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- || leishmania vaccine (ChAd63-KH) / York University, Kenya Medical Research Institute
Review, Journal: Advances in Leishmania Vaccines: Current Development and Future Prospects. (Pubmed Central) - Sep 29, 2024
Despite some success and years of effort, human vaccine trials have encountered difficulties in conferring durable protection against Leishmania, a problem that may be attributed to the parasite's antigenic diversity and the intricate nature of the host's immune response. The aim of this review is to provide a thorough overview of recent advances in Leishmania vaccine development, ranging from initial trials to recent achievements, such as the ChAd63-KH DNA vaccine, which underscores the potential for effective control of leishmaniasis through continued research in this field.
- || leishmania vaccine (ChAd63-KH) / York University, Kenya Medical Research Institute
Clinical, P2b data, Journal: A randomized, double-blind phase 2b trial to evaluate efficacy of ChAd63-KH for treatment of post kala-azar dermal leishmaniasis. (Pubmed Central) - Sep 10, 2024
P2b
Whole-blood transcriptomic analysis identified transcriptional modules associated with interferon responses and monocyte and dendritic cell activation. Thus, a single vaccination with ChAd63-KH showed no therapeutic efficacy in this subset of Sudanese patients with PKDL.
- || leishmania vaccine (ChAd63-KH) / York University, Kenya Medical Research Institute
P2b data, Journal: LEISH2b - A phase 2b study to assess the safety, efficacy, and immunogenicity of the Leishmania vaccine ChAd63-KH in post-kala azar dermal leishmaniasis. (Pubmed Central) - May 30, 2023
P2b
If therapeutic benefit of ChAd63-KH can be shown in PKDL further evaluation of the vaccine in other forms of leishmaniasis should be considered. Clinicaltrials.gov registration: NCT03969134.
- | leishmania vaccine (ChAd63-KH) / York University, Kenya Medical Research Institute
Trial completion: A Study to Assess the Safety, Efficacy and Immunogenicity of Leishmania Vaccine ChAd63-KH in PKDL (clinicaltrials.gov) - May 26, 2023
P2b, N=86, Completed, Sponsor: University of York
Clinicaltrials.gov registration: NCT03969134. Active, not recruiting --> Completed
- | leishmania vaccine (ChAd63-KH) / York University, Kenya Medical Research Institute
Enrollment change, Trial withdrawal: LEISH3: A Study to Assess Safety and Efficacy of a Leishmania Vaccine to Prevent Post Kala Azar Dermal Leishmaniasis (PKDL) (clinicaltrials.gov) - Sep 30, 2022
P2, N=0, Withdrawn, Sponsor: University of York
Active, not recruiting --> Completed N=262 --> 0 | Not yet recruiting --> Withdrawn
- | leishmania vaccine (ChAd63-KH) / York University, Kenya Medical Research Institute
Enrollment closed: A Study to Assess the Safety, Efficacy and Immunogenicity of Leishmania Vaccine ChAd63-KH in PKDL (clinicaltrials.gov) - Sep 30, 2022
P2b, N=86, Active, not recruiting, Sponsor: University of York
N=262 --> 0 | Not yet recruiting --> Withdrawn Recruiting --> Active, not recruiting
- | leishmania vaccine (ChAd63-KH) / York University, Kenya Medical Research Institute
Trial completion date, Trial primary completion date: LEISH3: A Study to Assess Safety and Efficacy of a Leishmania Vaccine to Prevent Post Kala Azar Dermal Leishmaniasis (PKDL) (clinicaltrials.gov) - Jan 21, 2022
P2, N=262, Not yet recruiting, Sponsor: University of York
Recruiting --> Active, not recruiting Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
- | leishmania vaccine (ChAd63-KH) / York University, Kenya Medical Research Institute
Trial completion date, Trial primary completion date: A Study to Assess the Safety, Efficacy and Immunogenicity of Leishmania Vaccine ChAd63-KH in PKDL (clinicaltrials.gov) - Jan 21, 2022
P2b, N=100, Recruiting, Sponsor: University of York
Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Dec 2023 --> Dec 2024 Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Oct 2021 --> Jun 2022
- FMP010 / GSK, Walter Reed Army Institute of Research
Phase classification: Evaluate the Safety and Efficacy of Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered With Adjuvant AS01B (clinicaltrials.gov) - Jun 9, 2020
P1b, N=30, Completed, Sponsor: U.S. Army Medical Research and Development Command
Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Oct 2021 --> Jun 2022 Phase classification: P1 --> P1b
- | leishmania vaccine (ChAd63-KH) / York University, Kenya Medical Research Institute
Enrollment open: A Study to Assess the Safety, Efficacy and Immunogenicity of Leishmania Vaccine ChAd63-KH in PKDL (clinicaltrials.gov) - Apr 13, 2020
P2b, N=100, Recruiting, Sponsor: University of York
Phase classification: P1 --> P1b Not yet recruiting --> Recruiting
- | leishmania vaccine (ChAd63-KH) / York University, Kenya Medical Research Institute
Trial completion date, Trial initiation date, Trial primary completion date: LEISH3: A Study to Assess Safety and Efficacy of a Leishmania Vaccine to Prevent Post Kala Azar Dermal Leishmaniasis (PKDL) (clinicaltrials.gov) - Mar 25, 2020
P2, N=262, Not yet recruiting, Sponsor: University of York
Not yet recruiting --> Recruiting Trial completion date: Dec 2023 --> Jul 2024 | Initiation date: Jan 2020 --> Oct 2020 | Trial primary completion date: Jul 2023 --> Dec 2023
- | leishmania vaccine (ChAd63-KH) / York University, Kenya Medical Research Institute
Trial initiation date: A Study to Assess the Safety, Efficacy and Immunogenicity of Leishmania Vaccine ChAd63-KH in PKDL (clinicaltrials.gov) - Jan 30, 2020
P2b, N=100, Not yet recruiting, Sponsor: University of York
Trial completion date: Dec 2023 --> Jul 2024 | Initiation date: Jan 2020 --> Oct 2020 | Trial primary completion date: Jul 2023 --> Dec 2023 Initiation date: Aug 2019 --> Mar 2020
- | leishmania vaccine (ChAd63-KH) / York University, Kenya Medical Research Institute
Trial completion: Leish2a: A Study of a New Leishmania Vaccine Candidate ChAd63-KH (clinicaltrials.gov) - Jan 28, 2020
P2a, N=24, Completed, Sponsor: University of York
Initiation date: Aug 2019 --> Mar 2020 Active, not recruiting --> Completed
- | leishmania vaccine (ChAd63-KH) / York University, Kenya Medical Research Institute
New P2 trial: LEISH3: A Study to Assess Safety and Efficacy of a Leishmania Vaccine to Prevent Post Kala Azar Dermal Leishmaniasis (PKDL) (clinicaltrials.gov) - Sep 26, 2019
P2, N=262, Not yet recruiting, Sponsor: University of York
- | leishmania vaccine (ChAd63-KH) / York University, Kenya Medical Research Institute
New P2b trial: A Study to Assess the Safety, Efficacy and Immunogenicity of Leishmania Vaccine ChAd63-KH in PKDL (clinicaltrials.gov) - May 30, 2019
P2b, N=100, Not yet recruiting, Sponsor: University of York
- | leishmania vaccine (ChAd63-KH) / York University, Kenya Medical Research Institute
Trial completion date, Trial primary completion date: Leish2a: A Study of a New Leishmania Vaccine Candidate ChAd63-KH (clinicaltrials.gov) - May 24, 2019
P2a, N=24, Active, not recruiting, Sponsor: University of York
Active, not recruiting --> Completed Trial completion date: Apr 2019 --> Dec 2019 | Trial primary completion date: Mar 2019 --> Sep 2019
- | leishmania vaccine (ChAd63-KH) / York University, Kenya Medical Research Institute
Enrollment closed, Trial completion date, Trial primary completion date: Leish2a: A Study of a New Leishmania Vaccine Candidate ChAd63-KH (clinicaltrials.gov) - Nov 19, 2018
P2a, N=24, Active, not recruiting, Sponsor: University of York
Trial completion date: Apr 2019 --> Dec 2019 | Trial primary completion date: Mar 2019 --> Sep 2019 Recruiting --> Active, not recruiting | Trial completion date: Dec 2018 --> Apr 2019 | Trial primary completion date: Sep 2018 --> Mar 2019
- | leishmania vaccine (ChAd63-KH) / York University, Kenya Medical Research Institute
Trial primary completion date: Leish2a: A Study of a New Leishmania Vaccine Candidate ChAd63-KH (clinicaltrials.gov) - Feb 5, 2018
P2a, N=24, Recruiting, Sponsor: University of York
Recruiting --> Active, not recruiting | Trial completion date: Dec 2018 --> Apr 2019 | Trial primary completion date: Sep 2018 --> Mar 2019 Trial primary completion date: Sep 2017 --> Sep 2018
- leishmania vaccine (ChAd63-KH) / York University, Kenya Medical Research Institute
Enrollment open: Leish2a: A Study of a New Leishmania Vaccine Candidate ChAd63-KH (clinicaltrials.gov) - Dec 12, 2016
P2a, N=24, Recruiting, Sponsor: University of York
Trial primary completion date: Sep 2017 --> Sep 2018 Not yet recruiting --> Recruiting
- leishmania vaccine (ChAd63-KH) / York University, Kenya Medical Research Institute
New P2a trial: Leish2a: A Study of a New Leishmania Vaccine Candidate ChAd63-KH (clinicaltrials.gov) - Sep 9, 2016
P2a, N=24, Not yet recruiting, Sponsor: University of York
- FMP010 / GSK, Walter Reed Army Institute of Research
Enrollment change: A Study to Determine the Effects of an Investigational Malaria Vaccine Given to Adults Living in the United States and Thereafter to Adults Living in Kenya (clinicaltrials.gov) - May 29, 2015
P1, N=26, Completed, Sponsor: U.S. Army Medical Research and Materiel Command
Not yet recruiting --> Recruiting N=56 --> 26
- | FMP010 / GSK, Walter Reed Army Institute of Research
New P1 trial: Evaluate the Safety and Efficacy of Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered With Adjuvant AS01B (clinicaltrials.gov) - May 29, 2015
P1, N=30, Completed, Sponsor: U.S. Army Medical Research and Materiel Command
- FMP010 / GSK, Walter Reed Army Institute of Research
Enrollment change: A Study to Determine the Effects of an Investigational Malaria Vaccine Given to Adults Living in the United States and Thereafter to Adults Living in Kenya (clinicaltrials.gov) - Mar 15, 2012
P1, N=56, Completed, Sponsor: U.S. Army Medical Research and Materiel Command
N=56 --> 26 N=26 --> 56