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Group B Meningococcal Vaccine (HOPS)

This study has been completed.
Sponsor:
Information provided by:
Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:
NCT00678652
First received: May 8, 2008
Last updated: December 1, 2010
Last verified: December 2010

May 8, 2008
December 1, 2010
April 2008
August 2009   (final data collection date for primary outcome measure)
Clinical and laboratory adverse events; development of bactericidal antibodies to the parent strain of group B meningococcus
Same as current
Complete list of historical versions of study NCT00678652 on ClinicalTrials.gov Archive Site
Total antibody response to the parent strain of group B meningococcus
Same as current
Not Provided
Not Provided
 
Group B Meningococcal Vaccine
A Phase 1 Dose-Escalation Study of the Safety and Immunogenicity of Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10, 25, 50, or 75 μg With Adjuvant

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Meningococcal Infection, Group B
Biological: Group B Meningococcal 8570 HOPS-G NOMV Vaccine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy (by physical examination and medical history) military or civilian males or females;
  • Age 18-45 years;
  • Able to give informed consent, understands risks and benefits of study, assents to use of blood samples for future research; understands and is willing to comply with all protocol procedures and time commitments;
  • Females must have a negative urine pregnancy test on vaccination day before each dose AND agree to practice an effective birth control method as necessary, for 6 months after the first vaccination;
  • Military service-members who wish to participate must obtain written permission from their immediate supervisor, department chief or equivalent, and company commander or equivalent.

Exclusion Criteria:

  • Current or history of significant organ/system disease;
  • History of allergy to any vaccine;
  • History of allergy to aluminum hydroxide;
  • Presence of significant unexplained laboratory abnormality that in the opinion of the PI may potentially confound the analysis of the study results;
  • HIV seropositive or any other immunosuppressive state;
  • Positive test for HBsAg or hepatitis C antibody;
  • Evidence or admission of on-going drug or alcohol abuse/dependence;
  • Intention to leave the area during the study such that the volunteer would miss 1 or more study days;
  • Prior receipt of any group B meningococcal outer membrane protein (OMP) vaccine or a vaccine containing meningococcal OMP;
  • Has received or plans to receive any live vaccine, Investigational New Drug (IND) products or significant immunosuppressive therapy* in the 28 days prior to, or any inactivated vaccine within 14 days before initial vaccination or throughout the study, or received parenteral immunoglobulin or blood products within 3 months of study initiation;

    • (Intra-articular, topical, or intranasal steroids, steroids applied to the eye, or ≤ 7 days of oral steroids are in general acceptable, depending on the formulation and condition for which they are prescribed. Inclusion of individuals receiving these medications will be made by the PI on a case by case basis)
  • High levels of baseline bactericidal antibodies against the vaccine strain on screening (>1:16) and/or throat carriage of Neisseria meningitidis at time of screening;
  • Positive urine pregnancy test prior to vaccination;
  • Lactation from first dose through 3 months after last dose;
  • Any condition in the opinion of the investigator that might interfere with the study vaccine.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00678652
WRAIR 1395, HSRRB Log A-14553, MIDRP AM0035_07_WR
No
Robert E. Miller, Ph.D, RAC, U.S. Army Medical Research and Materiel Command (USAMRMC)
U.S. Army Office of the Surgeon General
Not Provided
Principal Investigator: Paul B Keiser, M.D. WRAIR, Division of Bacterial and Rickettsial Diseases
Walter Reed Army Institute of Research (WRAIR)
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP