CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine +3 morebiological
Likely dose
10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccinefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00678652
NCT00678652Phase 1Completed
CompareCT.gov

Ph 1 Dose-Escalation Study of Safety and Immunogenicity of 3 Injections, at 0, 6, 2 Wks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Adm Intramuscularly to Healthy Subjects at 10, 25, 50, 75 μg With Adjuvant

U.S. Army Medical Research and Development Command·interventional·Posted May 15, 2008·Updated Dec 18, 2017

In Brief

A Phase 1 clinical trial evaluating 10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine, 25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine, and 2 other interventions for Meningococcal Infection, Group B. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether a vaccine based on outer membrane vesicles (NOMV) from genetically detoxified group B meningococcus is safe and effective for use as a vaccine. If so, the NOMV in this vaccine will be combined with NOMV from two other genetically modified strains as a potentially globally effective vaccine against group B meningococcus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Infection, Group B
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 15, 2008
Enrollment StartApr 1, 2008
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.1 years ago

Interventions

10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccinebiological

10 μg of Meningococcal 8570 HOPS-G NOMV Vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study

25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccinebiological

25 μg of Meningococcal 8570 HOPS-G NOMV Vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study

50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccinebiological

50 μg of Meningococcal 8570 HOPS-G NOMV Vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study

75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccinebiological

75 μg of Meningococcal 8570 HOPS-G NOMV Vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study