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8 Diseases |  |
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0 Trials |  |
39 News |  |
- | AERAS-404 / Sanofi
Clinical Trial,Phase I, Journal: Adolescent BCG revaccination induces a phenotypic shift in CD4+ T cell responses to Mycobacterium tuberculosis. (Pubmed Central) - Jun 19, 2024
In a companion phase 1b trial, HVTN 602/Aeras A-042, we characterize in-depth the cellular responses to BCG revaccination or to a H4:IC31 vaccine boost to identify T cell subsets that could be responsible for the protection observed...Additionally, a small cluster of Th17 TEM cells induced by BCG revaccination expresses high levels of CD103; these may represent recirculating tissue-resident memory cells that could provide pulmonary immune protection. Together, these results identify unique populations of CD4+ T cells with potential to be immune correlates of protection conferred by BCG revaccination.
- | AERAS-404 / Sanofi
Journal: Multidimensional analyses reveal modulation of adaptive and innate immune subsets by tuberculosis vaccines. (Pubmed Central) - Jun 22, 2021
Responses are measured by whole blood intracellular cytokine staining at baseline and 70 days after vaccination with H4:IC31 (subunit vaccine containing Ag85B and TB10.4), Bacille Calmette-Guerin (BCG, a live attenuated vaccine) or placebo (n = ~30 per group)...In vitro BCG re-stimulation also triggers responses by donor-unrestricted T cells, which may contribute to host responses against mycobacteria. BCG, which demonstrated efficacy against sustained Mycobacterium tuberculosis infection, modulates multiple immune cell subsets, in particular conventional Th1 and Th22 cells, which should be investigated in discovery studies of correlates of protection.
- GSK692342 / GSK, Bill & Melinda Gates Foundation, AERAS-404 / Sanofi
[VIRTUAL] Phase 2b controlled trial of M72/AS01E Vaccine to prevent Tuberculosis and Prevention of M. tuberculosis infection with H4:IC31 Vaccine or BCG Revaccination. (HALL - A) - Jan 11, 2021 - Abstract #NAPCON2020NAPCON_79;
- || AERAS-404 / Sanofi
Review, Journal: Vaccine strategies for the Mtb/HIV copandemic. (Pubmed Central) - Oct 23, 2020
Modification of these vaccine candidates against TB/HIV coinfection could reveal key correlates of protection in a representative animal model. This review discusses the (i) potential TB vaccine candidates that can be exploited for use as a dual vaccine against TB/HIV copandemic (ii) progress made in the realm of TB/HIV dual vaccine candidates in small animal model, NHP model, and human clinical trials (iii) the failures and promising targets for a successful vaccine strategy while delineating the correlates of vaccine-induced protection.
- | AERAS-404 / Sanofi
Preclinical, Journal: An in vitro functional assay to measure the biological activity of TB vaccine candidate H4-IC31. (Pubmed Central) - Aug 27, 2020
The CSA is specific to the H4-IC31 vaccine, determines the RSA of H4-IC31 in the range of 50% to 150% of the reference standard, and is stability indicating as it detects differences in RSA between intact and heat treated H4-IC31. Although the CSA does not provide a link to clinical efficacy, it fulfills the critical requirements for a biological potency test to assess TB vaccine candidates and can be used along with biochemical and immunochemical assays to define a product profile during clinical development, while eliminating the use of animals for product testing.
- || AERAS-404 / Sanofi
Clinical, Journal: Designing tuberculosis vaccine efficacy trials - lessons from recent studies. (Pubmed Central) - Jun 12, 2020
They are the first Prevention of Infection trial, evaluating the H4:IC31 candidate or BCG revaccination in high-risk adolescents and a Prevention of Disease trial evaluating the M72/AS01 candidate in M.tuberculosis-infected, healthy adults...Expert opinion: The opportunities created by these two trials for gaining critically important knowledge are game-changing for TB vaccine development. Their results clearly establish feasibility in the relatively near term of developing novel, effective vaccines that could be crucial to ending the TB epidemic.
- || AERAS-404 / Sanofi
Clinical, P1 data, Journal: A phase 1b randomized study of the safety and immunological responses to vaccination with H4:IC31, H56:IC31, and BCG revaccination in Mycobacterium tuberculosis-uninfected adolescents in Cape Town, South Africa. (Pubmed Central) - May 10, 2020
P1b
Characterization of the assays and the immunogenicity of these vaccines may help to identify valuable markers of protection for upcoming immune correlates analyses of C-040-404 and future TB vaccine efficacy trials. NIAID and Aeras.
- | AERAS-404 / Sanofi
Biomarker, Clinical, Journal: Meeting report: 5th Global Forum on TB Vaccines, 20-23 February 2018, New Delhi India. (Pubmed Central) - May 8, 2019
...New vaccines are in clinical trials, new routes of delivery are being tested, novel assays and biomarker signatures are being developed, and the results from the first prevention of infection clinical trial with the H4:IC31 vaccine candidate and BCG revaccination were presented...The following report presents highlights from talks presented at this Global Forum. A full program, abstract book and presentations (where publicly available) from the Forum may be found at tbvaccinesforum.org.
- |||| AERAS-404 / Sanofi
Trial completion: Phase 1/II, Safety and Immunogenicity Study of AERAS-404 in BCG-Primed Infants (clinicaltrials.gov) - Apr 9, 2018
P1/2, N=243, Completed, Sponsor: Aeras
A full program, abstract book and presentations (where publicly available) from the Forum may be found at tbvaccinesforum.org. Active, not recruiting --> Completed
- |||| AERAS-404 / Sanofi
Trial completion, P2 data: Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents (clinicaltrials.gov) - Oct 9, 2017
P2, N=990, Completed, Sponsor: Aeras
Active, not recruiting --> Completed Active, not recruiting --> Completed
- || AERAS-404 / Sanofi
P2 data, Trial primary completion date: Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents (clinicaltrials.gov) - Jan 24, 2017
P2, N=990, Active, not recruiting, Sponsor: Aeras
Active, not recruiting --> Completed Trial primary completion date: Sep 2016 --> Sep 2017
- ||| AERAS-404 / Sanofi
Enrollment closed, Trial primary completion date: Phase 1/II, Safety and Immunogenicity Study of AERAS-404 in BCG-Primed Infants (clinicaltrials.gov) - Jan 24, 2017
P1/2, N=243, Active, not recruiting, Sponsor: Aeras
Trial primary completion date: Sep 2016 --> Sep 2017 Enrolling by invitation --> Active, not recruiting | Trial primary completion date: Dec 2016 --> Dec 2017
- ||| AERAS-404 / Sanofi
Trial completion, P1 data: Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents (clinicaltrials.gov) - Jan 24, 2017
P1b, N=84, Completed, Sponsor: Aeras
Enrolling by invitation --> Active, not recruiting | Trial primary completion date: Dec 2016 --> Dec 2017 Active, not recruiting --> Completed
- || AERAS-404 / Sanofi
P1 data, Phase classification, Trial primary completion date: Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents (clinicaltrials.gov) - Jul 13, 2016
P1b, N=84, Active, not recruiting, Sponsor: Aeras
Active, not recruiting --> Completed Phase classification: P1 --> P1b | Trial primary completion date: May 2016 --> Nov 2016
- || AERAS-404 / Sanofi
P2 data, Trial primary completion date: Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents (clinicaltrials.gov) - Jun 14, 2016
P2, N=990, Active, not recruiting, Sponsor: Aeras
Phase classification: P1 --> P1b | Trial primary completion date: May 2016 --> Nov 2016 Trial primary completion date: Apr 2016 --> Sep 2016
- || AERAS-404 / Sanofi
Enrollment closed, P1 data: Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents (clinicaltrials.gov) - Mar 31, 2016
P1, N=84, Active, not recruiting, Sponsor: Aeras
Trial primary completion date: Apr 2016 --> Sep 2016 Recruiting --> Active, not recruiting
- || AERAS-404 / Sanofi
P2 data, Trial primary completion date: Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents (clinicaltrials.gov) - Jan 18, 2016
P2, N=990, Active, not recruiting, Sponsor: Aeras
Recruiting --> Active, not recruiting Trial primary completion date: Dec 2016 --> Apr 2016
- || AERAS-404 / Sanofi
Enrollment status: Phase 1/II, Safety and Immunogenicity Study of AERAS-404 in BCG-Primed Infants (clinicaltrials.gov) - Oct 23, 2015
P1/2, N=229, Enrolling by invitation, Sponsor: Aeras
Trial primary completion date: Dec 2016 --> Apr 2016 Recruiting --> Enrolling by invitation
- ||| AERAS-404 / Sanofi
Enrollment closed, P2 data: Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents (clinicaltrials.gov) - May 27, 2015
P2, N=990, Active, not recruiting, Sponsor: Aeras
Recruiting --> Enrolling by invitation Recruiting --> Active, not recruiting
- ||| AERAS-404 / Sanofi
Enrollment open, P1 data: Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents (clinicaltrials.gov) - May 26, 2015
P1, N=84, Recruiting, Sponsor: Aeras
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- ||| AERAS-404 / Sanofi
New P1 trial: C-013-404: A Study for Safety and Immunogenicity of BCG and AERAS-404 in HIV-Negative, TB-Negative, BCG-Naive Adults (clinicaltrials.gov) - Apr 17, 2015
P1, N=70, Completed, Sponsor: Aeras
- ||| AERAS-404 / Sanofi
New P1 trial, P1 data: Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents (clinicaltrials.gov) - Mar 5, 2015
P1, N=84, Not yet recruiting, Sponsor: Aeras
- AERAS-404 / Sanofi
New P1 trial: A Phase I Study to Evaluate Safety and Immunogenicity of AERAS 404 (C-011-404) (clinicaltrials.gov) - Apr 8, 2014
P1, N=40, Completed, Sponsor: Aeras
- ||||| AERAS-404 / Sanofi
New P2 trial, P2 data: Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents (clinicaltrials.gov) - Feb 27, 2014
P2, N=990, Recruiting, Sponsor: Aeras
- AERAS-404 / Sanofi
New P1 trial: A Phase I Study to Evaluate Safety and Immunogenicity of AERAS 404 Administered in Adults (clinicaltrials.gov) - Feb 26, 2014
P1, N=60, Completed, Sponsor: Aeras
- AERAS-404 / Sanofi
New P1 trial: A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS-404 Administered as Different Amounts of Antigen and Adjuvant Combinations in HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection (clinicaltrials.gov) - Feb 17, 2014
P1, N=64, Completed, Sponsor: Aeras
- |||| AERAS-404 / Sanofi
Enrollment open: Phase 1/II, Safety and Immunogenicity Study of AERAS-404 in BCG-Primed Infants (clinicaltrials.gov) - Jul 28, 2013
P1/2, N=229, Recruiting, Sponsor: Aeras
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||||| AERAS-404 / Sanofi
New P1/2 trial: Phase 1/II, Safety and Immunogenicity Study of AERAS-404 in BCG-Primed Infants (clinicaltrials.gov) - May 22, 2013
P1/2, N=229, Recruiting, Sponsor: Aeras