The effect of intensive treatment for schistosomiasis on response to vaccines among island adolescents in Uganda

Not Applicable

Completed

• Conditions: Vaccine responses; Infections and Infestations

• Registration Number: ISRCTN60517191
• Lead Sponsor: ondon School of Hygiene and Tropical Medicine

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33593768/ (added 05/05/2022) 2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33593767/ scientific rationale and cross-cutting analyses (added 26/10/2022)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Study Completion: 2020-11-30
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 479

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. BCG: BCG-specific IFN-gamma ELIspot response 8 weeks post BCG immunisation<br>2. YF-17D: neutralising antibody titres (plaque-reduction neutralisation test) at 4 weeks post YF immunisation<br>3. Ty21a: Salmonella typhi lipopolysaccharide (LPS)-specific immunoglobulin(Ig)G concentration at 4 weeks post Ty21a immunisation<br>4. HPV: IgG specific for L1-proteins of HPV-16/18 at 4 weeks post HPV priming immunisation<br>5. Td: tetanus and diphtheria toxoid-specific IgG concentration at 4 weeks post Td immunisation