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The Supported Studies Programme
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Vaccines



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Please find below some of the current areas of interest for Vaccines Human Subject Research. We are also interested in non-Human Subject Research studies. These were last updated 29 October 2019.

[Across Diseases & Technologies
General Vaccine Science, life course immunization]
• Studies assessing the challenges and proposed solutions to implement life course immunization, for both providers and population, taking into account socio-economic-political barriers and utilizing behavioural economics, to improve uptake and expand coverage.
• Studies on the aging parameters of the immune system (immunosenescence) and how they impact the immune response to vaccines of older adults versus young people.
• Studies on health care utilization related to the management of infectious diseases (IDs) and all vaccines preventable IDs in older adult.
• Studies on quality of life and dependency or other socio-economic consequences following an episode of infectious diseases (IDs) and all vaccines preventable IDs in older adult.
• Studies on the financial and economic impact of IDs within different perspectives: household (patient, care giver), Government, private payer (insurer, employer).
• Studies measuring the impact of communication and educational interventions (in particular if delivered in a digital format) on vaccine uptake, in particular in pregnant women and adults.
• Studies assessing factors impacting attitudes of women towards pre- and post-natal immunization.
• Studies assessing means of increasing vaccination coverage in adolescents.
• Studies on vaccination coverage for all vaccines recommended in adults in groups of countries.
• Studies related to trained immunity and its role in secondary infections.

[Chronic Obstructive Pulmonary Disease (COPD)]
• Bacteria and virus prevalence in COPD exacerbations.
• Impact of the lung microbiome on COPD exacerbations, including the pathogenic role of NTHi, Mcat as well as lung immunity.
• Bacteria and virus interaction in COPD exacerbations.
• Identification of biomarkers to assess the risk of COPD exacerbations caused by bacterial and viral infections.
• Perceptions on vaccination and vaccination uptake in clinical management of COPD patients.

[Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b (Hib), Poliomyelitis]
• Vaccine effectiveness or impact data, on pertussis, HiB and hepatitis disease following use of DTPa-combinations, in general and special populations.
• Pertussis burden of diseases/Health Economic studies in young infants, older children, adolescents, adults, older adults and patients with chronic diseases.
• Pertussis Maternal Immunisation: effectiveness and impact on childhood vaccination.
• Prevalence and duration of B. pertussis nasopharyngeal carriage in the population.
• Hexavalent vaccines in reduced schedules in pre-terms.

[Hepatitis]
• Impact of Hepatitis A universal mass vaccination on burden of disease, including use of different schedules.
• Hepatitis A and or hepatitis B seroprevalence data in specific populations.
• Economic evaluation and societal impact of hepatitis A outbreaks to healthcare utilisation, individuals and societies.
• Epidemiology and modelling study hep B burden of disease and the evolution of the rate of diagnosis.

[Herpes Zoster
Immunocompetent Older Adults (50 years of age and older)]
• Innovative solutions to improve 2-dose completion and series compliance.
• Observational studies to assess the awareness of: risk of shingles, post-herpetic neuralgia (PHN) and other herpes zoster (HZ) complications in older adults.
• Observational studies to assess the incidence of HZ, impact of HZ and complications on Quality of Life measures, role of caregivers, interference in daily activities, health care costs etc.
• Studies providing insights into the mechanism of action (adaptive and innate profiling of the vaccine, local immunity, role of the adjuvant system) as it relates to protection.

[Herpes Zoster
At-Risk/Immunocompromised Adults (18 years of age and older)]
• Evaluations of safety and immunogenicity in patients immunocompromised due to disease or therapy.
• Observational studies to assess awareness of the risk of shingles, PHN and other HZ complications in populations immunosuppressed due to disease and/or therapy, or with chronic conditions.
• Observational studies to assess the incidence of HZ, impact of HZ and complications on exacerbation/de-stabilization of chronic conditions (e.g Type-2 Diabetes, COPD), Quality of Life and cost of HZ complications.
• Studies assessing factors impacting knowledge, attitudes and practice to vaccinate those with chronic conditions, or patients immunocompromised due to disease or therapy.
• Studies providing insights into the mechanism of action (adaptive and innate profiling of the vaccine, local immunity, role of the adjuvant system) as it relates to protection.
• Burden of Illness/Burden of Disease studies (population and country-specific data gaps only).
Reminder: GSK Vaccines supply availability is one of the key criteria in the assessment of the Supported Studies proposals received.

[Human Papillomavirus]
• Effectiveness or impact of Human Papillomavirus vaccines against vaccine and non-vaccine types and duration of cross protection.
• Effectiveness of Human Papillomavirus vaccine on non-cervical cancers and pre-cancerous lesions/infections.
• Alternative schedules for Human Papillomavirus vaccine (e.g. mixed schedule, 1-dose).
• Impact of adjuvant in Human Papillomavirus vaccine on humoral and cellular immune responses.
• Immunogenicity, efficacy, safety in specific populations (immunocompromised, males etc.).

[Influenza (pandemic & seasonal)]
• Vaccination coverage overall, for quadrivalent influenza vaccines (QIVs), for brand specific vaccines, in WHO- identified risk groups.
• Co-administration studies in paediatric patients.

[Measles, Mumps, Rubella, Varicella (MMRV)]
• Impact of MMRV combination vaccines on Varicella and MMR coverage.
• Impact of varicella prevention programs (complications, hospitalization, costs).
• Effectiveness of GSK MMR vaccine (Measles/Mumps).
• Burden and severity of Varicella disease.
• Evidence to better understand the interplay between Varicella programs and herpes zoster disease (role of endogenous/exogenous boosting).
• MMR/V vaccination strategies (early protection, age groups).

[Neisseria]
• Effectiveness and impact of MenB vaccination program.
• Effectiveness or impact data after MenACWY vaccination in 2+1 schedule in infants.
• Effectiveness or impact data after MenACWY vaccination with one dose schedule in toddlers 12-23 months.
• Effectiveness or impact data after Meningococcal vaccination in older adults (> 65 years).
• Co-administration data following MenB vaccination in adolescents.
• Compliance of MenB and routine vaccination.
• Evaluating non-B effect of Bexsero on other Neisseria meningitidis serogroups.


[Streptococcus pneumoniae]
• Impact / effectiveness of Haemophilus influenzae protein-D conjugated pneumococcal vaccine (on overall disease (Invasive Pneumococcal Disease, Pneumonia, Otitis).
• Impact / effectiveness (IPD, Pneumonia, Otitis) of Haemophilus influenzae protein-D conjugated pneumococcal vaccine compared to PCV13 (e.g. following vaccine switch, or across regions/countries).

[Rotavirus]
• Evidence generation for Rotavirus (RV) Disease Morbidity Burden in areas with lack of local/regional data (Age stratified where possible, especially < 6 months of age and including preterm infants).
• Impact of RV vaccination on RV Gastroenteritis (RVGE) hospitalization, Nosocomial RVGE, Emergency Department / Outpatient Physician visits.
• Impact of RV vaccination schedules on:
a) compliance and completion of vaccination and its Health economic benefits,
b) RVGE morbidity/ mortality,
c) Rotavirus vaccination coverage
• Impact of RV vaccination in Preterm infants.
• Health Economic analysis to demonstrate impact of RV vaccination (e.g. Health care costs and resource allocation / Quality of care benefits / Reduction in work absenteeism).
• Exploring new approaches for improving Rotavirus Vaccination coverage.
• Added benefits of Rotavirus vaccination (e.g. herd effect).

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.



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