NCT03541499

Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults

Completed Phase 2 Results posted Last updated 19 September 2024

What this trial tests

Phase 2 trial testing BPZE1 in Pertussis in 50 participants. Completed in 15 May 2020.

Timeline

23 October 2018

Primary endpoint
15 May 2020

15 May 2020

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	50
Start date	23 October 2018
Primary completion	15 May 2020
Estimated completion	15 May 2020
Sites	1 location across United States

Drugs / interventions tested

• BPZE1 — full drug profile →
• Placebo

Conditions studied

• Pertussis — all drugs for Pertussis →
• Pertussis Immunisation — all drugs for Pertussis Immunisation →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 49, any sex, with Pertussis or Pertussis Immunisation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized, partially blind, placebo controlled, clinical trial evaluating a single intranasal dose of BPZE1 in healthy adults. The study will evaluate a lyophilized formulation of the product, with the goal of testing for the optimal dose for subsequent clinical trials. Fifty healthy adults, 18-49 years of age will be randomized to one of the four following treatment groups in a 3:3:3:1 ratio: 10\^7 colony forming units (CFU) of BPZE1 administered by VaxINator device, 10\^9 CFU of BPZE1 administered by VaxINator device, placebo administered by VaxINator device, 10\^9 CFU of BPZE1 administered by needleless tuberculin syringe. Study duration will be approximately 12 months with a subject participation duration of approximately 6 months. The primary objective of this study is to assess the safety and tolerability of a single intranasal dose of either 10\^7 or 10\^9 CFU of lyophilized BPZE1 vaccine.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advances in intranasal vaccine delivery: A promising non-invasive route of immunization.
   Kehagia E, Papakyriakopoulou P, Valsami G. · · 2023 · cited 69× · PMID 37179163 · DOI 10.1016/j.vaccine.2023.05.011
2. Live attenuated pertussis vaccine BPZE1 induces a broad antibody response in humans.
   Lin A, Apostolovic D, Jahnmatz M, Liang F, et al · · 2020 · cited 44× · PMID 31945015 · DOI 10.1172/jci135020
3. Next-Generation Pertussis Vaccines Based on the Induction of Protective T Cells in the Respiratory Tract.
   Chasaide CN, Mills KHG. · · 2020 · cited 39× · PMID 33096737 · DOI 10.3390/vaccines8040621
4. Acellular Pertussis Vaccine Components: Today and Tomorrow.
   Dewan KK, Linz B, DeRocco SE, Harvill ET. · · 2020 · cited 39× · PMID 32414005 · DOI 10.3390/vaccines8020217
5. Development of Nasal Vaccines and the Associated Challenges.
   Nian X, Zhang J, Zhang J, Huang S, et al · · 2022 · cited 33× · PMID 36297419 · DOI 10.3390/pharmaceutics14101983
6. Coping Strategies for Pertussis Resurgence.
   Nian X, Liu H, Cai M, Duan K, et al · · 2023 · cited 19× · PMID 37242993 · DOI 10.3390/vaccines11050889
7. Nanoplatform Based Intranasal Vaccines: Current Progress and Clinical Challenges.
   Bai Z, Wan D, Lan T, Hong W, et al · · 2024 · cited 14× · PMID 39185745 · DOI 10.1021/acsnano.3c10797
8. BCG vaccination improves DTaP immune responses in mice and is associated with lower pertussis incidence in ecological epidemiological studies.
   Broset E, Pardo-Seco J, Kanno AI, Aguilo N, et al · · 2021 · cited 12× · PMID 33711798 · DOI 10.1016/j.ebiom.2021.103254