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Vaccines
Timelines
Please note that: As a consequence of the current and developing Covid-19 pandemic, the call for proposal
timelines have been updated
(cycle 3)
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)
Although GSK are more likely to support studies aligned to our current areas of interest for supported studies, we are interested in supporting studies that are innovative and contribute to scientific knowledge relating to a product, a medical condition or advancing a technology.