Clinical trial NCT00788151: Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years
Official title: Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years Previously Vaccinated Against Yellow Fever in Peru
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dengue Virus
Dengue Fever
Dengue Hemorrhagic Fever
Dengue Diseases
Keywords: Dengue virus
Dengue fever
Dengue Hemorrhagic fever
Dengue diseases
Dengue vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-11-10
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease.

Primary Objectives:

* To describe the humoral immune response to dengue before and after each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years) previously vaccinated with yellow fever (YF) vaccine.
* To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years).
* To describe viremia after the first and second vaccinations with dengue vaccine in a subgroup of 130 randomized participants (100 participants in Dengue Vaccine Group and 30 participants in Control Group) in two age cohorts of children (6 to 11 years and 2 to 5 years).

Detailed description: Participants were randomized to receive either three injections of CYD dengue vaccine or two injections of placebo, and one injection of a pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively.

Eligibility criteria: Inclusion Criteria :

* Aged 2 to 11 years on the day of inclusion.
* Participant in good health, based on medical history, physical examination and laboratory parameters.
* Provision of Assent Form signed by the participants (for participants \>=8 years old) and Informed Consent Form signed by the parents or another legally acceptable representative (and by an independent witness for illiterate parent\[s\]).
* Participant and parents/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures.
* For a female participant of child-bearing potential (girls post-menarche), avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination, until at least 4 weeks after the last vaccination.
* Documented receipt of yellow fever vaccine since at least one month before the first vaccination.

Exclusion Criteria :

* Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
* For a female participant of child-bearing potential (girls post-menarche), known pregnancy.
* For a female participant of child-bearing potential (girls post-menarche), known pregnancy or positive pregnancy test in blood sample taken at Screening.
* 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 trial.
* 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 systemic corticosteroids therapy.
* Known systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
* Systemic hypersensitivity to YF vaccine or history of a life-threatening reaction to YF vaccine.
* 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 any 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 the first trial vaccination.
* Human Immunodeficiency Virus, hepatitis B antigen, or hepatitis C seropositivity in blood sample taken at Screening.
* Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening.
* Known previous vaccination with pneumococcal polysaccharide vaccine.

Primary outcomes:
measure: Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
timeFrame: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
measure: Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
timeFrame: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
measure: Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
timeFrame: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Secondary outcomes:
measure: Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
timeFrame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
measure: Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
timeFrame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
measure: Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
timeFrame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
measure: Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
timeFrame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
measure: Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
timeFrame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
measure: Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
timeFrame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
measure: Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
timeFrame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
measure: Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
timeFrame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
measure: Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
timeFrame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
measure: Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
timeFrame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
measure: Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
timeFrame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
measure: Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
timeFrame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
measure: Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
timeFrame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
measure: Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo
timeFrame: Pre-Injection 1 and 28 days Post-Injection 1
measure: GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo
timeFrame: Pre-Injection 1 and 28 days Post-Injection 1
measure: GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
timeFrame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Other outcomes:
Locations:
city: Chulucanas Morropon
country: Peru
state: Piura
Study officials:
affiliation: Sanofi Pasteur SA
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Crevat D. Immunogenicity and safety of tetravalent dengue vaccine in healthy Peruvian children aged 2 to 11 years, previously-vaccinated against yellow fever. "A re-emerging challenge in the Americas: opportunities for dengue research collaboration" Conference. Feb 15-18, 2011; San Juan, Puerto Rico.
citation: Lanata CF, Andrade T, Gil AI, Terrones C, Valladolid O, Zambrano B, Saville M, Crevat D. Immunogenicity and safety of tetravalent dengue vaccine in 2-11 year-olds previously vaccinated against yellow fever: randomized, controlled, phase II study in Piura, Peru. Vaccine. 2012 Sep 7;30(41):5935-41. doi: 10.1016/j.vaccine.2012.07.043. Epub 2012 Jul 31.