Safety and immunogenicity of the live attenuated intranasal pertussis vaccine BPZE1: a phase 1b, double-blind, randomised, placebo-controlled dose-escalation study

The Lancet Infectious Diseases
Maja JahnmatzBPZE1 study team

Abstract

Long-term protection and herd immunity induced by existing pertussis vaccines are imperfect, and a need therefore exists to develop new pertussis vaccines. This study aimed to investigate the safety, colonisation, and immunogenicity of the new, live attenuated pertussis vaccine, BPZE1, when given intranasally. This phase 1b, double-blind, randomised, placebo-controlled, dose-escalation study was done at the phase 1 unit, Karolinska Trial Alliance, Karolinska University Hospital, Stockholm, Sweden. Healthy adults (18-32 years) were screened and included sequentially into three groups of increasing BPZE1 dose strength (107 colony-forming units [CFU], 108 CFU, and 109 CFU), and were randomly assigned (3:1 within each group) to receive vaccine or placebo. Vaccine and placebo were administered in phosphate-buffered saline contained 5% saccharose as 0·4 mL in each nostril. The primary outcome was solicited and unsolicited adverse events between day 0 and day 28. The analysis included all randomised participants who received a vaccine dose. Colonisation with BPZE1 was determined by repeatedly culturing nasopharyngeal aspirates at day 4, day 7, day 11, day 14, day 21, and day 28 after vaccination. Immunogenicity, as serum IgG and IgA r...Continue Reading

References

Nov 1, 1994·Journal of Clinical Microbiology·W M JandaP C Schreckenberger
Feb 8, 1996·The New England Journal of Medicine·L GustafssonJ Storsaeter
Aug 14, 1999·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·H O Hallander
May 20, 2003·Journal of Clinical Pharmacology·Camilla BuöenMikael S Thomsen
Oct 14, 2005·The New England Journal of Medicine·Joel I WardUNKNOWN APERT Study Group
Jul 15, 2006·PLoS Pathogens·Nathalie MielcarekCamille Locht
Oct 31, 2009·PLoS Pathogens·Helen J Wearing, Pejman Rohani
Aug 3, 2013·Science·Arthur Allen
Nov 28, 2013·Proceedings of the National Academy of Sciences of the United States of America·Jason M WarfelTod J Merkel
Feb 15, 2014·The Journal of Infectious Diseases·Jason M WarfelTod J Merkel
Jun 25, 2015·BMC Medicine·Benjamin M Althouse, Samuel V Scarpino
Sep 17, 2015·The Pediatric Infectious Disease Journal·Tina TanCarl Heinz Wirsing von König
May 24, 2017·The Journal of Infectious Diseases·Camille LochtNathalie Mielcarek
Jun 18, 2017·The Lancet Infectious Diseases·Karene Hoi Ting YeungRaymond Christiaan W Hutubessy
Nov 29, 2017·Vaccine·Camille Locht
Nov 17, 2019·The Journal of Immunology : Official Journal of the American Association of Immunologists·Anne-Sophie DebrieCamille Locht
Jan 17, 2020·The Journal of Clinical Investigation·Ang LinKarin Loré

❮ Previous
Next ❯

Citations

Jul 21, 2020·The Lancet Infectious Diseases·Helen S Marshall, Nicholas Wood
Mar 6, 2021·Expert Review of Vaccines·Camille Locht
Apr 4, 2021·Vaccines·Camille Locht
Jul 3, 2021·Frontiers in Immunology·Violaine Dubois, Camille Locht
Jul 28, 2021·Nature Reviews. Immunology·Ed C Lavelle, Ross W Ward

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.