A Study to Evaluate Tolerability, Safety and Immunogenicity of MVX01 Pneumococcal Vaccine

A Phase 1, First-in Human, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study of the Tolerability, Safety, and Immunogenicity of MVX01, a Pneumococcal Vaccine Candidate, in Healthy Adult Participants

The objectives of this first-in-human study is to evaluate the tolerability, safety, and immunogenicity of MVX01, a pneumococcal vaccine candidate, at four dose levels.

Study Overview

• Status: Active, not recruiting
• Conditions: Pneumococcal Vaccine
• Intervention / Treatment: Biological: MVX01; Biological: MVX01 Placebo

Detailed Description

The study will enroll five cohorts. Ascending doses of MVX01 will be evaluated in cohorts 1-4, in participants 18-50 years of age. The highest tolerated dose from cohorts 1-4 will be evaluated in cohort 5, in participants 60-75 years of age. Cohort 1 will be open-label. Cohorts 2-5 will enroll two open-label sentinel participants followed by the remainder of the cohort which will be randomized and double-blind. Each participant will be administered two doses of study intervention via intramuscular injection, approximately 1 month apart. Immunogenicity will be evaluated up to approximately 6 months following administration of the second dose.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Velocity (Meridian) Clinical Research
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Alliance for Multispecialty research (AMR)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participant must be male or non-pregnant, non-lactating female ≥ 18 to ≤ 50 years of age for Cohorts 1 to 4 and ≥ 60 to ≤ 75 years of age for Cohort 5, at the time of signing the informed consent.
• Body mass index within the range 18 to 32 kg/m2 (inclusive) for Cohorts 1-4. Body mass index within the range 18 to 35 kg/m2 (inclusive) for Cohort 5.
• Participants who are free of clinically significant acute or chronic health conditions in the opinion of the Investigator.
• Have provided written informed consent prior to screening procedures.
• Participant's screening laboratory test results must be either within the normal range or deemed as not clinically significant by the Investigator.
• Venous access considered adequate for collection of safety laboratory samples and immunogenicity samples.
• Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. In addition, women of childbearing potential must agree to avoid heterosexual activity for a period of 14 days prior to the administration of study intervention.

Exclusion Criteria:

• Positive screening test suggesting a current infection due to human immunodeficiency virus, hepatitis C virus, or hepatitis B virus infection.
• Symptoms of active respiratory illness at the time of the first dose of study intervention or close contact with a known SARS-CoV-2 positive patient within 10 days of first dose of study intervention.
• Suspected or known alcohol and/or illicit drug abuse within the past 5 years.
• Regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
• Electrocardiogram abnormalities outside of accepted ranges (with some exceptions) or results considered to be clinically significant. Participants with QT interval corrected for heart rate according to Fridericia's formula > 450 msec (if male) or > 460 msec (if female) will be excluded.
• History of confirmed pneumococcal infection based on participant report of medical history during the previous 12 months.
• Use of any investigational (non-registered) drug within 30 days or 5 half-lives of the investigational drug prior to receiving the first dose of study intervention. All investigational (non-registered) drugs used should be noted.
• Use of chronic immunosuppressant agents or other immune-modifying drugs within 6 months prior to receiving the first dose of study intervention. Short-term use of corticosteroids (< 14 days) for an acute illness are allowed but last dose should be ≥ 28 days prior to administration of the first dose of study intervention. The use of topical, inhaled, and nasal glucocorticoids is permitted.
• Receipt of immunoglobulins and/or any blood products within the 3 months preceding Day 1 or planned administration of such products during the study and up Visit 6 (Day 57 [± 4 days]).
• Is planning to become pregnant in the time period from Screening up to 30 days following the last dose of study intervention.
• History of allergic disease, neurologic disease, or untoward reactions likely to be exacerbated by any component of the vaccine and/or known hypersensitivity to any component of the vaccine.
• Any condition that in the opinion of the Investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the study intervention or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
• Known or suspected severe immunological dysfunction in the opinion of the Investigator.
• History of administration of any vaccine within 30 days of prior to receiving the first dose of study intervention. Should a vaccine have been administered within the 30-day timeframe, inclusion into the study will be at the discretion of the Investigator. Vaccines may not be administered until after Visit 6 (Day 57 [± 4 days]). Participants should not intend to receive a licensed pneumococcal vaccine until after Visit 7 (Day 210 [± 14 days]). Participants will not be excluded based on previously having received a licensed pneumococcal vaccine as long as it was administered at least 30 days prior to receiving the first dose of study intervention.
• Unwilling or unable to forego donation of sperm, egg, blood, plasma, or platelets from Screening through Visit 6 (Day 57 [± 4 days]).
• In the opinion of the Investigator, any participant with a physical or laboratory finding or past medical history that might suggest a good quality of life for the participant is likely to be < 24 months at the time of Screening examination.
• Participants who, in the opinion of the Investigator, will not be able to comply with all the study procedures and visits as outlined in the protocol, including follow-up.
• A staff member or family member of a staff member of the clinical research organization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MVX01 Vaccine - Cohort 1; MVX01 Vaccine: liquid formulation, 0.5 mL intramuscular injection, 10 μg Frequency: 2 doses administered approximately 1 month apart Age: 18-50 years,	Biological: MVX01; Pneumococcal Vaccine Candidate
Experimental: MVX01 Vaccine or Placebo - Cohort 2; MVX01 Vaccine: liquid formulation, 0.5 mL intramuscular injection, 30 μg, or Placebo: liquid formulation, 0.5 mL intramuscular injection Frequency: 2 doses administered approximately 1 month apart Age: 18-50 years	Biological: MVX01; Pneumococcal Vaccine Candidate; Biological: MVX01 Placebo; Placebo
Experimental: MVX01 Vaccine or Placebo - Cohort 3; MVX01 Vaccine: liquid formulation, 0.5 mL intramuscular injection, 60 μg, or Placebo: liquid formulation, 0.5 mL intramuscular injection Frequency: 2 doses administered approximately 1 month apart Age: 18-50 years	Biological: MVX01; Pneumococcal Vaccine Candidate; Biological: MVX01 Placebo; Placebo
Experimental: MVX01 Vaccine or Placebo - Cohort 4; MVX01 Vaccine: liquid formulation, 0.5 mL intramuscular injection, 90 μg, or Placebo: liquid formulation, 0.5 mL intramuscular injection Frequency: 2 doses administered approximately 1 month apart Age: 18-50 years	Biological: MVX01; Pneumococcal Vaccine Candidate; Biological: MVX01 Placebo; Placebo
Experimental: MVX01 Vaccine or Placebo - Cohort 5; MVX01 Vaccine: liquid formulation, 0.5 mL intramuscular injection, 90 μg, or Placebo: liquid formulation, 0.5 mL intramuscular injection Frequency: 2 doses administered approximately 1 month apart Age: 60-75 years	Biological: MVX01; Pneumococcal Vaccine Candidate; Biological: MVX01 Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of immediate reactogenicity adverse events	Number and percentage of immediate reactogenicity events by severity. Including: Local expected at injection site: erythema/redness; induration/hardening; pain; pruritus/itching; tenderness.; Systemic expected: fatigue; fever; flu-like symptoms; headache; myalgia/muscle pain; nausea; rash; vomiting.	Up to 30 minutes after each dose
Incidence of solicited reactogenicity events	Number and percentage of solicited reactogenicity adverse events by severity. Including: Local expected at injection site: erythema/redness; induration/hardening; pain; pruritus/itching; tenderness.; Systemic expected: fatigue; fever; flu-like symptoms; headache; myalgia/muscle pain; nausea; rash; vomiting	Up to 7 days after each dose
Incidence of adverse events (AEs)	Number and percentage of adverse events reported spontaneously by the participant. The following summaries are planned: Overview of TEAEs.; All TEAEs.events.; All TEAEs by relationship to study intervention.; All TEAEs leading to discontinuation.; All TEAEs leading to death.; All TEAEs by severity.	Up to study day 61
Incidence of Serious Adverse Events (SAEs) and New-Onset Chronic Illness (NOCI)	Number and percentage of serious adverse events and new-onset chronic illnesses as determined by discretion of the investigator. The following summaries are planned: SAEs/NOCIs throughout study).; All SAEs considered at least possibly related to study intervention.	Up to study day 224
Changes in safety laboratory results compared to baseline	Assessment of adverse changes from baseline in safety laboratory results (standard panels for hematology, blood chemistry and urinalysis) that meet criteria as an adverse event as described in "Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, FDA 2007".	Up to study day 61
Changes in vital signs compared to baseline	Assessment of changes in vital signs (SBP, DBP, HR, RR, oral body temp) that meet criteria as an adverse event as described in "Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, FDA 2007".	Up to study day 61
Geometric Mean Titer (GMT) post immunization of Anti-pneumolysin (PLY) and anti-choline binding protein A (CbpA)	Anti-pneumolysin and anti-choline binding protein A serum immunoglobulin G antibody geometric mean titer as measured by enzyme-linked immunosorbent assay (ELISA) compared baseline. The anti-PLY and anti-CbpA antibody titers will be measured as >=2- and >=4-fold above baseline to determine GMTs and rates of seroconversion.	Up to study day 224

Collaborators and Investigators

• Sponsor: Matrivax Research and Development Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2023
• Primary Completion (Estimated): April 16, 2024
• Study Completion (Estimated): April 16, 2024

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pneumonia; Pneumonia, Bacterial; S. pneumoniae; Streptococcus Pneumoniae Infection; Healthy Human
• Other Study ID Numbers: MVX01-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No