
  • Current alcohol abuse or drug addiction.
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature \>= 38.0°C). A prospective participant should not be included in the study until the condition had resolved or the febrile event had 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Investigational Site Number 001

Vitória, 29040-091, Brazil

Location

Investigational Site Number 002

Bucaramanga, Colombia

Location

Investigational Site Number 003

Tegucigalpa, Honduras

Location

Investigational Site Number 004

Temixco, 62587, Mexico

Location

Investigational Site Number 005

Carolina, 984, Puerto Rico

Location

Related Publications (1)

  • Coronel D, Garcia-Rivera EJ, Rivera M, Arredondo-Garcia JL, Dietze R, Perroud AP, Cortes M, Bonaparte M, Zhao J, Tila M, Jackson N, Zambrano B, Noriega F. Dengue Vaccine Booster in Healthy Adolescents and Adults in Latin America: Evaluation 4-5 Years After a Primary 3-Dose Schedule. Pediatr Infect Dis J. 2019 May;38(5):e90-e95. doi: 10.1097/INF.0000000000002286.

    PMID: 30986790DERIVED

Related Links

MeSH Terms

Conditions

DengueSevere Dengue

Interventions

Dosage FormsSodium Chloride

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative TechniquesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Medical Director
Organization
Sanofi Pasteur
Contact-US@sanofi.com
800-633-1610

Study Officials

  • Medical Director

    Sanofi Pasteur Inc.

    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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
An observer-blind procedure was followed for the injection of the CYD Dengue Vaccine booster or placebo. Neither the observer Investigator, nor the Sponsor, nor the participant/participants' parent(s)/legally acceptable representative(s) knew which product was administered.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2015

First Posted

December 8, 2015

Study Start

April 14, 2016

Primary Completion

November 23, 2016

Study Completion

October 28, 2018

Last Updated

March 24, 2022

Results First Posted

June 14, 2019

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

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

Locations

BR(1)CO(1)PR(1)HO(1)ME(1)