Phase 1
N=34
Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis.
Meningitis, Meningococcal, Serogroup B
Bottom Line
View on ClinicalTrials.gov: NCT00248833 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Safety: Severity Summary of Solicited and Unsolicited Adverse Events — 67; 92; 70; 3 AEs
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine (Biological); 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- U.S. Army Medical Research and Development Command
- Primary completion
- Nov 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety: Severity Summary of Solicited and Unsolicited Adverse Events |
67; 92; 70; 3; 16; 10 | — |
| PRIMARY Safety: Adverse Event Type Summarized by Dose |
2; 0; 3; 0; 65; 75 | — |
| SECONDARY Weeks to Serconversion |
2.0; 4.0; 3.0; 8.0; 8.0; 8.0 | — |
| SECONDARY Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion |
80.0; 88.9; 100.0; 30.0; 66.7; 60.0 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT00248833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.