Infection by Streptococcus Group BPhase 1MVX13211NCT02459262
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non-pregnant Women 18-40 Years of Age.
A Phase 1 study testing GBS-NN vaccine in people with Infection by Streptococcus Group B, run by Minervax ApS at 1 site in United Kingdom.
Trial summary
Part A: The primary objective is to evaluate the safety and tolerability of a potential vaccine against Group B streptococcus. Part B: To evaluate the long term safety profile of the GBS-NN vaccine up to one year following the first dose. 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
- Infection by Streptococcus Group B
- What is being tested?
- GBS-NN vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2015to 21 Apr 2017
- 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 adult female volunteers (as determined by medical history, physical examination, laboratory test values, vital signs and electrocardiograms [ECGs] at screening) aged 18 - 40 years.
- Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
- Volunteers weight ≥ 50kg and ≤100kg at screening.
- Able to voluntarily provide written informed consent to participate in the study.
- Must understand the purposes and risks of the study and agree to follow the restrictions and schedule of procedures as defined in the protocol.
- Volunteers must be pre-menopausal. Volunteers who have had a hysterectomy will have pre-menopausal status confirmed by a FSH and oestradiol test.
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- Females of childbearing potential must have a negative pregnancy test at screening (β HCG) and prior to each dose and must be willing to use an adequate and highly effective method of contraception until at least Day 85 of the study. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, IUDs (Intrauterine Device), condoms, occlusive caps (cervical/vault caps) with spermicidal foam/gel/ film/cream/suppository. True sexual abstinence is acceptable when this is in line with the preferred and usual lifestyle of the volunteer (periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods, declaration of abstinence for the duration of the trial, and withdrawal are not acceptable methods of contraception)
- In Part A: Volunteers must be non-smokers for at least 3 months prior to first studyvaccine administration. In Part B: Volunteers may be light smokers i.e. up to a maximum of 5 cigarettes per day or nicotine equivalent.
- Must be willing to consent to have data entered into The Over Volunteering Prevention System (TOPS).
- The volunteer's primary care physician has confirmed within the last 12 months that there is nothing in their medical history that would preclude their enrolment into a clinical trial.
Who cannot join
- Volunteers 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 to be clinically significant, unless agreed in advance by the Sponsor's Responsible Medic and Principal Investigator.
- Current or history of drug or alcohol abuse, or a positive alcohol breath test prior to first dosing.
- Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- Participation in a clinical drug study during the 90 days preceding the initial dose in this study.
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- Any significant illness during the 4 weeks preceding check-in for this study (Day 1).
- Volunteers with a history of severe allergic reactions after previous vaccination.
- Volunteers 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.
- Volunteers receiving immunosuppressive therapy (e.g. systemic steroids, cancer therapies, methotrexate, azathioprine) in the 6 months prior to screening, antibiotics within 10 days of receiving the first dose or taking any short-term medications including over-the-counter preparations, vitamins, herbal and/or mineral supplements 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.
- Volunteers with tattoos at the proposed site of vaccine administration.
- Donation of blood or blood products within 90 days prior to vaccine administration.
- Volunteers who, in the opinion of the Investigator, are unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-part, Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability and Immunogenicity of a Dose Range og Group B Streptococcus Vaccine in Healthy Female Volunteers Aged 18 to 40.
Part A: The primary objective is to evaluate the safety and tolerability of a potential vaccine against Group B streptococcus.
Part B: To evaluate the long term safety profile of the GBS-NN vaccine up to one year following the first dose.
Read the detailed description
Part A: Subjects will receive 2 doses of the vaccine, GBS-NN, and will be followed for 12 weeks after the first dose of the vaccine. The following safety endpoints will be evaluated to support this objective: local and systemic reactogenicity; adverse events; laboratory tests; urinalysis; vital signs; 12-Lead ECG parameters; physical examination. In addition hereto, immunological parameters will be evaluated.
Part B: Subjects will receive one or 2 doses of GBS-NN, and will be followed for 12 months after the first dose of the vaccine. The following safety endpoints will be evaluated to support this objective: local and systemic reactogenicity; adverse events; laboratory tests; urinalysis; vital signs; 12-Lead ECG parameters; physical examination. In addition hereto, immunological parameters will be evaluated.
- Conditions
- Infection by Streptococcus Group B
- Being tested
- GBS-NN vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBS-NN vaccineBiological
Three dose levels will be administered, with and without Alhydrogel®
| Study group | Role | What they receive |
|---|---|---|
| GBS-NN Vaccine | Active comparator | GBS-NN vaccine administered either adsorbed to Alhydrogel® or alone. Receives: Biological: GBS-NN vaccine |
| Sterile dilution buffer with Alhydrogel | Placebo comparator | The placebo will contain either Alhydrogel® or buffer alone. Receives: Biological: GBS-NN vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A Number of Participants With Treatment Emergent Adverse Events
Number of Participants with Treatment Emergent Adverse Events
Measured: 12 weeks (to Day 85)
Part B Number of Participants With Treatment Emergent Adverse Events
Number of Participants with Treatment Emergent Adverse Events
Measured: 12 weeks (to Day 85)
Secondary outcomes (4)
Part A Antibody Concentration
Geometric mean antibody concentration
Measured: 12 weeks (Day 85)
Part B Antibody Concentration
Geometric mean antibody concentration
Measured: 12 weeks (Day 85)
Part B Antibody Concentration
Geometric mean antibody concentration
Measured: 1 year (Day 365)
Part B Number of Participants With Treatment Emergent Adverse Events
Number of Participants with Treatment Emergent Adverse Events
Measured: Day 85 to Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startMay 2015
- Primary completion12 Apr 2017
- Study completion21 Apr 2017
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infection by Streptococcus Group BStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minervax ApS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Per Fisher, PM/CEO, Study director, MinervaX ApS, Ole Maaløes Vej 3, DK-2200 Copenhagen N, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459262
- Sponsor's protocol ID
- 2014-004542-10
- Other IDs
- 2014
- Acronym
- MVX13211
- Status last verified
- Nov 2020
- First submitted
- 22 May 2015
- Last updated
- 14 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pawlowski A, Lannergard J, Gonzalez-Miro M, Cao D, Larsson S, Persson JJ, Kitson G, Darsley M, Rom AL, Hedegaard M, Fischer PB, Johansson-Lindbom B. A group B Streptococcus alpha-like protein subunit vaccine induces functionally active antibodies in humans targeting homotypic and heterotypic strains. Cell Rep Med. 2022 Feb 15;3(2):100511. doi: 10.1016/j.xcrm.2022.100511. eCollection 2022 Feb 15.
PubMed 35243418Fischer P, Pawlowski A, Cao D, Bell D, Kitson G, Darsley M, Johansson-Lindbom B. Safety and immunogenicity of a prototype recombinant alpha-like protein subunit vaccine (GBS-NN) against Group B Streptococcus in a randomised placebo-controlled double-blind phase 1 trial in healthy adult women. Vaccine. 2021 Jul 22;39(32):4489-4499. doi: 10.1016/j.vaccine.2021.06.046. Epub 2021 Jun 30.
PubMed 34215454
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part, Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability and Immunogenicity of a Dose Range og Group B Streptococcus Vaccine in Healthy Female Volunteers Aged 18 to 40.
- ClinicalTrials.gov ID
- NCT02459262
- Acronym / sponsor ID
- MVX13211 / 2014-004542-10
- Conditions
- Infection by Streptococcus Group B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Minervax ApSUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 12 Apr 2017 (actual)
- Study completion
- 21 Apr 2017 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Posted 14 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Part A: The primary objective is to evaluate the safety and tolerability of a potential vaccine against Group B streptococcus.
Part B: To evaluate the long term safety profile of the GBS-NN vaccine up to one year following the first dose.
Detailed description
Part A: Subjects will receive 2 doses of the vaccine, GBS-NN, and will be followed for 12 weeks after the first dose of the vaccine. The following safety endpoints will be evaluated to support this objective: local and systemic reactogenicity; adverse events; laboratory tests; urinalysis; vital signs; 12-Lead ECG parameters; physical examination. In addition hereto, immunological parameters will be evaluated.
Part B: Subjects will receive one or 2 doses of GBS-NN, and will be followed for 12 months after the first dose of the vaccine. The following safety endpoints will be evaluated to support this objective: local and systemic reactogenicity; adverse events; laboratory tests; urinalysis; vital signs; 12-Lead ECG parameters; physical examination. In addition hereto, immunological parameters will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GBS-NN Vaccine | Active comparator | Biological: GBS-NN vaccineGBS-NN vaccine administered either adsorbed to Alhydrogel® or alone. |
| Sterile dilution buffer with Alhydrogel | Placebo comparator | Biological: GBS-NN vaccineThe placebo will contain either Alhydrogel® or buffer alone. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy adult female volunteers (as determined by medical history, physical examination, laboratory test values, vital signs and electrocardiograms [ECGs] at screening) aged 18 - 40 years.
- Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
- Volunteers weight ≥ 50kg and ≤100kg at screening.
- Able to voluntarily provide written informed consent to participate in the study.
- Must understand the purposes and risks of the study and agree to follow the restrictions and schedule of procedures as defined in the protocol.
Key exclusion criteria (13 listed)
- Volunteers 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 to be clinically significant, unless agreed in advance by the Sponsor's Responsible Medic and Principal Investigator.
- Current or history of drug or alcohol abuse, or a positive alcohol breath test prior to first dosing.
- Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
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 vaccineThree dose levels will be administered, with and without Alhydrogel® | Biological | GBS-NN Vaccine, Sterile dilution buffer with Alhydrogel |
Primary outcome
Part A Number of Participants With Treatment Emergent Adverse Events
Time frame: 12 weeks (to Day 85)
Number of Participants with Treatment Emergent Adverse Events
Part B Number of Participants With Treatment Emergent Adverse Events
Time frame: 12 weeks (to Day 85)
Number of Participants with Treatment Emergent Adverse Events
4 secondary outcomes
Part A Antibody Concentration
Time frame: 12 weeks (Day 85)
Part B Antibody Concentration
Time frame: 12 weeks (Day 85)
Part B Antibody Concentration
Time frame: 1 year (Day 365)
Part B Number of Participants With Treatment Emergent Adverse Events
Time frame: Day 85 to Day 365
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35243418Pawlowski A, Lannergard J, Gonzalez-Miro M, Cao D, Larsson S, Persson JJ, Kitson G, Darsley M, Rom AL, Hedegaard M, Fischer PB, Johansson-Lindbom B. A group B Streptococcus alpha-like protein subunit vaccine induces functionally active antibodies in humans targeting homotypic and heterotypic strains. Cell Rep Med. 2022 Feb 15;3(2):100511. doi: 10.1016/j.xcrm.2022.100511. eCollection 2022 Feb 15.
- Derived from this study: PubMed 34215454Fischer P, Pawlowski A, Cao D, Bell D, Kitson G, Darsley M, Johansson-Lindbom B. Safety and immunogenicity of a prototype recombinant alpha-like protein subunit vaccine (GBS-NN) against Group B Streptococcus in a randomised placebo-controlled double-blind phase 1 trial in healthy adult women. Vaccine. 2021 Jul 22;39(32):4489-4499. doi: 10.1016/j.vaccine.2021.06.046. Epub 2021 Jun 30.
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Group B Streptococcal Infections
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.
Per Fisher, PM/CEO study director
MinervaX ApS, Ole Maaløes Vej 3, DK-2200 Copenhagen N, Denmark
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 vaccine in people with Infection by Streptococcus Group B, 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 10 inclusion and 13 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 14 Jan 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 14 Jan 2021). 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?
Part A Number of Participants With Treatment Emergent Adverse Events (time frame: 12 weeks (to Day 85)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02459262, which also lists 2 linked publications.
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 14 Jan 2021.