Can giving adolescents preventive treatment for malaria, before vaccination, improve immune responses to these vaccines?

Not Applicable

Completed

• Conditions: Vaccine responses; Not Applicable

• Registration Number: ISRCTN62041885
• Lead Sponsor: ondon School of Hygiene and Tropical Medicine

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33593769/ (added 16/08/2022) 2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33593767/ (added 03/05/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-23
• Study Completion: 2022-04-30
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 341

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 years and enrolled in primary 1 to 6
3. Written informed assent by participant and consent by parent or guardian
4. Agree to avoid pregnancy for the duration of the trial (female only)
5. Willing to provide locator information and to be contacted during the course of the trial
6. 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 illnesses.
2. Moderate or severe acute illness characterised any of the following symptoms: fever, impaired consciousness, convulsions, difficulty in breathing, vomiting; or as determined by the attending project clinician.
3. Family history of sudden death attributable to a heart condition in a first-degree relative
4. Family history of long QT syndrome
5. Know congenital prolongation of the QTc interval
6. History of known heart disease or fainting
7. Known allergy or history of adverse reaction to DP or to artemether-lumefantrine
8. History of serious psychiatric condition or disorder
9. Previous immunisation with Yellow Fever (YF), oral typhoid or Human Papillomavirus (HPV) vaccine; previous immunisation with BCG or Tetanus and diphtheria vaccine (Td) at age >5 years
10. Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents within 2 months prior to enrolment
11. Current use of medications known to prolong the QT interval (Table 2)
12. History of an allergic reaction to immunisation or any allergy likely to be exacerbated by any component of the study vaccines including egg or chicken proteins
13. Tendency to develop keloid scars
14. Haemoglobin less than 80g/L
15. Positive HIV serology
16. Positive pregnancy test
17. Female currently lactating, confirmed pregnancy or intention to become pregnant during the trial period
18. 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
19. 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

Secondary Outcome Measures

Name	Time	Method
1. Protective immunity is measured using proportions with protective neutralising antibody (YF); protective IgG levels (TT); seroconversion rates (Ty21a) at 4 weeks post the corresponding immunisation<br>2. Response waning is measured using primary outcome measures (all vaccines) repeated at week 52, and area-under-the curve (AUC) analyses<br>3. Priming versus boosting is measured using 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<br>4. Current malaria infection status and intensity is assessed retrospectively by PCR on stored samples collected on immunisation days and at week 52.