live-attenuated Bordetella pertussis vaccine (BPZE1) / ILiAD Biotechnologies - LARVOL DELTA

Efficacy, immunogenicity, and safety of the live attenuated nasal pertussis vaccine, BPZE1, in the UK: a randomised, placebo-controlled, phase 2b trial using a controlled human infection model with virulent Bordetella pertussis. (PubMed, Lancet Microbe) - P2 | "Intranasal BPZE1 vaccination prevented or substantially reduced infection after challenge with virulent B pertussis and is an attractive vaccine candidate. Given the favourable safety profile, large phase 3 trials are warranted to confirm these initial findings."

Journal • P2b data • Infectious Disease • Novel Coronavirus Disease • Pertussis • Respiratory Diseases

The potential public health benefit of live-attenuated pertussis vaccines. (PubMed, Expert Opin Drug Deliv) - "The most advanced candidate is BPZE1, which has successfully completed 6 clinical studies demonstrating safety, systemic and mucosal immunogenicity and the ability to prevent or substantially reduce B. pertussis infection. If BPZE1 is eventually adopted for global use, it will likely be a major breakthrough in the ultimate control of pertussis, which has plagued humanity for centuries."

Journal • Review • Cough • Infectious Disease • Pertussis • Respiratory Diseases

ILiAD and hVIVO Sign LOI for Pivotal Phase 3 Trial of BPZE1 Pertussis Vaccine Following FDA Meeting (Businesswire) - "ILiAD Biotechnologies, LLC...today announced that following a December 2024 Type C meeting with the United States Food and Drug Administration (FDA), ILiAD and hVIVO plc (hVIVO) have signed a Letter of Intent (LOI) to conduct a pivotal Phase 3 BPZE1 human challenge trial...Enrollment is targeted to begin H2 2025 pending financing."

FDA event • New P3 trial • Pertussis

Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children (clinicaltrials.gov) - P2 | N=367 | Completed | Sponsor: ILiAD Biotechnologies | Active, not recruiting ➔ Completed

Trial completion • Cough • Infectious Disease • Pertussis • Respiratory Diseases

Immunogenicity and Safety of BPZE1, an Intranasal Live Attenuated Pertussis Vaccine, Evaluated With and Without Tdap in Healthy Children 6 to 17 Years Old: A Phase 2b, Randomized, Active-Controlled Study (IDWeek 2024) - No abstract available

Clinical • P2b data • Infectious Disease • Pertussis

CHAMPION-1: Pertussis Challenge Study in Adults Vaccinated With BPZE1 (clinicaltrials.gov) - P2 | N=53 | Completed | Sponsor: ILiAD Biotechnologies | Active, not recruiting ➔ Completed | Phase classification: P2b ➔ P2

Phase classification • Trial completion • Cough • Infectious Disease • Pertussis • Respiratory Diseases

Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children (clinicaltrials.gov) - P2 | N=360 | Active, not recruiting | Sponsor: ILiAD Biotechnologies | Recruiting ➔ Active, not recruiting | Phase classification: P2b ➔ P2 | N=600 ➔ 360

Enrollment change • Enrollment closed • Phase classification • Cough • Infectious Disease • Pertussis • Respiratory Diseases

BPZE1, an intranasal live attenuated pertussis vaccine, evaluated in a bordetella pertussis challenge study in healthy adults: a phase 2b, randomized, placebo-controlled study (WVCE 2023) - No abstract available

Clinical • P2b data • Infectious Disease • Pertussis • Respiratory Diseases

CHAMPION-1: Pertussis Challenge Study in Adults Vaccinated With BPZE1 (clinicaltrials.gov) - P2b | N=53 | Active, not recruiting | Sponsor: ILiAD Biotechnologies | Recruiting ➔ Active, not recruiting

Enrollment closed • Cough • Infectious Disease • Pertussis • Respiratory Diseases

CHAMPION-1: Pertussis Challenge Study in Adults Vaccinated With BPZE1 (clinicaltrials.gov) - P2b | N=44 | Recruiting | Sponsor: ILiAD Biotechnologies | Active, not recruiting ➔ Recruiting

Enrollment open • Cough • Infectious Disease • Pertussis • Respiratory Diseases

Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children (clinicaltrials.gov) - P2b | N=600 | Recruiting | Sponsor: ILiAD Biotechnologies | Trial completion date: Jan 2024 ➔ Apr 2024

Trial completion date • Cough • Infectious Disease • Pertussis • Respiratory Diseases

CHAMPION-1: Pertussis Challenge Study in Adults Vaccinated With BPZE1 (clinicaltrials.gov) - P2b | N=44 | Active, not recruiting | Sponsor: ILiAD Biotechnologies | Recruiting ➔ Active, not recruiting

Enrollment closed • Cough • Infectious Disease • Pertussis • Respiratory Diseases

Immunogenicity and safety of BPZE1, an intranasal live attenuated pertussis vaccine, versus tetanus-diphtheria-acellular pertussis vaccine: a randomised, double-blind, phase 2b trial. (PubMed, Lancet) - P2b | "BPZE1 induced nasal mucosal immunity and produced functional serum responses. BPZE1 has the potential to avert B pertussis infections, which ultimately could lead to reduced transmission and diminished epidemic cycles. These results should be confirmed in large phase 3 trials."

Journal • P2b data • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

CHAMPION-1: Pertussis Challenge Study in Adults Vaccinated With BPZE1 (clinicaltrials.gov) - P2b | N=44 | Recruiting | Sponsor: ILiAD Biotechnologies | Trial completion date: Jun 2023 ➔ Sep 2023 | Trial primary completion date: Mar 2023 ➔ Jul 2023

Trial completion date • Trial primary completion date • Cough • Infectious Disease • Pertussis • Respiratory Diseases

Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children (clinicaltrials.gov) - P2b | N=600 | Recruiting | Sponsor: ILiAD Biotechnologies | Trial completion date: Dec 2022 ➔ Jan 2024 | Trial primary completion date: Dec 2022 ➔ Jan 2024

Trial completion date • Trial primary completion date • Cough • Infectious Disease • Pertussis • Respiratory Diseases

Safety and immunogenicity of live, attenuated intranasal Bordetella pertussis vaccine (BPZE1) in healthy adults. (PubMed, Vaccine) - "Lyophilized BPZE1 vaccine was well tolerated and immunogenic at the highest dose (10 CFU) delivered intranasally by VaxINator device and was not associated with any SAEs or prolonged shedding of BPZE1. Further evaluation of BPZE1 is warranted."

Journal • Infectious Disease • Pertussis • Respiratory Diseases

"ILiAD Biotechnologies Announces $42.8M Financing Round to Advance BPZE1 Pertussis Vaccine https://t.co/KlIRB7lZ4N" (@NewsFromBW)

Clinical • Infectious Disease • Pertussis • Respiratory Diseases

CHAMPION-1: Pertussis Challenge Study in Adults Vaccinated With BPZE1 (clinicaltrials.gov) - P2b | N=44 | Recruiting | Sponsor: ILiAD Biotechnologies

New P2b trial • Cough • Infectious Disease • Pertussis • Respiratory Diseases

Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children (clinicaltrials.gov) - P2b; N=600; Recruiting; Sponsor: ILiAD Biotechnologies; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Immunology • Infectious Disease • Pertussis • Respiratory Diseases • PCR

FDA Grants ILiAD Biotechnologies Fast Track Designation for Next Generation Pertussis Vaccine BPZE1 (Businesswire) - "ILiAD Biotechnologies...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BPZE1, a next generation vaccine for active booster immunization against pertussis."

Fast track designation • Infectious Disease • Pertussis

ILiAD Biotechnologies Announces First School-Age Participants Enrolled in BPZE1 Pertussis Vaccine Phase 2b SUPER Clinical Trial (Businesswire) - "ILiAD Biotechnologies announces enrollment of the first participants in the SUPER Trial (Standing Up to PERtussis) – the first study in school-age children of BPZE1, a live attenuated intranasal pertussis vaccine. The SUPER Trial is a multicenter, randomized, placebo-controlled, and observer-blinded Phase 2b study in healthy school age children across 12 to 16 sites in the United Kingdom and Australia to assess the immunological response and safety profile of a single dose of BPZE1 with and without co-administration of BOOSTRIX®. Approximately 600 participants 6 to 16 years old will be randomly assigned to one of three study groups."

Enrollment status • Infectious Disease • Pertussis

Innovative vaccine trial for childhood illness opens in Leicester (National Health Executive) - "Researchers at the University Hospitals of Leicester NHS Trust are seeking volunteers for a clinical study to evaluate a new vaccine against pertussis – also known as ‘whooping cough’...Researchers in the study are using an experimental vaccine, BPZE1, to attempt to combat infection and transmission of the disease...At least 30 volunteers are hoped to be recruited at Leicester Royal Infirmary."

Trial status • Infectious Disease • Pertussis

Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children (clinicaltrials.gov) - P2b; N=600; Not yet recruiting; Sponsor: ILiAD Biotechnologies

Clinical • New P2b trial • Immunology • Infectious Disease • Pertussis • Respiratory Diseases • PCR

[VIRTUAL] Serum Bactericidal Activity Induced by Live Attenuated Pertussis Vaccine BPZE1 is Comparable to Boostrix™ (IDWeek 2021) - "In this exploratory investigation, the novel intranasal live-attenuated pertussis vaccine BPZE1 induced SBA titers that were similar to Boostrix using a B. pertussis strain representative of current disease isolates. SBA-Prn correlations were high post-Boostrix, consistent with prior reports showing Prn is the acellular vaccine antigen that mediates SBA. In contrast, BPZE1 bactericidal antibodies appear broader than Prn which may be important given the global rise of Prn-deficient B. pertussis strains."

Infectious Disease • Pertussis

ILiAD Biotechnologies Reports Preliminary Data Demonstrating Pertussis Vaccine Candidate BPZE1, but Not Boostrix, Induces Functional Bactericidal Antibodies Against Pertactin Negative B. Pertussis (Businesswire) - P2, N=300; NCT03942406; Sponsor: ILiAD Biotechnologies; "ILiAD Biotechnologies, LLC (ILiAD) presented a breakthrough finding today on the effect of BPZE1, a live attenuated intranasal pertussis vaccine, on serum bactericidal activity (SBA) against PRN(+) and PRN(-) Bordetella pertussis strains at the virtual ID Week 2021 conference (sponsored by Infectious Disease Society of America). Pertactin (PRN) is a highly immunogenic virulence factor secreted by Bordetella pertussis (B. pertussis)...the study showed that while BPZE1 and Boostrix induced significant increases (>75% subjects with >2x fold rise) in SBA against a PRN(+) B. pertussis strain, only BPZE1 induced significant increases (>75% subjects with >2x fold rise) in SBA titres against a PRN(-) B. pertussis strain."

P2b data • Infectious Disease • Pertussis