Impact of BCG revaccination on the response to unrelated vaccines in a Ugandan adolescent birth cohort: randomised controlled trial protocol C for the 'POPulation differences in VACcine responses' (POPVAC) programme. Issue 2 (16th February 2021)

• Record Type: Journal Article
• Authors: Zirimenya, Ludoviko; Nkurunungi, Gyaviira; Nassuuna, Jacent; Natukunda, Agnes; Mutebe, Alex; Oduru, Gloria; Kabami, Grace; Akurut, Hellen; Onen, Caroline; Namutebi, Milly; Serubanja, Joel; Nakazibwe, Esther; Akello, Florence; Tumusiime, Josephine; Sewankambo, Moses; Kiwanuka, Samuel; Kiwudhu, Fred; Kizindo, Robert; Kizza, Moses; Wajja, Anne; Cose, Stephen; Muwanga, Moses; Webb, Emily; Elliott, Alison M
• Other Names: author non-byline.; Amongin Rebecca author non-byline.; Nassanga Beatrice author non-byline.; Nambuya Irene author non-byline.; Kabuubi Prossy author non-byline.; Niwagaba Emmanuel author non-byline.; Zziwa Christopher author non-byline.; Ninsiima Caroline author non-byline.; Amongi Susan author non-byline.; Akello Mirriam author non-byline.; Sewankambo Moses author non-byline.; Nsubuga Denis author non-byline.; Abiriga David author non-byline.; Kizza Moses author non-byline.; Nansukusa Samsi author non-byline.; Kaleebu Pontiano author non-byline.; Smits Hermelijn author non-byline.; Yazdanbakhsh Maria author non-byline.; Dam Govert van author non-byline.; Corstjens Paul author non-byline.; Staedke Sarah author non-byline.; Luzze Henry author non-byline.; Kaweesa James author non-byline.; Tukahebwa Edridah author non-byline.; Tumushabe Elly author non-byline.
• Is Part Of: BMJ open. Volume 11:Issue 2(2021)
• Publication Date: 2021-02-16
• Subjects: vaccine -- BCG -- immunisation -- uganda; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-040430
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: There is evidence that BCG immunisation may protect against unrelated infectious illnesses. This has led to the postulation that administering BCG before unrelated vaccines may enhance responses to these vaccines. This might also model effects of BCG on unrelated infections. Methods and analysis: To test this hypothesis, we have designed a randomised controlled trial of BCG versus no BCG immunisation to determine the effect of BCG on subsequent unrelated vaccines, among 300 adolescents (aged 13–17 years) from a Ugandan birth cohort. Our schedule will comprise three main immunisation days (week 0, week 4 and week 28): BCG (or no BCG) revaccination at week 0; yellow fever (YF-17D), oral typhoid (Ty21a) and human papillomavirus (HPV) prime at week 4; and HPV boost and tetanus/diphtheria (Td) boost at week 28. Primary outcomes are anti-YF-17D neutralising antibody titres, Salmonella typhi lipopolysaccharide-specific IgG concentration, IgG specific for L1-proteins of HPV-16/HPV-18 and tetanus and diphtheria toxoid-specific IgG concentration, all assessed at 4 weeks after immunisation with YF, Ty21a, HPV and Td, respectively. Secondary analyses will determine effects on correlates of protective immunity (where recognised correlates exist), on vaccine response waning and on whether there are differential effects on priming versus boosting immunisations. We will also conduct exploratory immunology assays among subsets of participants to further characterise effects of BCG revaccination on vaccine responses. Further analyses will assess which life course exposures influence vaccine responses in adolescence. Ethics and dissemination: Ethics approval has been obtained from relevant Ugandan and UK ethics committees. Results will be shared with Uganda Ministry of Health, relevant district councils, community leaders and study participants. Further dissemination will be done through conference proceedings and publications. Trial registration number: ISRCTN10482904 .