Streptococcus Agalactiae InfectionPhase 2/3NCT06592586
A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
A Phase 2/3 study testing GBS-NN/NN2 vaccine in people with Streptococcus Agalactiae Infection and Neonatal Sepsis, run by Minervax ApS at 6 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia
- What is being tested?
- GBS-NN/NN2 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 7 Mar 2025to 30 Jun 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Denmark3 sites
Aarhus Universitetshospital
Aarhus N, Central Jutland, 8200
Hvidovre Hospital - Department Of Obstetrics And Gynaecology
Copenhagen, Capital Region, 2650
Sygehus Lillebælt - Kolding Sygehus
Kolding, Region Syddanmark, 6000
South Africa3 sites
Sefako Makgatho Health Sciences University, Medunsa Clinical Research Unit (MeCRU)
Ga-Rankuwa, Gauteng, 0204
Wits Reproductive Health and HIV Institute (Wits RHI)
Johannesburg, Guateng Province, 2001
Setshaba Research Centre
Pretoria, Guateng Province, 0152
About this study
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
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.
- Conditions
- Streptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia, Meningitis, Neonatal Infection, Gram-Positive Bacterial Infections
- Being tested
- GBS-NN/NN2 vaccine
- Keywords
- Immunology, Streptococcus agalactiae, Lancefield's Group B Streptococcus, Pregnancy
- Medical subject headings
- Streptococcal Infections, Neonatal Sepsis, Pneumonia, Meningitis, Gram-Positive Bacterial Infections, Bacterial Infections, Bacterial Infections and Mycoses, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBS-NN/NN2 vaccineBiological
0.5 mL (50 μg GBS-NN +50 μg GBS-NN2 adsorbed to 0.5 mg aluminium as Alhydrogel®)
| Study group | Role | What they receive |
|---|---|---|
| Non-Pregnant Participants: No GBS-NN/NN2 Booster Dose | No intervention | Participants who received at least one dose of GBS-NN/NN2 during the parent trial (MVX0004) who do not become pregnant during this trial will not receive a GBS-NN/NN2 booster dose. |
| Pregnant Participants: GBS-NN/NN2 Booster Dose | Experimental | Participants who received at least one dose of GBS-NN/NN2 during the parent trial (MVX0004) and, become pregnant during this trial, and qualify, will receive a GBS-NN/NN2 booster dose. Receives: Biological: GBS-NN/NN2 vaccine |
| Pregnant Participants: No GBS-NN/NN2 Booster Dose | No intervention | Participants who received at least one dose of GBS-NN/NN2 during the parent trial (MVX0004) and, become pregnant during this trial but do not qualify for receiving a GBS-NN/NN2 booster dose. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Participants: Concentration of IgG Antibodies to AlpN Proteins in Blood Serum
Measured: Up to approximately 4 years
Secondary outcomes (20)
Concentration of IgG Antibodies to AlpN Proteins in Blood Serum in Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Measured: Pre-dose, 1 month post-dose, at delivery, and 6 months post-delivery
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
Measured: At Delivery, at any time during the trial (Up to approximately 4 years)
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
Measured: 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 Participants who did not Receive the of GBS-NN/NN2 Booster Dose
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: Up to approximately Day 7 post-dose
Number of Participants Experiencing Unsolicited AEs Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Measured: Up to approximately Day 28 post-dose
Number of Participants Experiencing SAEs Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 6 months post-birth
Number of Infants Experiencing SAEs Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Measured: Up to 6 months post-birth
Number of Infants Experiencing AESIs Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Measured: Up to 6 months post-birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start7 Mar 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus Agalactiae InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minervax ApS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592586
- Sponsor's protocol ID
- MVX008
- Other IDs
- 2024-516364-28
- Status last verified
- Aug 2026
- First submitted
- 9 Sep 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06592586
- Acronym / sponsor ID
- MVX008
- Conditions
- Streptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia, Meningitis, Neonatal Infection, Gram-Positive Bacterial Infections
- Keywords
- Immunology, Streptococcus agalactiae, Lancefield's Group B Streptococcus, Pregnancy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Minervax ApSUniversity, hospital or other
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-Pregnant Participants: No GBS-NN/NN2 Booster Dose | No intervention | –Participants who received at least one dose of GBS-NN/NN2 during the parent trial (MVX0004) who do not become pregnant during this trial will not receive a GBS-NN/NN2 booster dose. |
| Pregnant Participants: GBS-NN/NN2 Booster Dose | Experimental | Biological: GBS-NN/NN2 vaccineParticipants who received at least one dose of GBS-NN/NN2 during the parent trial (MVX0004) and, become pregnant during this trial, and qualify, will receive a GBS-NN/NN2 booster dose. |
| Pregnant Participants: No GBS-NN/NN2 Booster Dose | No intervention | –Participants who received at least one dose of GBS-NN/NN2 during the parent trial (MVX0004) and, become pregnant during this trial but do not qualify for receiving a GBS-NN/NN2 booster dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GBS-NN/NN2 vaccine0.5 mL (50 μg GBS-NN +50 μg GBS-NN2 adsorbed to 0.5 mg aluminium as Alhydrogel®) | Biological | Pregnant Participants: GBS-NN/NN2 Booster Dose |
Primary outcome
All Participants: Concentration of IgG Antibodies to AlpN Proteins in Blood Serum
Time frame: Up to approximately 4 years
20 secondary outcomes
Concentration of IgG Antibodies to AlpN Proteins in Blood Serum in Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Time frame: Pre-dose, 1 month post-dose, at delivery, and 6 months post-delivery
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
Time frame: At Delivery, at any time during the trial (Up to approximately 4 years)
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
Time frame: 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 Participants who did not Receive the of GBS-NN/NN2 Booster Dose
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Up to approximately Day 7 post-dose
Number of Participants Experiencing Unsolicited AEs Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Time frame: Up to approximately Day 28 post-dose
Number of Participants Experiencing SAEs Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 6 months post-birth
Number of Infants Experiencing SAEs Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Time frame: Up to 6 months post-birth
Number of Infants Experiencing AESIs Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Time frame: Up to 6 months post-birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing GBS-NN/NN2 vaccine in people with Streptococcus Agalactiae Infection and Neonatal Sepsis, run by Minervax ApS at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All Participants: Concentration of IgG Antibodies to AlpN Proteins in Blood Serum (time frame: Up to approximately 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.