NCT04204096

Immune Equivalence Between Multi-dose and Single Dose Formulation of Vi-DT and Their Overall Safety (Phase III)

Completed Phase 3 Last updated 27 August 2021

What this trial tests

Phase 3 trial testing Vi-DT (Multi-dose formulation) in Typhoid in 1,800 participants. Completed in 29 January 2021.

Timeline

4 February 2020

Primary endpoint
11 September 2020

29 January 2021

Quick facts

Lead sponsor	International Vaccine Institute
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	1,800
Start date	4 February 2020
Primary completion	11 September 2020
Estimated completion	29 January 2021
Sites	4 locations across Philippines

Drugs / interventions tested

• Vi-DT (Multi-dose formulation) — full drug profile →
• Vi-DT (Single dose formulation) — full drug profile →
• Control Vaccine — full drug profile →

Conditions studied

• Typhoid — all drugs for Typhoid →

Sponsor

International Vaccine Institute

Who can join

Adults 6 Months to 45, any sex, with Typhoid. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, randomized, observer-blinded, controlled, immune equivalence study of a multi-dose (MD) formulation with 2PE preservative of SK bioscience Vi-DT compared to single dose (SD) formulation without preservative of SK bioscience Vi-DT in participant (6 months - 45 years) including safety population.

The study objectives are as follows:

* Primary objective. Demonstrate the immune equivalence as measured by anti-Vi IgG Geometric Mean Titer (GMT) of multi dose formulation against single dose formulation of Vi-DT (18-45 year age stratum), at 4 weeks after a single dose.
* Secondary objective 1. Demonstrate the immune equivalence as measured by seroconversion rates of anti-Vi IgG antibody titres of multi dose formulation against single dose formulation of Vi-DT vaccine (18-45 year age stratum) at 4 weeks after a single dose.
* Secondary objective 2. Describe safety profile in all age strata combined (age 6 months - 45 years old) and in each age stratum, at 4 weeks after a single dose of SD/MD formulation/control (Meningococcal Conjugate Vaccine).

There are total 5 scheduled visits as follows:

* Visit 1(D-7 to 0): Screening
* Visit 2(D0): Enrollment, vaccination, safety follow-up and blood collection for immunogenicity assessment (only for subjects 18 years old and above)
* Visit 3(D7): Safety follow-up
* Visit 4(D28): Safety follow-up and blood collection for immunogenicity assessment (only for subjects 18 years old and above)
* V5(D168): Safety follow-up

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Phase 3, Multicenter, Randomized, Controlled Trial to Evaluate Immune Equivalence and Safety of Multidose and Single-dose Formulations of Vi-DT Typhoid Conjugate Vaccine in Healthy Filipino Individuals 6 Months to 45 Years of Age.
   Carlos JC, Tadesse BT, Borja-Tabora C, Alberto E, et al · · 2022 · cited 3× · PMID 35664443 · DOI 10.1016/j.lanwpc.2022.100484