Pneumococcal VaccinePhase 1NCT06337643
A Study to Evaluate Tolerability, Safety and Immunogenicity of MVX01 Pneumococcal Vaccine
A Phase 1 study testing MVX01 in people with Pneumococcal Vaccine, run by Matrivax Research and Development Corporation at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Vaccine
- What is being tested?
- MVX01
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Mar 2023to 16 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Alliance for Multispecialty Research (AMR)
Knoxville, Tennessee, 37909
Velocity (Meridian) Clinical Research
Savannah, Georgia, 31406
About this study
Official title: 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.
Read the 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.
- Conditions
- Pneumococcal Vaccine
- Being tested
- MVX01, MVX01 Placebo
- Keywords
- Streptococcus Pneumoniae Infection, Pneumonia, S. pneumoniae, Pneumonia, Bacterial, Healthy Human
- Medical subject headings
- Pneumococcal Infections, Pneumonia, Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVX01Biological
Pneumococcal Vaccine Candidate
MVX01 PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| MVX01 Vaccine - Cohort 1 | Experimental | MVX01 Vaccine: liquid formulation, 0.5 mL intramuscular injection, 10 μg Frequency: 2 doses administered approximately 1 month apart Age: 18-50 years, Receives: Biological: MVX01 |
| MVX01 Vaccine or Placebo - Cohort 2 | Experimental | 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 Receives: Biological: MVX01; Biological: MVX01 Placebo |
| MVX01 Vaccine or Placebo - Cohort 3 | Experimental | 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 Receives: Biological: MVX01; Biological: MVX01 Placebo |
| MVX01 Vaccine or Placebo - Cohort 4 | Experimental | 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 Receives: Biological: MVX01; Biological: MVX01 Placebo |
| MVX01 Vaccine or Placebo - Cohort 5 | Experimental | 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 Receives: Biological: MVX01; Biological: MVX01 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 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.
Measured: Up to study day 224
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start7 Mar 2023
- Primary completion16 Apr 2024 (estimated)
- Study completion16 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matrivax Research and Development Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337643
- Sponsor's protocol ID
- MVX01-01
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2023
- Last updated
- 29 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06337643
- Acronym / sponsor ID
- MVX01-01
- Conditions
- Pneumococcal Vaccine
- Keywords
- Streptococcus Pneumoniae Infection, Pneumonia, S. pneumoniae, Pneumonia, Bacterial, Healthy Human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Matrivax Research and Development CorporationIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 16 Apr 2024 (estimated)
- Study completion
- 16 Apr 2024 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MVX01 Vaccine - Cohort 1 | Experimental | Biological: MVX01MVX01 Vaccine: liquid formulation, 0.5 mL intramuscular injection, 10 μg Frequency: 2 doses administered approximately 1 month apart Age: 18-50 years, |
| MVX01 Vaccine or Placebo - Cohort 2 | Experimental | Biological: MVX01, Biological: MVX01 PlaceboMVX01 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 |
| MVX01 Vaccine or Placebo - Cohort 3 | Experimental | Biological: MVX01, Biological: MVX01 PlaceboMVX01 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 |
| MVX01 Vaccine or Placebo - Cohort 4 | Experimental | Biological: MVX01, Biological: MVX01 PlaceboMVX01 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 |
| MVX01 Vaccine or Placebo - Cohort 5 | Experimental | Biological: MVX01, Biological: MVX01 PlaceboMVX01 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MVX01Pneumococcal Vaccine Candidate | Biological | MVX01 Vaccine - Cohort 1, MVX01 Vaccine or Placebo - Cohort 2, MVX01 Vaccine or Placebo - Cohort 3, MVX01 Vaccine or Placebo - Cohort 4, MVX01 Vaccine or Placebo - Cohort 5 |
| MVX01 PlaceboPlacebo | Biological | MVX01 Vaccine or Placebo - Cohort 2, MVX01 Vaccine or Placebo - Cohort 3, MVX01 Vaccine or Placebo - Cohort 4, MVX01 Vaccine or Placebo - Cohort 5 |
Primary outcome
Incidence of immediate reactogenicity adverse events
Time frame: Up to 30 minutes after each dose
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.
Incidence of solicited reactogenicity events
Time frame: Up to 7 days after each dose
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
Incidence of adverse events (AEs)
Time frame: Up to study day 61
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.
Incidence of Serious Adverse Events (SAEs) and New-Onset Chronic Illness (NOCI)
Time frame: Up to study day 224
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.
Changes in safety laboratory results compared to baseline
Time frame: Up to study day 61
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".
Changes in vital signs compared to baseline
Time frame: Up to study day 61
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".
Geometric Mean Titer (GMT) post immunization of Anti-pneumolysin (PLY) and anti-choline binding protein A (CbpA)
Time frame: Up to study day 224
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MVX01 in people with Pneumococcal Vaccine, run by Matrivax Research and Development Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of immediate reactogenicity adverse events (time frame: Up to 30 minutes after each dose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.