Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years

Phase 2

Completed

• Conditions: Dengue Virus; Dengue Hemorrhagic Fever; Dengue Diseases; Dengue Fever
• Interventions: Biological: CYD Dengue Vaccine Serotypes 1, 2, 3, and 4; Biological: Pneumococcal polysaccharide vaccine

• Registration Number: NCT00788151
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Study Timeline

• Study Start: 2008-09-26
• Study First Submitted: 2008-11-07
• Study First Submitted QC: 2008-11-07
• Study First Posted: 2008-11-10
• Primary Completion: 2010-02-16
• Study Completion: 2010-08-16
• Results First Submitted: 2019-05-24
• Results First Submitted QC: 2019-05-24
• Results First Posted: 2019-07-29
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-10
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CYD Dengue vaccine group	CYD Dengue Vaccine Serotypes 1, 2, 3, and 4	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Control group	Pneumococcal polysaccharide vaccine	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo	Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3	Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo	Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3	Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
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	Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3	Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo	Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3	Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo	Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3	Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo	Pre-Injection 1 and 28 days Post-Injection 2 and 3	Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution.
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo	Pre-Injection 1 and 28 days Post-Injection 2 and 3	Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer \>= 10 1/dilution.
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	Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3	Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.
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	Pre-Injection 1 and 28 days Post-Injection 2 and 3	Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution.
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo	Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3	GMTs of antibodies against parental dengue virus serotypes were assessed by the microneutralization assay. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo	Pre-Injection 1 and 28 days Post-Injection 2 and 3	Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution.
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	Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3	Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>= 10 1/dilution.
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	Pre-Injection 1 and 28 days Post-Injection 2 and 3	GMTs of antibodies against parental dengue virus serotypes were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo	Pre-Injection 1 and 28 days Post-Injection 1	GMTs of antibodies against yellow fever virus were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
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	Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3	Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.
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	Pre-Injection 1 and 28 days Post-Injection 2 and 3	Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution.
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo	Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3	Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.
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	Pre-Injection 1 and 28 days Post-Injection 2 and 3	Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>= 10 1/dilution.
Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo	Pre-Injection 1 and 28 days Post-Injection 1	Seropositivity for yellow fever was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution. Percentage values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.