Clinical trial NCT04531098: A Bridging Study: Comparing Two Lots of Sci-B-Vac™ and Engerix-B in Healthy Adults
Official title: A Bridging Study: Comparing Two Sci-B-Vac™ Batches in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Sci-B-Vac
Prophylactic vaccine
Hepatitis B vaccines
Phase 3
pre-S1
pre-S2
Surface antigen
3-antigen
Lead sponsor: VBI Vaccines Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-28
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind, three-arm, two-stage, randomized study
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

Healthy adults 18 to 45 years of age who were seronegative for HBsAg, anti-HBs, anti-Hepatitis B core antigen, HIV, and Hepatitis C Virus (HCV)

Exclusion Criteria:

* Evidence of alcoholism or drug abuse, history of HIV, or HCV
* Blood transfusions within the three months prior to inclusion in the study
* Uncontrolled hypertension and other cardiovascular diseases
* Chronic/concurrent administration (\>14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids were permitted
* History of anaphylaxis (including shock) or any significant allergy or atopy

Primary outcomes:
measure: Percentage of Participants With an Antibody Response (≥10 IU/Liter) to Hepatitis B Surface Antigens One Month After the Third Vaccination
timeFrame: Day 210
Secondary outcomes:
measure: Percentage of Participants With an Anti-HBs Antibody Titer ≥10 IU/Liter at Days 180, 210 and 360.
timeFrame: Days 180, 210, and 360
measure: Anti-HBs Geometric Mean Concentration (GMC)
timeFrame: Days 180, 210, and 360
measure: Percentage of Participants With an Anti-HBs Antibody Titer ≥100 IU/Liter at Days 180, 210 and 360.
timeFrame: Days 180, 210 and 360
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: National Institute of Hygiene and Epidemiology (NIHE)
Study officials:
affiliation: National Institute of Hygiene and Epidemiology (NIHE), Hanoi, Vietnam
name: Do G Canh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diaz-Mitoma F, Popovic V, Spaans JN. Assessment of immunogenicity and safety across two manufacturing lots of a 3-antigen hepatitis B vaccine, Sci-B-Vac(R), compared with Engerix-B(R) in healthy Asian adults: A phase 3 randomized clinical trial. Vaccine. 2021 Jun 29;39(29):3892-3899. doi: 10.1016/j.vaccine.2021.05.067. Epub 2021 Jun 8.