Immunogenicity and Safety of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine

NCT01897402 | Completed Phase 2 Results

• 1 other identifier: JN-NM-002
• Study Type: interventional
• Target: 525
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the production of antibodies to a new conjugate vaccine, NmVac4-A/C/Y/W-135-DT, as a measure of vaccine effectiveness, compared to the production of antibodies to a similar, licensed meningococcal (Groups A, C, Y, W-135) polysaccharide diphtheria toxoid (DT) conjugate vaccine. The investigators will also evaluate the safety of NmVac4-A/C/Y/W-135-DT™ conjugate vaccine compared to the licensed vaccine. The hypothesis is that the test vaccine is comparable to the licensed active control vaccine.

Conditions

Meningococcal Meningitis; Meningococcal Infections

Keywords

Central Nervous System Infections; Meningitis; toxoid; Meningococcal vaccine; conjugate vaccines

Outcome Measures

Primary Outcomes (1)

• Seroresponse (Percent Seroconversion).

  Rise in antibody titers in serum at 4 weeks after vaccination, compared to baseline titer for meningococcal serogroups A, C, Y, and W-135. Serum Bactericidal Assay with human complement: Antibody titer ≥1:8 for subjects with titer \<1:8 at baseline or a 4-fold rise in antibody levels.

  Week 4 after injection

Secondary Outcomes (2)

• Solicited Adverse Events From Diary Cards

  Day 0 to Day 7 after vaccination

• Non Solicited Adverse Events

  up to 6 months

Study Arms (2)

Test Vaccine

EXPERIMENTAL

NmVac4-A/C/Y/W-135-DT™ conjugate vaccine

Biological: Test Vaccine

US Licensed Vaccine

ACTIVE COMPARATOR

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Biological: US Licensed Vaccine

Interventions

Test Vaccine BIOLOGICAL

NmVac4-A/C/Y/W-135-DT™ conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each of Serogroup A, C, W-135, and Y PS conjugated to approximately 26 µg total diphtheria toxoid.

Also known as: meningococcal meningitis conjugate vaccine, quadrivalent, NmVac4-A/C/Y/W-135-DT™

Test Vaccine

US Licensed Vaccine BIOLOGICAL

Meningococcal (Groups A,C,Y,W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135 and Y conjugated to approximately 48 µg total diphtheria toxoid.

Also known as: meningococcal meningitis conjugate vaccine, quadrivalent

US Licensed Vaccine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant is willing and able to give informed consent and comply with all aspects of the evaluation after the nature of the study is explained.
• Male or female, aged 18 to 55 years old
• In general good health with no significant chronic or acute conditions that would interfere with immune response or expected Adverse Event (AE) evaluation in the opinion of the investigator as determined by Medical history and/or History-directed physical examination
• Abstinence or use of effective contraception by the participants or their partners during the trial and continuing for four weeks after vaccination will be required for males or female participants of child bearing potential.
• Able (in the opinion of the investigator) to comply with all study requirements.

You may not qualify if:

• Unwilling or unable to understand study requirements and give written informed consent for the study.
• Prisoners.
• History of Guillain-Barré syndrome (GBS).
• Pregnancy (confirmed by positive pregnancy test) or lactation.
• Previous diagnosis of laboratory confirmed meningococcal disease.
• Previous meningococcal meningitis vaccination in the last five years
• Laboratory abnormalities that are considered Grade 2 or higher (based on AE, ranges as described in the protocol appendix) that in the opinion of the Investigator would raise safety concerns for participation in the study or interfere with evaluation of study objectives, or abnormalities \>2 times the Upper Limit of Normal range (ULN).
• Known or suspected autoimmune or connective tissue disorders, including rheumatoid arthritis and congenital or acquired immunodeficiency. Does not include mild to moderate seasonal/perennial allergies treated with over the counter antihistamines.
• Use of systemic immunosuppressive drugs or therapy within 6 months prior to study enrollment, not including topical or inhaled steroids/cytotoxic agents. Includes anti-cancer chemotherapy, radiation, and long term systemic corticosteroid therapy. History of anaphylactic shock, severe asthma, urticaria, or other allergic or hypersensitivity reactions following vaccination or known hypersensitivity to any vaccine component.
• Received blood, blood products, plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months.
• Use of systemic antibiotics within 72 hours prior to study enrollment.
• History of cirrhosis or hepatitis.
• Known bleeding disorder or condition associated with a prolonged bleeding time.
• Positive results of testing for hepatitis B surface antigen (HepBsAg), Hepatitis C or HIV-1 or HIV-2 antibodies. Known or suspected HIV or Hepatitis B or C infection.
• Positive results of drug screen that cannot be explained by use of approved prescription medication (amphetamine, tetrahydrocannabinol (THC), cocaine). Current (past 30 days) heavy smokers (greater than or equal 1 pack per day).tetrahydrocannabinol

Sponsors & Collaborators

• JN-International Medical Corporation: lead

Study Sites (3)

Mid Atlantic Urology Associates LLC

Greenbelt, Maryland, 20770, United States

Location

Chesapeake Research Group

Pasadena, Maryland, 21122, United States

Location

IRC Clinics

Towson, Maryland, 21204, United States

Location

MeSH Terms

Conditions

Meningitis, Meningococcal; Meningococcal Infections; Central Nervous System Infections; Meningitis

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Limitations and Caveats

Three subjects, 1 female and 2 males, received incorrect vaccine. They are listed according to randomized treatment in the baseline population, but were analyzed according to the actual vaccine received in the safety population (outcomes 2 and 3).

Results Point of Contact

• Title: Regulatory Affairs Director
• Organization: JN-International Medical Corporation

dr_orten@jn-vaccines.org

4028843477

Study Officials

• Alberto Yataco, MD

  IRC Clinics,

  PRINCIPAL INVESTIGATOR

• Jeffrey E Atkinson, MD

  Chesapeake Research Group

  PRINCIPAL INVESTIGATOR

• Myron I Murdock, MD

  Mid Atlantic Urology Associates LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: July 12, 2013
• Study Start: July 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 23, 2015
• Results First Posted: April 23, 2015

Record last verified: 2015-04

Locations

US (3)