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MenPF-1 - A New Vaccine Against Meningococcal Disease

Primary Purpose

Serogroup B Meningococcal Disease

Status
Unknown status
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
MenPF-1.
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Serogroup B Meningococcal Disease

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low dose vaccine arm

High dose vaccine arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Safety
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

Secondary Outcome Measures

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.

Full Information

First Posted
May 23, 2012
Last Updated
April 6, 2018
Sponsor
University of Oxford
Collaborators
Wellcome Trust, Norwegian Institute of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT01640652
Brief Title
MenPF-1 - A New Vaccine Against Meningococcal Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Wellcome Trust, Norwegian Institute of Public Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Serogroup B Meningococcal Disease

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose vaccine arm
Arm Type
Experimental
Arm Description
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.
Arm Title
High dose vaccine arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
MenPF-1.
Intervention Description
A new vaccine against meningococcal disease.
Primary Outcome Measure Information:
Title
Safety
Description
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
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Immunogenicity
Description
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.
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew J Pollard, PhD
Organizational Affiliation
Oxford Vaccine Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25982025
Citation
Marsay 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.
Results Reference
result
PubMed Identifier
30177258
Citation
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.
Results Reference
derived
Links:
URL
http://www.ovg.ox.ac.uk/
Description
OVG website

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MenPF-1 - A New Vaccine Against Meningococcal Disease

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