Streptococcus pneumoniae serotype 3 (SPN3) remains a significant contributor to invasive pneumococcal disease globally, despite its inclusion in widely administered vaccines. The next generation of pneumococcal vaccines may confer better protection against this serotype, reducing disease burden. We describe an ethically approved protocol for a double-blind randomised controlled trial assessing the impact of VAXNEUVANCE (15-valent pneumococcal conjugated vaccine (PCV15)) and 0.9% saline (placebo) on the acquisition, density and duration of SPN3 carriage using a controlled human infection model.

Healthy adults aged 18–50 years will be randomised 1:1 to receive PCV15 or placebo. Participants will be considered enrolled on the trial at vaccination. One month following vaccination, all participants will be intranasally inoculated with SPN3. Following inoculation, participants will be followed up on days 2, 7, 14 and 28 to monitor safety, SPN3 colonisation status, density and duration, as well as immune responses. The primary endpoint of the study is to assess the rate of SPN3 acquisition between vaccinated and unvaccinated participants defined by classical microbiological methods. Secondary endpoints will determine the density and duration of SPN3 colonisation and compare the immune responses between study groups. An exploratory cohort of 5 participants will be asked to consent to a nasal biopsy procedure during a screening visit and a second nasal biopsy 28 days after PCV15 vaccination. This cohort will only receive PCV15 and will not be challenged. Through this exploratory cohort, we will explore gene expression changes induced by PCV15 vaccination and their visualisation (spatial location) within the nasal tissue.

This protocol has been reviewed by the sponsor, funder and external peer reviewers. The study is approved by the NHS Research and Ethics Committee (Reference: 24/SC/0388) and by the Medicines and Healthcare Products Regulatory Agency (Reference: CTA 21584/0485/001-0001).

NCT06731374 – ISRCTN91656864.

Health coaching is the process of working with a trained coach, peer, or healthcare professional towards self-determined health and wellness goals. Health coaching is being increasingly adopted in multiple healthcare settings and has been shown to improve overall health outcomes and long-term maintenance of chronic conditions in multiple countries and healthcare settings. Research surrounding the costs of implementing health coaching and its effects on healthcare costs, particularly long-term costs, has been limited. Although analysis of healthcare costs has become an important priority in recent years, the available literature looking at the cost impacts of health coaching is small and inconclusive, finding mixed results with a variety of methodologies. This scoping review aims to identify gaps in the literature and help set a research agenda regarding the costs of health coaching implementation and its impacts.

The scoping review will be structured according to Levac et al’s enhancement to Arksey and O’Malley’s framework for conducting scoping reviews. PubMed, Embase, and the Health and Medicine Collection will be searched for peer-reviewed research that includes health and wellness coaching and some measurement of cost. Details about the type of study, cost analysis, methodology and results from the included articles will be extracted and summarised. Full-text publications, excluding editorials and opinion pieces, included in this scoping review will be published in 2017 or later, will be written in English, will align with the definition of health coaching as described by the National Board for Health and Wellness Coaching, and will include cost measurement. This review will include publications not captured in the previous integrative literature review looking at the cost-effectiveness of health coaching.

Findings will be disseminated through a peer-reviewed publication and through presentations to both health system and community-based entities currently using or considering adopting health coaching. Ethics approval is not a requirement for this review as no human research participants will be involved. All data will be obtained from publicly available literature, with no primary data generated.