Clinical trials: Phase 1b
Healthy Volunteers
ShigETEC Vaccine Study in Bangladesh
The goal of this clinical trial is to test ShigETEC vaccine, a combination vaccine against Shigella and ETEC diarrhoea in Bangladeshi adults (aged 18-45 years) and paediatric participants of three different age groups (aged 2-5…
- Trial name
- NCT05987488
- Testing
- ShigETEC live, attenuated, oral vaccine
- Where
- Bangladesh
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Eveliqure Biotechnologies GmbH
Atopic Immunoglobulin E-Mediated Allergic Disorder
A Phase 1b Study of STMC-103H in Multi-Sensitized Allergic Subjects Who Are Otherwise Healthy
The primary objective of this study is to assess the safety and tolerability of STMC-103H compared to placebo in allergic subjects who are otherwise healthy.
- Trial name
- NCT03819881
- Testing
- STMC-103H
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Siolta Therapeutics, Inc.
Tuberculosis
Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents
The aims of the phase 1b trial described here are to facilitate identification of assays and immune responses that could then be evaluated as correlates of risk and correlates of protection in efficacy studies and ultimately to…
- Trial name
- NCT02378207
- Testing
- H4:IC31, H56:IC31, BCG
- Where
- South Africa
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Aeras
Malaria,Falciparum
Safety and Immunogenicity of SUM-101 Malaria Vaccine in Children and Infants Living in Burkina Faso
This clinical trial aims to learn about the safety and immunogenicity of the blood-stage malaria vaccine candidate SUM-101 in infants and children, paving the way for its incorporation into a multi-stage malaria vaccine.
- Trial name
- SUM-101 (NCT06618885)
- Testing
- SUM-101
- Where
- Burkina Faso
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- European Vaccine Initiative
Atopic Dermatitis, Type 1 Hypersensitivity
Allergic Disease Onset Prevention Study
This is a Phase 1b/2, randomized, double-blind, multi-center study to evaluate the safety, tolerability, and preliminary clinical efficacy of STMC-103H in neonates and infants at risk for developing allergic disease (Type 1…
- Trial name
- adored (NCT05003804)
- Testing
- STMC-103H
- Where
- 31 sites in United States, Australia and 1 more
- Volunteers
- 283 people, healthy volunteers welcome
- Sponsor
- Siolta Therapeutics, Inc.
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
Respiratory Syncytial Virus
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy preterm…
- Trial name
- MEDI8897 1b (NCT02290340)
- Testing
- MEDI8897 10 mg, MEDI8897 25 mg, MEDI8897 50 mg
- Where
- 13 sites in United States, Chile and 1 more
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Respiratory Syncytial Virus Infections
Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children
This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as drops in the nose.
- Trial name
- NCT04444284
- Testing
- Investigational RSV vaccine MV-012-968 (Dosage 1), Investigational RSV vaccine MV-012-968 (Dosage 2), Investigational RSV vaccine MV-012-968 (Dosage 3)
- Where
- 3 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Meissa Vaccines, Inc.
Malaria,Falciparum
A Study to Determine if a New Malaria Vaccine is Safe and Induces Immunity Among Kenyan Adults, Young Children and Infants
This is a clinical trial to evaluate the safety and immunogenicity of R21/MM in healthy Kenyan participants from the different age groups.Participants will receive 3 vaccinations 4 weeks apart.
- Trial name
- NCT03580824
- Testing
- R21 in Matrix- M adjuvant vaccine
- Where
- Kenya
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Malaria
L9LS MAb in Malian Infants
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of L9LS in infants in Mali and to evaluate the impact of L9LS on subsequent R21/Matrix-MTM vaccine immunogenicity.
- Trial name
- NCT06461026
- Testing
- L9LS, R21/Matrix-MTM
- Where
- 3 sites in Mali
- Volunteers
- 327 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Human Metapneumovirus and Human Parainfluenza Infection
Safety and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3) Vaccine, in Healthy Adults, and Children 12 to 59 Months of Age With Serologic Evidence of Prior Exposure
This clinical study will assess the safety and immunogenicity of 2 dose levels of mRNA-1653, a combined human metapneumovirus and human parainfluenza virus type 3 vaccine, in healthy adults (18 to 49 years of age) and 2 dose…
- Trial name
- NCT04144348
- Testing
- mRNA-1653
- Where
- 19 sites in United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Netherton Syndrome
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
This is a first-in-human, Phase 1/1b, 4-part study that includes the evaluation of safety, tolerability, pharmacokinetics (PK), and immunogenicity of BCX17725 when administered via single and multiple doses in healthy adult…
- Trial name
- NCT06539507
- Testing
- BCX17725
- Where
- 12 sites in United States, Australia and 3 more
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- BioCryst Pharmaceuticals
Memory Disorders
AIT-082 Phase 1B Study
AIT-082 is a novel small molecule that crosses the blood-brain barrier to enhance nerve function by increasing levels of neurotrophic growth factors and encouraging nerve sprouting in the brain.
- Trial name
- NCT00000180
- Testing
- AIT-082
- Where
- 4 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Institute on Aging (NIA)
Ebola-Bundibugyo Virus Disease (Ebola-BDBV)
A Study to Investigate the Safety and Immunogenicity of mRNA-1469 in African Participants 1 to 65 Years of Age
The main objective of this trial is to evaluate the safety of mRNA-1469
- Trial name
- NCT07919197
- Testing
- mRNA-1469
- Where
- Uganda
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
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
H3N2 Influenza
Assess the Safety and Immunogenicity of One or Two Doses of Sing2016 M2SR H3N2 Influenza Vaccine
This is a Phase 1b, randomized, double-blind, dose-escalating, age de-escalating, placebo-controlled study of 200 children, ages 6 months to 17 years.
- Trial name
- NCT04960397
- Testing
- Sing2016 M2SR H3N2
- Where
- 4 sites in United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pneumococcal Infectious Disease
A Phase 1b Clinical Trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
A phase 1b clinical trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2 months (42-89 days) and 2 to 5 years.
- Trial name
- NCT06183216
- Testing
- Sinovac PCV13, PREVNAR 13
- Where
- China
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Sinovac Research and Development Co., Ltd.
Pediculosis Capitis (Head Lice)
A Pharmacokinetic (PK) Study of NatrOVA Topical Creme (1%) in Pediatric Subjects 6 to 24 Months of Age
This is an open label, single center, single dose PK study of NatrOVA Creme Rinse (1%), an investigational treatment for head lice and nits, in normal, healthy infants.
- Trial name
- NCT00410709
- Testing
- NatrOVA Creme Rinse (1%)
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- ParaPRO LLC
Cystic Fibrosis
Study to Assess Amphotericin B Cystetic for Inhalation (ABCI) Doses in Healthy Volunteers & People with Cystic Fibrosis
This is a 3-part, single-ascending dose Phase 1a randomized, double-blind, placebo-controlled study in healthy volunteers (Part A) and multiple-ascending dose Phase 1a randomized, double-blind, placebo-controlled study in healthy…
- Trial name
- ABCI (NCT05802264)
- Testing
- ABCI
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Cystetic Medicines, Inc.
Malaria,Falciparum
MSP3-CRM-Vac4All/ Alhydrogel® Vaccine
Two-arm, randomized, double-blinded and controlled clinical trial to first assess the safety and tolerability of the vaccine in a Phase 1b trial and proceed to assess its efficacy against clinical malaria in young children living…
- Trial name
- NCT05776017
- Testing
- MSP3-CRM-Vac4All/ Alhydrogel®, Anti-Rabies Vaccine
- Where
- Mali
- Volunteers
- 465 people, healthy volunteers welcome
- Sponsor
- Vac4All