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Pneumococcal VaccinesPhase 2NCT05297578

Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults

A Phase 2 study testing 24-Valent Pneumococcal Conjugate Vaccine and Pneumococcal 20-valent Conjugate Vaccine in people with Pneumococcal Vaccines, run by Vaxcyte, Inc. at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 65 years of age and older. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Pneumococcal Vaccines
What is being tested?
24-Valent Pneumococcal Conjugate Vaccine and Pneumococcal 20-valent Conjugate Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
207 participants
Where
20 sitesUnited States
Study dates
15 Jun 2022to 15 Feb 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Male or female age 65 or older.
  • Able and willing to complete the informed consent process.
  • Available for clinical follow-up through the last study visit at 6 months after the study vaccination.
  • In good general health as determined by medical history, vital signs, physical examination, and clinical judgment of the investigator. Preexisting medical conditions must be stable as defined by no change in treatment at least 6 weeks prior to study participation.
  • Willing to have blood samples collected, stored indefinitely, and used for research purposes.
  • Able to provide proof of identity to the satisfaction of the study staff completing the enrollment process.

Who cannot join

  • Previous pneumococcal disease (either confirmed or by self-reporting).
  • Previous receipt of a licensed or investigational pneumococcal vaccine.
  • Receipt of any investigational study product within 30 days prior to enrollment into the study, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
  • Planned or actual administration of any licensed vaccine during the period starting 30 days before enrollment into the study through Day 29.
  • Physical examination indicating any clinically significant medical condition.
  • Body Temperature > 38.0°C (> 100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescheduled).
Show all 15Show fewer
  • Previous or existing diagnosis of HIV, Hepatitis B or Hepatitis C.
  • History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
  • Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with intramuscular injections or blood draws.
  • Any other chronic or clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety or rights of the subject or confound evaluation of the study vaccine.
  • Any medical, psychiatric, or social condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a subject's ability to give informed consent.
  • Received blood or blood product (including Immune Globulin IV) within 90 days prior to enrollment into the study.
  • Received systemic corticosteroids for ≥ 14 consecutive days and has not completed treatment ≤30 days prior to enrollment into the study.
  • Receiving immunosuppressive therapy.
  • History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Accel Research Sites-Birmingham Clinical Research Unit

    Birmingham, Alabama, 35216

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Meridian Clinical Research

    Cincinnati, Ohio, 45219

  • Accel Research Sites - DeLand Clinical Research Unit

    DeLand, Florida, 32720

  • Healthcare Research Network II, LLC

    Flossmoor, Illinois, 60422

  • Healthcare Research Network

    Hazelwood, Missouri, 63042

  • CenExel RCA

    Hollywood, Florida, 33024

  • Accellacare of Charleston

    Mt. Pleasant, South Carolina, 29464

  • AMR New Orleans

    New Orleans, Louisiana, 70119

  • AMR Newton, formerly Heartland Research Associates

    Newton, Kansas, 67114

  • Coastal Carolina Research

    North Charleston, South Carolina, 29405

  • Meridian Clinical Research

    Omaha, Nebraska, 68134

  • Accellacare of Rocky Mount

    Rocky Mount, North Carolina, 27804

  • CenExel JBR Clinical Research

    Salt Lake City, Utah, 84107

  • Clinical Trials of Texas, LLC

    San Antonio, Texas, 78229

  • Meridian Clinical Research

    Savannah, Georgia, 31406

  • Pivotal Research Solutions

    Stonecrest, Georgia, 30038

  • Precision Clinical Research

    Sunrise, Florida, 33351

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah, 84088

  • AMR Wichita West

    Wichita, Kansas, 67205

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Observer-Blind, Dose-Finding, Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Adults 65 Years and Older

The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 65 years of age and older.

Read the detailed description

The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels (Low: 1.1 mcg; Mid: 2.2 mcg; or Mixed: 2.2/4.4 mcg) compared to Prevnar 20™ (PCV20) in adults 65 years of age and older.

Being tested
24-Valent Pneumococcal Conjugate Vaccine, Pneumococcal 20-valent Conjugate Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 24-Valent Pneumococcal Conjugate VaccineBiological

    0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1

  • Pneumococcal 20-valent Conjugate VaccineBiological

    Also called Prevnar 20, PCV20

    0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1

Study groups in NCT05297578
Study groupRoleWhat they receive
VAX-24 Low DoseExperimentalParticipants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.
Receives: Biological: 24-Valent Pneumococcal Conjugate Vaccine
VAX-24 Mid DoseExperimentalParticipants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1.
Receives: Biological: 24-Valent Pneumococcal Conjugate Vaccine
VAX-24 Mixed DoseExperimentalParticipants will receive a single dose of VAX-24 2.2 mcg/4.4 mcg administered as an intramuscular injection on Day 1.
Receives: Biological: 24-Valent Pneumococcal Conjugate Vaccine
PCV20Active comparatorParticipants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.
Receives: Biological: Pneumococcal 20-valent Conjugate Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination

    Solicited local reactions included redness/erythema, swelling/induration, and pain at injection site

    Measured: 7 days after vaccination

  2. Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination

    Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain within 7 days of vaccination

    Measured: 7 days after vaccination

  3. Percentage of Subjects Reporting Unsolicited Adverse Events Within 1 Month After Vaccination

    Percentage of participants with at least one Treatment Emergent Adverse Event (unsolicited AEs and SAEs)

    Measured: 1 month after vaccination

  4. Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCIs)

    Percentage of participants with serious adverse events (SAEs) and new onset of chronic illness (NOCIs)

    Measured: 6 months after vaccination

Secondary outcomes (2)

  1. VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)

    The change from baseline to 1 month post-vaccination in the immune response directed against each of the 24 serotypes was evaluated by measuring serotype-specific functional antibody responses with an opsonophagocytic (OPA) assay that assesses the functional capacity of pneumococcal antibodies.

    Measured: 1 month after vaccination

  2. 24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)

    The change from baseline to 1 month post-vaccination in the immune response directed against each of the 24 serotypes was evaluated by measuring IgG levels using an IgG multiplexed electrochemoluminescent assay (ECLA). Values below the lower limit of quantitation (LLOQ) were analyzed as 0.5*LLOQ. Values above the upper limit of quantitation (ULOQ) were analyzed as 1*ULOQ.

    Measured: 1 month after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2022
  2. Study start15 Jun 2022
  3. Primary completion15 Feb 2023
  4. Study completion15 Feb 2023

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05297578
Sponsor's protocol ID
VAX24-102
Status last verified
Sep 2024
First submitted
17 Mar 2022
Last updated
9 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Vaxcyte is committed to providing access to anonymized data from the company's clinical trials for the purpose of legitimate scientific research. Requests for data may be addressed to datasharing@vaxcyte.com. Requests must be accompanied by a detailed analysis plan and will be reviewed for scientific validity. Data will be made available after initial product approval. Sharing of data may require execution of a data-sharing agreement.

Publications

  • Wassil J, Sisti M, Fairman J, Rankin B, Clark J, Bennett S, Johnson D, Migone TS, Nguyen K, Paschenko A, Sauer P, Iki S, Hanson ME, Simon JK. A phase 2, randomized, blinded, dose-finding, controlled clinical trial to evaluate the safety, tolerability, and immunogenicity of a 24-valent pneumococcal conjugate vaccine (VAX-24) in healthy adults 65 years and older. Vaccine. 2024 Nov 14;42(25):126124. doi: 10.1016/j.vaccine.2024.07.025. Epub 2024 Jul 17.

    PubMed 39025698

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 24-Valent Pneumococcal Conjugate Vaccine and Pneumococcal 20-valent Conjugate Vaccine in people with Pneumococcal Vaccines, run by Vaxcyte, Inc. at 20 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 6 inclusion and 15 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: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination (time frame: 7 days after vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05297578, which also lists 1 linked publication.

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 9 Oct 2024.

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