Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00617344
Recruitment Status : Completed
First Posted : February 18, 2008
Results First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

This study used 3 different formulations of tetravalent CYD dengue vaccine.

The primary objective of the study was to evaluate the neutralizing antibody response after 2 doses of two different formulations of tetravalent dengue vaccine administered at Month 0 and Month 6.

The secondary objectives were:

  • To evaluate the safety of the 3 formulations of tetravalent CYD dengue vaccine.
  • To describe the neutralizing antibody responses to each of the 3 vaccine formulations.
  • To describe vaccine viremia after the first and second dose of each of the 3 vaccine formulations in a subset of participants.

Condition or disease Intervention/treatment Phase
Dengue Fever Dengue Hemorrhagic Fever Dengue Virus Biological: Tetravalent CYD Dengue Vaccine , 5555 formulation Biological: Tetravalent CYD Dengue Vaccine , 5553 formulation Biological: Tetravalent CYD Dengue Vaccine, 4444 formulation Phase 2

Detailed Description:

All participants provided blood samples for immunogenicity assessments, while vaccine viremia was assessed in a subset of participants in each group.

Safety was assessed in all participants as follows: solicited adverse event (AE) prelisted in the diary card were collected for 7 days after vaccination for solicited injection site reactions and 14 days for solicited systemic reactions , unsolicited AEs were collected for 28 days after vaccination, and serious adverse event (SAE) information collected throughout the study up to 6 months after vaccination.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Three Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Adults Aged 18 to 45 Years in the US
Actual Study Start Date : April 17, 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Arm Intervention/treatment
Experimental: CYD Dengue Vaccine 5555 Formulation
Participants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
Biological: Tetravalent CYD Dengue Vaccine , 5555 formulation
A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively.

Experimental: CYD Dengue Vaccine 5553 Formulation
Participants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
Biological: Tetravalent CYD Dengue Vaccine , 5553 formulation
A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively

Experimental: CYD Dengue Vaccine 4444 Formulation
Participants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
Biological: Tetravalent CYD Dengue Vaccine, 4444 formulation
A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively




Primary Outcome Measures :
  1. Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation [ Time Frame: Pre-injection 1 (Day 0), 30 days post-injection 2 (Month 7) ]
    Percentage of participants with antibody titers >= 10 (1/dil) against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by dengue plaque reduction neutralization test (PRNT).


Secondary Outcome Measures :
  1. Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain [ Time Frame: Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13) ]
    Percentage of participants with antibody titers >= 10 1/dil against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by PRNT.

  2. Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes [ Time Frame: Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13) ]
    Percentage of participants with antibody titers >= 10 1/dil against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by PRNT. In this outcome measure, participants with antibody titers >= 10 1/dil against any 1 of the 4 serotypes or any 2 of the 4 serotypes or any 3 of the 4 serotypes or with all 4 serotypes were reported.

  3. Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain [ Time Frame: Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13) ]
    Geometric mean titers against each dengue virus serotype (1, 2, 3 and 4) strain was measured by PRNT.

  4. Number of Participants With Solicited Injection Site Reactions After Any Vaccination [ Time Frame: 7 days after any injection 1, 2 or 3 ]
    Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 1: Easily tolerated, Grade 2: Sufficiently discomforting to interfere with normal behavior or activities, Grade 3: Incapacitating, unable to perform usual activities. Erythema:- Grade 1: <2.5 cm, Grade 2: >=2.5 to <5 cm, Grade 3: >=5 cm. Swelling:- Grade 1: <2.5 cm, Grade 2: >=2.5 to <5 cm, Grade 3: >=5 cm.

  5. Number of Participants With Solicited Systemic Reactions After Any Vaccination [ Time Frame: 14 days after any injection 1, 2 or 3 ]
    Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: - Grade1: >=37.5°C to <=38.0°C (>=99.5°F to <=100.4°F), Grade 2: >38.0°C to <=39.0°C (>100.4°F to <= 102.2°F), Grade 3: >39.0°C (>102.2°F). Headache, malaise, myalgia and asthenia: Grade 1: noticeable but does not interfere with daily activities, Grade 2: interferes with daily activities, Grade 3: prevents daily activities.

  6. Number of Participants With Vaccine Viremia [ Time Frame: 7 days post-injection 1 and 2, 14 days post-injection 1 and 2 ]
    Vaccine viremia (level of vaccine virus in blood samples taken from participants) was measured by an assay yellow fever reverse transcriptase polymerase chain reaction which allowed the detection of vaccine viremia of any serotype (1, 2, 3 and 4).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, as determined by medical history, clinical examination, and biological safety parameters.
  • Aged 18 to 45 years on the day of inclusion.
  • Provision of informed consent signed by the participant or another legally acceptable representative.
  • For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, and until at least 4 weeks after the last study vaccination.
  • Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

  • Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
  • For a woman of child-bearing potential, known or suspected pregnancy or positive serum/urine pregnancy test.
  • Breast-feeding woman.
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 10 mg). Topical steroids were allowed.
  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.
  • Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.
  • Current or past alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures.
  • Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response.
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
  • Planned receipt of any vaccine in the 4 weeks following each of the trial vaccinations.
  • Human Immunodeficiency Virus (HIV), hepatitis B surface antigen, or hepatitis C virus seropositivity in blood sample taken at Screening.
  • Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
  • Clinically significant laboratory test abnormalities (as determined by the investigator) in blood sample taken at Screening.
  • Previous residence in, travel or planned travel of more than 2 weeks during the study period to areas with high dengue infection endemicity.
  • Reported history of flavivirus infection as reported by the participant.
  • Previous vaccination against flavivirus diseases (including Japanese encephalitis, tick-borne encephalitis, and yellow fever).
  • Flavivirus vaccination planned during the trial period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617344


Locations
Layout table for location information
United States, Alabama
Investigational Site 004
Hoover, Alabama, United States, 35126
United States, California
Investigational Site 002
San Diego, California, United States, 92103
Investigational Site 005
Vallejo, California, United States, 94589
United States, Louisiana
Investigational Site 001
New Orleans, Louisiana, United States, 70119
United States, Missouri
Investigational Site 003
Springfield, Missouri, United States, 65802
Sponsors and Collaborators
Sanofi
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company

Publications of Results:
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00617344     History of Changes
Other Study ID Numbers: CYD12
First Posted: February 18, 2008    Key Record Dates
Results First Posted: June 11, 2019
Last Update Posted: June 11, 2019
Last Verified: May 2019
Keywords provided by Sanofi:
Dengue fever
Dengue hemorrhagic fever
Dengue virus
Additional relevant MeSH terms:
Layout table for MeSH terms
Severe Dengue
Dengue
Hemorrhagic Fevers, Viral
Fever
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs