NCT02623725

Study of a Booster Dose of a Tetravalent Dengue Vaccine in Subjects Who Previously Completed the 3-dose Schedule

Immunogenicity and Safety of a Tetravalent Dengue Vaccine Given as a Booster Injection in Adolescents and Adults Who Previously Completed the 3-dose Schedule in a Study Conducted in Latin America

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 13 Years – 22 Years
• Healthy volunteers: Accepted

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.

Detailed description

Healthy adolescents and adults who received 3 doses of the tetravalent dengue vaccine 4 to 5 years earlier in previous CYD dengue vaccine trials (CYD13 and CYD30) received either a booster dose CYD dengue vaccine or a placebo on Day 0. They were evaluated for safety and antibody persistence of the booster injection up to 2 years post-vaccination.

Conditions

• Dengue Fever
• Dengue Hemorrhagic Fever

Interventions

Type	Name	Description
BIOLOGICAL	CYD Dengue Vaccine (5-dose formulation)	0.5 mL, Subcutaneous
BIOLOGICAL	Placebo, NaCl 0.9%	0.5 mL, Subcutaneous

Timeline

• Start date: 2016-04-14
• Primary completion: 2016-11-23
• Completion: 2018-10-28
• First posted: 2015-12-08
• Last updated: 2022-03-24
• Results posted: 2019-06-14

Locations

5 sites across 5 countries: Brazil, Colombia, Honduras, Mexico, Puerto Rico

Regulatory

• FDA-regulated drug study