GBS-NN/NN2 vaccine / Streptococcus Agalactiae Infection / Neonatal Sepsis · Phase 2/3 Trial

A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women

ClinicalTrials.gov · September 4, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for an active Phase 2/3 trial of a novel Group B Streptococcus (GBS) vaccine in pregnant women. The primary aim is to measure persistence of IgG antibody responses to specific GBS antigens over approximately 4 years. No results have been posted in this registry record.

What was studied

Phase 2/3, Interventional, Non Randomized, Parallel, Open label, Prevention purpose. Streptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia, Meningitis, Neonatal Infection, Gram-Positive Bacterial Infections, Bacterial Infections, Bacte…; Female; age from 18 Years; accepts healthy volunteers. Intervention: Pregnant Participants: GBS-NN/NN2 Booster Dose. Compared with: Non-Pregnant Participants: No GBS-NN/NN2 Booster Dose — No Intervention; Pregnant Participants: No GBS-NN/NN2 Booster Dose — No Intervention. n = 137. 6 sites: Denmark, South Africa.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 2/3 registry record of an active trial with no reported results; the study is designed to evaluate antibody persistence to a novel GBS vaccine in pregnant women but has not yet yielded outcome data.

Study design

As stated by the source record.

MethodsPrimary outcome measure: All Participants: Concentration of IgG Antibodies to AlpN Proteins in Blood Serum (assessed at Up to approximately 4 years)

DesignPhase 2/3, Interventional, Non Randomized, Parallel, Open label, Prevention purpose

PopulationStreptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia, Meningitis, Neonatal Infection, Gram-Positive Bacterial Infections, Bacterial Infections, Bacte…; Female; age from 18 Years; accepts healthy volunteers

Sample size137

InterventionPregnant Participants: GBS-NN/NN2 Booster Dose

ComparatorNon-Pregnant Participants: No GBS-NN/NN2 Booster Dose — No Intervention; Pregnant Participants: No GBS-NN/NN2 Booster Dose — No Intervention

Setting6 sites: Denmark, South Africa

Reported figures

Quoted from the source exactly as published.

Planned enrollment137

Study phasePhase 2/3

Primary outcome measureConcentration of IgG Antibodies to AlpN Proteins in Blood Serum, up to approximately 4 years

Follow-up durationApproximately 4 years

Caveats

No clinical or immunological results are reported in this registry record; trial is active and ongoing.
Primary outcome is a surrogate immunological measure (antibody concentration); clinical efficacy in preventing neonatal GBS disease has not been assessed.
Study design features such as randomization, blinding, control arm structure, and comparator are not described in this registry excerpt.
Specific eligibility criteria and recruitment site(s) are not provided in the registry record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2/3 interventional trial; design details beyond phase not stated.

Directness

moderate

Primary outcome is immunological (IgG antibodies) in pregnant women; clinical benefit not yet assessed.

Consistency

insufficient

Single study arm; no comparative data reported in registry record.

Risk of bias

insufficient

Registry record does not describe blinding, randomization, or allocation concealment.

Sample adequacy

moderate

Actual enrollment 137 participants; adequacy for immunogenicity endpoints unclear.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06592586). This is a study registration, not published results. Lead sponsor: Minervax ApS. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2, PHASE3. Study type: INTERVENTIONAL. Enrollment: 137 participants (ACTUAL). Conditions: Streptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia, Meningitis, Neonatal Infection, Gram-Positive Bacterial Infections, Bacterial Infections, Bacterial Infections and Mycoses, Infections. Interventions: BIOLOGICAL: GBS-NN/NN2 vaccine. Primary outcome measures: All Participants: Concentration of IgG Antibodies to AlpN Proteins in Blood Serum , Up to approximately 4 years. Brief summary: The main objective of the study is to evaluate the persistence of the immunoglobulin G (IgG) antibody responses, specific to Alpha-like protein CN (AlpCN), Ribosomal Protein N (RibN), Alpha-like protein 1N (Alp1N), and Alpha-like protein 2 and 3 (Alp2-3N), after a primary vaccination with GBS-NN/NN2 in all participants.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

GBS-NN/NN2 vaccineStreptococcus Agalactiae InfectionNeonatal SepsisNCT06592586PneumoniaMinervax ApS