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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
42
A single dose of ChAdOx1 nCov-19 delivered intranasally (IN)
CCVTM, University of Oxford, Churchill Hospital
Oxford, United Kingdom
Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of solicited signs and symptoms
Occurrence of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination
Time frame: 7 days
Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of unsolicited signs and symptoms
Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination
Time frame: 28 days
Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of adverse events as identified by change in baseline safety laboratory measures
Change from baseline for safety laboratory measures (hematology and biochemistry) at Day 7 (and Day 35 for 2 dose groups only). Safety laboratory measures include clinical blood tests for full blood count, liver function and renal function as graded on a predetermined toxicity grading scale.
Time frame: 7 or 35 days
Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of serious adverse events (SAEs)
Occurrence of SAEs and AWESIs collected throughout the trial
Time frame: 4 months
Assess the mucosal immune response to intranasal administration of one or two doses of ChAdOx1 nCov-19 in healthy adult volunteers
Quantification of spike-binding mucosal antibody, collected using SAM strips at D0, D7, D14, D28, D42 (2 dose groups only), D56, D112. Includes characterisation of dose-response relationship
Time frame: 112 days
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