- Wits University will begin its second Covid-19 vaccine clinical trial this week
- A Phase 1 trial using the vaccine candidate was completed in Australia, and showed positive results
- The SA trial will enrol around 2 900 participants, and you can register as a volunteer
The University of Witwatersrand (Wits) is beginning their second Covid-19 vaccine trial, and began screening participants on 17 August, according to a press release by the university.
Named the NVX-CoV2373 trial, it will test whether the nanoparticle S-protein, in the Covid-19 vaccine candidate known as NVX-CoV2373, protects against Covid-19 disease in adults aged 18–64 years old.
The vaccine is produced by biotech company, Novavax, based in the US, who are known for producing vaccines for serious infectious diseases.
The SA study is part of a larger, global clinical programme to evaluate the vaccine candidate, including larger Phase 3 studies with approximately 30 000 participants (to be launched throughout the world).
Novavax received a $15 million (R261 million) grant by The Bill & Melinda Gates Foundation for the SA trial.
Trial will consist of two groups
The Novavax Phase 2 clinical trial will be led by Wits Professor of Vaccinology, Shabir Madhi, who is also leading the South African Ox1Cov-19 Vaccine VIDA-Trial. Madhi engaged personally with Novavax and motivated for clinical development of the vaccine to be undertaken in SA.
The trial will enrol approximately 2 900 volunteers aged 18–64 years old, and will evaluate the vaccine candidate’s safety, immunogenicity, and efficacy (protection against Covid-19). It will consist of the enrollment of two cohorts (sample groups):
- One cohort will evaluate the efficacy, safety and immunogenicity of the vaccine in approximately 2 650 healthy, HIV-negative adults.
- The second cohort will evaluate the safety and immunogenicity of the vaccine in approximately 240 medically stable, HIV-positive adults.
Technology that is being used for this vaccine has previously been (successfully) used to develop vaccines against influenza (flu) virus, as well as experimental vaccines against Ebola and Respiratory Syncytial Virus (RSV).
The vaccine candidate is engineered from the genetic sequence of SARS-CoV-2, the virus that causes Covid-19 disease.
Phase 1 showed positive results
Preclinical studies of this vaccine demonstrated that it elicits antibodies that block the binding of spike protein to receptors targeted by SARS-CoV-2. This blocking is a critical aspect of effective vaccine protection.
According to the release, studies of this Novavax vaccine have already been done in non-human primates and have shown protection against SARS-CoV-2 infection in upper airways (nasal passages), as well as protection against lower airway (lung) disease.
A Phase 1 clinical trial was conducted in healthy adults aged 18–59 years in Australia, and was noted to be generally well-tolerated among participants. The data is available online on preprint server medRXIV, and has been submitted for peer-review to a scientific journal.
Participation in trials is important for vaccines access
“The major motivation for Covid-19 vaccines being evaluated at an early stage in South Africa is to generate evidence in the African context on how well these vaccines work in settings such as our own,” says Madhi, also drawing on the importance of vaccine access within an African context:
“This would enable informed decision-making when advocating for the adoption of this [NVX-CoV2373 vaccine candidate] or other Covid-19 vaccines in African countries, once they are shown to be safe and effective.”
Madhi explained that participation in these clinical trials at the outset will be beneficial in South Africa being among the first in line to access these vaccines, once they become available.
You can volunteer to participate in the Covid-19 vaccine trial here.