The impact of BCG vaccination on the response to other vaccines among Ugandan adolescents (POPVAC C)

Not Applicable

Completed

• Conditions: Vaccine responses; Infections and Infestations

• Registration Number: ISRCTN10482904
• Lead Sponsor: ondon School of Hygiene and Tropical Medicine

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33593770/ (added 05/05/2022) 2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33593767/ (added 03/05/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Study Completion: 2022-04-30
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Participants must meet all of the following criteria to enter the trial:
1. A participant in the Entebbe Mother and Baby Study. Participants will be aged 13-17 years of age.
2. Written informed consent by parent or guardian
3. Written informed assent by participant
4. Willing to remain in the study area for the duration of the study
5. Willing to provide locator information and to be contacted during the course of the trial
6. Agree to avoid pregnancy for the duration of the trial (female only)
7. Able and willing (in the investigator's opinion) to comply with all the study requirements

Exclusion Criteria

1. Concurrent enrolment into another clinical trial. Of note, EMaBS participants enrolled into trial TB042 Open label, dose escalation and age de-escalation for ChAdOx1 85A in Ugandan adults and adolescents, followed by a Phase IIa randomised, open-label trial among adolescents comparing ChAdOx1 85A prime followed by MVA85A boost versus BCG re-vaccination” will not be eligible to enrol into this study. If they have not already received the vaccines offered in this study, they will be given the opportunity to receive them, as a service (not as part of a study) once TB042 follow up has been completed.
2. Clinically significant history of immunodeficiency (including HIV), cancer, cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness
3. History of serious psychiatric condition or disorder
4. Previous immunisation with YF, oral typhoid or HPV vaccine; previous immunisation with BCG or Td at age >5 years
5. Concurrent oral or systemic steroid medication or the concurrent use of other
immunosuppressive agents within 2 months prior to enrolment
6. 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
7. Tendency to develop keloid scars
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 eight weeks post BCG immunisation <br>2. YF-17D: neutralising antibody titres (plaque-reduction neutralisation test) at four weeks post YF immunisation <br>3. Ty21a: Salmonella typhi lipopolysaccharide (LPS)-specific immunoglobulin(Ig)G concentration at four weeks post Ty21a immunisation <br>4. HPV: IgG specific for L1-proteins of HPV-16/18 at four weeks post HPV priming immunisation <br>5. Td: tetanus and diphtheria toxoid-specific IgG concentration at four weeks post Td immunisation

Secondary Outcome Measures

Name	Time	Method
1. Protective immunity. Proportions with protective neutralising antibody (YF); protective IgG levels (TT); seroconversion rates (Ty21a) at four weeks post the corresponding immunisation.<br>2. Response waning. Primary outcome measures (all vaccines) repeated at week 52, and area-under-the curve (AUC) analyses. <br>3. Priming versus boosting. Effects on priming versus boosting will be examined for HPV only, comparing outcomes four weeks after the first, and four weeks after the second vaccine dose.