Clinical Trial: Immunogenicity and Safety of a Tetravalent Dengue Vaccine Booster Injection in Subjects Who Previously Completed a 3-dose Schedule

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Singapore

Brief Summary:

The aim of the study is to assess and describe the booster effect of a CYD dengue vaccine dose administered 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 (GTMR) of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in subjects from CYD 28 trial (subjects from Group 1 only).

Secondary Objectives:

  • If the primary objective of non-inferiority is achieved: To demonstrate the superiority, in terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in subjects from CYD28 trial (subjects from Group 1 only).
  • To describe the immune responses elicited by the CYD dengue vaccine booster or placebo injection in subjects who received three doses of the CYD dengue vaccine in the CYD28 trial in all subjects.
  • To describe the neutralizing Abs levels of each dengue serotype post-dose 3 (CYD28 subjects) and immediately prior to booster or placebo injection in all subjects.
  • To describe the neutralizing Ab persistence 6 months, 1 year and 2 years post booster or placebo injection in all study subjects.
  • To evaluate the safety of booster vaccination with CYD dengue vaccine in all study subjects.

Detailed Summary: Healthy adolescents and adults who received 3 doses of the tetravalent dengue vaccine 5 years earlier in a previous CYD dengue vaccine trial (CYD28 - NCT00880893) will receive a booster injection of either a CYD dengue vaccine or a placebo on Day 0. They will be evaluated for safety and antibody persistence of the booster injection up to 2 years post-vaccination.
Sponsor: Sanofi Pasteur, a Sanofi Company

Current Primary Outcome: Neutralizing antibody levels against each dengue virus serotype measured 28 days after the third CYD dengue vaccine injection and 28 days after the booster injection in the CYD Dengue Vaccine Group [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-booster vaccination ]

Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Neutralizing antibody levels against each of the four parental dengue virus strains of the CYD dengue vaccine as determined by PRNT immediately prior and 28 days post booster or placebo injection [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-booster vaccination ]
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT).
  • Number of subjects with seroconversion 28 days after injection for each of the 4 parental dengue virus strains of CYD dengue vaccine [ Time Frame: Day 0 (pre-vaccination) and 28 days post-booster injection ]
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT). Seroconversion is percentage of subjects with either a pre-booster titer < 10 (1/dil) and a post-booster titer ≥ 40 (1/dil), or a pre-booster titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-booster titer
  • Summary of neutralizing antibody levels against each of the four parental dengue virus strains after the third CYD dengue vaccine injection and immediately prior to booster or placebo injection [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-booster vaccination ]
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT).
  • Summary of neutralizing antibody levels against each of the four parental dengue virus strains at 6 months, 1 year and 2 years post booster or placebo injection [ Time Frame: 6 Months up to 2 years post-booster vaccination ]
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT).
  • Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during trial [ Time Frame: Day 0 up to 2 years post-vaccination ]
    Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Asthenia


Original Secondary Outcome: Same as current

Information By: Sanofi

Dates:
Date Received: July 1, 2016
Date Started: July 2016
Date Completion: December 2018
Last Updated: July 5, 2016
Last Verified: July 2016