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
  Purpose

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.


Condition Intervention Phase
Meningococcal Infection, Group B
Biological: Group B Meningococcal 8570 HOPS-G NOMV Vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Institute of Research (WRAIR):

Primary Outcome Measures:
  • Clinical and laboratory adverse events; development of bactericidal antibodies to the parent strain of group B meningococcus

Secondary Outcome Measures:
  • Total antibody response to the parent strain of group B meningococcus

Estimated Enrollment: 36
Study Start Date: April 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678652

Locations
United States, Maryland
Clinical Trials Center, WRAIR
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
U.S. Army Office of the Surgeon General
Investigators
Principal Investigator: Paul B Keiser, M.D. WRAIR, Division of Bacterial and Rickettsial Diseases
  More Information

Additional Information:
No publications provided

Responsible Party: Robert E. Miller, Ph.D, RAC, U.S. Army Medical Research and Materiel Command (USAMRMC)
ClinicalTrials.gov Identifier: NCT00678652     History of Changes
Other Study ID Numbers: WRAIR 1395, HSRRB Log A-14553, MIDRP AM0035_07_WR
Study First Received: May 8, 2008
Last Updated: December 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Walter Reed Army Institute of Research (WRAIR):
Meningococcal vaccine
Neisseria meningitidis

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 28, 2014