Clinical trial NCT06592586: A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
Official title: A Follow-up Trial to Assess the Persistence of the Immune Response to the Group B Streptococcus Vaccine (GBS-NN/NN2) After a Primary Vaccination of Healthy Pregnant Women, and to Assess Safety, Reactogenicity, and Immunogenicity of the GBS-NN/NN2 Vaccine When Administered During Follow-Up as a 1 Booster Dose During a New Pregnancy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Streptococcus Agalactiae Infection
Neonatal Sepsis
Pneumonia
Meningitis
Neonatal Infection
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Keywords: Immunology
Streptococcus agalactiae
Lancefield's Group B Streptococcus
Pregnancy
Lead sponsor: Minervax ApS
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 338
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Participant living in Denmark or South Africa who has participated either in Trial MVX0004 (NCT05154578) or MVX0005 (NCT04596878) 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 or MVX0005, whatever is applicable.
* Participant who are 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 or MVX0005.
* 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.
* 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 (other than GBS-NN/NN2 in the MVX0004 or MVX0005 Trial) GBS vaccines or who is planning to receive any marketed or investigational (other than GBS NN/NN2) GBS vaccines during this trial.

Primary outcomes:
measure: All Participants: Concentration of IgG Antibodies to AlpN Proteins in Blood Serum
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Concentration of IgG Antibodies to AlpN Proteins in Blood Serum Following GBS-NN/NN2 Booster Dose
timeFrame: Pre-dose, 1 month pots-dose, at delivery, and 6 months post-delivery
measure: Difference in Concentration of IgG Antibodies Between Maternal and Cord Blood at Delivery Following GBS-NN/NN2 Booster Dose
timeFrame: Up until delivery, approximately 5 years
measure: Concentration of IgG Antibodies to AlpN Proteins in Blood Serum at Delivery in the Absence of GBS-NN/NN2 Booster Dose
timeFrame: Up until delivery, approximately 5 years
measure: Difference in Concentration of IgG Antibodies Between Maternal and Cord Blood at Delivery in the Absence of GBS-NN/NN2 Booster Dose
timeFrame: Up until delivery, approximately 5 years
measure: Concentration of IgG Antibody to AlpN Proteins in Blood Serum of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
timeFrame: At delivery and at 1 and 3 months post-birth
measure: Concentration of IgG Antibody to AlpN Proteins in Cord Blood of Offspring from Pregnant Participants who did not Received the GBS-NN/NN2 Booster Dose
timeFrame: Up until birth, approximately 5 years
measure: All Participants: Number of Participants Experiencing Procedure-related Serious Adverse Events (SAEs)
timeFrame: Up to approximately 5 years
measure: Number of Participants Experiencing Solicited Local and Systemic Adverse Events (AEs) Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
timeFrame: Up to approximately Day 7
measure: Number of Participants Experiencing Unsolicited AEs Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
timeFrame: Up to approximately Day 28
measure: Number of Participants Experiencing SAEs Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
timeFrame: Up to approximately 6 months post-delivery
measure: Number of Participants Experiencing AE of Special Interest (AESI) Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
timeFrame: Up until delivery, approximately 5 years
measure: Gestational Age (GA) of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
timeFrame: Up until birth, approximately 5 years
measure: Weight of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
timeFrame: Up until birth, approximately 5 years
measure: Length of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
timeFrame: Up until birth, approximately 5 years
measure: Head Circumference of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
timeFrame: Up until birth, approximately 5 years
measure: Apgar Score of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
timeFrame: Up until birth, approximately 5 years
measure: Number of Offspring Experiencing Unsolicited AEs from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
timeFrame: Up to 1 month post-birth, approximately 5 years
measure: Developmental Milestones of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose as Assessed by the Ages & Stages Questionnaire, 3rd Edition (ASQ-3)
timeFrame: At 6 months post-birth, approximately 5 years
measure: Number of Offspring Experiencing Medically-attended AEs (MAAEs) from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
timeFrame: Up to 6 months post-birth, approximately 5 years
measure: Number of Offspring Experiencing SAEs from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
timeFrame: Up to 6 months post-birth, approximately 5 years
measure: Number of Offspring Experiencing AESIs from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
timeFrame: Up to 6 months post-birth, approximately 5 years
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital
state: Midtjylland
city: Kolding
country: Denmark
facility: Sygehus Lillebælt - Kolding Sygehus
state: Syddanmark
city: Ga-Rankuwa
country: South Africa
facility: Sefako Makgatho Health Sciences University, Medunsa Clinical Research Unit (MeCRU)
state: Gauteng
city: Johannesburg
country: South Africa
facility: Wits Reproductive Health and HIV Institute (Wits RHI)
state: Guateng Province
city: Pretoria
country: South Africa
facility: Setshaba Research Centre
state: Guateng Province
Study officials:
References: