Please find below the current areas of interest for Vaccines Human Subject Research - 2023 Cycle 2.

[RSV & RSV vaccination in vulnerable groups (adults with health conditions, older adults 60 years of age and older)]

•   Immunopathology, pathophysiology, and downstream effects of RSV infections in adults with and without co-morbidities
•   RSV correlates of protection in natural infections
•   Epidemiology of RSV: incidence of RSV in older adult population and in at-risk populations (e.g. immunocompromised), downstream consequences, RSV mortality, etc
•   Studies to understand RSV testing practices to estimate the extent of under-diagnosis and/or under ascertainment
•   Studies to understand the medical & economic burden, and impact of RSV to patients, caregivers in different healthcare settings, including long-term care facilities
•   Clinical studies evaluating the safety and/or immunogenicity of RSV vaccination in specific at-risk populations, concomitantly or not with other vaccines or therapeutic regimen
•   Studies to understand the transmission/reinfection of RSV as well as transmission after vaccination

Key criteria for Supported Studies include vaccine availability & regulatory authorization in the population in scope

[Neisseria]

•   Real World Evidence (RWE) on impact of 4CMenB vaccination programs on MenB epidemiology and non B epidemiology
•   4CMenB booster dose in individuals primed as infants or young children
•   Impact of different vaccination schedules (MenB vaccines) on compliance and completion of adolescent vaccination program
•   The 4CMenB vaccine's duration of protection against gonorrhea
•   RWE (real world impact/effectiveness) against gonorrhea as a result of implementing the 4CMenB vaccine in adolescent vaccination programs

[Influenza (pandemic & seasonal)]

•   Vaccination coverage overall, for quadrivalent influenza vaccines (QIVs), for specific vaccines, in WHO- identified risk groups

[Adult Immunisation]

•   Studies assessing the impact, challenges, and solutions to implement life course immunization
•   Studies on vaccination coverage for vaccines recommended in adults, including high-risk groups
•   Studies on healthcare utilization related to the management of infectious diseases in the hospital and post-discharge care settings
•   Studies on quality of life and dependency or other socio-economic consequences following an episode of infectious diseases and vaccine preventable diseases in older adults
•   Studies on the potential impact of adult vaccination on health inequalities
•   Studies measuring the impact of communication and educational interventions on vaccine coverage in adults
•   Studies on the aging parameters of the immune system and how they impact the immune response to vaccines of older adults
•   Studies on communication between Health Care Professionals and patients

[Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b (Hib), Poliomyelitis]

•   Pertussis effect on patients with Asthma/COPD
•   Pertussis effect on quality of life (depression, anxiety, missed days of childcare/work)
•   Effect of Tdap vaccination on antibiotic use in respiratory patients
•   Real world evidence of DTPa-combinations, in general and special populations
•   Pertussis burden of diseases/Health Economic studies
•   Impact of Pertussis Maternal Immunisation
•   B. pertussis nasopharyngeal carriage
•   Haemophilus influenzae type b carriage

[Rotavirus]

•   Impact of RV vaccination and/or schedule on
-   hospitalization, emergency department and outpatient visits due to RVGE
-   nosocomial infections
-   strain epidemiology
-   compliance, completion, coverage
•   Exploring new approaches for improving Rotavirus Vaccination coverage
•   Rotavirus (RV) Disease Burden
-   in areas with lack of local/regional data (Age stratified where possible)
-   Among infants < 6 months of age including high risk group
-   Beyond Gastroenteritis(GE)
•   Impact of Rotavirus vaccination (e.g., herd effect and beyond GE, e.g. Diabetes Type 1 , seizures)

[Streptococcus pneumonia]

•   Impact / effectiveness of Haemophilus influenzae protein-D conjugated pneumococcal vaccine (on overall disease, Pneumonia, Otitis)

[Hepatitis]

•   Impact of hepatitis A outbreaks
•   Hepatitis A/B seroprevalence data in specific populations
•   Long-term protection with hepatitis B vaccines in infant and adult populations
•   Long-term protection with combined hepatitis A & B vaccines in infant and adult populations
•   Viral hepatitis risk for travellers
•   Hepatitis A/B burden of disease in adults
•   Use of hepatitis vaccines in adult risk groups and other susceptible populations (including: coverage rates, knowledge, attitudes, and practices )
•   Impact of Hepatitis A/B universal vaccination

[Herpes Zoster]

•   Studies to assess the incidence and burden of disease of HZ, impact of HZ and its complications on quality-of-Life measures, interference in daily activities, health care costs
•   Studies to assess the awareness of risk and impact of shingles, post-herpetic neuralgia (PHN) and other herpes zoster (HZ) complications in at-risk adults (including adults at risk due to age-related
decline in immunity and those at increased risk due to underlying disease and/or therapy)
•   Studies to understand barriers and attitude to vaccination against herpes zoster in non-interventional study setting
•   Studies providing insights into the mechanism of action of recombinant zoster vaccine (RZV) vaccination
•   Studies to assess the risk of complications (other than PHN)
•   Effectiveness and real-world impact of RZV vaccination in adults at risk for HZ
•   Evaluations of safety and/or immunogenicity and/or efficacy of the recombinant zoster vaccine in at-risk populations

Reminder: GSK Vaccines supply availability is one of the key criteria in the assessment of the Supported Studies proposals received

[Human Papillomavirus]

•   Effectiveness/Real world evidence of the AS04 adjuvanted Human Papillomavirus vaccine
•   Studies supporting insight to ASO4 mode of action
•   Studies to better understand barriers to HPV vaccination

[Measles, Mumps, Rubella, Varicella (MMR/V)]

•   Impact of MMRV combination vaccines on Varicella and MMR coverage
•   Impact of Varicella prevention programs (complications, hospitalization, healthcare costs)
•   Effectiveness of GSK's MMR vaccine (Measles/Mumps)
•   Burden of illness of varicella including severity and incidence of complication / hospitalisation for Varicella disease
•   Health outcome studies on concomitant implementation of Varicella and Herpes Zoster vaccination policies
•   MMR/V vaccination strategies (early vaccination, age groups)