Phase I Safety Study of B/HPIV3/S-6P Vaccine Via Nasal Spray in Adults
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ClinicalTrials.gov Identifier: NCT06026514 |
Recruitment Status :
Recruiting
First Posted : September 7, 2023
Last Update Posted : November 8, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | August 30, 2023 | ||||
First Posted Date ICMJE | September 7, 2023 | ||||
Last Update Posted Date | November 8, 2023 | ||||
Actual Study Start Date ICMJE | September 18, 2023 | ||||
Estimated Primary Completion Date | November 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Rise in serum neutralizing antibody titer to SARS-CoV-2 S protein [ Time Frame: On days 63, 70, 84, 180, 360 ] Will be measured by ELISA and neutralization assay
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Phase I Safety Study of B/HPIV3/S-6P Vaccine Via Nasal Spray in Adults | ||||
Official Title ICMJE | A Phase I Study of the Safety and Immunogenicity of the Recombinant, Live-Attenuated, Bovine/Human Parainfluenza Virus Vector Vaccine Expressing the 6P-Prefusion-Stabilized Version of the SARS-CoV-2 Spike Protein, Administered in Two Sequential Doses as Nasal Spray to Adults 18 to 50 Years of Age | ||||
Brief 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. | ||||
Detailed 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Sequential Assignment Intervention Model Description: Recombinant, Live-Attenuated, Bovine/Human Parainfluenza Virus Vector Vaccine Expressing the 6P-Prefusion-Stabilized Version of the SARS-CoV-2 Spike Protein, Administered in two Sequential Doses as Nasal Spray to Adults 18 to 50 Years of Age Masking: None (Open Label)Primary Purpose: Prevention |
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Condition ICMJE | SARS-CoV-2 Infection | ||||
Intervention ICMJE | Biological: B/HPIV3/S-6P
Intranasal vaccine.
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Study Arms ICMJE | Experimental: Intranasal Vaccine
B/HPIV3/S-6P vaccine intranasally given in 2 doses, 56 days apart.
Intervention: Biological: B/HPIV3/S-6P
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 2025 | ||||
Estimated Primary Completion Date | November 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT06026514 | ||||
Other Study ID Numbers ICMJE | CIR 355 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
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Investigators ICMJE | Not Provided | ||||
PRS Account | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
Verification Date | November 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |