NCT02810340

Brief Summary

The primary objective of this study is to evaluate the safety of adjuvanted and non-adjuvanted formulations of MCV-5 vaccine. The secondary objective is to assess the immune response of adjuvanted and non-adjuvanted formulations of MCV-5 vaccine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2017

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

March 30, 2021

Completed
Last Updated

June 9, 2021

Status Verified

August 1, 2019

Enrollment Period

1.2 years

First QC Date

June 20, 2016

Results QC Date

October 16, 2018

Last Update Submit

May 25, 2021

Conditions

Meningococcal Vaccines

Outcome Measures

Primary Outcomes (3)

  • Number and Percentage of Participants Experiencing Solicited Events

    Solicited reactions (reactogenicity) were collected following vaccination through Day 7. If a solicited sign or symptom had started during the seven days post-vaccination period and continued beyond Day 7, it was still assessed as a solicited reaction.

    7 days

  • Number and Percentage of Subjects Experiencing Unsolicited Adverse Events, by Severity

    Adverse events (AE) were collected through day 28. Safety clinical laboratory evaluations were performed at Screening and at Day 8 and included: hemoglobin (HgB), white blood cells (WBC), platelet counts, alanine transaminase (ALT), albumin, total bilirubin, and creatinine. In addition, screening laboratory tests included serum HCG pregnancy tests for females of childbearing potential only, and screening for human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) infection. AE severity was graded as per the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, November 2014, of the US National Institute of Health.

    28 days

  • Number of Subjects Experiencing Serious Adverse Events

    Serious adverse events (AE) were collected 6 months post-immunization. Safety clinical laboratory evaluations were performed at Screening and at Day 8 and included: hemoglobin (HgB), white blood cells (WBC), platelet counts, alanine transaminase (ALT), albumin, total bilirubin, and creatinine. In addition, screening laboratory tests included serum HCG pregnancy tests for females of childbearing potential only, and screening for human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) infection.

    180 days

Secondary Outcomes (5)

  • Number and Percentage of Participants With Seroconversion for Meningococcal Polysaccharide A, C, Y, W and X Specific Antibodies

    28 days

  • Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:8), at Baseline and After 28 Days

    Baseline and Day 29

  • Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:128), at Baseline and After 28 Days

    Baseline and Day 29

  • Geometric Mean Titer (GMT) of Meningococcal Polysaccharide A, C, Y, W and X Specific Antibodies at Baseline and After 28 Days

    Baseline and Day 29

  • Geometric Mean Fold Change in Meningococcal Polysaccharide A, C, Y, W and X Specific Antibody Titers

    28 days

Study Arms (3)

MCV-5 with adjuvant

EXPERIMENTAL

Received a single intramuscular injection of Adjuvanted MCV-5.

Biological: Adjuvanted MCV-5

MCV-5 without adjuvant

EXPERIMENTAL

Received a single intramuscular injection of Non-Adjuvanted MCV-5.

Biological: Non-Adjuvanted MCV-5

Menactra®

ACTIVE COMPARATOR

Received a single intramuscular injection of Menactra.

Biological: Menactra®

Interventions

Adjuvanted MCV-5BIOLOGICAL

Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant.

MCV-5 with adjuvant
Non-Adjuvanted MCV-5BIOLOGICAL

Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM).

MCV-5 without adjuvant
Menactra®BIOLOGICAL

Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation.

Menactra®

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • \. 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Vaccine Development

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

  • Chen WH, Neuzil KM, Boyce CR, Pasetti MF, Reymann MK, Martellet L, Hosken N, LaForce FM, Dhere RM, Pisal SS, Chaudhari A, Kulkarni PS, Borrow R, Findlow H, Brown V, McDonough ML, Dally L, Alderson MR. Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine containing serogroups A, C, Y, W, and X in healthy adults: a phase 1, single-centre, double-blind, randomised, controlled study. Lancet Infect Dis. 2018 Oct;18(10):1088-1096. doi: 10.1016/S1473-3099(18)30400-6. Epub 2018 Aug 14.

    PMID: 30120069DERIVED

MeSH Terms

Interventions

Meningococcal Vaccines

Intervention Hierarchy (Ancestors)

Bacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Jorge Flores
Organization
PATH
jeflores@path.org
(202) 822-0033

Study Officials

  • Wilbur Chen, MD,MS

    University of Maryland Scool of Medicine, Baltimore

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 22, 2016

Study Start

August 1, 2016

Primary Completion

October 13, 2017

Study Completion

October 13, 2017

Last Updated

June 9, 2021

Results First Posted

March 30, 2021

Record last verified: 2019-08

Locations

US(1)