Safety, Tolerability and Immunogenicity of Alveavax-v1.2, a BA.2/Omicron-optimized, DNA Vaccine for COVID-19 Prevention
Condition: Sars-CoV-2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      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
    

Intervention name(s): Alveavax-v1.2; Janssen Ad26.COV2.S
Intervention type(s): Drug; Drug
Intervention description(s): BA.2/Omicron optimized plasmid DNA vaccine for the prevention of COVID-19; COVID-19 vaccine by Janssen / Johnson & Johnson
Other intervention name(s): Alveavax; Janssen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Sars; Sars-CoV-2; COVID-19; Vaccine; pDNA; plasmid DNA; COVID19