Clinical trials: sponsored by BioNTech SE
Genital Herpes Simplex Type 2
A Clinical Trial in Healthy Volunteers and Volunteers With Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions
This exploratory trial will have three parts. Part A is a dose escalation part, Part B is an expanded safety and dose evaluation part, and Part C is a safety and immunogenicity evaluation part in individuals with recurrent HSV-2…
- Trial name
- NCT05432583
- Testing
- BNT163
- Where
- 6 sites in United States
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
COVID-19, SARS-COV-2 Infection
A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age
This study is designed to find out how well the COVID-19 vaccine protects people 50 to 64, who don't have any serious health problems, compared to a group that receives a vaccine that doesn't contain an ingredient to protect…
- Trial name
- NCT07300839
- Testing
- BNT162b2 Vaccine
- Where
- 196 sites in United States
- Volunteers
- 5,240 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
HIV -1 Infection
A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIV
This study will test a new ribonucleic acid (RNA)-based vaccine called BNT168 in adults living both with and without human immunodeficiency virus (HIV), to see how safe it is, how well it triggers the body's immune response and…
- Trial name
- NCT07698600
- Testing
- BNT168
- Where
- 4 sites in United States, South Africa
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Bacterial Vaginosis
A First-in-human Safety Trial of BNT331 Administered as Single Ascending Doses in Healthy Women and as Multiple Ascending Doses in Women Diagnosed With Bacterial Vaginosis
This was a two-part, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy (for Part B) of BNT331 in healthy women (Part A) and in women diagnosed…
- Trial name
- NCT06469164
- Testing
- BNT331
- Where
- 6 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
COVID-19 Vaccines
A Study of COVID-19 Vaccine(s) in Children and Adults
The purpose of this study is to learn about the safety and effects of updated COVID-19 vaccines (called BNT162b2) in participants 5 Through 64 Years of Age with risk factors for Severe COVID-19, and Participants 65 Years of Age…
- Trial name
- NCT07798648
- Testing
- BNT162b2
- Where
- 14 sites in United States
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Monkeypox
A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines
This was a dose-escalation, Phase I/II study evaluating the safety, tolerability, reactogenicity and immunogenicity of the investigational RNA-based multivalent vaccine candidate BNT166a for active immunization against monkeypox…
- Trial name
- NCT05988203
- Testing
- BNT166a
- Where
- 9 sites in United States, United Kingdom
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
HIV -1 Infection
A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV
This study will test the safety and blood levels of the antibody BNT351 in people living without and with human immunodeficiency virus (HIV).
- Trial name
- NCT07392372
- Testing
- BNT351
- Where
- 6 sites in United States, Germany
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Malaria
A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
This was a randomized, dose-escalation Phase I/IIa study to evaluate safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P.
- Trial name
- NCT06069544
- Testing
- BNT165c, BNT165d
- Where
- 5 sites in United States
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Influenza,Human, COVID-19
A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People
This study is to learn about flu and COVID vaccines, either alone or when mixed together. Healthy people aged 18 or older can join. Participants will get one shot in each arm, either a flu or COVID vaccine, alone or mixed.
- Trial name
- NCT06683352
- Testing
- Investigational Influenza Vaccine, COVID-19 Vaccine, Investigational Influenza/COVID-19 Vaccine
- Where
- 22 sites in United States
- Volunteers
- 1,353 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Mpox (Monkeypox), Smallpox
A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa
This is a randomized, double-blind, placebo-controlled study which aims to assess the safety, reactogenicity, and immunogenicity after one and two doses of BNT166a or placebo in healthy participants.
- Conditions
- Mpox (Monkeypox), Smallpox, Orthopoxvirus Infection
- Trial name
- NCT07379580
- Testing
- BNT166a
- Where
- 6 sites in Democratic Republic of the Congo, South Africa
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
COVID-19 Vaccines
A Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of Age
The purpose of this study is to learn about the safety and effects of an updated COVID-19 vaccine (called BNT162b2) in adults 18 to 64 years of age.
- Trial name
- NCT07730450
- Testing
- BNT162b2 Vaccine, Tdap Vaccine
- Where
- 5 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
COVID-19, SARS-COV-2 Infection
A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That Are Considered at Higher Risk of Severe COVID-19
The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19, called BNT162b2 (2025/2026 formulation).
- Trial name
- NCT07222384
- Testing
- BNT162b2 (2025/2026 formulation)
- Where
- 29 sites in United States, Puerto Rico
- Volunteers
- 344 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2
A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children
The purpose of this clinical trial is to learn about the safety, extent of the side effects, and immune responses of the study vaccine (called variant-adapted BNT162b2 RNA-based vaccine) in healthy children.
- Conditions
- SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19
- Trial name
- NCT05543616
- Testing
- Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
- Where
- 96 sites in United States, Brazil and 3 more
- Volunteers
- 4,338 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
COVID-19, SARS-COV-2 Infection
A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Participants Ages 12 Through 64 Years Considered at Higher Risk of Severe COVID-19, and Participants Ages ≥65 Years
The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19.
- Trial name
- NCT07069309
- Testing
- BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)
- Where
- 19 sites in United States
- Volunteers
- 774 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children
This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and…
- Trial name
- NCT04816643
- Testing
- Biological/Vaccine: BNT162b2 10mcg, BNT162b2 20mcg, BNT162b2 30mcg
- Where
- 128 sites in United States, Brazil and 4 more
- Volunteers
- 11,837 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals
The purpose of this clinical protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people.
- Trial name
- NCT05997290
- Testing
- BNT162b2 (Omi XBB.1.5), BNT162b2 (Omi JN.1), BNT162b2 (Omi KP.2)
- Where
- 37 sites in United States
- Volunteers
- 1,051 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals.
- Trial name
- NCT04368728
- Testing
- BNT162b1, BNT162b2, BNT162b2SA
- Where
- 175 sites in United States, Argentina and 4 more
- Volunteers
- 46,969 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2
Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population
This was a phase II, randomized, placebo-controlled, observer-blinded study of the safety and immunogenicity of SARS-CoV-2 messenger RNA (mRNA) vaccine (BNT162b2) in Chinese healthy population.
- Trial name
- NCT04649021
- Testing
- BNT162b2
- Where
- China
- Volunteers
- 960 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Tuberculosis
Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers
This is a two-part randomized, placebo-controlled, observer-blind, safety and dose-finding Phase Ib/IIa study. This study will evaluate up to four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to…
- Trial name
- NCT05547464
- Testing
- BNT164a1, BNT164b1
- Where
- 8 sites in Mozambique, South Africa
- Volunteers
- 497 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Influenza, COVID-19 (Coronavirus Disease 2019)
A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People
The purpose of this study is to learn about how the flu and COVID vaccines act when given alone or when mixed together. This study is seeking healthy participants aged 18 or older.
- Trial name
- NCT06821061
- Testing
- Investigational Influenza Vaccine, Investigational COVID-19 Vaccine, Investigational Influenza and COVID-19 Combination Vaccine
- Where
- 31 sites in United States
- Volunteers
- 2,650 people, healthy volunteers welcome
- Sponsor
- BioNTech SE