NCT04816019

A Study of Intranasal ChAdOx1 nCOV-19

A Phase I Study to Determine Safety, Tolerability and Immunogenicity of Intranasal Administration of the COVID Vaccine ChAdOx1 nCOV-19 in Healthy UK Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Open label, dose escalation study to investigate: 1. Safety, tolerability and immunogenicity of one or two doses of intranasal ChAdOx1 nCOV-19, in vaccine naïve individuals, with randomisation between one and two dose groups. 2. Safety, tolerability and immunogenicity of intranasal ChAdOx1 nCOV-19, given as a booster dose in individuals who have had two intramuscular COVID-19 vaccinations.

Detailed description

The study will include up to 54 healthy adult participants, divided into five groups. Groups 1-3 will consist of vaccine-naïve volunteers and groups 4-5 will consist of volunteers who have received 2 doses of IM COVID-19 vaccine. Groups 1-3 will receive three vaccine dose levels (low i.e. 5x10\^9vp, high i.e. 5x10\^10 VP, and moderate i.e. 2x10\^10 VP ChAdOx1 nCOV-19 IN). The low and high dose groups will each have safety lead-in subgroups. All volunteers will be consented for receipt of a booster vaccine at approximately 4 weeks post first vaccine. All volunteers will be randomly allocated 1:1 to receive an intranasal booster vaccine as indicated, stratified by first dose level. Group 4 will consist of volunteers who have received 2 intramuscular doses of ChAdOx1 nCoV-19, at least eight weeks apart, and group 5 will consist of volunteers who have received 2 intramuscular doses of BNT162b, at least three weeks apart. Both of these groups will receive a single standard dose (5x1010vp) on intranasal ChAdOx1 nCOV-19.

Conditions

• Coronavirus

Interventions

Type	Name	Description
BIOLOGICAL	ChAdOx1 nCov-19	A single dose of ChAdOx1 nCov-19 delivered intranasally (IN)

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2021-03-25
• Last updated: 2022-10-24

Locations

1 site across 1 country: United Kingdom