Phase 1 Safety and Immunogenicity of Meningococcal Vaccine

Completed · Phase 1

Conditions studied: Meningococcal Infection, Group B

In brief

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.

Key facts

Study ID

NCT00678652

Run by

U.S. Army Medical Research and Development Command

People needed

36

Starts

2008-04-01

Expected to finish

2009-08-01

Last updated by the study team

2017-12-18

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Trials Center, WRAIR — Silver Spring, Maryland, United States

Full record on ClinicalTrials.gov

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