Wednesday, April 1, 2020

COVID-19: Vaccines under development

COVID-19 pandemic has led researchers around the world to work on developing a safe and effective vaccine. At present, there are 5 agents which are being extensively tested as potential vaccines. Here is some information about them.
1. mRNA- 1273 

Trial: Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection
   
- novel lipid nanoparticle encapsulated mRNA based vaccine that encodes for spike protein of SARS-CoV-2
- an open-label phase I dose-ranging clinical trial in the United States
- Study Population: 45 healthy people, males and non-pregnant women aged 18-55
    - enrolled in one of three cohorts - 25mcg, 100mcg, 250mcg
    - IM injection of the vaccine on Day 1 and 29 in deltoid
    - Follow up: 1,2,4 weeks post each vaccination, 3,6,12 months post second vaccine

- Objective
    - To evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 3 dosages in healthy adults 
    - To evaluate the immunogenicity as measured by Immunoglobulin G (IgG) enzyme-linked immunosorbent assay ELISA to the SARS-CoV-2 S (spike) protein following a 2-dose vaccination schedule of mRNA-1273 at Day 57

2. BCG Vaccine

BCG vaccine — developed for Tuberculosis. It has favorable in vitro or in vivo effect against RSV, Yellow fever, HSV, HPV. The hypothesis is that it may induce partial protection against the susceptibility to and/or severity of SARS-CoV-2 infection

Trial 1: BCG-CORONA reducing health care workers absenteeism in SARS-CoV-2 pandemic through Bacillus Calmette-Guérin vaccination, a randomized controlled trial (BCG-CORONA)

- RCT in the Netherlands 

- Study population: 1000 Health care workers with direct COVID-infected patient      
  contact
- Study duration: 6 months
- Objective: 
    - To reduce absenteeism among HCW with direct patient contacts during the epidemic phase of COVID19
    - To reduce hospital admission, ICU admission or death in HCW with direct patient contacts during the epidemic phase of COVID19

Trial 2: BRACE - BCG Vaccination to Reduce the Impact of COVID-19 in Australian Healthcare Workers Following Coronavirus Exposure (BRACE) Trial

- Open-label two group phase III RCT in Australia

- Study population: 4170 Healthcare workers
- Study duration: 12 months
- Objective:
    - COVID 19 disease incidence over 6 months, by 12 months
    - severe COVID 19 disease incidence over 6 months, by 12 months


3. Synthetic Minigene Vaccine

Artificial antigen-presenting cell Vaccine - a synthetic minigene that has been engineered based on conserved domains of the viral structural proteins and a polyprotein protease. The vaccine will be produced using a vector system to express viral proteins and immune modulators genes to modify artificial antigen-presenting cells (APC) and to activate T cells


Trial 1: Safety and Immunity of COVID-19 aAPC Vaccine

- Open-label phase I study in China

- Study population: 100 participants aged 6months to 80 years
- Objective: 
    - Injection of COVID-19/aAPC vaccine to volunteers to evaluate the safety
- To evaluate the anti- COVID-19 reactivity of the COVID-19/aAPC vaccine

Trial 2: Phase I/II Multicenter Trial of Lentiviral Minigene Vaccine (LV-SMENP) of COVID-19 Coronavirus

- Open-label Phase I/II study in China

-Study population: 100 participants aged 6months to 80 years
- Objective:
    - Injection and infusion of LV-SMENP DC and antigen-specific cytotoxic T cell vaccines to  
healthy volunteers and COVID-19 infected patients to evaluate the safety
- To evaluate the anti- COVID-19 efficacy of the LV-SMENP DC and antigen-specific  
cytotoxic T cell vaccines

4. ChAdOx1 nCoV-19 Vaccine

Trial: A Phase I/II Study to Determine Efficacy, Safety, and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19 in UK Healthy Adult Volunteers

- Single-blinded, Randomized Phase I/II study in UK
-Study population: 510 participants aged 18 to 55 years
- Objective: 
    - To assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19
    - To assess safety of the candidate ChAdOx1 nCoV


5. Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Trial: A Single-center,Open-label,Dose-escalating Phase I Clinical Trial to Evaluate Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Healthy Adults Aged 18-60 Years Old

- Open label, dose-escalating Phase I study in China
-Study population: 108 participants aged 18 to 60 years
- Objective:
    - To evaluate the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Written by Devi Bavishi
Reference: clincialtrials.gov

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