A partial clinical hold placed on Blue Lake Biotechnology’s Phase I/IIa trial of its respiratory syncytial virus (RSV) vaccine has been lifted.
This follows the US Food and Drug Administration’s (FDA) call to hit pause on all RSV vaccine trials involving infants or RSV-negative children under five after safety concerns were raised in these patient populations.
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In late 2024, the agency placed a hold on all clinical trials of this nature after some participants treated in Moderna’s trial, mRNA-1365-P101, developed vaccine-associated enhanced respiratory disease (VAERD). Following this outcome, Moderna discontinued mRNA-1345’s development in seronegative infants under the age of two in September 2024. The trial was also investigating mRNA-1345.
While cases of VAERD were observed in vaccine recipients during Moderna’s early-stage trial, the FDA has acknowledged that this trend has not been observed in Blue Lake’s Phase I/IIa trial (NCT05655182) of intranasal BLB201 thus far.
After a Type C discussion, Blue Lake got the FDA nod to enrol both RSV-positive and negative children above the age of 18 months in the study. This leaves the US-based biotech open to potentially develop BLB201, an intranasal vaccine candidate, in an infant population moving forward.
Before the partial clinical hold was placed on the study, BLB201 demonstrated its potential in patients aged between eight and 59 months, having reduced the risk of contracting symptomatic RSV by more than 80%.
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By GlobalDataDuring the partial clinical hold, Blue Lake continued to enrol RSV-positive children over two years onto the trial.
Blue Lake’s CMO, Henry Radziewicz, said: “In light of recent setbacks in trials sponsored by other RSV vaccine developers, BLB201 now represents the most advanced paediatric RSV vaccine for young children in clinical development.”
Tackling RSV in the early days
RSV is a highly common virus that causes the hospitalisation of 80,000 children under five years old every year, according to Blue Lake.
Despite its high prevalence, vaccine development efforts in younger patient populations had been few and far between up until recently. This is because two toddlers died from vaccine-associated severe respiratory infections after receiving an RSV candidate in the 1960s.
However, in recent years, pharma companies have once again been looking to develop RSV vaccines for younger patients. These efforts saw MSD – known as Merck & Co in the US – gain FDA approval for its RSV asset, Enflonsia (clesrovimab-cfor) in infants following the positive outcome of the Phase III CLEVER study.
