Meningitis, Meningococcal, Serogroup BPhase 1NCT00248833
Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis.
A Phase 1 study testing 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine and 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine in people with Meningitis, Meningococcal, Serogroup B, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
The purpose of this study is to determine if the vaccine called Group B Meningococcal 44/76 MOS NOMV 5D Vaccine is safe and free from side effects and if it will protect people from meningitis. This study will vaccinate three groups of people. In the first 2 groups, the study will be double-blinded. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal, Serogroup B
- What is being tested?
- 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine and 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2005to Dec 2007
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy military or civilian males or non-pregnant, non-lactating females
- Age 18-45
- Give informed consent and understand risk and benefit of study
- Understands and willing to comply with all protocol procedures and time commitment
- FEMALES only: surgically sterilized or received a negative pregnancy test on day of first injection AND agrees to practice adequate birth control, if necessary, for the next 7 months after first vaccination.
Who cannot join
- Currently has or has had a history of significant organ/system disease
- History of allergy to any vaccine
- Allergy to component of vaccine such as aluminum hydroxide
- Presence of significant unexplained laboratory abnormality
- HIV sero-positive or any other immunosuppressive state
- Positive test for HBsAg, or hepatitis C
Show all 10Show fewer
- Ongoing drug abuse/dependence
- Received any live vaccine, experimental products or immunosuppressive therapy in the last 28 days or inactivated vaccine in the past 14 days, or received parenteral immunoglobulin or blood products within the past 3 months
- Intention to leave study area for an extended period of time during the study
- Females: positive urine pregnancy test prior to vaccination
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Institute of Research, Clinical Trials Center
Silver Spring, Maryland, 20910
About this study
Official title: Phase 1 Dose Esc Study of Safety and Immun of 3 Injections, Given at 0, 6 and 24 Wks, of Grp B Meningococcal 44/76 MOS NOMV 5D Vaccine Admin to Healthy Subjs IM With and Without Adjuvant
The purpose of this study is to determine if the vaccine called Group B Meningococcal 44/76 MOS NOMV 5D Vaccine is safe and free from side effects and if it will protect people from meningitis.
This study will vaccinate three groups of people. In the first 2 groups, the study will be double-blinded. This means that neither the volunteer or the medical team will know which formulation of the vaccine was administered. The third group of volunteers and the medical team will know that they are receiving the higher dose of the vaccine.
Read the detailed description
Meningococcal disease is a contagious bacterial disease caused by Neisseria meningitidis that can kill children and young adults very quickly. Meningococci are divided into distinct sergroups based on their polysaccharide outer capsule, which is the usual target antigen for vaccines. Serogroup A is the main cause of epidemics in Africa and in the United States, sergroups B, C and Y predominate. In the United States, no vaccine is yet available to offer protection against serogroup B which currently accounts for 32% of all meningococcal disease in the United States.
This study serves as a proof of concept for our new NOMV Group B single strain monovalent vaccine model which is obtained from a genetically modified parent. If successful we plan to develop a multivalent Group B vaccine for routine use for military recruits at the beginning of basic training, for college students, particularly those who live in dormitories, and for use by travelers to countries recognized as having hyperendemic disease.
- Conditions
- Meningitis, Meningococcal, Serogroup B
- Being tested
- 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine, 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine
- Medical subject headings
- Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25ug Group B Meningococcal 44/76 MOS NOMV 5D VaccineBiological
The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.
50ug Group B Meningococcal 44/76 MOS NOMV 5D VaccineBiological
The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o adjuvant | Experimental | Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks. Receives: Biological: 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D with adjuvant | Experimental | Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D with AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks. Receives: Biological: 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o adjuvant | Experimental | Subjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks. Receives: Biological: 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Severity Summary of Solicited and Unsolicited Adverse Events
Solicited and unsolicited summary of severity of adverse events (AEs) during the 7 day follow-up period after each vaccination
Measured: 7 day f/u period after each vaccination
Safety: Adverse Event Type Summarized by Dose
Adverse events summarized by type and dose
Measured: 7 days after each vaccination
Secondary outcomes (2)
Weeks to Serconversion
Weeks to seroconversion evaluated by serum bactericidal assay. Immunogenicity was determined by assessing the number of subjects, in each cohort, who seroconverted. Seroconversion was defined as a 4-fold or greater increase in serum bactericidal antibodies against the vaccine strain. The geometric mean bactericidal titer (GMT) for each group was determined prior to vaccination and at 2 weeks after each vaccination. For each group, the GMT ratio relative to baseline and after 1, 2, or 3 vaccinations and the 95% 2-sided confidence interval was determined. A seroconversion of ≥50% of the subjects after 2 or more doses would meet the criteria for further vaccine development.
Measured: 26 weeks
Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion
Percentage of subjects with ELISA 2-fold and 4-fold increase from baseline IgG antibody Conversion
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2005 (estimated)
- Study start5 Dec 2005
- Primary completion30 Nov 2006
- Study completionDec 2007
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 Meningitis, Meningococcal, Serogroup 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
- Single group
- Model description
- The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). Two dosage levels were investigated: 25 µg with and without adjuvant and 50 µg of protein without adjuvant. Each dose was given intramuscularly at 0, 6, and 24 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Sponsor
- Investigators
- Barnett Gibbs, MD, Principal investigator, Walter Reed Army Institute of Research (WRAIR)Paul B Keiser, Principal investigator, Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248833
- Sponsor's protocol ID
- WRAIR 1178
- Other IDs
- HSRRB A-13513
- Status last verified
- Jan 2018
- First submitted
- 2 Nov 2005
- Last updated
- 29 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: WRAIR
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Dose Esc Study of Safety and Immun of 3 Injections, Given at 0, 6 and 24 Wks, of Grp B Meningococcal 44/76 MOS NOMV 5D Vaccine Admin to Healthy Subjs IM With and Without Adjuvant
- ClinicalTrials.gov ID
- NCT00248833
- Acronym / sponsor ID
- WRAIR 1178
- Conditions
- Meningitis, Meningococcal, Serogroup B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Study start
- 5 Dec 2005 (actual)
- Primary completion
- 30 Nov 2006 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 4 Nov 2005 (estimated)
- Results
- Posted 29 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the vaccine called Group B Meningococcal 44/76 MOS NOMV 5D Vaccine is safe and free from side effects and if it will protect people from meningitis.
This study will vaccinate three groups of people. In the first 2 groups, the study will be double-blinded. This means that neither the volunteer or the medical team will know which formulation of the vaccine was administered. The third group of volunteers and the medical team will know that they are receiving the higher dose of the vaccine.
Detailed description
Meningococcal disease is a contagious bacterial disease caused by Neisseria meningitidis that can kill children and young adults very quickly. Meningococci are divided into distinct sergroups based on their polysaccharide outer capsule, which is the usual target antigen for vaccines. Serogroup A is the main cause of epidemics in Africa and in the United States, sergroups B, C and Y predominate. In the United States, no vaccine is yet available to offer protection against serogroup B which currently accounts for 32% of all meningococcal disease in the United States.
This study serves as a proof of concept for our new NOMV Group B single strain monovalent vaccine model which is obtained from a genetically modified parent. If successful we plan to develop a multivalent Group B vaccine for routine use for military recruits at the beginning of basic training, for college students, particularly those who live in dormitories, and for use by travelers to countries recognized as having hyperendemic disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). Two dosage levels were investigated: 25 µg with and without adjuvant and 50 µg of protein without adjuvant. Each dose was given intramuscularly at 0, 6, and 24 weeks.
| Arm | Type | Receives |
|---|---|---|
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o adjuvant | Experimental | Biological: 25ug Group B Meningococcal 44/76 MOS NOMV 5D VaccineSubjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks. |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D with adjuvant | Experimental | Biological: 25ug Group B Meningococcal 44/76 MOS NOMV 5D VaccineSubjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D with AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks. |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o adjuvant | Experimental | Biological: 50ug Group B Meningococcal 44/76 MOS NOMV 5D VaccineSubjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy military or civilian males or non-pregnant, non-lactating females
- Age 18-45
- Give informed consent and understand risk and benefit of study
- Understands and willing to comply with all protocol procedures and time commitment
- FEMALES only: surgically sterilized or received a negative pregnancy test on day of first injection AND agrees to practice adequate birth control, if necessary, for the next 7 months after first vaccination.
Key exclusion criteria (10 listed)
- Currently has or has had a history of significant organ/system disease
- History of allergy to any vaccine
- Allergy to component of vaccine such as aluminum hydroxide
- Presence of significant unexplained laboratory abnormality
- HIV sero-positive or any other immunosuppressive state
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 |
|---|---|---|
| 25ug Group B Meningococcal 44/76 MOS NOMV 5D VaccineThe study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks. | Biological | 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o adjuvant, 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D with adjuvant |
| 50ug Group B Meningococcal 44/76 MOS NOMV 5D VaccineThe study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks. | Biological | 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o adjuvant |
Primary outcome
Safety: Severity Summary of Solicited and Unsolicited Adverse Events
Time frame: 7 day f/u period after each vaccination
Solicited and unsolicited summary of severity of adverse events (AEs) during the 7 day follow-up period after each vaccination
Safety: Adverse Event Type Summarized by Dose
Time frame: 7 days after each vaccination
Adverse events summarized by type and dose
2 secondary outcomes
Weeks to Serconversion
Time frame: 26 weeks
Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion
Time frame: 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. WRAIR
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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.
Barnett Gibbs, MD principal investigator
Walter Reed Army Institute of Research (WRAIR)
Paul B Keiser principal investigator
Walter Reed Army Institute of Research (WRAIR)
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 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine and 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine in people with Meningitis, Meningococcal, Serogroup B, run by U.S. Army Medical Research and Development Command at 1 site in United States.
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 5 inclusion and 10 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 29 Oct 2018. 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 States. 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?
Yes. Results are posted in the registry (first posted 29 Oct 2018). 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?
Safety: Severity Summary of Solicited and Unsolicited Adverse Events (time frame: 7 day f/u period after each vaccination). 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?
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 29 Oct 2018.