Vaccination with Adenovirus Type 5 Vector-Based COVID-19 Vaccine as the Primary Series in Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 1/2 Clinical Trial.

Publication date: Mar 11, 2024

This randomized, double-blind, placebo-controlled phase 1/2 trial aimed at evaluating the safety and immunogenicity of Ad5-nCoV via aerosolized or intramuscular or intramuscular-aerosolized routes in SARS-CoV-2-negative adults aged over 18 years. In the phase 1 trial, participants were sequentially enrolled into one of five regimen cohorts: Low-Dose (two doses of aerosolized Ad5-nCoV with 0. 5 cD7 10 viral particles [vps] per dose), Middle-Dose (two doses of aerosolized Ad5-nCoV with 1. 0 cD7 10 vps per dose), High-Dose (two doses of aerosolized Ad5-nCoV with 2. 0 cD7 10 vps per dose), Mixed (intramuscular Ad5-nCoV with 5. 0 cD7 10 vps [first dose] and aerosolized Ad5-nCoV with 2. 0 cD7 10 vps [second dose]), and Single-Dose (one dose of aerosolized Ad5-nCoV with 1. 0 cD7 10 vps). Eligible participants in the phase 2 trial were stratified by 18-59 years old or ‚Č•60 years old and then were sequentially enrolled into one of six regimen cohorts: Low-Dose, Middle-Dose, High-Dose, Mixed, Single-Dose, and Intramuscular (one dose of intramuscular Ad5-nCoV with 1. 0 cD7 10 vps). The intervals between the two doses were 56 days. Participants were randomly allocated in 3:1 (phase 1) and 5:1 (phase 2) ratios to receive either Ad5-nCoV or the placebo in each cohort. This study is registered on ClinicalTrials. gov, NCT04840992. Most adverse reactions that occurred during the solicited period were mild and moderate. One serious adverse event (myelodysplastic syndrome) was considered potentially related to the aerosolized Ad5-nCoV. The GMTs of neutralizing antibodies in the Mixed group were the highest with 57. 03 (95% CI: 23. 95, 135. 80) and 97. 37 (95% CI: 74. 30, 127. 59) in phase 1 and 2 trials, respectively, 28 days after the second dose (p < 0. 0001), which showed significantly higher immune responses compared to other regimens with aerosolized or intramuscular Ad5-nCoV alone.

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Concepts Keywords
Adenovirus aerosolized Ad5-nCoV
Adults COVID-19 vaccine
Clinicaltrials immunogenicity
Myelodysplastic primary series vaccination
Nct04840992 safety

Semantics

Type Source Name
disease VO vaccination
disease VO COVID-19 vaccine
disease VO Ad5-nCoV
disease VO dose
disease VO adverse event
disease MESH myelodysplastic syndrome
disease MESH COVID 19
disease VO vaccine
drug DRUGBANK Coenzyme M
disease VO effective
disease VO Ad26.COV2.S
disease VO USA
disease MESH Emergency
disease VO organization
disease VO population
disease VO Viruses
disease VO effectiveness
disease MESH infection
disease VO immunization
disease IDO history
disease VO protocol
disease IDO replication
disease IDO blood
disease VO titer
disease IDO assay
drug DRUGBANK Flunarizine
disease MESH Seroconversion
disease VO antibody titer
disease IDO cell
disease VO ANOVA
disease VO vaccinated
disease MESH Dysphonia
disease IDO symptom
disease VO injection
disease IDO site
disease VO mouth

Original Article

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