RT Journal Article
SR Electronic
T1 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
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e040430
DO 10.1136/bmjopen-2020-040430
VO 11
IS 2
A1 Zirimenya, Ludoviko
A1 Nkurunungi, Gyaviira
A1 Nassuuna, Jacent
A1 Natukunda, Agnes
A1 Mutebe, Alex
A1 Oduru, Gloria
A1 Kabami, Grace
A1 Akurut, Hellen
A1 Onen, Caroline
A1 Namutebi, Milly
A1 Serubanja, Joel
A1 Nakazibwe, Esther
A1 Akello, Florence
A1 Tumusiime, Josephine
A1 Sewankambo, Moses
A1 Kiwanuka, Samuel
A1 Kiwudhu, Fred
A1 Kizindo, Robert
A1 Kizza, Moses
A1 Wajja, Anne
A1 Cose, Stephen
A1 Muwanga, Moses
A1 Webb, Emily
A1 Elliott, Alison M
A1 
YR 2020
UL http://bmjopen.bmj.com/content/11/2/e040430.abstract
AB 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.