NCT06026514

Phase I Safety Study of B/HPIV3/S-6P Vaccine Via Nasal Spray in Adults

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	B/HPIV3/S-6P	Intranasal vaccine.

Timeline

• Start date: 2023-09-18
• Primary completion: 2025-01-16
• Completion: 2025-06-30
• First posted: 2023-09-07
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study