Vaccine responses Infections and Infestations
Conditions
Interventions
A randomisation code will be generated by the trial statistician using a randomly permuted block size. Participants will be allocated in a 1:1 ratio to receive either intensive or standard praziquante
timings adjusted to accommodate school terms) during follow up. Participants in the standard arm will receive annual PZQ (Uganda Ministry of Health (MoH) policy) given after immunisation and after pri
Sponsors
London School of Hygiene and Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Attending the selected school and planning to continue to attend the school for the duration of the study 2. Aged 9 to 17 year and enrolled in primary 4, 5 or 6 3. Written informed consent by parent or guardian 4. Written informed assent by participant 5. Agree to avoid pregnancy for the duration of the trial (female only) 6. Willing to provide locator information and to be contacted during the course of the trial 7. Able and willing (in the investigator's opinion) to comply with all the study requirements
Exclusion criteria
Exclusion criteria: 1. Clinically significant history of immunodeficiency (including HIV), cancer, cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness 2. History of serious psychiatric condition or disorder 3. Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents within 2 months prior to enrolment 4. History of allergic reaction to immunisation or any allergy likely to be exacerbated by any component of the study vaccines including egg or chicken proteins 5. History of previous immunisation with YF, oral typhoid or HPV vaccine; previous immunisation with BCG or Td at age >5 years 6. Tendency to develop keloid scars 7. Haemoglobin less than 82g/L 8. Positive HIV serology 9. Positive pregnancy test 10. Female currently lactating, confirmed pregnancy or intention to become pregnant during the trial period 11. Use of an investigational medicinal product or non-registered drug, live vaccine, or medical device other than the study vaccines for 30 days prior to dosing with the study vaccine, or planned use during the study period 12. Administration of immunoglobulins and/or any blood products within the three months preceding the planned trial immunisation date
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. BCG: BCG-specific IFN-gamma ELIspot response 8 weeks post BCG immunisation 2. YF-17D: neutralising antibody titres (plaque-reduction neutralisation test) at 4 weeks post YF immunisation 3. Ty21a: Salmonella typhi lipopolysaccharide (LPS)-specific immunoglobulin(Ig)G concentration at 4 weeks post Ty21a immunisation 4. HPV: IgG specific for L1-proteins of HPV-16/18 at 4 weeks post HPV priming immunisation 5. Td: tetanus and diphtheria toxoid-specific IgG concentration at 4 weeks post Td immunisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 24/07/2019: 1. Protective immunity. Proportions with protective neutralising antibody (YF); protective IgG levels (TT); seroconversion rates (Ty21a) at 4 weeks post the corresponding immunisation 2. Response waning. Primary outcome measures (all vaccines) repeated at week 52, and area-under-the curve (AUC) analyses 3. Priming versus boosting. Effects on priming versus boosting will be examined for HPV only, comparing outcomes 4 weeks after the first, and 4 weeks after the second vaccine dose 4. Current S. mansoni infection status and intensity. This will be determined by serum/plasma levels of circulating anodic antigen (CAA). The method is quantitative, highly specific for Schistosoma infection, and much more sensitive than the conventional Kato Katz method. CAA will be assessed retrospectively on stored samples collected at baseline, on immunisation days, and on primary and secondary endpoint days. Previous secondary outcome measures: 1. Protective immunity. Proportions with protective neutralising antibody (YF); protective IgG levels (TT); seroconversion rates (Ty21a) at 4 weeks post the corresponding immunisation 2. Response waning. Primary outcome measures (all vaccines) repeated at week 52, and area-under-the curve (AUC) analyses 3. Priming versus boosting. Effects on priming versus boosting will be examined for HPV only, comparing outcomes 4 weeks after the first, and 4 weeks after the second vaccine dose | — |
Countries
Uganda
Contacts
Public ContactEmily Webb
Outcome results
None listed