Group B Streptococcus Infection
Conditions
Brief summary
This is an open label booster vaccine follow-up study. Participants who had received a primary course of GBS-NN/NN2 or placebo in Study MVX0002 will be invited to return to receive a booster dose (or first dose in the case of placebo or vaccine naïve participants) 1 to 5 years after the completion of the primary course of vaccination. All participants will receive a single dose of GBS-NN/NN2 containing 50μg of each fusion protein.
Detailed description
This is an open label vaccine booster follow-up study. Participants who had received a primary course of GBS-NN/NN2 or placebo in Study MVX0002 will be invited to return to receive a booster dose (or first dose in the case of placebo or vaccine naïve participants) 1 to 5 years after the completion of the primary course of vaccination. All participants will receive a single dose of GBS-NN/NN2 containing 50μg of each fusion protein. A minimum of 30 and a maximum of 40 female participants will be recruited, comprised of between 20 and 30 participants who had received previous vaccination with GBS-NN/NN2 in the MVX0002 study and up to 10 participants who had received placebo in the MVX0002 study. If an insufficient number of participants (less than 5) who previously received placebo return to this study, vaccine naïve participants will be recruited. The study will include 7 visits: Visit 1 (Screening), Visit 2 (Day 1 dosing), Visit 3 (Day 8), Visit 4 (Day 29), Visit 5 (Day 57), Visit 6 (Day 85) and Visit 7 (Day 183 Follow-up).
Interventions
BIOLOGICALGBS-NN/NN2
GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS/NN2
Sponsors
Minervax ApS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Open label booster vaccine study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
To be confirmed at Screening: 1. Women who have participated in study MVX0002, with GBS-NN/NN2 vaccine and received active vaccine or placebo (unless it is necessary to recruit vaccine naïve participants to bolster the number of participants who received placebo in MVX0002). 2. Able to voluntarily provide written informed consent to participate in the study. 3. Healthy female participants aged 18-40 years (vaccine naïve participants only). 4. Female participant of childbearing potential willing to use a highly effective method of contraception (in addition to a condom for male partners), if applicable (unless of non-childbearing potential or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the participant) from the first dose until completion of the Day 85 visit. A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. For the purposes of this study, this definition of a female of childbearing potential applies to all females in the study i.e., those who participated in the MVX0002 study and those who are considered vaccine naïve. 5. Female participant of non-childbearing potential. For the purposes of this study, this is defined as the participant being at least 4 months post-surgical sterilisation (including bilateral fallopian tube ligation or bilateral oophorectomy with or without hysterectomy). 6. Female participant with a negative pregnancy test at Screening and prior to dose. 7. Female participant of menopausal status confirmed by demonstrating at Screening that the serum level of the follicle stimulating hormone (FSH) falls within the respective pathology reference range. In the event a participant's menopausal status has been clearly established (for example, the participant indicates she has been amenorrhoeic for 10 years, confirmed by medical history, etc), but serum FSH levels are not consistent with a postmenopausal status, determination of the participant's eligibility to be included in the study will be at the Investigator's discretion following consultation with the Sponsor. 8. Body mass index (BMI) ≥18 and ≤30 kg/m2 (vaccine naïve participants only). 9. Participants' weight ≥ 50 kg and ≤ 100 kg at Screening (vaccine naïve participants only). 10. Non-smokers for at least 3 months prior to study vaccine administration. 11. No clinically significant abnormal test results for serum biochemistry, haematology and/or urine analyses within 28 days before dose administration of the IMP. 12. Participants with a negative urinary drugs of abuse (DOA) screen (including alcohol) test results, determined within 28 days before dose administration of the IMP (N.B.: A positive test result may be repeated at the Investigator's discretion, if on prescribed opiates resulting in a positive test, participants may be eligible at the investigators discretion). 13. No clinically significant abnormalities in vital signs (supine blood pressure/heart rate, respiration rate, tympanic temperature) determined within 28 days before dose of IMP. 14. Participants with a negative coronavirus (COVID-19) Reverse Transcription Polymerase Chain Reaction (RT-PCR) test on admission (Day 1 or Day-1 if deemed appropriate by the Principal Investigator (PI)) if required at the time. To be re-confirmed prior to dose administration: 1. Participants continue to meet all screening inclusion criteria. 2. Participants with a negative urinary drugs of abuse screen (including alcohol) prior to dose administration. 3. Participants with a negative pregnancy test. 4. Participants with a negative COVID-19 RT-PCR test on admission (Day 1) (or Day -1 if deemed appropriate by the PI) if required at the time.
Exclusion criteria
To be confirmed at Screening: 1. Participants who have an autoimmune disease. 2. Participants who have a current infection or any significant illness at Screening (such participants can be rescreened once the active infection or significant illness has resolved). 3. Participants with history or presence of significant cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, psychiatric, autoimmune disease or current infection. 4. Laboratory values at Screening which are deemed by the Investigator to be clinically significantly abnormal. 5. Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab). 6. Participation in a clinical drug study during the 90 days or 5 half-lives, whichever is longer, preceding the initial dose in this study (such participants can be rescreened once the 90-day or 5 half-lives period has elapsed). 7. Participants with a history of severe allergic reactions after previous vaccination. 8. Participants with a history of hypersensitivity to the Investigational Medicinal Product (IMP) or any of the excipients within the IMP or documented allergy to aminoglycosides. 9. Participants who have received any vaccine within 7 days of dosing, or who are planning to receive a vaccine up to 7 days after receiving the GBS-NN/NN2 vaccine. 10. Participants who have received immunosuppressive therapy within the 6 months prior to Screening. 11. Participants with tattoos at the proposed site of vaccine administration. 12. Participants who, in the opinion of the Investigator, are unsuitable for participation in the study. 13. Pregnant or breast feeding. 14. Current or history of drug or alcohol abuse, or a positive urine alcohol test prior to dosing (prescribed opiates are acceptable). 15. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 28 days or 5 half-lives (whichever is longer) prior to the first dose of IMP with the exception of contraceptives and paracetamol (applies to vaccine naïve participants i.e., those who did not participate in the MVX0002 study and participants from the MVX0002 study (both active and placebo) who have not developed new medical conditions which require the use of chronic medications considered as permitted). If participants who participated in the MVX0002 study (either active or placebo recipients) have developed new medical conditions which require the use of chronic medications that do not affect the immune system, the inclusion of such participants will be permitted at the discretion of the Investigator on a case-by-case basis and, only if it is considered that the inclusion within the MVX0003 study will not be detrimental to participant safety. 16. Donation of blood or blood products within 90 days prior to vaccine administration. To be re-confirmed prior to dose administration: 1. Development of any
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Emergent Adverse Events | 12 weeks (Day 85) | Number of participants with treatment emergent adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Emergent Adverse Events | 6 months (Day 183) | Number of participants with treatment emergent adverse events |
| Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values) | From Day 1 to Day 85 | Absolute values of antibody concentration specific for GBS-NN and GBS-NN2 |
| Antibody Concentration Specific for GBS-NN and GBS-NN2 (Fold Increase) | From Day 1 to Day 85 | Geometric mean fold increase in antibody concentration specific for GBS-NN and GBS-NN2 |
| Antibody Concentration Specific for GBS-NN and GBS-NN2 | MVX002 day 85, MVX003 day 1 and MVX003 day 85 | Geometric least square mean of antibody concentrations specific for GBS-NN and GBS-NN2 at day 85 of MVX002 study and day 1 and 85 of MVX003 study. |
Countries
United Kingdom
Participant flow
Recruitment details
Participants were recruited based on their participation on the previous MVX0002 study. The first participant was enrolled on August 17, 2021 and the last one was enrolled on August 8, 2022.
Pre-assignment details
27 patients were enrolled and received the study vaccine. 1 participant was withdrawn and not replaced (the participant requested withdrawal from the study).
Participants by arm
| Arm | Count |
|---|---|
| MVX0002 25 μg GBS-NN/NN2 Patients received a booster dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2 following an initial primary vaccination course with the vaccine GBS-NN/NN2 25 μg in the previous study MVX0002. | 10 |
| MVX0002 50 μg GBS-NN/NN2 Patients received a booster dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2 following an initial primary vaccination course with the vaccine GBS-NN/NN2 50 μg in the previous study MVX0002. | 7 |
| MVX0002 Placebo/Vaccine Naïve Vaccine naïve participants (either placebo recipients from study MVX0002 or new vaccine naïve participants) received a dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2. | 10 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | MVX0002 25 μg GBS-NN/NN2 | MVX0002 50 μg GBS-NN/NN2 | MVX0002 Placebo/Vaccine Naïve |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 10 Participants | 7 Participants | 10 Participants |
| Age, Continuous | 31.4 years STANDARD_DEVIATION 6.54 | 31.4 years STANDARD_DEVIATION 5.6 | 34.6 years STANDARD_DEVIATION 5.83 | 29.2 years STANDARD_DEVIATION 7.51 |
| BMI | 25.680 kg/m² STANDARD_DEVIATION 2.4268 | 25.559 kg/m² STANDARD_DEVIATION 2.6777 | 25.396 kg/m² STANDARD_DEVIATION 2.3944 | 25.999 kg/m² STANDARD_DEVIATION 2.4144 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 10 Participants | 7 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 1.639 meters STANDARD_DEVIATION 0.0658 | 1.644 meters STANDARD_DEVIATION 0.0578 | 1.639 meters STANDARD_DEVIATION 0.0805 | 1.633 meters STANDARD_DEVIATION 0.0691 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 10 Participants | 7 Participants | 10 Participants |
| Region of Enrollment United Kingdom | 27 participants | 10 participants | 7 participants | 10 participants |
| Sex: Female, Male Female | 27 Participants | 10 Participants | 7 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Weight | 69.01 kg STANDARD_DEVIATION 8.31 | 68.98 kg STANDARD_DEVIATION 6.87 | 68.33 kg STANDARD_DEVIATION 9.408 | 69.53 kg STANDARD_DEVIATION 9.625 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 7 | 0 / 10 |
| other Total, other adverse events | 10 / 10 | 7 / 7 | 10 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 7 | 0 / 10 |
Outcome results
Primary
Treatment Emergent Adverse Events
Number of participants with treatment emergent adverse events
Time frame: 12 weeks (Day 85)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MVX0002 25 μg GBS-NN/NN2 | Treatment Emergent Adverse Events | Number of participants reporting at least one TEAE | 10 Participants |
| MVX0002 25 μg GBS-NN/NN2 | Treatment Emergent Adverse Events | Number of participants with Mild TEAE | 4 Participants |
| MVX0002 25 μg GBS-NN/NN2 | Treatment Emergent Adverse Events | Number of participants with Moderate TEAE | 6 Participants |
| MVX0002 25 μg GBS-NN/NN2 | Treatment Emergent Adverse Events | Number of participants with Severe TEAE | 0 Participants |
| MVX0002 25 μg GBS-NN/NN2 | Treatment Emergent Adverse Events | Number of participants with TEAE by relationship to Study Drug: Reasonable Possibility | 10 Participants |
| MVX0002 25 μg GBS-NN/NN2 | Treatment Emergent Adverse Events | Number of participants with TEAE by relationship to Study Drug: No Reasonable Possibility | 0 Participants |
| MVX0002 50 μg GBS-NN/NN2 | Treatment Emergent Adverse Events | Number of participants with TEAE by relationship to Study Drug: No Reasonable Possibility | 3 Participants |
| MVX0002 50 μg GBS-NN/NN2 | Treatment Emergent Adverse Events | Number of participants reporting at least one TEAE | 7 Participants |
| MVX0002 50 μg GBS-NN/NN2 | Treatment Emergent Adverse Events | Number of participants with Severe TEAE | 0 Participants |
| MVX0002 50 μg GBS-NN/NN2 | Treatment Emergent Adverse Events | Number of participants with TEAE by relationship to Study Drug: Reasonable Possibility | 4 Participants |
| MVX0002 50 μg GBS-NN/NN2 | Treatment Emergent Adverse Events | Number of participants with Mild TEAE | 2 Participants |
| MVX0002 50 μg GBS-NN/NN2 | Treatment Emergent Adverse Events | Number of participants with Moderate TEAE | 5 Participants |
| MVX0002 Placebo/Vaccine Naïve | Treatment Emergent Adverse Events | Number of participants with Mild TEAE | 4 Participants |
| MVX0002 Placebo/Vaccine Naïve | Treatment Emergent Adverse Events | Number of participants with Moderate TEAE | 6 Participants |
| MVX0002 Placebo/Vaccine Naïve | Treatment Emergent Adverse Events | Number of participants with TEAE by relationship to Study Drug: No Reasonable Possibility | 2 Participants |
| MVX0002 Placebo/Vaccine Naïve | Treatment Emergent Adverse Events | Number of participants with Severe TEAE | 0 Participants |
| MVX0002 Placebo/Vaccine Naïve | Treatment Emergent Adverse Events | Number of participants reporting at least one TEAE | 10 Participants |
| MVX0002 Placebo/Vaccine Naïve | Treatment Emergent Adverse Events | Number of participants with TEAE by relationship to Study Drug: Reasonable Possibility | 8 Participants |
Secondary
Antibody Concentration Specific for GBS-NN and GBS-NN2
Geometric least square mean of antibody concentrations specific for GBS-NN and GBS-NN2 at day 85 of MVX002 study and day 1 and 85 of MVX003 study.
Time frame: MVX002 day 85, MVX003 day 1 and MVX003 day 85
Population: Only participants who received placebo during the MVX0002 study were analyzed for this outcome measure in the MVX0002 Placebo/Vaccine Naïve arm. Vaccine naïve participants were excluded.
| Arm | Measure | Group | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|---|
| MVX0002 25 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 | Anti-GBSNN2 Antibody - MVX002 Day 85 | 29.1 μg/mL |
| MVX0002 25 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 | Anti-GBSNN Antibody - MVX002 Day 85 | 11.8 μg/mL |
| MVX0002 25 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 | Anti-GBSNN Antibody - MVX003 Day 85 | 45.5 μg/mL |
| MVX0002 25 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 | Anti-GBSNN2 Antibody - MVX003 Day 1 | 7.03 μg/mL |
| MVX0002 25 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 | Anti-GBSNN Antibody - MVX003 Day 1 | 3.43 μg/mL |
| MVX0002 25 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 | Anti-GBSNN2 Antibody - MVX003 Day 85 | 61.5 μg/mL |
| MVX0002 50 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 | Anti-GBSNN Antibody - MVX003 Day 1 | 6.56 μg/mL |
| MVX0002 50 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 | Anti-GBSNN Antibody - MVX003 Day 85 | 83.3 μg/mL |
| MVX0002 50 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 | Anti-GBSNN2 Antibody - MVX003 Day 85 | 110 μg/mL |
| MVX0002 50 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 | Anti-GBSNN2 Antibody - MVX002 Day 85 | 31.0 μg/mL |
| MVX0002 50 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 | Anti-GBSNN2 Antibody - MVX003 Day 1 | 6.77 μg/mL |
| MVX0002 50 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 | Anti-GBSNN Antibody - MVX002 Day 85 | 22.6 μg/mL |
| MVX0002 Placebo/Vaccine Naïve | Antibody Concentration Specific for GBS-NN and GBS-NN2 | Anti-GBSNN Antibody - MVX002 Day 85 | 0.0247 μg/mL |
| MVX0002 Placebo/Vaccine Naïve | Antibody Concentration Specific for GBS-NN and GBS-NN2 | Anti-GBSNN2 Antibody - MVX003 Day 1 | 0.206 μg/mL |
| MVX0002 Placebo/Vaccine Naïve | Antibody Concentration Specific for GBS-NN and GBS-NN2 | Anti-GBSNN2 Antibody - MVX003 Day 85 | 4.42 μg/mL |
| MVX0002 Placebo/Vaccine Naïve | Antibody Concentration Specific for GBS-NN and GBS-NN2 | Anti-GBSNN2 Antibody - MVX002 Day 85 | 0.117 μg/mL |
| MVX0002 Placebo/Vaccine Naïve | Antibody Concentration Specific for GBS-NN and GBS-NN2 | Anti-GBSNN Antibody - MVX003 Day 1 | 0.0669 μg/mL |
| MVX0002 Placebo/Vaccine Naïve | Antibody Concentration Specific for GBS-NN and GBS-NN2 | Anti-GBSNN Antibody - MVX003 Day 85 | 1.59 μg/mL |
Secondary
Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values)
Absolute values of antibody concentration specific for GBS-NN and GBS-NN2
Time frame: From Day 1 to Day 85
Population: Immunogenicity Set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MVX0002 25 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values) | Anti-GBSNN antibodies : Day 1 (Absolute value) | 3.4314 μg/mL |
| MVX0002 25 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values) | Anti-GBSNN antibodies : Day 85 (Absolute value) | 45.4768 μg/mL |
| MVX0002 25 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values) | Anti-GBSNN2 antibodies : Day 1 (Absolute value) | 7.0260 μg/mL |
| MVX0002 25 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values) | Anti-GBSNN2 antibodies : Day 85 (Absolute value) | 61.4636 μg/mL |
| MVX0002 50 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values) | Anti-GBSNN2 antibodies : Day 85 (Absolute value) | 109.9307 μg/mL |
| MVX0002 50 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values) | Anti-GBSNN antibodies : Day 1 (Absolute value) | 6.5606 μg/mL |
| MVX0002 50 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values) | Anti-GBSNN2 antibodies : Day 1 (Absolute value) | 6.7734 μg/mL |
| MVX0002 50 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values) | Anti-GBSNN antibodies : Day 85 (Absolute value) | 83.3289 μg/mL |
| MVX0002 Placebo/Vaccine Naïve | Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values) | Anti-GBSNN2 antibodies : Day 85 (Absolute value) | 4.7237 μg/mL |
| MVX0002 Placebo/Vaccine Naïve | Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values) | Anti-GBSNN antibodies : Day 85 (Absolute value) | 1.6497 μg/mL |
| MVX0002 Placebo/Vaccine Naïve | Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values) | Anti-GBSNN2 antibodies : Day 1 (Absolute value) | 0.2275 μg/mL |
| MVX0002 Placebo/Vaccine Naïve | Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values) | Anti-GBSNN antibodies : Day 1 (Absolute value) | 0.0838 μg/mL |
Secondary
Antibody Concentration Specific for GBS-NN and GBS-NN2 (Fold Increase)
Geometric mean fold increase in antibody concentration specific for GBS-NN and GBS-NN2
Time frame: From Day 1 to Day 85
Population: Immunogenicity Set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MVX0002 25 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 (Fold Increase) | Anti-GBSNN antibodies (fold increase) | 13.25 ratio |
| MVX0002 25 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 (Fold Increase) | Anti-GBSNN2 antibodies (fold increase) | 8.75 ratio |
| MVX0002 50 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 (Fold Increase) | Anti-GBSNN antibodies (fold increase) | 12.70 ratio |
| MVX0002 50 μg GBS-NN/NN2 | Antibody Concentration Specific for GBS-NN and GBS-NN2 (Fold Increase) | Anti-GBSNN2 antibodies (fold increase) | 16.23 ratio |
| MVX0002 Placebo/Vaccine Naïve | Antibody Concentration Specific for GBS-NN and GBS-NN2 (Fold Increase) | Anti-GBSNN antibodies (fold increase) | 19.70 ratio |
| MVX0002 Placebo/Vaccine Naïve | Antibody Concentration Specific for GBS-NN and GBS-NN2 (Fold Increase) | Anti-GBSNN2 antibodies (fold increase) | 20.76 ratio |
Secondary
Treatment Emergent Adverse Events
Number of participants with treatment emergent adverse events
Time frame: 6 months (Day 183)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MVX0002 25 μg GBS-NN/NN2 | Treatment Emergent Adverse Events | 5 Participants |
| MVX0002 50 μg GBS-NN/NN2 | Treatment Emergent Adverse Events | 2 Participants |
| MVX0002 Placebo/Vaccine Naïve | Treatment Emergent Adverse Events | 4 Participants |