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| Status |
Public on Mar 19, 2018 |
| Title |
Adjuvant associated peripheral-blood mRNA profiles and kinetics induced by the adjuvanted recombinant-protein candidate tuberculosis vaccine M72/AS01 in BCG-vaccinated adults |
| Organism |
Homo sapiens |
| Experiment type |
Expression profiling by array
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| Summary |
Systems biology has the potential to identify gene signatures associated with vaccine immunogenicity or protective efficacy. The main objective of our study was to identify optimal post-vaccination time points for evaluating blood RNA-expression profiles in recipients of the candidate tuberculosis vaccine M72/AS01. In this phase II open-label study (NCT01669096), healthy Bacillus Calmette-Guérin (BCG)-primed, HIV-negative adults were administered two doses (30-days apart) of M72/AS01. Blood samples were collected pre-dose 1, pre-dose 2 and 1, 7, 10, 14, 17 and 30 days post-dose 2. RNA expression in blood and peripheral-blood mononuclear cells (PBMCs) was quantified using microarray technology. The data analysis used as a reference, a PBMC-gene signature that was associated with the protective efficacy of a similarly adjuvanted candidate malaria vaccine. Peripheral-blood CD4+ T-cell reactivity, serum interferon-gamma (IFNG) concentrations and safety were also assessed. Twenty subjects completed the study and 18 subjects received two doses. The observed safety profile was similar to previous trials. Serum IFNG responses and M72-specific CD4+ T cell responses to vaccination were detected as expected, based on previous trial experience. PBMC and whole-blood RNA-expression data at day 14 post-dose 2 relative to pre-vaccination and whole-blood RNA-expression data at 7, 10, and 17 days post-dose 2 relative to pre-vaccination could be used to classify vaccine recipients into gene-signature positive or gene-signature negative groups. In conclusion, whole blood sampled from the 7, 10, 14, or 17 day post-vaccination time points, in addition to pre-vaccination, could be selected to assess potentially clinically relevant responses to M72/AS01 using transcriptome analysis.
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| Overall design |
There are 50 WB (whole blood) samples and 114 PBMC (pheripheral blood mononuclear cells) samples from 18 distinct human subjects, at various time points during vaccination schedule: subjects are injected with M72/AS01E tuberculosis vaccine candidate at D0 and D30, whole blood samples are collected at D0, D30, D31, D37, D40, D44 and D47 and PBMC samples are collected at D0, D31, D44. There is no replicate, control or reference sample.
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| Contributor(s) |
van den Berg RA, De Mot L, Leroux-Roels G, Bechtold V, Clement F, Coccia M, Jongert E, Evans TG, Gillard P, van der Most RG |
| Citation(s) |
29632533 |
| |
| Submission date |
Aug 09, 2017 |
| Last update date |
Jul 25, 2021 |
| Contact name |
Laurane De Mot |
| E-mail(s) |
[email protected]
|
| Organization name |
GSK Vaccines
|
| Street address |
Rue de l'Institut 89
|
| City |
Rixensart |
| ZIP/Postal code |
1330 |
| Country |
Belgium |
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| Platforms (1) |
| GPL570 |
[HG-U133_Plus_2] Affymetrix Human Genome U133 Plus 2.0 Array |
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| Samples (164)
|
| GSM2737889 |
WB, Day 37, PID 6 |
| GSM2737890 |
WB, Day 47, PID 6 |
| GSM2737891 |
WB, Day 30, PID 15 |
| GSM2737892 |
WB, Day 30, PID 9 |
| GSM2737893 |
WB, Day 40, PID 5 |
| GSM2737894 |
WB, Day 31, PID 16 |
| GSM2737895 |
WB, Day 37, PID 15 |
| GSM2737896 |
WB, Day 47, PID 7 |
| GSM2737897 |
WB, Day 31, PID 7 |
| GSM2737898 |
WB, Day 37, PID 5 |
| GSM2737899 |
WB, Day 44, PID 16 |
| GSM2737900 |
WB, Day 30, PID 16 |
| GSM2737901 |
WB, Day 37, PID 12 |
| GSM2737902 |
WB, Day 37, PID 17 |
| GSM2737903 |
WB, Day 37, PID 9 |
| GSM2737904 |
WB, Day 31, PID 10 |
| GSM2737905 |
WB, Day 0, PID 10 |
| GSM2737906 |
WB, Day 44, PID 4 |
| GSM2737907 |
WB, Day 31, PID 1 |
| GSM2737908 |
WB, Day 47, PID 14 |
| GSM2737909 |
WB, Day 0, PID 18 |
| GSM2737910 |
WB, Day 37, PID 14 |
| GSM2737911 |
WB, Day 30, PID 1 |
| GSM2737912 |
WB, Day 37, PID 13 |
| GSM2737913 |
WB, Day 47, PID 12 |
| GSM2737914 |
WB, Day 47, PID 18 |
| GSM2737915 |
WB, Day 0, PID 12 |
| GSM2737916 |
WB, Day 47, PID 10 |
| GSM2737917 |
WB, Day 37, PID 4 |
| GSM2737918 |
WB, Day 31, PID 11 |
| GSM2737919 |
WB, Day 47, PID 2 |
| GSM2737920 |
WB, Day 40, PID 18 |
| GSM2737921 |
WB, Day 40, PID 14 |
| GSM2737922 |
WB, Day 30, PID 6 |
| GSM2737923 |
WB, Day 40, PID 13 |
| GSM2737924 |
WB, Day 44, PID 14 |
| GSM2737925 |
WB, Day 44, PID 18 |
| GSM2737926 |
WB, Day 31, PID 9 |
| GSM2737927 |
WB, Day 40, PID 2 |
| GSM2737928 |
WB, Day 30, PID 11 |
| GSM2737929 |
WB, Day 40, PID 8 |
| GSM2737930 |
WB, Day 47, PID 8 |
| GSM2737931 |
WB, Day 30, PID 10 |
| GSM2737932 |
WB, Day 44, PID 12 |
| GSM2737933 |
WB, Day 30, PID 13 |
| GSM2737934 |
WB, Day 40, PID 10 |
| GSM2737935 |
WB, Day 0, PID 2 |
| GSM2737936 |
WB, Day 31, PID 13 |
| GSM2737937 |
WB, Day 40, PID 15 |
| GSM2737938 |
WB, Day 40, PID 12 |
| GSM2737939 |
WB, Day 40, PID 1 |
| GSM2737940 |
WB, Day 47, PID 17 |
| GSM2737941 |
WB, Day 37, PID 18 |
| GSM2737942 |
WB, Day 0, PID 17 |
| GSM2737943 |
WB, Day 30, PID 5 |
| GSM2737944 |
WB, Day 31, PID 15 |
| GSM2737945 |
WB, Day 31, PID 2 |
| GSM2737946 |
WB, Day 47, PID 13 |
| GSM2737947 |
WB, Day 37, PID 2 |
| GSM2737948 |
WB, Day 44, PID 10 |
| GSM2737949 |
WB, Day 37, PID 10 |
| GSM2737950 |
WB, Day 0, PID 16 |
| GSM2737951 |
WB, Day 40, PID 9 |
| GSM2737952 |
WB, Day 44, PID 6 |
| GSM2737953 |
WB, Day 40, PID 11 |
| GSM2737954 |
WB, Day 31, PID 4 |
| GSM2737955 |
WB, Day 31, PID 8 |
| GSM2737956 |
WB, Day 0, PID 8 |
| GSM2737957 |
WB, Day 30, PID 4 |
| GSM2737958 |
WB, Day 47, PID 9 |
| GSM2737959 |
WB, Day 30, PID 14 |
| GSM2737960 |
WB, Day 0, PID 4 |
| GSM2737961 |
WB, Day 47, PID 11 |
| GSM2737962 |
WB, Day 0, PID 11 |
| GSM2737963 |
WB, Day 40, PID 16 |
| GSM2737964 |
WB, Day 40, PID 4 |
| GSM2737965 |
WB, Day 40, PID 6 |
| GSM2737966 |
WB, Day 31, PID 17 |
| GSM2737967 |
WB, Day 40, PID 7 |
| GSM2737968 |
WB, Day 0, PID 15 |
| GSM2737969 |
WB, Day 30, PID 2 |
| GSM2737970 |
WB, Day 31, PID 18 |
| GSM2737971 |
WB, Day 44, PID 17 |
| GSM2737972 |
WB, Day 31, PID 12 |
| GSM2737973 |
WB, Day 0, PID 1 |
| GSM2737974 |
WB, Day 44, PID 11 |
| GSM2737975 |
WB, Day 44, PID 5 |
| GSM2737976 |
WB, Day 47, PID 1 |
| GSM2737977 |
WB, Day 44, PID 2 |
| GSM2737978 |
WB, Day 31, PID 5 |
| GSM2737979 |
WB, Day 44, PID 9 |
| GSM2737980 |
WB, Day 31, PID 6 |
| GSM2737981 |
WB, Day 0, PID 13 |
| GSM2737982 |
WB, Day 0, PID 9 |
| GSM2737983 |
WB, Day 31, PID 14 |
| GSM2737984 |
WB, Day 30, PID 17 |
| GSM2737985 |
WB, Day 44, PID 7 |
| GSM2737986 |
WB, Day 0, PID 6 |
| GSM2737987 |
WB, Day 44, PID 13 |
| GSM2737988 |
WB, Day 30, PID 7 |
| GSM2737989 |
WB, Day 0, PID 5 |
| GSM2737990 |
WB, Day 30, PID 18 |
| GSM2737991 |
WB, Day 37, PID 11 |
| GSM2737992 |
WB, Day 44, PID 8 |
| GSM2737993 |
WB, Day 44, PID 15 |
| GSM2737994 |
WB, Day 37, PID 7 |
| GSM2737995 |
WB, Day 0, PID 7 |
| GSM2737996 |
WB, Day 44, PID 1 |
| GSM2737997 |
WB, Day 30, PID 8 |
| GSM2737998 |
WB, Day 0, PID 14 |
| GSM2737999 |
WB, Day 47, PID 4 |
| GSM2738000 |
PBMC, Day 0, PID 5 |
| GSM2738001 |
PBMC, Day 31, PID 5 |
| GSM2738002 |
PBMC, Day 44, PID 5 |
| GSM2738003 |
PBMC, Day 0, PID 3 |
| GSM2738004 |
PBMC, Day 31, PID 3 |
| GSM2738005 |
PBMC, Day 44, PID 3 |
| GSM2738006 |
PBMC, Day 0, PID 6 |
| GSM2738007 |
PBMC, Day 31, PID 6 |
| GSM2738008 |
PBMC, Day 44, PID 6 |
| GSM2738009 |
PBMC, Day 0, PID 2 |
| GSM2738010 |
PBMC, Day 31, PID 2 |
| GSM2738011 |
PBMC, Day 44, PID 2 |
| GSM2738012 |
PBMC, Day 0, PID 1 |
| GSM2738013 |
PBMC, Day 31, PID 1 |
| GSM2738014 |
PBMC, Day 44, PID 1 |
| GSM2738015 |
PBMC, Day 0, PID 13 |
| GSM2738016 |
PBMC, Day 31, PID 13 |
| GSM2738017 |
PBMC, Day 44, PID 13 |
| GSM2738018 |
PBMC, Day 0, PID 15 |
| GSM2738019 |
PBMC, Day 31, PID 15 |
| GSM2738020 |
PBMC, Day 44, PID 15 |
| GSM2738021 |
PBMC, Day 0, PID 7 |
| GSM2738022 |
PBMC, Day 31, PID 7 |
| GSM2738023 |
PBMC, Day 44, PID 7 |
| GSM2738024 |
PBMC, Day 0, PID 17 |
| GSM2738025 |
PBMC, Day 31, PID 17 |
| GSM2738026 |
PBMC, Day 44, PID 17 |
| GSM2738027 |
PBMC, Day 0, PID 14 |
| GSM2738028 |
PBMC, Day 31, PID 14 |
| GSM2738029 |
PBMC, Day 44, PID 14 |
| GSM2738030 |
PBMC, Day 0, PID 18 |
| GSM2738031 |
PBMC, Day 44, PID 18 |
| GSM2738032 |
PBMC, Day 31, PID 18 |
| GSM2738033 |
PBMC, Day 0, PID 10 |
| GSM2738034 |
PBMC, Day 31, PID 10 |
| GSM2738035 |
PBMC, Day 44, PID 10 |
| GSM2738036 |
PBMC, Day 0, PID 4 |
| GSM2738037 |
PBMC, Day 31, PID 4 |
| GSM2738038 |
PBMC, Day 44, PID 4 |
| GSM2738039 |
PBMC, Day 0, PID 12 |
| GSM2738040 |
PBMC, Day 31, PID 12 |
| GSM2738041 |
PBMC, Day 44, PID 12 |
| GSM2738042 |
PBMC, Day 0, PID 8 |
| GSM2738043 |
PBMC, Day 31, PID 8 |
| GSM2738044 |
PBMC, Day 44, PID 8 |
| GSM2738045 |
PBMC, Day 0, PID 9 |
| GSM2738046 |
PBMC, Day 31, PID 9 |
| GSM2738047 |
PBMC, Day 0, PID 11 |
| GSM2738048 |
PBMC, Day 31, PID 11 |
| GSM2738049 |
PBMC, Day 44, PID 11 |
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| Relations |
| BioProject |
PRJNA397768 |
| Supplementary file |
Size |
Download |
File type/resource |
| GSE102459_RAW.tar |
749.0 Mb |
(http)(custom) |
TAR (of CEL) |
| Processed data included within Sample table |
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