A follow-up trial of GBS NN/NN2 vaccine in healthy pregnant women

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Minervax ApS

Participant type

Pediatric, Healthy volunteers

Age range

0-17 years, 18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

7 Mar 2025 → ongoing

Decision date (initial)

2024-12-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

MinervaX ApS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety

To evaluate the persistence of the IgG antibody responses, specific to AlpCN, RibN, Alp1N, and Alp2 3N, after a primary vaccination with GBS NN/NN2 in all participants

Secondary objectives 11

1. 1. For pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine: To evaluate the IgG antibody responses specific to AlpCN, RibN, Alp1N, and Alp2-3N
2. 2. For the pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine and their infant: To determine the transfer rate of antibody concentrations (IgG) between maternal and cord blood at delivery/ birth
3. 3. For pregnant participants who did not receive a booster dose of the GBS-NN/NN2 vaccine:To evaluate the IgG antibody responses specific to AlpCN, RibN, Alp1N, and Alp2-3N/NN2 vaccine
4. 4. For the pregnant participants who did not receive a booster dose of the GBS-NN/NN2 vaccine and their infant: To determine the transfer rate of antibody concentrations (IgG) between maternal and cord blood at delivery/birth in pregnant participants who did not receive a booster dose of the GBS-NN/NN2 vaccine and their infant
5. 5. For the infants born to participants who received a booster dose of the GBS-NN/NN2 vaccine: To evaluate IgG antibody levels, specific to AlpCN, RibN, Alp1N, and Alp2-3N in infants born to participants who received a booster dose of the GBS-NN/NN2 vaccine
6. 6. For the infants born to participants who did not receive a booster dose of the GBS-NN/NN2 vaccine: To evaluate IgG antibody levels, specific to AlpCN, RibN, Alp1N, and Alp2-3N in infants born to participants who did not receive a booster dose of the GBS-NN/ NN2 vaccine
7. 7. For all participants: To assess safety in all participants
8. 8. or pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine: To a ssess reactogenicity following a booster dose of the GBS-NN/NN2 vaccine
9. 9. For pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine: To assess safety following a booster dose of the GBS-NN/NN2 vaccine
10. 10. For the infants born to participants who received a booster dose of the GBS-NN/NN2 vaccine: To assess safety in infants born to participants who received a booster dose of the GBS-NN/NN2 vaccine
11. 11. For the pregnant participants who received a booster dose of the GBS-NN/NN2 va ccine and their infant: To evaluate the functional activity of vaccine-specific antibodies in an OPkA in pregnant participants who received a booster dose of the GBS-NN/NN2 va ccine and their infant

Conditions and MedDRA coding

Prevention of Group B streptoccoccus infection

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1. Participant living in Denmark or South Africa who has participated either in Trial MVX0004 or MVX0005 and has received at least 1 dose of the GBS-NN/NN2 vaccine
2. 2. Participant who is able to read and understand and capable of giving personal signed informed consent
3. 3. Participant who is willing and able to comply with scheduled visits, the investigational plan, and other trial procedures
4. 4. Participant who is granting access to their trial-related medical records and to their trial materials from Trials MVX0004 or MVX0005, whatever is applicable
5. 5. 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 9

1. 1. 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 employees
2. 2. Participant with confirmed Group B Streptococcus (GBS) infection since participation in Tria l MVX0004 or MVX0005
3. 3. 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
4. 4. 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;
5. 5. Participant with known or suspected immunodeficiency or cancer or a family history of congenital or hereditary immunodeficiency
6. 6. 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
7. 7. 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
8. 8. Participant with current or history of drug or alcohol abuse, as judged by the investigator
9. 9. Participant who received any marketed or investigational (other than GBS-NN/NN2 in the MVX0004 or MVX0005 Tria l) GBS vaccines or who is planning to receive any marketed or investigational (other than GBS-NN/NN2) GBS vaccines during this trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL, m easured once a year in all participants

Secondary endpoints 17

1. 1. In the pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine: Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL pre-dose, at 1 month post-dose, a t delivery, and 6 months after delivery
2. 2. In pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine and their infant: The ratios of antibody concentrations (IgG) between maternal and cord blood at delivery/birth
3. 3. In the pregnant participants who did not receive a booster dose of the GBS-NN/NN2 vaccine: Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL at delivery
4. 4. In pregnant participants who did not receive a booster dose of the GBS-NN/NN2 vaccine and their infant: The ratios of antibody concentrations (IgG) between maternal and cord blood at delivery/birth
5. 5. In the infants born to participants who received a booster dose of the GBS-NN/NN2 vaccine: Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in cord blood and at 1 month and 3 months of age
6. 6. In the infants born to participants who did not receive a booster dose of the GBS-NN/NN2 vaccine: Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in cord blood
7. 7. In all participants: Any trial procedure-related SAEs (ie, SAEs related to blood sampling) during the entire trial period
8. 8. In the pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine: Proportion of participants with solicited local and systemic AEs within 7 days after dosing (ie, day of dosing +6 days post-dose)
9. 9. In the pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine: Proportion of participants with unsolicited AEs within 28 days after dosing (ie, the day of dosing +27 days post-dose)
10. 10. In the pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine: Proportion of participants with SAEs up to 6 months after delivery
11. 11. In the pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine: Proportion of participants with AESIs up to delivery
12. 12. In the infants born to participants who received a booster dose of the GBS-NN/NN2 vaccine: GA, weight, length, head circumference, and Apgar score
13. 13. In the infants born to participants who received a booster dose of the GBS-NN/NN2 vaccine: Proportion of infant participants with unsolicited AEs up to 1 month of age
14. 14. In the infants born to participants who received a booster dose of the GBS-NN/NN2 vaccine: Developmental milestones at 6 months of age
15. 15. In the infants born to participants who received a booster dose of the GBS-NN/NN2 vaccine:Proportion of infant participants with MAAEs, SAEs, and AESIs up to 6 months of age
16. 16. In pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine and their infant: OPkA titres in maternal blood at 1 month post-dose and at delivery
17. 17. In pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine and their infant: PkA titres in infant participants cord blood and at 1 month and 3 months of age

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Minervax ApS

Sponsor organisation

Minervax ApS

Address

Nordre Fasanvej 215

City

Frederiksberg

Postcode

2000

Country

Denmark

Scientific contact point

Organisation

Minervax ApS

Contact name

MinervaX ApS

Public contact point

Organisation

Minervax ApS

Contact name

MinervaX ApS

Third parties 3

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications