Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US
1 other identifier
interventional
260
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2008
5 active sites
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
February 6, 2008
CompletedFirst Posted
Study publicly available on registry
February 18, 2008
CompletedStudy Start
First participant enrolled
April 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
June 11, 2019
CompletedJune 11, 2019
May 1, 2019
1.6 years
February 6, 2008
May 21, 2019
May 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
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).
Pre-injection 1 (Day 0), 30 days post-injection 2 (Month 7)
Secondary Outcomes (6)
Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain
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 At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes
Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13)
Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain
Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13)
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
7 days after any injection 1, 2 or 3
Number of Participants With Solicited Systemic Reactions After Any Vaccination
14 days after any injection 1, 2 or 3
- +1 more secondary outcomes
Study Arms (3)
CYD Dengue Vaccine 5555 Formulation
EXPERIMENTALParticipants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
CYD Dengue Vaccine 5553 Formulation
EXPERIMENTALParticipants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
CYD Dengue Vaccine 4444 Formulation
EXPERIMENTALParticipants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
Interventions
A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively.
A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively
A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively
Eligibility Criteria
You may qualify if:
- Healthy, as determined by medical history, clinical examination, and biological safety parameters.
- 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.
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (5)
Investigational Site 004
Hoover, Alabama, 35126, United States
Investigational Site 002
San Diego, California, 92103, United States
Investigational Site 005
Vallejo, California, 94589, United States
Investigational Site 001
New Orleans, Louisiana, 70119, United States
Investigational Site 003
Springfield, Missouri, 65802, United States
Related Publications (1)
Dayan GH, Thakur M, Boaz M, Johnson C. Safety and immunogenicity of three tetravalent dengue vaccine formulations in healthy adults in the USA. Vaccine. 2013 Oct 17;31(44):5047-54. doi: 10.1016/j.vaccine.2013.08.088. Epub 2013 Sep 7.
PMID: 24021313RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi Pasteur, a Sanofi Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2008
First Posted
February 18, 2008
Study Start
April 17, 2008
Primary Completion
December 1, 2009
Study Completion
February 1, 2010
Last Updated
June 11, 2019
Results First Posted
June 11, 2019
Record last verified: 2019-05