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PHH-1V111 is a protein-based COVID-19 vaccine developed by HIPRA HUMAN HEALTH S.L. It is authorised as a medicine in the European Union under the product name BIMERVAX, and the version studied in the trial described here is called BIMERVAX LP.8.1.[1] The vaccine is classified under ATC code J07BN, a group that covers other viral vaccines.[1]
PHH-1V111 is a recombinant, adjuvanted COVID-19 vaccine.[1] "Recombinant" means the vaccine contains a protein produced in a laboratory rather than a live or inactivated virus. "Adjuvanted" means it includes a substance that helps strengthen the immune response. The vaccine is supplied as an emulsion for injection and is given by intramuscular injection.[1] The product name under which it is authorised in the European Union is BIMERVAX LP.8.1 emulsion for injection COVID-19 Vaccine (recombinant, adjuvanted).[1] The authorisation holder is HIPRA HUMAN HEALTH S.L.[1]
As a protein-based vaccine, PHH-1V111 presents a piece of the SARS-CoV-2 virus — a protein — to the immune system. The immune system then learns to recognise this protein and produces antibodies against it. The trial measured neutralising antibodies, which are antibodies that can block the virus from entering cells.[1] The LP.8.1 version is designed to target the Omicron LP.8.1 variant and other epidemiologically relevant SARS-CoV-2 variants.[1]
PHH-1V111 is given as an intramuscular injection.[1] The pharmaceutical form used in the trial is an emulsion for injection, containing 40 micrograms of the vaccine.[1]
One completed Phase 3 trial investigated BIMERVAX LP.8.1 in 68 participants with COVID-19 as the condition of interest.[1] The trial was open-label and single-arm, meaning all participants received the vaccine and there was no comparison group.[1]
The trial measured two main things. First, safety and tolerability were assessed by recording solicited local reactions (such as pain at the injection site) and systemic events (such as fever or fatigue) through Day 7 after vaccination, as well as unsolicited adverse events, serious adverse events, adverse events of special interest, and related medically attended adverse events through the end of the study.[1] Second, immunogenicity was measured by neutralising antibody titres against Omicron LP.8.1 and other SARS-CoV-2 variants at baseline and at Day 14, using a pseudovirion-based neutralisation assay (PBNA).[1] The trial also reported the geometric mean fold rise (GMFR) in neutralising antibody titres from baseline to Day 14.[1]
The clinical trial record does not report side effect results, only that safety was assessed through solicited local and systemic reactions, unsolicited adverse events, serious adverse events, adverse events of special interest, and medically attended adverse events.[1]
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