Group B Streptococcus InfectionPhase 1NCT05005247
Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine
A Phase 1 study testing GBS-NN/NN2 in people with Group B Streptococcus Infection, run by Minervax ApS at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Group B Streptococcus Infection
- What is being tested?
- GBS-NN/NN2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Aug 2021to 5 Aug 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be confirmed at Screening:
- 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).
- Able to voluntarily provide written informed consent to participate in the study.
- Healthy female participants aged 18-40 years (vaccine naïve participants only).
- 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.
- 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).
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- Female participant with a negative pregnancy test at Screening and prior to dose.
- 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.
- Body mass index (BMI) ≥18 and ≤30 kg/m2 (vaccine naïve participants only).
- Participants' weight ≥ 50 kg and ≤ 100 kg at Screening (vaccine naïve participants only).
- Non-smokers for at least 3 months prior to study vaccine administration.
- No clinically significant abnormal test results for serum biochemistry, haematology and/or urine analyses within 28 days before dose administration of the IMP.
- 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).
- No clinically significant abnormalities in vital signs (supine blood pressure/heart rate, respiration rate, tympanic temperature) determined within 28 days before dose of IMP.
- 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:
- Participants continue to meet all screening inclusion criteria.
- Participants with a negative urinary drugs of abuse screen (including alcohol) prior to dose administration.
- Participants with a negative pregnancy test.
- 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.
Who cannot join
- To be confirmed at Screening:
- Participants who have an autoimmune disease.
- 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).
- 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.
- Laboratory values at Screening which are deemed by the Investigator to be clinically significantly abnormal.
- Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).
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- 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).
- Participants with a history of severe allergic reactions after previous vaccination.
- 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.
- 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.
- Participants who have received immunosuppressive therapy within the 6 months prior to Screening.
- Participants with tattoos at the proposed site of vaccine administration.
- Participants who, in the opinion of the Investigator, are unsuitable for participation in the study.
- Pregnant or breast feeding.
- Current or history of drug or alcohol abuse, or a positive urine alcohol test prior to dosing (prescribed opiates are acceptable).
- 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.
- Donation of blood or blood products within 90 days prior to vaccine administration.
- To be re-confirmed prior to dose administration:
- Development of any exclusion criteria since the Screening visit.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements since the Screening visit 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).
- Participation in a clinical study since the Screening visit.
- Donation of blood or blood products since the Screening visit.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Simbec Clinical Pharmacology
Merthyr Tydfil, Wales, CF48 4DR
About this study
Official title: A follow-on Study to Assess the Safety and Immunogenicity of a Booster Dose of GBS-NN/NN2 Vaccine 1 to 5 Years After GBS-NN/NN2 Recipients in Study MVX0002 Have Completed the Primary Vaccination Course, in Comparison With a Single Dose of GBS-NN/NN2 Administered in Placebo Participants From Study MVX0002 or Vaccine naïve Participants
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.
Read the 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).
- Conditions
- Group B Streptococcus Infection
- Being tested
- GBS-NN/NN2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBS-NN/NN2Biological
GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS/NN2
| Study group | Role | What they receive |
|---|---|---|
| GBS-NN/NN2 | Experimental | Single dose 0.5 millilitre (mL) intramuscular injection of GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS/NN2 Receives: Biological: GBS-NN/NN2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events
Number of participants with treatment emergent adverse events
Measured: 12 weeks (Day 85)
Secondary outcomes (4)
Treatment Emergent Adverse Events
Number of participants with treatment emergent adverse events
Measured: 6 months (Day 183)
Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values)
Absolute values of antibody concentration specific for GBS-NN and GBS-NN2
Measured: From Day 1 to Day 85
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
Measured: From Day 1 to Day 85
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.
Measured: MVX002 day 85, MVX003 day 1 and MVX003 day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start17 Aug 2021
- Primary completion5 Aug 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Group B Streptococcus 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label booster vaccine study
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minervax ApS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geoff Kitson, Study director, gkitson@propharmapartners.uk.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005247
- Sponsor's protocol ID
- MVX0003
- Status last verified
- Jul 2024
- First submitted
- 5 Aug 2021
- Last updated
- 10 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A follow-on Study to Assess the Safety and Immunogenicity of a Booster Dose of GBS-NN/NN2 Vaccine 1 to 5 Years After GBS-NN/NN2 Recipients in Study MVX0002 Have Completed the Primary Vaccination Course, in Comparison With a Single Dose of GBS-NN/NN2 Administered in Placebo Participants From Study MVX0002 or Vaccine naïve Participants
- ClinicalTrials.gov ID
- NCT05005247
- Acronym / sponsor ID
- MVX0003
- Conditions
- Group B Streptococcus Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Minervax ApSUniversity, hospital or other
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Posted 10 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label booster vaccine study
| Arm | Type | Receives |
|---|---|---|
| GBS-NN/NN2 | Experimental | Biological: GBS-NN/NN2Single dose 0.5 millilitre (mL) intramuscular injection of GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS/NN2 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- 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).
- Able to voluntarily provide written informed consent to participate in the study.
- Healthy female participants aged 18-40 years (vaccine naïve participants only).
- 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.
- 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).
Key exclusion criteria (22 listed)
- Participants who have an autoimmune disease.
- 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).
- 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.
- Laboratory values at Screening which are deemed by the Investigator to be clinically significantly abnormal.
- Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).
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/NN2GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS/NN2 | Biological | GBS-NN/NN2 |
Primary outcome
Treatment Emergent Adverse Events
Time frame: 12 weeks (Day 85)
Number of participants with treatment emergent adverse events
4 secondary outcomes
Treatment Emergent Adverse Events
Time frame: 6 months (Day 183)
Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values)
Time frame: From Day 1 to Day 85
Antibody Concentration Specific for GBS-NN and GBS-NN2 (Fold Increase)
Time frame: From Day 1 to Day 85
Antibody Concentration Specific for GBS-NN and GBS-NN2
Time frame: MVX002 day 85, MVX003 day 1 and MVX003 day 85
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Geoff Kitson study director
gkitson@propharmapartners.uk.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GBS-NN/NN2 in people with Group B Streptococcus Infection, run by Minervax ApS at 1 site in United Kingdom.
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 20 inclusion and 22 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: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Emergent Adverse Events (time frame: 12 weeks (Day 85)). 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 10 Oct 2024.