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GBS-NN2 is an investigational vaccine component developed by MinervaX A/S. It is a fusion protein that, together with GBS-NN, forms the GBS-NN/NN2 vaccine candidate. The substance is registered in the EU Clinical Trials Information System (CTIS) under the name GBS-NN, GBS-NN2 and is classified in the therapeutic area of bacterial infections and mycoses.[1] The product records show no marketing authorisation, meaning GBS-NN2 is still an investigational substance.[1]
GBS-NN2 is designed as a vaccine to stimulate the immune system against group B streptococcus. The trial records indicate that the vaccine targets specific proteins called AlpN proteins, including RibN, Alp1N, Alp2N, and AlpCN.[1] These are surface proteins found on group B streptococcus bacteria. By exposing the immune system to fusion proteins based on these bacterial targets, the vaccine aims to generate antibodies that can recognise and help protect against GBS infection. In the pivotal trial, the vaccine's ability to induce functional antibody titres protective against infant GBS early-onset disease (iGBS EoD) and late-onset disease (iGBS LoD) is being assessed.[3]
GBS-NN2 is formulated as a solution for injection and is administered by intramuscular injection.[1] The trial records describe a dose of 50 micrograms of each fusion protein (GBS-NN and GBS-NN2) combined with 500 micrograms of aluminium as Alhydrogel, an adjuvant that helps enhance the immune response.[1] In two product records, the substance is part of a fixed combination.[1]
Three Phase 4 clinical trials are authorised in the EU, all investigating GBS-NN/NN2 for the prevention of group B streptococcus infection. The largest is a pivotal safety and immunogenicity maternal immunisation trial with 6,341 participants, which includes both a Phase 2 and Phase 3 component.[3] A co-administration trial with 564 healthy non-pregnant women aged 18 to 49 years is testing the vaccine given with and without the Tdap vaccine (Boostrix).[1] A follow-up trial with 137 healthy pregnant women is measuring how long IgG antibodies specific to the AlpN proteins persist after primary vaccination.[2]
The trials measure different outcomes. The co-administration trial assesses antibody concentrations for RibN, Alp1N, Alp2N, and AlpCN, as well as anti-tetanus, anti-diphtheria, and anti-pertussis antibodies, and monitors solicited local and systemic adverse events (AEs) within 7 days after each dose, unsolicited AEs within 28 days, and serious adverse events (SAEs) throughout the trial.[1] The follow-up trial measures IgG antibody concentrations specific to the AlpN proteins in micrograms per millilitre, assessed once a year in all participants.[2] The pivotal trial assesses functional antibody titres at birth in infant participants and whether these titres reach predefined protective thresholds against early-onset and late-onset GBS disease.[3]
The trial records describe the monitoring of side effects rather than reporting known side effect profiles. The co-administration trial is specifically designed to evaluate reactogenicity — the expected local and systemic reactions after vaccination — by recording 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 pivotal trial also monitors serious adverse events and adverse events of special interest (AESIs) in both maternal and infant participants compared to placebo.[3]
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