Diarrhoeal disease due to Shigella infection
Conditions
Interventions
altSonflex123dose C eu
altSonflexplacebo
altSonflex123dose C AF
Boostrix Adult and menveo
altSonflex123dose C Africa child
altSonflex123dose B Africa child
Menveo and typhim Child Middle dose
Menveo and Typhim Vi Child Full dose
altSonflex123 dose C Africa infant safety
altSonflex123 dose B Africa infant safety
altSonflex123 dose A Africa infant safety
Menveo and infanrix Infant safety full dose
Menveo and Infanrix Infant safety medium dose
Menveo Infant safety low dose
altSonflex123 dose C Africa infant dose finding
altSonflex123 dose B Africa infant dose finding
altSonflex123 dose A Africa infant dose finding
Menveo and Infanrix Infant dose finding
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All participants: • Participants and/or participants' parent(s)/legally acceptable representative(s) LAR(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). • Written or witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study specific procedure. • Healthy participants as established by medical history, clinical examination, and laboratory assessment. • Participants satisfying all screening requirements. • Participants seronegative for hepatitis B, and hepatitis C. • Participants negative for human leukocyte antigen B27 (HLA-B27). Adults 18 to 50 years of age: • A male or female between, and including, 18 and 50 years of age at the time of the first study intervention administration. • Female participant of non-childbearing potential may be enrolled in the study. • Female participants of childbearing potential may be enrolled in the study, if the participant: • has practiced adequate contraception for 1 month prior to study intervention administration, and • has a negative pregnancy test on the day of study intervention administration, and • has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series. • Participants seronegative for human immunodeficiency virus (HIV). Children 24 to 59 months of age: • A male or female between, and including, 24 and 59 months of age at the time of first vaccination. • Normal nutritional Z score (-2 standard deviation or greater). • Previously completed routine childhood vaccinations to the best knowledge of the participant's parent(s)/LAR(s). • Born after gestation period of =37 weeks. • Participants seronegative for HIV. • Participants negative for HIV as confirmed by DNA PCR testing
Exclusion criteria
Exclusion criteria: All participants: • Known exposure to Shigella during lifetime of the participant as confirmed during interview with the participant or documented by patient records, recent travel* to a country where Shigella or other enteric infections are endemic, or recent occupation* involving Shigella species. *Limited to Adults 18 to 50 years of age in Europe. • Progressive, unstable or uncontrolled clinical conditions. • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine. • Any confirmed or suspected immunosuppressive or immunodeficient condition. • Hypersensitivity, including allergy, to medicinal products or medical equipment whose use is foreseen in this study. • Clinical conditions representing a contraindication to IM vaccination and blood draws. o Any behavioural or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study. o Acute disease and/or fever at the time of enrolment* • Any clinically significant haematological and/or biochemical laboratory abnormality. o Confirmed positive COVID-19 test during the period starting 30 days before the first administration of study vaccines. o Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. o Administration of long-acting immune-modifying drugs at any time during the study period. o Prior receipt of an experimental Shigella vaccine or live Shigella challenge. o Use of any investigational or non-registered product* other than the study vaccine during the period. • Acute or chronic illness • Chronic administration of immunosuppressants or other immune-modifying drugs • Pregnant or lactating female • History of or current chronic alcohol consumption and/or drug abuse • Administration of immunoglobulins and/or any blood products or plasma derivatives, or bone marrow transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-serotype specific Shigella lipopolysaccharide (LPS) serum immunoglobulin G (IgG) titers in infants 9 months of age in Africa ;Number of adults 18 to 50 years of age with solicited systemic events;Number of adults 18 to 50 years of age with solicited administration site events;Number of adults 18 to 50 years of age with unsolicited adverse events;Number of adults 18 to 50 years of age with serious adverse events (SAEs);Number of adults 18 to 50 years of age with deviations from normal values of haematological, renal, and hepatic panel test results;Number of children 24 to 59 months of age in Africa with solicited administration site events ;Number of children 24 to 59 months of age in Africa with solicited systemic events ;Number of children 24 to 59 months of age in Africa with unsolicited AEs ;Number of children 24 to 59 months of age in Africa with SAEs;Number of children 24 to 59 months of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results ;Number of infants 9 months of age in Africa with solicited administration site events;Number of infants 9 months of age in Africa with solicited systemic events ;Number of infants 9 months of age in Africa with unsolicited AEs;Number of infants 9 months of age in Africa with SAEs;Number of infants 9 months of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of adults 18 to 50 years of age in Europe achieving an ELISA level equivalent to =1:800 titer against S. sonnei LPS;Number of adults 18 to 50 years of age in Africa achieving an ELISA level equivalent to =1:800 titer against S. sonnei LPS;Number of children 24 to 59 months of age in Africa achieving an ELISA level equivalent to =1:800 titer against S. sonnei LPS;Number of infants 9 months of age in Africa achieving an ELISA level equivalent to =1:800 titer against S. sonnei LPS;Number of adults 18 to 50 years of age in Europe achieving an ELISA level equivalent to =1:1600 titer against S. sonnei LPS;Number of adults 18 to 50 years of age in Africa achieving an ELISA level equivalent to =1:1600 titer against S. sonnei LPS;Number of children 24 to 59 months of age in Africa achieving an ELISA level equivalent to =1:1600 titer against S. sonnei LPS;Number of infants 9 months of age in Africa achieving an ELISA level equivalent to =1:1600 titer against S. sonnei LPS;Number of adults 18 to 50 years of age in Europe showing at least a 4-fold increase in anti-serotype specific Shigella LPS/OAg serum IgG concentrations;Number of adults 18 to 50 years of age in Africa showing at least a 4-fold increase in anti-serotype specific Shigella LPS serum IgG titers;Number of children 24 to 59 months of age in Africa showing at least a 4-fold increase in anti-serotype specific Shigella LPS serum IgG titers;Number of infants 9 months of age in Africa showing at least a 4-fold increase in anti-serotype specific Shigella LPS serum IgG titers;Anti-measles IgG concentrations in infants 9 months of age in the dose-finding groups in Africa;Anti-rubella IgG concentrations in infants 9 months of age in the dose-finding groups in Africa;Number of infants 9 months of age in the dose-finding groups in Africa achieving anti-measles IgG concentrations of =150 mIU/mL and =200 mIU/mL;Number of infants 9 months of age in the dose-finding groups in Africa achieving anti-rubella IgG concentratio | — |
Countries
Belgium, Kenya
Contacts
Public ContactCharles Kilel
Kenya Medical Research Institute United States Army Medical Research Directorate Africa Kenya
Outcome results
None listed