COVID-19 Vaccine Clinical Trial
Official title:
Phase 2/3 Study to Evaluate Safety, Tolerability and Immunogenicity of a Recombinant Protein-based Vaccine Against SARS-CoV-2, in a Population of Adult Volunteers Previously Vaccinated Against SARS-CoV-2 Virus.
The goals of this clinical trial are: 1. Phase 2: to test a gamma adapted recombinant vaccine against SARS-CoV-2 in healthy adult volunteers, previously vaccinated against the SARS-CoV-2 virus. 2. Phase 3 (first volunteer enrollement on March 25, 2023): to test a recombinant vaccine against SARS-CoV-2 comparing three different versions (Gamma Variant RBD-based ARVAC-CG vaccine, Omicron Variant RBD-based ARVAC-CG vaccine, Bivariant Gamma/Omicron RBD-based ARVAC-CG vaccine), in adult volunteers previously vaccinated against the SARS-CoV-2 virus The main questions to be answered are: 1. Phase 2: 1. What si the immune response after one dose of vaccine? 2. What is the safety and tolerability profile of this vaccine? 2. Phase 3 : 1. What is the immune response triggered by each vaccine formulation against Wuhan, gamma, and omicron variants. 2. What is the safety and tolerability profile of this vaccine? In phase 2, participants will receive one dose of the study vaccine and one dose of placebo 28 days apart, in a cross-over design. In phase 3 (not yet recruitment), participants will be randomized to receive one of the three possible types of vaccines and all of them will receive one dose of the corresponding vaccine and 1 dose of placebo 28 days apart, in a cross over design.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05049226 -
Third Dose Vaccination With AstraZeneca or Pfizer COVID-19 Vaccine Among Adults Received Sinovac COVID-19 Vaccine
|
Phase 2 | |
| Recruiting |
NCT05998824 -
COVID-19 Vaccination Hesitancy in Adults With Sickle Cell Disease
|
N/A | |
| Recruiting |
NCT05097053 -
A Heterologous 3rd COVID-19 Vaccine of MVC-COV1901 to Evaluate Immunogenicity and Safety in Adults With ChAdOx1-nCov-19
|
Phase 4 | |
| Active, not recruiting |
NCT05463419 -
A Phase II/III Study of PIKA Recombinant SARS-CoV-2 Vaccine as a Booster Dose.
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT05293223 -
Phase IIB Study of Recombinant Novel Coronavirus Vaccine
|
Phase 2 | |
| Completed |
NCT04691947 -
Safety and Immunogenicity of Two Different Strengths of the Inactivated COVID-19 Vaccine ERUCOV-VAC
|
Phase 1 | |
| Completed |
NCT05288231 -
Cardiac Manifestation in Adolescent After Pfizer COVID-19 Injection in Thailand
|
||
| Completed |
NCT04546841 -
Safety and Immunogenicity Trial of Multi-peptide Vaccination to Prevent COVID-19 Infection in Adults
|
Phase 1 | |
| Recruiting |
NCT04963790 -
Enabling Family Physicians to Reduce Vaccine Hesitancy and Increase Covid-19 Vaccine Uptake
|
N/A | |
| Completed |
NCT05216601 -
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of MVC-COV1901 or MVC-COV1901(Beta) Against COVID-19
|
Phase 1 | |
| Completed |
NCT04566276 -
ChulaCov19 Vaccine in Healthy Adults
|
Phase 1/Phase 2 | |
| Completed |
NCT04915820 -
Iron and COVID-19 Vaccine Response
|
N/A | |
| Completed |
NCT05268679 -
Covid-19 Vaccine Response in Heart Transplant Recipients
|
||
| Completed |
NCT04898946 -
Serological Response to mRNA and Inactivated COVID-19 Vaccine in Health Care Workers in Hong Kong
|
||
| Recruiting |
NCT05869968 -
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
|
||
| Active, not recruiting |
NCT05197712 -
Evaluation of the Safety, Tolerability, and Reactogenicity of the Baiya SARS-CoV-2 Vax 2 Vaccine for COVID-19 Disease
|
Phase 1 | |
| Recruiting |
NCT05553743 -
Researchers at UC San Diego Are Learning About the Benefits of Human Milk and How it Influences Infant and Child Health
|
||
| Active, not recruiting |
NCT05188469 -
Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVID and EG-COVARo in Healthy Adult Volunteers
|
Phase 1/Phase 2 | |
| Completed |
NCT04764422 -
Assess the Safety and Immunogenicity of NDV-HXP-S Vaccine in Thailand
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04838080 -
Safety and Immunogenicity of the Inactivated Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine Compared to Placebo
|
Phase 1 |