GBS-NN/NN2 / Minervax - LARVOL DELTA

Prevalence of candidate vaccine targets and genomic features of pediatric invasive Streptococcus agalactiae in Japan. (PubMed, J Infect Dis) - "This nationwide genomic surveillance study suggests that current maternal GBS vaccine candidates would provide broad coverage for pediatric invasive infections in Japan. The identification of persistent and regionally disseminated lineages highlights the importance of investigating potential, yet poorly understood, transmission routes, including environmental reservoirs, to inform future prevention strategies."

Journal • CNS Disorders • Infectious Disease • Pediatrics • Septic Shock

Immunogenicity and safety of a Group B Streptococcus vaccine in pregnant women with and without HIV (FIGO 2025) - P2 | "Women who have received a vaccine within 28 days of receiving the first dose of GBS NN/NN2 or placebo or who expect to require vaccination during the course of the study... Infants born to vaccinated mothers had detectable IgG concentrations up to at least 3 months post-birth, suggesting successful transfer of maternal antibodies. No statistically significant differences were observed between mothers living with HIV and those without HIV. GBS-AlpN was shown to be immunogenic in pregnant women living with and without HIV, with an acceptable safety profile."

Clinical • Anemia • Cardiovascular • CNS Disorders • Cognitive Disorders • Developmental Disorders • Diabetes • Hematological Disorders • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Hypertension • Immunology • Infectious Disease • Inflammation • Influenza • Metabolic Disorders • Pertussis • Psychiatry • Respiratory Diseases • Tetanus • Type 2 Diabetes Mellitus

Safety and immunogenicity of a single booster dose of the group B streptococcus AlpN candidate vaccine (GBS-AlpN) in previously vaccinated healthy women compared with a single dose in previously unvaccinated women. (PubMed, Vaccine) - "Following the demonstration of the safety and immunogenicity of a maternal GBS vaccine containing the fused N-terminal domains of two Alp proteins (αCN and RibN) in healthy adult women, a second-generation vaccine has been developed (GBS-AlpN, GBS-NN/NN2), which also contains the N-terminal domain of the Alp1 and Alp2/3 proteins (Alp1N and Alp2/3 N)...A single dose of GBS-AlpN was well-tolerated and elicited a strong booster antibody response against all four Alp-N-terminal domains in previously vaccinated women and a weaker primary response in the previously unvaccinated women. If these results can be generalised to pregnant women, it is likely that two doses will be required for an initial pregnancy, but a single dose could be sufficient in subsequent pregnancies in clinical practice."

Journal • Infectious Disease

A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women (clinicaltrials.gov) - P2/3 | N=338 | Recruiting | Sponsor: Minervax ApS | Trial completion date: Jun 2030 ➔ Jun 2029 | Trial primary completion date: Jun 2030 ➔ Jun 2029 | Not yet recruiting ➔ Recruiting

Enrollment open • Trial completion date • Trial primary completion date • CNS Disorders • Dermatology • Infectious Disease • Pneumonia • Respiratory Diseases • Septic Shock

A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women (clinicaltrials.gov) - P2/3 | N=338 | Not yet recruiting | Sponsor: Minervax ApS

New P2/3 trial • CNS Disorders • Dermatology • Infectious Disease • Pneumonia • Respiratory Diseases • Septic Shock

GBS-NN/NN2 (50 µg of Each Fusion Protein [GBS-NN and GBS-NN2] in Combination With 500 µg Aluminum as Alhydrogel®) Given With and Without the Tdap Vaccine in Healthy Non-pregnant Women 18 to 49 Years of Age (clinicaltrials.gov) - P2/3 | N=564 | Not yet recruiting | Sponsor: Minervax ApS

Combination therapy • New P2/3 trial • Infectious Disease

Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants (clinicaltrials.gov) - P1 | N=90 | Completed | Sponsor: Minervax ApS | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

Update on Clinical Vaccine Program - GBS-NN/NN2 (ESPID 2024) - No abstract available

Clinical

Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women (clinicaltrials.gov) - P2 | N=272 | Completed | Sponsor: Minervax ApS | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

A Follow up Study of Group B Streptococcus Vaccine (GBS-NN/NN2 Vaccine) in Healthy Volunteers (clinicaltrials.gov) - P=N/A | N=55 | Enrolling by invitation | Sponsor: Minervax ApS

New trial • Infectious Disease

Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants (clinicaltrials.gov) - P1 | N=90 | Active, not recruiting | Sponsor: Minervax ApS | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease

Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV (clinicaltrials.gov) - P2 | N=205 | Completed | Sponsor: Minervax ApS | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

Preclinical development of a novel Group B Streptococcus (GBS) vaccine candidate for maternal immunization based upon the alpha-like protein family of GBS surface proteins (Alp). (PubMed, Birth Defects Res) - "In both studies, the pregnant animals developed immune responses to GBS-NN and GBS-NN2 proteins and concentrations of antibodies to both fusion proteins were detected in the fetuses and in the amniotic fluid. Data generated during these reproductive studies indicated a suitable safety margin (approximately 40-fold clinical dose) considered appropriate to support a subsequent human trial of GBS-NN/NN2 administered in the second and third trimesters of pregnancy."

Journal • Preclinical

Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: Minervax ApS

New P1 trial • Infectious Disease

Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women (clinicaltrials.gov) - P2 | N=272 | Active, not recruiting | Sponsor: Minervax ApS | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2023 ➔ Nov 2023 | Trial primary completion date: Jan 2023 ➔ Apr 2023

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease

Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV (clinicaltrials.gov) - P2 | N=205 | Active, not recruiting | Sponsor: Minervax ApS | Trial completion date: Jun 2022 ➔ May 2023

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine (clinicaltrials.gov) - P1 | N=27 | Completed | Sponsor: Minervax ApS | Active, not recruiting ➔ Completed | N=40 ➔ 27 | Trial primary completion date: May 2022 ➔ Aug 2022

Enrollment change • Trial completion • Trial primary completion date • Infectious Disease

Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV (clinicaltrials.gov) - P2 | N=205 | Active, not recruiting | Sponsor: Minervax ApS | Recruiting ➔ Active, not recruiting | N=150 ➔ 205

Enrollment change • Enrollment closed • Human Immunodeficiency Virus • Infectious Disease

Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women (clinicaltrials.gov) - P2 | N=270 | Recruiting | Sponsor: Minervax ApS | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: Minervax ApS | Recruiting ➔ Active, not recruiting | Trial completion date: May 2022 ➔ Aug 2022 | Trial primary completion date: Jan 2022 ➔ May 2022

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease

Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women (clinicaltrials.gov) - P2; N=270; Not yet recruiting; Sponsor: Minervax ApS

Clinical • New P2 trial • Infectious Disease

Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV (clinicaltrials.gov) - P2; N=150; Recruiting; Sponsor: Minervax ApS; Trial primary completion date: Jun 2021 ➔ Mar 2022

Clinical • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: Minervax ApS; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • PCR

Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Minervax ApS

New P1 trial • Infectious Disease • PCR

Safety and immunogenicity of a prototype recombinant alpha-like protein subunit vaccine (GBS-NN) against Group B Streptococcus in a randomised placebo-controlled double-blind phase 1 trial in healthy adult women. (PubMed, Vaccine) - P1 | "The prototype GBS-NN vaccine was found to be well tolerated and highly immunogenic with an optimal regimen of two doses of 50 µg in the presence of adjuvant. Further development of a maternal vaccine based on the N-terminal domains of the alpha-like protein family of GBS is warranted (NCT02459262)."

Clinical • Journal • P1 data • Immunology • Infectious Disease