Bacterial Infections, Bacterial Infections and Mycoses, Gram-Positive Bacterial Infections, Infections, Meningitis, Neonatal Infection, Neonatal Sepsis, Pneumonia, Streptococcus Agalactiae Infection
Conditions
Keywords
Immunology, Streptococcus agalactiae, Lancefield's Group B Streptococcus, Pregnancy
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.
Interventions
BIOLOGICALGBS-NN/NN2 vaccine
0.5 mL (50 μg GBS-NN +50 μg GBS-NN2 adsorbed to 0.5 mg aluminium as Alhydrogel®)
Sponsors
Minervax ApS
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participant living in Denmark or South Africa who has participated in Trial MVX0004 (NCT05154578) and has received at least 1 dose of the GBS-NN/NN2 vaccine. * Participant who is able to read and understand and capable of giving personal signed informed consent. * Participant who is willing and able to comply with scheduled visits, the investigational plan, and other trial procedures. * Participant who is granting access to their trial-related medical records and to their trial materials from Trials MVX0004. * Participant who is expected to be available for the duration of the trial and who can be contacted by telephone during trial participation.
Exclusion criteria
* Any personnel involved in the conduct of the trial (and their family members), including, but not limited to, site staff members, MinervaX employees, and any vendor or contract research organisation (CRO) employees. * Participant with confirmed Group B Streptococcus (GBS) infection since participation in Trial MVX0004. * Participant with any psychiatric condition, including recent (within the past year) active suicidal ideation/behaviour that may increase the risk of trial participation or, in the investigator's judgement, make the participant unsuitable for participation in the trial. * Participant who participated in other trials involving investigational drug(s) or devices within 28 days prior to trial entry, and/or are participating in other trials involving investigational drug(s) or devices at trial entry, or plan to (continue to) participate in other trials involving investigational drug(s) or devices during this trial. * Participant with known or suspected immunodeficiency or cancer or a family history of congenital or hereditary immunodeficiency. Note: Human immunodeficiency virus (HIV) infection is not an exclusion criterion if HIV viral load is ≤1000 copies/mL and the participant has been on antiretroviral therapy for at least 3 months prior to screening and is clinically stable. * Participant receiving chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to trial entry. An immunosuppressive dose of glucocorticoid will be defined as a systemic dose ≥10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted. * Participant who received blood, blood products, plasma derivatives, or any immunoglobulin preparations in the 12 weeks prior to trial entry or is planning to receive such products during this trial. * Participant with current or history of drug or alcohol abuse, as judged by the investigator. * Participant who received any marketed or investigational GBS vaccines (other than GBS-NN/NN2 in the MVX0004 Trial) or who is planning to receive any marketed or investigational (other than GBS NN/NN2) GBS vaccines during this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All Participants: Concentration of IgG Antibodies to AlpN Proteins in Blood Serum | Up to approximately 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Concentration Ratio of IgG Antibodies Between Maternal and Cord Blood at Delivery in Participants who did not Receive the of GBS-NN/NN2 Booster Dose | At Delivery, at any time during the trial (Up to approximately 4 years) |
| Concentration of IgG Antibody to AlpN Proteins in Blood Serum in Infants Born to Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | At birth and at 1 and 3 months post-birth |
| Concentration of IgG Antibody to AlpN Proteins in Cord Blood in Infants Born to Pregnant Participants who did not Receive the GBS-NN/NN2 Booster Dose | At Delivery, at any time during the trial (Up to approximately 4 years) |
| All Participants: Number of Participants Experiencing Procedure-related Serious Adverse Events (SAEs) | Up to approximately 4 years |
| Number of Participants Experiencing Solicited Local and Systemic Adverse Events (AEs) Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up to approximately Day 7 post-dose |
| Number of Participants Experiencing Unsolicited AEs Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up to approximately Day 28 post-dose |
| Number of Participants Experiencing SAEs Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up to approximately 6 months post-delivery |
| Number of Participants Experiencing AEs of Special Interest (AESI) Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up until delivery, at any time during the trial (Up to approximately 4 years) |
| Gestational Age (GA) of Infants Born to Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | At Delivery, at any time during the trial (Up to approximately 4 years) |
| Weight of Infants Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | At Delivery, at any time during the trial (Up to approximately 4 years) |
| Length of Infants Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | At Delivery, at any time during the trial (Up to approximately 4 years) |
| Head Circumference of Infants Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | At Delivery, at any time during the trial (Up to approximately 4 years) |
| Apgar Score of Infants Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | At Delivery, at any time during the trial (Up to approximately 4 years) |
| Number of Infants Experiencing Unsolicited AEs Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up to 1 month post-birth |
| Number of Infants Experiencing Medically-attended AEs (MAAEs) Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up to 6 months post-birth |
| Number of Infants Experiencing SAEs Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up to 6 months post-birth |
| Number of Infants Experiencing AESIs Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up to 6 months post-birth |
| Concentration of IgG Antibodies to AlpN Proteins in Blood Serum in Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Pre-dose, 1 month post-dose, at delivery, and 6 months post-delivery |
| Concentration of IgG Antibodies to AlpN Proteins in Blood Serum at Delivery in Pregnant Participants who did not Receive the GBS-NN/NN2 Booster Dose | At Delivery, at any time during the trial (Up to approximately 4 years) |
| Concentration Ratio of IgG Antibodies Between Maternal and Cord Blood at Delivery in Pregnant Participants who Received the GBS-NN/NN2 Booster Dose and their Infant | At Delivery, at any time during the trial (Up to approximately 4 years) |
Countries
Denmark, South Africa
Outcome results
None listed