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Study of Meninigococcal Conjugate Vaccine Containing Serogroups A,C,Y,W and X (MCV5) in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02810340
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
PATH

Brief Summary:
MCV-5 is a vaccine being studied for use against a germ that causes infections of the brain and/or the blood. There are several licensed vaccines that protect against meningitis caused by 4 different types of the germ, but there is one type of the germ that these vaccines do not protect against. MCV-5 includes the same coverage as these other vaccines and includes a fifth type. The purpose of this study is to test how this vaccine affects adult human volunteers when compared to a licensed meningitis vaccine. Investigators will monitor volunteers for side effects and collect blood to test for antibodies.

Condition or disease Intervention/treatment Phase
Meningococcal Vaccines Biological: MCV-5 with adjuvant Biological: MCV-5 without adjuvant Biological: Menactra Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of a New Meningococcal Conjugate Vaccine Containing Serogroups A,C,Y,W and X in Healthy Adults
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : August 14, 2017
Actual Study Completion Date : August 14, 2017

Arm Intervention/treatment
Experimental: MCV-5 with adjuvant
MCV-5 adjuvanted with Alum administered as a single IM injection, each dose contains 5 micrograms of each of meningococcal polysaccharide A, C, Y, W, and X, along with 125 micrograms of Alum adjuvant
Biological: MCV-5 with adjuvant
Experimental: MCV-5 without adjuvant
MCV-5 without adjuvant administered as a single IM injection, each dose contains 5 micrograms of each of meningococcal polysaccharide A, C, Y, W, and X
Biological: MCV-5 without adjuvant
Active Comparator: Menactra
Menactra administered as a single IM injection, each dose contains 4 micrograms of each of meningococcal polysaccharide A, C, Y, and W
Biological: Menactra



Primary Outcome Measures :
  1. reactogenicity assessed by occurrence, severity of solicited local and systemic reactions [ Time Frame: Day 7 post vaccination ]
  2. occurrence of unsolicited adverse events by severity and relatedness to vaccination [ Time Frame: 28 days post vaccination ]
  3. occurrence of serious adverse events [ Time Frame: 180 days post vaccination ]

Secondary Outcome Measures :
  1. Percentage of participants with ≥4-fold increase in post-immunization rabbit complement serum bactericidal activity (rSBA) [ Time Frame: 28 days post vaccination ]
  2. The percentage of participants with an rSBA titer of 1:8 and 1:128 [ Time Frame: 28 days post vaccination ]
  3. Geometric mean titers (GMTs) of Meningococcal Polysaccharide A, C, Y, W, and X specific antibodies [ Time Frame: 28 days post vaccination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18-45 years
  • Written informed consent of volunteers
  • Healthy as established by medical history, laboratory evaluation and screening evaluations
  • Participants are able to understand and comply with planned study procedures and be available for all study visits
  • Female subjects must be of non-childbearing potential (defined as surgically sterile or postmenopausal for more than 1 year), or if of childbearing potential must be practicing abstinence or using an effective licensed method of birth control

Exclusion Criteria:

  • Previous vaccination against Neisseria meningitidis.
  • Known exposure to Neisseria meningitidis in the past.
  • History of meningitis or seizures or any neurological or psychiatric disorder.
  • Administration of any other vaccine within 30 days prior or after administration of study vaccines.
  • Use of any investigational or non-registered drug or vaccine within 30 days prior to the administration of study vaccines or planned during the study.
  • History of allergic disease or known hypersensitivity to any component of the three study vaccines.
  • History of Serious Adverse Reactions following administration of Tetanus Toxoid, Diphtheria Toxoid or CRM containing vaccines.
  • History of Guillan-Barré syndrome.
  • Confirmed or suspected immunosuppressive or immune-deficient condition. 10. A family history of congenital or hereditary immunodeficiency.
  • Chronic administration (defined as more than 14 days) of immune-suppressants or other immune-modifying agents within six months prior to administration of study vaccine.
  • 12. Laboratory confirmed infection of either hepatitis B virus (HBs Ag positive on ELISA), hepatitis C virus (anti-HCV positive on ELISA as well as PCR) or human immunodeficiency virus (HIV on ELISA).
  • Major congenital defects or serious chronic illness.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history, physical examination or laboratory screening tests.
  • Known bleeding disorders.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccines or planned administration during the vaccine period.
  • History (within the past year) or signs of alcohol or substance abuse.
  • Pregnancy or lactation.
  • A Body Mass Index (BMI) equal to or above 30.
  • Any other condition, which in the opinion of the investigator, might interfere with the study objectives, jeopardize the safety or rights of the participant or making it unlikely the participant could complete the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810340


Locations
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United States, Maryland
Center for Vaccine Development
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
PATH
Investigators
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Principal Investigator: Wilbur Chen, MD,MS University of Maryland Scool of Medicine, Baltimore
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT02810340    
Other Study ID Numbers: VAC-046
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018