Clinical Trials Logo

Clinical Trial Summary

This Phase 1 clinical trial will evaluate the safety and immunogenicity of an intranasal vaccine candidate, a recombinant, live-attenuated, bovine/human parainfluenza virus vector vaccine expressing the 6-P prefusion-stabilized version of the SARS-CoV-2 spike protein.


Clinical Trial Description

The proposed study is a single center, open label study to be conducted at the Johns Hopkins Bloomberg School of Public Health, Center for Immunization Research (CIR) in Baltimore, MD. Participants will be followed for 12 months after the first immunization, so the duration of study participation will be 12 months after receipt of initial vaccination. Approximately 30 subjects will be enrolled in a rolling fashion to receive 2 doses of the B/HPIV3/S-6P vaccine intranasally 56 days apart. Participants who are enrolled and receive the first vaccine dose will not be replaced, even in the event they are ineligible or unable to take the second dose. Up to 60 subjects will be consented to ensure that 30 subjects are eligible for enrollment and vaccination. Volunteers will be enrolled in a staggered fashion: Group 1: Up to 5 volunteers will be enrolled and vaccinated. Group 2: Up to 10 volunteers will be enrolled and vaccinated. Group 3: The remaining volunteers (up to 15) will be enrolled and vaccinated. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06026514
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact Kawsar Talaat, MD
Phone 410-336-9164
Email ktalaat@jhu.edu
Status Recruiting
Phase Phase 1
Start date September 18, 2023
Completion date June 2025

See also
  Status Clinical Trial Phase
Terminated NCT04555096 - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19 Phase 2
Completed NCT04593641 - This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19) Phase 1
Recruiting NCT05200754 - Trial With or Without Infusion of SARS-CoV-2 Antibody Containing Plasma in High-Risk Patients With COVID-19 Phase 2
Completed NCT04583995 - A Study Looking at the Effectiveness, Immune Response, and Safety of a COVID-19 Vaccine in Adults in the United Kingdom Phase 3
Recruiting NCT06255860 - SARS-COV-2 Reinfection and Multisystem Inflammatory Syndrome in Children (MIS-C) Risk: Matched Case-control Study
Recruiting NCT04516811 - Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19 Phase 3
Recruiting NCT05012826 - Osteopathy and Physiotherapy Compared to Physiotherapy Alone on Fatigue and Functional Status in Long COVID N/A
Completed NCT05007236 - Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection. Phase 2
Completed NCT05523739 - Safety and Efficacy Study of STI-1558 in Healthy Adults and SARS-CoV-2-Positive Patients Phase 1
Suspended NCT04738136 - Safety, Tolerability and Efficacy Of S-1226 in Moderate Severity Covid-19 Bronchiolitis/Pneumonia Phase 2
Recruiting NCT04584658 - Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19) Infection (DYADS Study)
Recruiting NCT04547114 - Breath Analysis for SARS-CoV-2 in Infected and Healthy Subjects
Completed NCT05119348 - Transmission of Coronavirus Disease 2019 (COVID19) in Crowded Environments N/A
Completed NCT05096962 - COVID-19: SARS-CoV-2-CZ-PREVAL-II Study
Recruiting NCT04534400 - Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure
Completed NCT04527354 - Pilot Study to Assess Efficacy and Safety of Treamid in the Rehabilitation of Patients After COVID-19 Pneumonia Phase 2
Completed NCT04583982 - ImmuneSense™ COVID-19 Study
Completed NCT05077176 - Phase 3 Booster Vaccination Against COVID-19 Phase 3
Completed NCT05584189 - COVID-19 MP Biomedicals Rapid SARS-CoV-2 Antigen Test Usability N/A
Completed NCT04600999 - Clinical Trial of Favipiravir Treatment of Patients With COVID-19 Phase 3