Phase I clinical trial dataset: naked DNA SARS-CoV-2 Omicron BA.2 booster vaccine Alveavax-v1.2 against Janssen Ad26.COV2.S comparator, NCT05844202
Safety and Immunogenicity of a DNA SARS-CoV-2 vaccine (Alveavax-v1.2): Results of a first-in-human, open-label, active-controlled, randomized dose-finding study of intradermal and subcutaneous application in primary Ad26.COV2.S vaccinated healthy individuals. We conducted a Phase I open-label, active-controlled, randomized safety and dose-finding study for the naked DNA Omicron BA.2 booster vaccine Alveavax-v1.2. Healthy participants previously immunized with a single Janssen Ad26.COV2.S vaccine were recruited from seven non-hospital study sites in South Africa. Primary outcome was safety and tolerability on day 28 after vaccination; secondary endpoints were humoral immunogenicity, clinical efficacy and success rate of intradermal (ID) injections. A central randomization system allocated participants into the groups in blocks ranging from 1 to 5: low dose - 0.5 mg ID; standard dose - 2 mg ID; high dose - 8 mg (4 ID of 2 mg each); subcutaneous injection - 8 mg; control - Janssen Ad26.COV2.S booster as a single intramuscular injection. All analyses were based on a modified Intent-To-Treat (mITT) population. ClinicalTrials.gov Identifier: NCT05844202. As this was a phase I study, all data were analyzed descriptively without a formal statistical hypothesis and sample sizes were not based on a statistical power calculation. Figure 1 illustrates the participants included in the safety and immunogenicity analyses. The safety population was the set of all study participants who were administered with a dose of the vaccine candidate. Participants were grouped as treated. All enrolled participants who received a study vaccine and experienced at least one post-baseline immunogenicity readout comprised the modified intent-to-treat (mITT) population. Missing or non- evaluable measurements were not replaced. The mITT and Safety populations were identical. The mITT population was used instead of the per protocol population for the immunogenicity analyses as the differences to the Janssen control were small and the former included more participants. Categorical variables were summarized as frequencies and percentages. Continuous variables were summarized using descriptive statistics (number of participants with an observation [n], mean, standard deviation [SD], median, and range). Where partial dates (missing day or missing day and month) were recorded on the electronic case report form (CRF) and where these could not be resolved by queries, dates were estimated for the purpose of calculating durations. Statistical analysis was performed using SAS® software (version 9.4 or higher; SAS Institute Inc., USA). AEs were coded using MedDRA version 25.1. Coding included the system organ class and preferred term.
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