NCT04531098

A Bridging Study: Comparing Two Lots of Sci-B-Vac™ and Engerix-B in Healthy Adults

A Bridging Study: Comparing Two Sci-B-Vac™ Batches in Healthy Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 402 (actual)
• Sponsor: VBI Vaccines Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This was a single-blind, 3-arm, comparative, controlled, randomized, study conducted at one site in Vietnam whose primary objective was to demonstrate clinical equivalence of the two production lots of Sci-B-Vac vaccine produced at two different facilities (OLD facility (Lot A) and NEW facility (Lot B) with respect to anti-hepatitis B-Surface (HBs) response. Secondary efficacy analysis was performed to demonstrate non-inferiority of seroprotection of each lot of Sci-B-Vac vaccine when compared to Engerix-B vaccine

Detailed description

This was a single-blind, 3-arm, comparative, controlled, randomized, study conducted at one site in Vietnam. Following a screening period, healthy eligible subjects (n = 402) were enrolled and randomized to receive Sci-B-Vac (OLD facility (Lot A) and NEW facility (Lot B), or Engerix-B. The study was conducted in two stages, approximately a year-and-a-half apart. In the first stage (Stage I) beginning in March 2006, Sci-B-Vac (Lot A) vaccine was compared to Engerix-B; and in the second stage (Stage II) beginning in November 2007, the Sci-B-Vac (Lot B) vaccine was compared to Engerix-B. The subjects assigned to the Engerix-B group were equally divided between the stages, 67 subjects in the Engerix-B group in Stages I and II, respectively, for a total of 134 subjects, such that the final number of randomized subjects in Stage 1 and Stage 2 across the Sci-B-Vac Lot A, Sci-B-Vac Lot B and Engerix-B was 1:1:1, respectively. Immunogenicity evaluations for Stage I data (Visits 5 and 6) were conducted together with Stage II data.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	Sci-B-Vac-Lot B	Sci-B-Vac Lot B -10 μg of HBsAg, intramuscular injection of 10 μg/ml
BIOLOGICAL	Sci-B-Vac-Lot A	Sci-B-Vac Lot A - 10 μg of HBsAg, intramuscular injection of 10 μg/ml
BIOLOGICAL	Engerix-B	Engerix-B (hepatitis B vaccine (recombinant)) is indicated for active immunization against hepatitis B virus infection

Timeline

• Start date: 2006-03-02
• Primary completion: 2008-12-31
• Completion: 2008-12-31
• First posted: 2020-08-28
• Last updated: 2022-07-26
• Results posted: 2022-06-24

Locations

1 site across 1 country: Vietnam