Group B Strep InfectionPhase 1MVX0002NCT03807245
Group B Streptococcus Vaccine in Healthy Females
A Phase 1 study testing GBS-NN/NN2 with Alhydrogel® 25 and GBS-NN/NN2 with Alhydrogel® 50 in people with Group B Strep Infection, run by Minervax ApS at 1 site in United Kingdom.
Trial summary
A Phase I, randomised, single centre, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus vaccine. 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 Strep Infection
- What is being tested?
- GBS-NN/NN2 with Alhydrogel® 25 and GBS-NN/NN2 with Alhydrogel® 50
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jan 2019to 7 May 2020
- 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
- Healthy female subjects aged 18 - 40 years.
- Body mass index (BMI) ≥18 and ≤30 kg/m2.
- Subjects weight ≥50kg and ≤100kg at screening.
- Able to voluntarily provide written informed consent to participate in the study.
- Subjects are pre-menopausal.
- Females of childbearing potential must have a negative pregnancy test at screening (β HCG) and prior to each dose. To prevent pregnancy female subjects of childbearing potential must take adequate contraceptive precautions for the entire duration of study participation (up to Day 85). Adequate and highly effective contraceptive precautions include:
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- Established use of oral, injected or implanted hormonal methods of contraception.
- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). [For female subjects, the vasectomised male partner should be the sole partner for that subject].
- True abstinence, when this is in line with the preferred and usual lifestyle of the subject.
- [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].
- The chosen contraception method(s) must be followed from the first dose until at least Day 85 of the study.
- Non-smokers for at least 3 months prior to first study vaccine administration.
Who cannot join
- Subjects who have received GBS-NN vaccine previously.
- Subjects 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.
- Pregnant or lactating females.
- Laboratory values at screening which are deemed by the investigator to be clinically significantly abnormal.
- Positive drug screen for drugs of abuse or a positive alcohol urine test prior to first dosing unless there is a documented medical explanation for the positive result other than drugs of abuse (e.g., the subject has been prescribed opioids for pain).
- Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
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- Participation in a clinical drug study during the 90 days preceding the initial dose in this study.
- Any significant illness during the 4 weeks preceding check-in for this study (Day 1).
- Subjects with a history of allergic reactions after previous vaccination.
- Subjects who have received any vaccine within 30 days of screening, or who are planning to receive a vaccine up to Day 85 of the study.
- Subjects receiving immunosuppressive therapy in the 6 months prior to screening, taking any short-term medications including over-the-counter (OTC) preparations, within 7 days of the first dose. Chronic medications such as antihypertensives, bronchodilators, oral contraceptives or statins that do not affect the immune system, will be permitted and allowed to continue during the study at the discretion of the Investigator. Paracetamol will be permitted for the treatment of headache or other symptoms. Use of OTC vitamins and dietary supplements is allowed
- Subjects with tattoos at the proposed site of vaccine administration.
- Donation of blood or blood products within 90 days prior to vaccine administration or intending to donate blood or blood products within 90 days of the last visit.
- Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Simbec Research Limited
Merthyr Tydfil, Wales, CF48 4DR
About this study
Official title: A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Group B Streptococcus Vaccine (GBS-NN/NN2 With Alhydrogel®) in Healthy Female Subjects Aged 18 to 40
A Phase I, randomised, single centre, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus vaccine.
Read the detailed description
There will be 4 arms in 2 cohorts of 30 subjects. Cohort 1 will receive two 0.5 mL injections, 4 weeks apart, each consisting of 25 μg of GBS-NN and 25 μg of GBS-NN2 (24 subjects) or placebo (6 subjects). Cohort 2 (30 subjects) will receive two 0.5 mL injections, 4 weeks apart, each consisting of 50 μg of GBS-NN and 50 μg of GBS-NN2 (24 subjects) or placebo (6 Subjects). All vaccines will be adsorbed to 500 μg Al3+ as Alhydrogel®.
Safety will be assessed after all subjects have completed Visit 4 (Day 8) for Cohort 1, at which point the decision will be made as to whether proceeding with administration of the doses in cohort 2 is appropriate.
- Conditions
- Group B Strep Infection
- Being tested
- GBS-NN/NN2 with Alhydrogel® 25, Placebo GBS-NN/NN2 with Alhydrogel® 25, Placebo GBS-NN/NN2 with Alhydrogel® 50, GBS-NN/NN2 with Alhydrogel® 50
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBS-NN/NN2 with Alhydrogel® 25Biological
GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
Placebo GBS-NN/NN2 with Alhydrogel® 25Biological
GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
Placebo GBS-NN/NN2 with Alhydrogel® 50Biological
GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
GBS-NN/NN2 with Alhydrogel® 50Biological
GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| GBS-NN/NN2 with Alhydrogel® 25 | Experimental | GBS-NN/NN2 with Alhydrogel® 25 mcg intramuscular 2 times with 4 weeks apart Receives: Biological: GBS-NN/NN2 with Alhydrogel® 25 |
| Placebo GBS-NN/NN2 with Alhydrogel® 25 | Placebo comparator | Intramuscular injection with Alhydrogel® 2 times with 4 weeks apart Receives: Biological: Placebo GBS-NN/NN2 with Alhydrogel® 25 |
| GBS-NN/NN2 with Alhydrogel® 50 | Experimental | Intramuscular GBS-NN/NN2 with Alhydrogel® injection 50 mcg 2 times with 4 weeks apart Receives: Biological: GBS-NN/NN2 with Alhydrogel® 50 |
| Placebo GBS-NN/NN2 with Alhydrogel® 50 | Placebo comparator | Intramuscular injection with Alhydrogel® 2 times with 4 weeks apart Receives: Biological: Placebo GBS-NN/NN2 with Alhydrogel® 50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events
Number of Participants with Treatment Emergent Adverse Events
Measured: 85 days
Secondary outcomes (4)
Immunoglobulin(Ig)G Antibody Concentration
Adjusted geometric mean concentration (GMC)
Measured: Day 85
Fold Change in Antibody Concentration
Geometric mean fold change in antibody concentration from Day 1 to Day 85 for each group.
Measured: Day 1 to Day 85
Seroconversion Rate
4-fold increase in Immunoglobulin(Ig)G antibody concentration
Measured: Day 85
Number of Participants With an Immune Response to First and Second Doses
Number of participants with Immunoglobulin(Ig)G antibody concentration above thresholds
Measured: Day 29 and Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start9 Jan 2019
- Primary completion14 Oct 2019
- Study completion7 May 2020
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 Strep 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minervax ApS
- Sponsor type
- University, hospital or other
- Collaborators
- Simbec Research
- Responsible party
- Sponsor
- Investigators
- Geoff Kitson, Study director, gkitson@propharmapartners.uk.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807245
- Sponsor's protocol ID
- 2017-003871-27
- Other IDs
- 2017
- Acronym
- MVX0002
- Status last verified
- Nov 2020
- First submitted
- 9 Jan 2019
- Last updated
- 2 Feb 2021
- 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 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Group B Streptococcus Vaccine (GBS-NN/NN2 With Alhydrogel®) in Healthy Female Subjects Aged 18 to 40
- ClinicalTrials.gov ID
- NCT03807245
- Acronym / sponsor ID
- MVX0002 / 2017-003871-27
- Conditions
- Group B Strep Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Minervax ApSUniversity, hospital or other
- Collaborators
- Simbec Research
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 14 Oct 2019 (actual)
- Study completion
- 7 May 2020 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Posted 24 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase I, randomised, single centre, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus vaccine.
Detailed description
There will be 4 arms in 2 cohorts of 30 subjects. Cohort 1 will receive two 0.5 mL injections, 4 weeks apart, each consisting of 25 μg of GBS-NN and 25 μg of GBS-NN2 (24 subjects) or placebo (6 subjects). Cohort 2 (30 subjects) will receive two 0.5 mL injections, 4 weeks apart, each consisting of 50 μg of GBS-NN and 50 μg of GBS-NN2 (24 subjects) or placebo (6 Subjects). All vaccines will be adsorbed to 500 μg Al3+ as Alhydrogel®.
Safety will be assessed after all subjects have completed Visit 4 (Day 8) for Cohort 1, at which point the decision will be made as to whether proceeding with administration of the doses in cohort 2 is appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GBS-NN/NN2 with Alhydrogel® 25 | Experimental | Biological: GBS-NN/NN2 with Alhydrogel® 25GBS-NN/NN2 with Alhydrogel® 25 mcg intramuscular 2 times with 4 weeks apart |
| Placebo GBS-NN/NN2 with Alhydrogel® 25 | Placebo comparator | Biological: Placebo GBS-NN/NN2 with Alhydrogel® 25Intramuscular injection with Alhydrogel® 2 times with 4 weeks apart |
| GBS-NN/NN2 with Alhydrogel® 50 | Experimental | Biological: GBS-NN/NN2 with Alhydrogel® 50Intramuscular GBS-NN/NN2 with Alhydrogel® injection 50 mcg 2 times with 4 weeks apart |
| Placebo GBS-NN/NN2 with Alhydrogel® 50 | Placebo comparator | Biological: Placebo GBS-NN/NN2 with Alhydrogel® 50Intramuscular injection with Alhydrogel® 2 times with 4 weeks apart |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy female subjects aged 18 - 40 years.
- Body mass index (BMI) ≥18 and ≤30 kg/m2.
- Subjects weight ≥50kg and ≤100kg at screening.
- Able to voluntarily provide written informed consent to participate in the study.
- Subjects are pre-menopausal.
Key exclusion criteria (14 listed)
- Subjects who have received GBS-NN vaccine previously.
- Subjects 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.
- Pregnant or lactating females.
- Laboratory values at screening which are deemed by the investigator to be clinically significantly abnormal.
- Positive drug screen for drugs of abuse or a positive alcohol urine test prior to first dosing unless there is a documented medical explanation for the positive result other than drugs of abuse (e.g., the subject has been prescribed opioids for pain).
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 with Alhydrogel® 25GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart | Biological | GBS-NN/NN2 with Alhydrogel® 25 |
| Placebo GBS-NN/NN2 with Alhydrogel® 25GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart | Biological | Placebo GBS-NN/NN2 with Alhydrogel® 25 |
| Placebo GBS-NN/NN2 with Alhydrogel® 50GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart | Biological | Placebo GBS-NN/NN2 with Alhydrogel® 50 |
| GBS-NN/NN2 with Alhydrogel® 50GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart | Biological | GBS-NN/NN2 with Alhydrogel® 50 |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events
Time frame: 85 days
Number of Participants with Treatment Emergent Adverse Events
4 secondary outcomes
Immunoglobulin(Ig)G Antibody Concentration
Time frame: Day 85
Fold Change in Antibody Concentration
Time frame: Day 1 to Day 85
Seroconversion Rate
Time frame: Day 85
Number of Participants With an Immune Response to First and Second Doses
Time frame: Day 29 and Day 85
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
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mulTiplex Immunoassay qualiTy assuRance Panel
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Not yet recruitingObservational study
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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 with Alhydrogel® 25 and GBS-NN/NN2 with Alhydrogel® 50 in people with Group B Strep 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 14 inclusion and 14 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 2 Feb 2021. 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. Some participants in this study may receive a placebo. 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 24 Dec 2020). 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?
Number of Participants With Treatment Emergent Adverse Events (time frame: 85 days). 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 2 Feb 2021.