Novavax’s South Africa-based Phase IIb trial investigating its COVID-19 vaccine NVX-CoV2373 has results likely to be revealed within the next fortnight, a source familiar with the trial said. The company completed its data entry in the past several days, he added.
NVX-CoV2373 belongs to the second wave of COVID-19 vaccines which are yet to garner any regulatory authorisation. Other second wave vaccines include those by Johnson & Johnson and CureVac. Although a Novavax spokesperson said detailed progress of the Phase IIb trial is not publicly available, the trial is on schedule. According to a presentation from the JP Morgan Annual Healthcare Conference this month, preliminary data are expected early 1Q21.
But multiple 2020 company media releases state timelines depend on local illness rates. In the Phase IIb, 23–50 infection events would trigger efficacy analysis. The 4,422-participant trial started recruiting volunteers in August and completed its enrolment in November, according to a 30 November media release. The study includes 245 medically stable, human immunodeficiency virus (HIV)-positive volunteers. The Phase IIb trial is valuable as it is specific for South Africa, and it would shed light on the vaccine’s efficacy in HIV-positive patients, the source explained. Immunogenicity and safety are the primary endpoints in HIV-positive participants.
NVX-CoV2373 is a two-dose protein subunit vaccine with the second shot administered after 21 days. The Phase IIb is an event-driven trial, with primary endpoints in HIV-negative patients looking into safety and number of symptomatic mild, moderate or severe COVID-19 infections seven days after the second dose, ClinicalTrials.gov states. In the HIV-positive cohort, these event-driven measures are secondary endpoints.
South Africa’s existing regulatory, consent and ethics frameworks around HIV vaccine trial investigations helped with regards to quick initiation and straightforward progress of COVID-19 vaccine trials in the country, the source said. Clinical trial site staff are proactive in ensuring volunteers understand the study process, like the importance of the second shot, he added. Volunteers who might have to travel long distances are reimbursed, he noted.
NVX-CoV2373 is in two Phase III trials. The UK-based Phase III trial was announced as having completed its 15,000-participant enrolment target in the aforementioned 30 November media release. This trial, which will serve as the basis for licensure in the UK, European Union, and other countries, has interim data expected early 2021.
On 28 December, Novavax initiated a second Phase III trial with sites in the US and Mexico, which aims to recruit up to 30,000 volunteers. A trial investigator said this trial has had a slow start but this is not surprising owing to recruitment opening during the holiday season. Though Novavax has yet to detail timelines for this Phase III trial, sites were selected based on high transmission rates to quicken accumulation of infection events, a 28 December media release states.
Novavax has a market cap of $7.4bn.
Reynald Castaneda is an Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.