Clinical trials: De-escalation
Safety, Immunogenicity
EMaBS TB Vaccine Study
The study will commence with a dose-escalation and age de-escalation study in healthy adults and adolescents from the previous Entebbe Mother and Baby Study (EMaBS) in Entebbe, Uganda, focusing on ChAdOx1 85A, to provide safety…
- Trial name
- NCT03681860
- Testing
- ChAdOx185A, MVA85A, BCG
- Where
- 2 sites in Uganda, United Kingdom
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- University of Oxford
HER2-positive Breast Cancer
Four Cycles Taxane With Trastuzumab and Pertuzumab Neoadjuvant Therapy Among Low Risk HER2 Positive Patients
Neoadjuvant therapy in the treatment of breast cancer is not only a means of breast conserving surgery, but also a sensitive scheme for patients, in order to reduce the treatment grade, low toxicity and high efficiency.
- Trial name
- LRNacHER2 (NCT06722599)
- Where
- China
- Volunteers
- 171 people
- Sponsor
- Shu Wang
Diarrhoea
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a.
- Trial name
- NCT05073003
- Testing
- AltSonflex1-2-3 High Dose, AltSonflex1-2-3 Medium Dose, AltSonflex1-2-3 Low Dose
- Where
- 2 sites in Belgium, Kenya
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Safety, Tolerability and Immunogenicity of PfSPZ Vaccine in an Age De-escalation Trial in Equatorial Guinea.
This trial will evaluate the safety, tolerability, and immunogenicity of PfSPZ Vaccine in healthy Equatoguinean adults, adolescents, children and infants who receive doses of 0.9x10^6, 1.8x10^6 or 2.7x10^6 PfSPZ Vaccine via…
- Trial name
- NCT02859350
- Testing
- PfSPZ Vaccine, PfSPZ Challenge (for CHMI), Normal Saline
- Where
- Equatorial Guinea
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria,Falciparum
A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 Combined With R21/Matrix-M (a "Multi-stage" Malaria Vaccine)
This is a Phase Ib age de-escalation, dose escalation, open-label study to assess the safety and immunogenicity of the multi-stage malaria vaccine candidate R21 plus RH5.1 and/or R78C in Matrix-M in adults aged 18-35 years and…
- Trial name
- VAC093 (NCT06958198)
- Testing
- R21, RH5.1, R78C
- Where
- Burkina Faso
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Sepsis
Use of Procalcitonin, a Blood Test to Guide Antibiotic Therapy for Sepsis in Adults
Trial design: Randomised controlled, two-arm, parallel, clinical trial to assess the efficacy and safety of sequential daily procalcitonin assessments to guide de-escalation of empirical antibiotic therapy in adult patients with…
- Trial name
- PROCALBAN (NCT05955612)
- Testing
- Procalcitonin measurement
- Where
- Bangladesh
- Volunteers
- 532 people
- Sponsor
- University of Oxford
Salmonella Infections
A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants
The purpose of this study is to evaluate the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid…
- Trial name
- NCT07286370
- Testing
- Low dose of iNTS-TCV, Full dose of iNTS-TCV, TYPHIBEV
- Where
- The Gambia
- Volunteers
- 537 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
BRAF V600 Mutation, Low-grade Glioma
Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas
This phase II trial studies how well de-escalating the drugs dabrafenib and trametinib works in treating patients with low-grade gliomas that have a BRAF V600 gene mutation.
- Conditions
- BRAF V600 Mutation, Low-grade Glioma, Low Grade Glioma of Brain, Recurrent Low Grade Glioma
- Trial name
- PNOC037 (NCT07110246)
- Testing
- Dabrafenib, Trametinib, Magnetic Resonance Imaging (MRI)
- Where
- 12 sites in United States
- Volunteers
- 96 people
- Sponsor
- University of California, San Francisco
Malaria
Pfs230D1M-EPA/AS01 Vaccine, a Transmission Blocking Vaccine Against Plasmodium Falciparum, in an Age De-Escalation Trial of Children and a Family Compound Trial in Mali
Background: Malaria affects many people in Mali and other parts of Africa. It is spread by mosquito bites. Malaria can make people sick or can lead to death.
- Trial name
- NCT03917654
- Testing
- Pfs230D1M-EPA/AS01, HAVRIX, TYPHIM Vi (Salmonella typhi vaccine)
- Where
- Mali
- Volunteers
- 1,301 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Measles, Rubella
Measles and Rubella Vaccine Microneedle Patch Phase 1-2 Age De-escalation Trial
This is a phase 1/2, single-centre, double-blind, double-dummy, randomized, active-controlled, age de-escalation trial. Age de-escalation will be based on a review of the safety data from the preceding cohort (adults for toddlers…
- Conditions
- Measles, Rubella, Vaccination, Healthy
- Trial name
- NCT04394689
- Testing
- Measles Rubella Vaccine (MRV-SC), MRV-MNP, PLA-MNP
- Where
- The Gambia
- Volunteers
- 281 people, healthy volunteers welcome
- Sponsor
- Micron Biomedical, Inc
Plasmodium Falciparum Infection, Malaria
Anti-malaria MAb in Kenyan Children
The purpose of this study is to evaluate the safety and tolerability of one-time subcutaneous (SC) administration of monoclonal antibody (MAb) L9LS in healthy Kenyan children aged 5 months to 10 years, as well as the protective…
- Trial name
- NCT05400655
- Testing
- L9LS
- Where
- Kenya
- Volunteers
- 912 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Monkeypox (Mpox)
Evaluate the Safety and Immunogenicity of the MVA-SIBP Vaccine in the Democratic Republic of the Congo
To evaluate the safety and immunogenicity of the MVA-SIBP vaccine using a double-blind, randomized, controlled, age de-escalation design conducted in Kinshasa, Democratic Republic of the Congo (DRC).
- Trial name
- NCT07253675
- Testing
- MVA-SIBP low dose, MVA-SIBP high dose, MVA-BN
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Shanghai Institute Of Biological Products
Malaria,Falciparum
Safety, Pharmacokinetics, and Plasmodium Falciparum Transmission-reducing Activity of Monoclonal Antibody TB31F in Mali
Mali faces a significant challenge with malaria, particularly among its younger population. While existing measures like seasonal chemoprevention and vaccination have shown efficacy, further innovations are necessary to combat…
- Trial name
- NCT06413108
- Testing
- TB31F, Normal saline
- Where
- Mali
- Volunteers
- 167 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Extra Cranial Non Seminomateous Malignant Germ Cell Tumour
A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent
The main objective is to assess the benefit-risk ratio of a risk-adapted strategy for treatment of extra cranial NSMGCT in children and adolescent.
- Trial name
- NCT02104986
- Testing
- Velbe-Bleomycin-Cisplatin, Vepeside-ifosfamide-Cisplatin
- Where
- 27 sites in France
- Volunteers
- 117 people
- Sponsor
- Centre Leon Berard
HER2-positive Breast Cancer
De-escalation of Neoadjuvant Chemotherapy Regimens With Targeted Therapy Among HER2 Positive Patients
Neoadjuvant therapy is currently the standard treatment process for locally advanced breast cancer, especially for human epidermal growth factor receptor 2 (HER2) positive and triple negative breast cancer, which meets the…
- Trial name
- NacHER2 (NCT06700369)
- Where
- China
- Volunteers
- 519 people
- Sponsor
- Shu Wang
Healthy Volunteers
Study To Evaluate Safety, Tolerability, and Pharmacokinetics of MAM01 in African Population
This study will test a new drug (MAM01) to find which doses are safe and could help prevent people from getting malaria for at least 4 months. The study will take place in parts of Africa where malaria is common.
- Trial name
- NCT06408857
- Testing
- MAM01 300 mg SC, MAM01 300 mg IM, MAM01 2000 mg IV
- Where
- 2 sites in Uganda
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
Fanconi Anemia
TBI Dose De-escalation for Fanconi Anemia
This is a single arm, total body irradiation (TBI) trial. All patients will be prescribed TBI 300 cGy with the goal of evaluating secondary endpoints.
- Trial name
- NCT00352976
- Testing
- Cyclophosphamide, Fludarabine, Total Body Irradiation
- Where
- United States
- Volunteers
- 83 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Typhoid Fever
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in subjects from various age groups in India and Pakistan where Typhoid Fever is highly endemic and an efficacious vaccine…
- Trial name
- NCT01229176
- Testing
- Vi-CRM197 vaccine, Vi Polysaccharide (PS) vaccine, Pneumococcal conjugate vaccine
- Where
- 2 sites in India, Pakistan
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Novartis
Malaria,Falciparum
Safety and Immunogenicity of ChAd63 RH5 and MVA RH5 in Adults, Young Children and Infants Living in Tanzania
This is a dose-escalation, age de-escalation randomised double-blind controlled Phase Ib trial to assess the safety, tolerability and immunogenicity of ChAd63-RH5 administered with MVA-RH5 in a heterologous prime-boost regimen.
- Trial name
- NCT03435874
- Testing
- ChAd63 RH5, MVA RH5, Rabies Vaccine
- Where
- Tanzania
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Anti-Bacterial Agents
Carbapenems De-escalation as Antimicrobial Stewardship
Early de-escalation of carbapenems can reduce unnecessary use of carbaepenems compared with late de-escalation without compromised clinical outcomes
- Trial name
- NCT03114358
- Testing
- Early Carbapenem de-escalation
- Volunteers
- 104 people
- Sponsor
- Chiang Mai University