Safety, Tolerability and Immunogenicity of Alveavax-v1.2, a BA.2/Omicron-optimized, DNA Vaccine for COVID-19 Prevention
Status:
Completed
Trial end date:
2023-03-02
Target enrollment:
Participant gender:
Summary
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.