Human Volunteer Rotavirus Vaccine Study
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ABSTRACT:
PROVIDER: PRJEB25634 | ENA |
REPOSITORIES: ENA
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Project description:Rotavirus Vaccine Immunogenicity (RoVI) shotgun metagenomics
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Project description:<p>The PROVIDE study (Dhaka, Bangladesh) is a randomized clinical trial platform which evaluated the efficacy of delayed-dose oral rotavirus vaccine as well as the benefit of an injectable polio vaccine replacing one dose of oral polio vaccine. This rigorous infrastructure supported the additional examination of hypotheses of vaccine underperformance. Primary and secondary efficacy and immunogenicity measures for rotavirus and polio vaccines were measured, as well as the impact of maternal and childhood malnutrition, environmental enteropathy, and additional exploratory variables.</p> <p>This study has been conducted to test the role of epigenetics in malnutrition, specifically the genome-wide role of histone modifications, which are known to provide a precise signature of metabolic state and immune system function.</p>
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Project description:Gut microbiota composition effect the efficacy of rotavirus vaccine
| PRJEB78739 | ENA
Project description:Successful development of HIV-vaccination strategies will also depend on the ability to use novel approaches to analyse and integrate immunogenicity data generated in vaccine trials. The ANRS VAC 18 trial evaluated the immunogenicity of HIV-LIPO-5 vaccine (5 HIV peptides coupled to a palmytoil tail) administered at W0, 4, 12 and 24 in healthy volunteers. 62-69% of vaccinees developed HIV-specific ELISpot responses by W26. Here we present extensive immunogenicity assessments in a subset of vaccinees using ELISpot, lymphoproliferation, intracellular cytokine staining (ICS), cytokine multiplex and transcriptomic analyses. Peripheral blood mononuclear cells from volunteers collected before and following vaccinations were stimulated with HIV LIPO 5 vaccine, Gag peptides contained or not in the vaccine as controls. Different time points and stimulation conditions were compared, using false discovery rate to control for test multiplicity. 74% and 30% of vaccinees had cultured ELISpot and lymphoproliferation responses at W14, respectively. Ex-vivo ICS showed mainly single IL-2 producing cells. Secretion of IFN-γ, TNF-α, IL-5, and IL-13 increased significantly in response to Gag stimulation after culture at W14 compared to W0. An induction of metallothionein genes was consistently detected after HIV-LIPO-5 stimulation at W0 and W14 related to the adjuvant effect of the lipid tail. After vaccination (W14), significant probes increased substantially (>1200 probes) including IFN-γ, CXCL9, IL2RA, TNFAIP6, CCL3L1 and IL-6 W14 (fold change > 100%). In conclusion, HIV LIPO-5 vaccination elicited memory precursor responses with a Th1 and Th2 profile. The signature profile before vaccination provides information about the adjuvant effect of the lipid tail. Consistently with cytokine responses, vaccination is associated with a modulation in gene expression. This combined approach allowed to identify new signatures of HIV vaccine response and indicates that HIV-LIPO-5 could be further developed as a prime component of heterologous prime boost strategies. PBMC mRNA of 12 healthy volunteers, stimulate in four different conditions (HIV-LIPO-5, Gag+, Gag-, NS) during 6 and 24 hours before and after vaccination (week 0 and week 14)
2013-07-30 | E-GEOD-39506 | biostudies-arrayexpress
Project description:The time course of whole blood gene expression was measured after the fourth immunisation at month 6 in participants who had been randomised into vaccine or placebo group 1 of the clinical protocol HVTN087 - A phase 1 trial to evaluate the safety, tolerability, and immunogenicity of an IL-12 pDNA enhanced HIV-1 multi-antigen pDNA vaccine delivered intramuscularly with electroporation, with an HIV-1 rVSV vaccine boost, in healthy HIV-uninfected adult participants (NCT01578889).
2022-01-12 | GSE125019 | GEO
Project description:The failure to date of all S. aureus vaccine trials has been a conundrum and underlines fundamental flaws in current translational models. A major difference between humans and laboratory animals is the early and frequent exposure of humans to S. aureus compared to animals, which is not accounted for in vaccine studies. In recapitulating the failed IsdB human vaccine trial, we showed that mice previously infected with S. aureus do not mount a protective vaccine antibody response, unlike naïve mice. S. aureus infection induces robust but non-neutralizing anti-IsdB antibodies that target different but overlapping IsdB epitopes compared to IsdB vaccine. In the setting of prior S. aureus infection, however, IsdB vaccine recalls the non-protective humoral response which further competes and reduces efficacy of protective vaccine-generated specific antibodies. Vaccination against the heme-binding domain of IsdB or select IsdB epitope can overcome interference by S. aureus infection. Using an adoptive transfer model, we showed that human serum antibodies against IsdB and another vaccine target, ClfA, are also non-protective and blocked anti-staphylococcal immunity conferred by passive immunizations. Overall, our study demonstrates proof of concept that failure of anti-S. aureus active and passive immunizations could be explained by non-protective imprint of prior host-pathogen interaction.
2023-01-28 | GSE193543 | GEO
Project description:Successful development of HIV-vaccination strategies will also depend on the ability to use novel approaches to analyse and integrate immunogenicity data generated in vaccine trials. The ANRS VAC 18 trial evaluated the immunogenicity of HIV-LIPO-5 vaccine (5 HIV peptides coupled to a palmytoil tail) administered at W0, 4, 12 and 24 in healthy volunteers. 62-69% of vaccinees developed HIV-specific ELISpot responses by W26. Here we present extensive immunogenicity assessments in a subset of vaccinees using ELISpot, lymphoproliferation, intracellular cytokine staining (ICS), cytokine multiplex and transcriptomic analyses. Peripheral blood mononuclear cells from volunteers collected before and following vaccinations were stimulated with HIV LIPO 5 vaccine, Gag peptides contained or not in the vaccine as controls. Different time points and stimulation conditions were compared, using false discovery rate to control for test multiplicity. 74% and 30% of vaccinees had cultured ELISpot and lymphoproliferation responses at W14, respectively. Ex-vivo ICS showed mainly single IL-2 producing cells. Secretion of IFN-γ, TNF-α, IL-5, and IL-13 increased significantly in response to Gag stimulation after culture at W14 compared to W0. An induction of metallothionein genes was consistently detected after HIV-LIPO-5 stimulation at W0 and W14 related to the adjuvant effect of the lipid tail. After vaccination (W14), significant probes increased substantially (>1200 probes) including IFN-γ, CXCL9, IL2RA, TNFAIP6, CCL3L1 and IL-6 W14 (fold change > 100%). In conclusion, HIV LIPO-5 vaccination elicited memory precursor responses with a Th1 and Th2 profile. The signature profile before vaccination provides information about the adjuvant effect of the lipid tail. Consistently with cytokine responses, vaccination is associated with a modulation in gene expression. This combined approach allowed to identify new signatures of HIV vaccine response and indicates that HIV-LIPO-5 could be further developed as a prime component of heterologous prime boost strategies.
2013-07-30 | GSE39506 | GEO
Project description:We report a first-in-human trial evaluating safety and immunogenicity of a recombinant BCG, AERAS-422, over-expressing TB antigens Ag85A, Ag85B, and Rv3407 and expressing mutant perfringolysin. Interpretation: The unexpected development of VZV in two of eight healthy adult vaccine recipients resulted in discontinuation of AERAS-422 vaccine development. Immunological and transcriptomal data identified correlations with the development of TB immunity and VZV that require further investigation.
2016-09-22 | GSE87186 | GEO
Project description:To study the gene expression after administrating an inactivated EV71 vaccine, we have employed whole human genome microarray expression profiling to emphasize the gene expression profile of the immune system in response to an inactivated EV71 vaccine in humans and confirmed that such an immune response was generated as the result of the positive mobilization of the immune system. Human peripheral blood from this vaccine or placebo was isolated, extracted the RNA and screened by microarray. The results showed significantly greater neutralizing antibody and specific T cell responses in vaccine group after two inoculations on days 0 and 28. Additionally, more than 600 functional genes that were up- or down-regulated in PBMCs were identified by the microarray assay, and these genes included 68 genes associated with the immune response in vaccine group. The vaccine inoculation group and the placebo control group, originated from the cohort of phase II clinical trial, consisted of 20 subjects (aged from 6-11 months, average: 9.6 months). The trial was randomized, double-blinded and placebo-controlled, and all of the parents or guardians of the subjects were required to sign an informed consent explaining the experiment.
2015-05-06 | E-GEOD-68548 | biostudies-arrayexpress