Status:
COMPLETED
Phase 1 Safety and Immunogenicity of Meningococcal Vaccine
Lead Sponsor:
U.S. Army Medical Research and Development Command
Conditions:
Meningococcal Infection, Group B
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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,...
Detailed Description
This was a Phase 1, outpatient, open-label, dose-escalating study to evaluate the safety, tolerability, and immunogenicity of 4 doses of the Group B Meningococcal HOPS-G 8570 NOMV vaccine in healthy s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00678652
Start Date
April 1 2008
End Date
August 1 2009
Last Update
December 18 2017
Active Locations (1)
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1
Clinical Trials Center, WRAIR
Silver Spring, Maryland, United States, 20910