Serogroup B Meningococcal DiseasePhase 1NCT01640652
MenPF-1 - A New Vaccine Against Meningococcal Disease
A Phase 1 study testing MenPF-1. in people with Serogroup B Meningococcal Disease, run by University of Oxford at 1 site in United Kingdom.
Trial summary
In this study the investigators are testing a new vaccine against Neisseria meningitidis, the leading infective cause of childhood death in the UK. This bug (also known as meningococcus) can infect the lining of the brain (meningitis) or the blood stream (septicaemia) and can affect all ages, but especially children… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Serogroup B Meningococcal Disease
- What is being tested?
- MenPF-1.
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2012to 6 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to give informed consent for participation in the study
- Aged between 18 and 50 years
- In good health as determined by medical history, physical examination and clinical judgment of the investigators
- (Females) Willing to use effective contraception (such as the oral contraceptive pill, contraceptive implant or barrier methods) from one month prior and for the duration of the study
- Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of diary cards
- Willing to allow his or her General Practitioner and/or Consultant, if appropriate, to be notified of participation in the study
- Confirmation from GP that they are aware of the inclusion and exclusion criteria and are satisfied from their knowledge of the volunteer that they are suitable to enrol
Who cannot join
- History of significant organ/system disease that could interfere with trial conduct or completion
- Have any known or suspected impairment or alteration of immune function
- Study significant abnormalities on screening investigations at the discretion of an Investigator
- Receipt of a live vaccine within 4 weeks prior to vaccination or a killed vaccine within 7 days prior to vaccination
- Plan to receive any vaccine other than the study vaccine within 4 weeks following vaccination
- Scheduled procedures requiring general anaesthesia during the study
Show all 17Show fewer
- Participant who is terminally ill
- Receipt of immunoglobulin or any blood product transfusion within 3 months of study start
- Participation in another research study involving an investigational product in the past 12 weeks, or are planning to do so within the 20 weeks of this study
- Previously having received a meningococcal B vaccine of any kind
- Previous occurrence of disease caused by N. meningitidis
- Inability, in the opinion of the Investigator, to comply with all study requirements
- Female participants who are pregnant, lactating or planning pregnancy during the course of the study
- Any other significant disease or disorder which, in the opinion of the Investigator, may
- Put the participants at risk because of participation in the study
- Influence the result of the study
- Impair the participant's ability to participate in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: A Phase I, Single Centre, Open-label Dose-escalation Study to Assess the Safety and Immunogenicity of Three Doses of 25µg or 50 µg of Meningococcal Serogroup B Outer Membrane Vesicle Vaccine MenPF-1
In this study the investigators are testing a new vaccine against Neisseria meningitidis, the leading infective cause of childhood death in the UK. This bug (also known as meningococcus) can infect the lining of the brain (meningitis) or the blood stream (septicaemia) and can affect all ages, but especially children, adolescents and young adults.
The bug is classified into different groups based on its outer capsule (or shell), and this study will test a new vaccine to protect against group B meningococcus (MenB) disease, which is the most common type in the UK.
Read more
Vaccines are given to prepare the immune system to fight an infection. Vaccines work by stimulating the immune system to produce specialised proteins (called antibodies) and white blood cells designed to kill the bug later in life if needed.
Vaccines against other types of meningococcus have been developed and saved many lives. However MenB is different because its outer capsule does not stimulate the immune system very effectively. There is therefore no broadly effective vaccine against MenB disease.
Read the detailed description
The vaccine the investigators are testing in this study is known as MenPF-1, and uses two bacterial proteins called PorA and FetA. PorA works to move particles across the bacterial cell wall, and FetA is needed to bind to iron that the bacteria need in order to grow. These proteins are found on almost all meningococcal bugs so they are an excellent target for the immune system, and it is thought that they could be the key to developing a new vaccine against MenB disease.
MenPF-1 is a type of vaccine known as an Outer Membrane Vesicle (OMV) vaccine. This means that it has been produced from 'blebs' of the meningococcal bug's outer membrane, released by the meningococcus both during natural infection and in the laboratory. These outer membrane vesicles contain the PorA and FetA proteins, so can be used to make vaccines. The techniques used to produce the OMVs to make MenPF-1 are the same as those used in other very similar safe and effective vaccines. The MenB strain that the investigators use naturally produces PorA protein, and has been genetically modified to produce increased amounts of FetA for the OMV vaccine.
MenPF-1 contains:
- Many proteins, but especially PorA and FetA
- Aluminium, which is safe and commonly used in many vaccines to better activate the immune system
- Sugar and water for injection
It is worth noting that the vaccine product MenPF-1 is designed to work against MenB and, even if successful, would not protect against all forms of meningitis. Also, it is not a live vaccine and therefore cannot cause a meningitis infection.
- Conditions
- Serogroup B Meningococcal Disease
- Being tested
- MenPF-1.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenPF-1.Biological
A new vaccine against meningococcal disease.
| Study group | Role | What they receive |
|---|---|---|
| Low dose vaccine arm | Experimental | To investigate safety, tolerability and immunogenicity of 25 µg of the serogroup B meningococcal protein vaccine MenPF-1 in healthy adults aged 18 to 50 years of age when given three doses of vaccine with 8 weeks interval. Receives: Biological: MenPF-1. |
| High dose vaccine arm | Experimental | To investigate safety, tolerability and immunogenicity of 50 µg of the serogroup B meningococcal protein vaccine MenPF-1 in healthy adults aged 18 to 50 years of age when given three doses of vaccine with 8 weeks interval. Receives: Biological: MenPF-1. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate safety and tolerability of 25 µg or 50 µg of the serogroup B meningococcal protein vaccine MenPF-1
This will be measured by the recording and assessment of the following local and systemic adverse events following administration of each vaccine dose:
- Tenderness and pain at the injection site
- Induration
- Redness
- Swelling
- Headache
- Malaise
- Myalgia
- Nausea and/or vomiting
- Fever
- Blood parameters
- Any unsolicited symptom(s) not listed above
Measured: 20 weeks
Secondary outcomes (1)
Immunogenicity
Immunological assays to study the immune responses to vaccines, including:
- Serum bactericidal antibody (SBA) assay.
- Antibody concentration against vaccine antigens.
- Quantification of circulating vaccine-induced B-cells.
- Quantification of vaccine-induced, antigen specific T-cell responses and associated cytokine production.
- Serum opsonophagocytic activity.
- Gene expression profile after immunization and DNA storage for investigation of the genetic associations with the immune response.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completion6 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Serogroup B Meningococcal DiseaseStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Norwegian Institute of Public Health
- Responsible party
- Sponsor
- Investigators
- Andrew J Pollard, PhD, Principal investigator, Oxford Vaccine Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640652
- Sponsor's protocol ID
- 2011/06
- Status last verified
- Apr 2018
- First submitted
- 23 May 2012
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Green CA, Sande CJ, de Lara C, Thompson AJ, Silva-Reyes L, Napolitano F, Pierantoni A, Capone S, Vitelli A, Klenerman P, Pollard AJ. Humoral and cellular immunity to RSV in infants, children and adults. Vaccine. 2018 Oct 1;36(41):6183-6190. doi: 10.1016/j.vaccine.2018.08.056. Epub 2018 Aug 31.
PubMed 30177258Marsay L, Dold C, Green CA, Rollier CS, Norheim G, Sadarangani M, Shanyinde M, Brehony C, Thompson AJ, Sanders H, Chan H, Haworth K, Derrick JP, Feavers IM, Maiden MC, Pollard AJ. A novel meningococcal outer membrane vesicle vaccine with constitutive expression of FetA: A phase I clinical trial. J Infect. 2015 Sep;71(3):326-37. doi: 10.1016/j.jinf.2015.05.006. Epub 2015 May 15.
PubMed 25982025
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Centre, Open-label Dose-escalation Study to Assess the Safety and Immunogenicity of Three Doses of 25µg or 50 µg of Meningococcal Serogroup B Outer Membrane Vesicle Vaccine MenPF-1
- ClinicalTrials.gov ID
- NCT01640652
- Acronym / sponsor ID
- 2011/06
- Conditions
- Serogroup B Meningococcal Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Wellcome Trust, Norwegian Institute of Public Health
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 16 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the investigators are testing a new vaccine against Neisseria meningitidis, the leading infective cause of childhood death in the UK. This bug (also known as meningococcus) can infect the lining of the brain (meningitis) or the blood stream (septicaemia) and can affect all ages, but especially children, adolescents and young adults.
The bug is classified into different groups based on its outer capsule (or shell), and this study will test a new vaccine to protect against group B meningococcus (MenB) disease, which is the most common type in the UK.
Vaccines are given to prepare the immune system to fight an infection. Vaccines work by stimulating the immune system to produce specialised proteins (called antibodies) and white blood cells designed to kill the bug later in life if needed.
Vaccines against other types of meningococcus have been developed and saved many lives. However MenB is different because its outer capsule does not stimulate the immune system very effectively. There is therefore no broadly effective vaccine against MenB disease.
Detailed description
The vaccine the investigators are testing in this study is known as MenPF-1, and uses two bacterial proteins called PorA and FetA. PorA works to move particles across the bacterial cell wall, and FetA is needed to bind to iron that the bacteria need in order to grow. These proteins are found on almost all meningococcal bugs so they are an excellent target for the immune system, and it is thought that they could be the key to developing a new vaccine against MenB disease.
MenPF-1 is a type of vaccine known as an Outer Membrane Vesicle (OMV) vaccine. This means that it has been produced from 'blebs' of the meningococcal bug's outer membrane, released by the meningococcus both during natural infection and in the laboratory. These outer membrane vesicles contain the PorA and FetA proteins, so can be used to make vaccines. The techniques used to produce the OMVs to make MenPF-1 are the same as those used in other very similar safe and effective vaccines. The MenB strain that the investigators use naturally produces PorA protein, and has been genetically modified to produce increased amounts of FetA for the OMV vaccine.
MenPF-1 contains:
- Many proteins, but especially PorA and FetA
- Aluminium, which is safe and commonly used in many vaccines to better activate the immune system
- Sugar and water for injection
It is worth noting that the vaccine product MenPF-1 is designed to work against MenB and, even if successful, would not protect against all forms of meningitis. Also, it is not a live vaccine and therefore cannot cause a meningitis infection.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose vaccine arm | Experimental | Biological: MenPF-1.To investigate safety, tolerability and immunogenicity of 25 µg of the serogroup B meningococcal protein vaccine MenPF-1 in healthy adults aged 18 to 50 years of age when given three doses of vaccine with 8 weeks interval. |
| High dose vaccine arm | Experimental | Biological: MenPF-1.To investigate safety, tolerability and immunogenicity of 50 µg of the serogroup B meningococcal protein vaccine MenPF-1 in healthy adults aged 18 to 50 years of age when given three doses of vaccine with 8 weeks interval. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Willing and able to give informed consent for participation in the study
- Aged between 18 and 50 years
- In good health as determined by medical history, physical examination and clinical judgment of the investigators
- (Females) Willing to use effective contraception (such as the oral contraceptive pill, contraceptive implant or barrier methods) from one month prior and for the duration of the study
- Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of diary cards
Key exclusion criteria (17 listed)
- History of significant organ/system disease that could interfere with trial conduct or completion
- Have any known or suspected impairment or alteration of immune function
- Study significant abnormalities on screening investigations at the discretion of an Investigator
- Receipt of a live vaccine within 4 weeks prior to vaccination or a killed vaccine within 7 days prior to vaccination
- Plan to receive any vaccine other than the study vaccine within 4 weeks following vaccination
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 |
|---|---|---|
| MenPF-1.A new vaccine against meningococcal disease. | Biological | High dose vaccine arm, Low dose vaccine arm |
Primary outcome
To investigate safety and tolerability of 25 µg or 50 µg of the serogroup B meningococcal protein vaccine MenPF-1
Time frame: 20 weeks
This will be measured by the recording and assessment of the following local and systemic adverse events following administration of each vaccine dose: 1. Tenderness and pain at the injection site 2. Induration 3. Redness 4. Swelling 5. Headache 6. Malaise 7. Myalgia 8. Nausea and/or vomiting 9. Fever 10. Blood parameters 11. Any unsolicited symptom(s) not listed above
1 secondary outcome
Immunogenicity
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Background: PubMed 30177258Green CA, Sande CJ, de Lara C, Thompson AJ, Silva-Reyes L, Napolitano F, Pierantoni A, Capone S, Vitelli A, Klenerman P, Pollard AJ. Humoral and cellular immunity to RSV in infants, children and adults. Vaccine. 2018 Oct 1;36(41):6183-6190. doi: 10.1016/j.vaccine.2018.08.056. Epub 2018 Aug 31.
- Results publication: PubMed 25982025Marsay L, Dold C, Green CA, Rollier CS, Norheim G, Sadarangani M, Shanyinde M, Brehony C, Thompson AJ, Sanders H, Chan H, Haworth K, Derrick JP, Feavers IM, Maiden MC, Pollard AJ. A novel meningococcal outer membrane vesicle vaccine with constitutive expression of FetA: A phase I clinical trial. J Infect. 2015 Sep;71(3):326-37. doi: 10.1016/j.jinf.2015.05.006. Epub 2015 May 15.
- OVG websiteLink provided by the sponsor.
- MenPF-1 - A New Vaccine Against Meningococcal DiseaseLink provided by the sponsor.
- Humoral and cellular immunity to RSV in infants, children and adultsLink provided by the sponsor.
- A novel meningococcal outer membrane vesicle vaccine with constitutive expression of FetA: A phase I clinical trialLink provided by the sponsor.
Related trials for Serogroup B Meningococcal Disease
Active, not recruitingPhase 4
A Study on the Immune Response and Safety of a Vaccine Against N. Meningitidis Serogroup B Infection in Healthy Infants From 2 Months of Age
Meningitis, Meningococcal
RecruitingPhase 4
Investigating Gender and Sex Differences in Immune Responses Through Vaccination of Transgender and Cisgender Persons
Meningococcal Meningitis, Serogroup B, Transgender Persons
RecruitingPhase 2
Meningococcal B Vaccine in Patients with Asplenia
Splenectomy; Status
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.
Andrew J Pollard, PhD principal investigator
Oxford Vaccine Group
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 MenPF-1. in people with Serogroup B Meningococcal Disease, run by University of Oxford 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 7 inclusion and 17 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 7 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To investigate safety and tolerability of 25 µg or 50 µg of the serogroup B meningococcal protein vaccine MenPF-1 (time frame: 20 weeks). 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 NCT01640652, 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 7 Dec 2023.