Immunogenicity and Safety of a Booster Vaccination With a Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Healthy Adults Volunteers Fully Vaccinated Followed by an Extension Period to Study a Fourth Dose Administration.

COVID-19 Clinical Trial

Official title:
A Phase IIb, Double-blind, Randomised, Active-controlled, Multi-centre, Non-inferiority Trial Followed by a Phase III, Single-arm, Open-label Trial, to Assess Immunogenicity and Safety of a Booster Vaccination With a Recombinant Protein RBD Fusion Dimer Candidate (PHH-1V) Against the Virus That Cause COVID-19, Know as Severe Acute Respiratoy Syndrome Coronavirus 2 (SARS-CoV-2)SARS-CoV-2, in Adults Fully Vaccinated Against COVID-19 Followed by an Extension Period to Study a Fourth Dose Administration of PHH-1V.

Status Completed

Clinical Trial Summary

This Phase IIb clinical study aims to compare the immunogenicity and safety of a booster dose of recombinant protein RBD fusion dimer vaccine as a heterologous booster (to subjects who have received the second dose of the Pfizer-BioNTech (Comirnaty) COVID-19 vaccine at least 182 days prior to the booster dose in this study) versus a homologous booster (subjects who received the second dose of the Comirnaty COVID-19 vaccine at least 182 days prior to the booster dose in this study) will receive a third dose of the Comirnaty vaccine). The extension part of the study aims to compare the immunogenicity and safety of a fourth dose of PHH-1V in subjects with a primovaccination with Pfizer-BioNTech (Comirnaty) COVID-19 vaccine plus either a booster dose of Comirnaty or PHH-1V versus those with three vaccinations of Comirnaty.

Clinical Trial Description

The study population includes 1075 healthy adults aged above 18 years old who have received two doses of the Comirnaty vaccine, and are at least 182 days and less than 365 days after their second dose will be randomly assigned to two treatment arms. In each arm, volunteers will be randomized in a ratio Test vaccine:Comirnaty of 2:1. Each participant will receive one booster immunisation and will be followed for 1 year to evaluate immunogenicity response and assess the safety of the test vaccine in comparison to Cominarty. The study population of the extension part includes 200 healthy adults abode 18 years old who have received or: 3 doses of Comirnaty vaccine, or 2 doses of Comirnaty + 1 dose of PHH-1V. Each participant will receive one dose of PHH-1V. ;

Study Design

Related Conditions & MeSH terms

COVID-19
Respiration Disorders
Respiratory Tract Diseases
SARS-CoV-2 Acute Respiratory Disease

Clinical Trial Details

NCT number	NCT05142553
Study type	Interventional
Source	Hipra Scientific, S.L.U
Contact
Status	Completed
Phase	Phase 2
Start date	November 16, 2021
Completion date	May 29, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06065033` - Exercise Interventions in Post-acute Sequelae of Covid-19	N/A
Completed	`NCT06267534` - Mindfulness-based Mobile Applications Program	N/A
Completed	`NCT05047601` - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection	Phase 2/Phase 3
Recruiting	`NCT04481633` - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection	N/A
Recruiting	`NCT05323760` - Functional Capacity in Patients Post Mild COVID-19	N/A
Completed	`NCT04537949` - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults	Phase 1/Phase 2
Completed	`NCT04612972` - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru	Phase 3
Recruiting	`NCT05494424` - Cognitive Rehabilitation in Post-COVID-19 Condition	N/A
Active, not recruiting	`NCT06039449` - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2	Phase 3
Enrolling by invitation	`NCT05589376` - You and Me Healthy
Completed	`NCT05158816` - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting	`NCT04341506` - Non-contact ECG Sensor System for COVID19
Completed	`NCT04384445` - Zofin (Organicell Flow) for Patients With COVID-19	Phase 1/Phase 2
Completed	`NCT04512079` - FREEDOM COVID-19 Anticoagulation Strategy	Phase 4
Active, not recruiting	`NCT05975060` - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.	Phase 2/Phase 3
Active, not recruiting	`NCT05542862` - Booster Study of SpikoGen COVID-19 Vaccine	Phase 3
Terminated	`NCT05487040` - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease	Phase 1
Withdrawn	`NCT05621967` - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation	N/A
Terminated	`NCT04498273` - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80	Phase 3
Active, not recruiting	`NCT06033560` - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure