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GBS-NN is an investigational vaccine being developed for the prevention of group B streptococcus (GBS) infection. The product records in the EU Clinical Trials Information System list the registry name as GBS-NN, GBS-NN2, reflecting that the vaccine combines two fusion proteins, GBS-NN and GBS-NN2, in a fixed combination.[1] The substance is classified in the therapeutic area of bacterial infections and mycoses.[2] There is no marketing authorisation in the product records, meaning GBS-NN is still an investigational substance and not yet an authorised medicine.[3] The product is supplied by Minervax A/S.[1]
GBS-NN is a protein-based vaccine designed to stimulate an immune response against group B streptococcus. The vaccine contains two fusion proteins, GBS-NN and GBS-NN2, which are based on surface proteins of the bacterium known as AlpN proteins.[3] In the trials, researchers measure antibodies against specific components including RibN, Alp1N, Alp2N, and AlpCN.[1] The goal of vaccination is to induce antibodies in the mother that can be transferred to the infant, providing protection against invasive group B streptococcus disease in newborns.[3]
GBS-NN is formulated as a solution for injection and is given by the intramuscular route.[1] In the registered trials, the dose used is 50 micrograms of each fusion protein, given together with 500 micrograms of aluminium as Alhydrogel in one trial.[1] The vaccine is administered as an injection into the muscle, consistent with the intramuscular route recorded in the product data.[2]
Three clinical trials of GBS-NN are registered in the EU Clinical Trials Information System, all with the status "Authorised".[1][2][3] All three are phase 4 trials, which typically evaluate a product after it has been studied in earlier phases, though GBS-NN has no marketing authorisation in these records.[3] The largest trial is a pivotal safety and immunogenicity trial in maternal immunisation, enrolling 6,341 participants.[3] A second trial, with 564 participants, tests co-administration of GBS-NN/NN2 with the Tdap vaccine in healthy non-pregnant women aged 18 to 49 years.[1] The third trial follows 137 healthy pregnant women to evaluate the persistence of antibody responses after primary vaccination.[2]
The trials include different populations. One trial enrols healthy non-pregnant women aged 18 to 49 years.[1] Another trial enrols healthy pregnant women.[2] The pivotal trial is a maternal immunisation trial, meaning it includes pregnant women, and also measures outcomes in their infants.[3] One trial compares GBS-NN/NN2 given with and without the Tdap vaccine, as well as against a placebo of 0.9% sodium chloride.[1] The pivotal trial also uses a placebo comparator.[3]
The trials measure immune responses and safety. In the co-administration trial, the primary outcomes include antibody concentrations against tetanus toxoid, diphtheria toxoid, pertussis antigens, and the AlpN proteins RibN, Alp1N, Alp2N, and AlpCN, as well as solicited local and systemic adverse events within 7 days after each dose, unsolicited adverse events within 28 days, and serious adverse events from the first dose to the end of the trial.[1] The follow-up trial measures concentrations of IgG antibodies specific to the AlpN proteins once a year to assess persistence.[2] The pivotal trial measures functional antibody titres at birth in infants, and whether these titres reach predefined protective thresholds against early-onset and late-onset invasive GBS disease, as well as serious adverse events and adverse events of special interest in both mothers and infants.[3]
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