Serogroup B Meningococcal Disease Clinical Trial
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
| NCT number | NCT01640652 |
| Other study ID # | 2011/06 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | |
| Last updated | |
| Start date | August 2012 |
| Est. completion date | May 6, 2022 |
| Verified date | April 2018 |
| Source | University of Oxford |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 52 |
| Est. completion date | May 6, 2022 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 50 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Centre for Clinical Vaccinology & Tropical Medicine (CCVTM) | Oxford | Oxfordshire |
| Lead Sponsor | Collaborator |
|---|---|
| University of Oxford | Norwegian Institute of Public Health, Wellcome Trust |
United Kingdom,
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. — View 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 expr — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
20 weeks | |
| Secondary | 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. |
20 weeks |