Phase I, randomized, observer-blind, placebo-controlled studies to evaluate the safety, reactogenicity and immunogenicity of an investigational non-typeable Haemophilus influenzae (NTHi) protein vaccine in adults

Abstract

This study confirms that the NTHi vaccine formulations had an acceptable reactogenicity and safety profile and were immunogenic in adults. These results justify further clinical development of this NTHi vaccine candidate.

Haemophilus influenzae Pyomyositis in a Patient with Diabetic Ketoacidosis: A Unique Case and Review of Literature

“…The source of our patient's organism (nontypeable H. influenzae ) remains unclear, especially in the setting of no recent travel, sick contacts including children, or recent upper respiratory tract infection. Nontypeable H. influenzae vaccine in adults has been studied and further clinical trial is warranted to explore clinical benefits [13–15]. …”

Paediatric and adult bronchiectasis: Vaccination in prevention and management

“…PD is an outer membrane lipoprotein, which is immunogenic and highly conserved in both encapsulated and NTHi strains, although PD‐deficient mutants have been described . Additional H. influenzae proteins under investigation as potential vaccine targets include protein F, P4, P6, OMP26, pilin A and protein E, each of which demonstrate varying levels of stability during prolonged periods of H. influenzae infection …”

“…Phase II trials of an investigational pneumococcal protein vaccine containing pneumolysin toxoid and histidine‐triad protein in healthy adults and toddlers have been completed and immunogenicity has been demonstrated. Phase I trials of multi‐formulations of an investigational H. influenzae protein vaccine using combinations of PD, protein E and pilin A with different adjuvants have been completed in 48 healthy adults aged 18–40 years and in 270 current and former smokers aged 50–70 years . Good antibody responses were demonstrated for all vaccines; however, antibody and cellular immune responses (evaluated in the second study only) were highest with the ASO1‐adjuvanted formulation …”

A Review of Possible Triggering or Therapeutic Effects of Antimicrobial Vaccines on Psoriasis

“…Additionally, in a recent placebo-controlled study, evaluating the 'nontypeable Haemophilus influenza protein vaccine', a psoriasis case was reported to be associated with injection of saline placebo at 114 days post-dose 3 in the placebo group indicating the Koebner effect [31]. …”