Sars-CoV-2 Infection Clinical Trial
Official title:
A Phase 1 Open-label, Active-controlled, Randomized Dose-finding Study to Evaluate Safety, Tolerability, and Immunogenicity of Intradermal and Subcutaneous Application of the Plasmid DNA SARS-CoV-2 Omicron BA.2 Vaccine Alveavax-v1.2 in Primary Ad26.COV2.S Vaccinated Healthy Individuals
The investigated product is a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Booster Vaccine candidate optimized for the Omicron/BA.2 variant. There are currently no licensed, variant-optimized vaccines to prevent infection with SARS-CoV-2 Omicron/BA.2. Approved or authorized SARS-CoV-2 vaccines are expensive, require a stringent cold chain, and have large-scale manufacturing issues, resulting in very limited availability in low- and middle-income countries (LMICs). Given the rapid global spread of the Omicron/BA.2 variant and potential for future novel SARS-CoV-2 variants, the rapid development of an easy-to-manufacture and easy-to-distribute vaccine is of great importance. The objective of the study is to assess the tolerability, safety, and immunogenicity of different doses and routes of administration of the Alveavax-v1.2 vaccine in healthy individuals. The study aims to evaluate: - the safety and tolerability of Alveavax-v1.2 in healthy participants compared to a control booster vaccine in a dose-finding design; - the immunogenicity against SARS-CoV-2 BA.2/Omicron after a booster dose of Alveavax-v1.2; - the clinical efficacy against SARS-CoV-2 after a booster dose of Alveavax-v1.2; - and the success rate of intradermal (ID) injections.
This is a first in human, open-label, active-controlled, randomized dose-finding study to evaluate safety, tolerability, and immunogenicity of intradermal (ID) and subcutaneous (SC) application of the plasmid DNA SARS-CoV-2 Omicron BA.2 vaccine Alveavax-v1.2 in primary Ad26.COV2.S vaccinated healthy individuals. Primary Ad26.COV2.S vaccinated participants will be randomized into one of 5 treatment arms to receive Alveavax-v1.2 or a Ad26.COV2.S control booster vaccine. Participants will be enrolled at multiple sites in South Africa within 28 days after the initial screening to ensure they meet all the inclusion criteria and none of the exclusion criteria. Each participant will be administered a booster vaccine on Day 1 of the study and will be monitored afterwards. Solicited local/systemic reactions will be recorded after vaccination in the participant's diary card for up to 7 days (the vaccine administration day and 6 days later). A total of 130 participants of any sex, aged between 18 and 65 years, who satisfy the inclusion and exclusion criteria are planned to be enrolled in five groups and with vaccine administered according to their dose arm as follows: Low dose: 0.5 mg Alveavax-v1.2 in one ID injection Standard dose: 2 mg Alveavax-v1.2 in one ID injection High dose: 8mg Alveavax-v1.2 in four ID injections SC injection: 8mg Alveavax-v1.2 in one SC injection Control: Janssen Ad26.COV2.S in one intramuscular (IM) injection ;
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