Phase 1 Safety and Immunogenicity of Meningococcal Vaccine

ClinicalTrials.gov ID: NCT00678652

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT00678652
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: U.S. Army Medical Research and Development Command; Federal
Enrollment: 36 participants

Conditions and interventions

Conditions

Meningococcal Infection, Group B

Interventions

10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine Biological
25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine Biological
50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine Biological
75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine Biological

Biological

Eligibility (public fields only)

Age range: 18 Years to 45 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 2008 (Type not available)
Primary completion: Aug 2009 (Actual)
Completion: Aug 2009 (Actual)
Last update posted: Dec 18, 2017

2008 – 2009

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Clinical Trials Center, WRAIR	Silver Spring	Maryland	20910	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00678652, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 18, 2017 · Synced Nov 14, 2026