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Cancer Vaccine

31-Valent Pneumococcal Vaccine for Preventing Pneumococcus-related Diseases

Phase 1 & 2
Waitlist Available
Research Sponsored by Vaxcyte, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female aged 50 to 64 years (inclusive) for Stage 1, or 50 years and older (inclusive) for Stage 2 at the time of randomization into the study
Able to access and use a smartphone, tablet, computer, or other device connected to Wi-Fi or cellular network for completion of an electronic diary
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days after vaccination
Awards & highlights

Study Summary

This trial tests the safety and effectiveness of a new vaccine in adults 50-64, compared to the existing Prevnar 20 vaccine.

Who is the study for?
Adults aged 50-64 for Stage 1, and 50+ for Stage 2, in good health with the ability to consent and follow-up. Must be willing to provide blood samples and use a smart device. Women must not be pregnant or breastfeeding and agree to contraception. Excludes those with previous pneumococcal disease/vaccine, recent investigational products, certain vaccines within a month before enrollment, acute illnesses, significant medical conditions including bleeding disorders or immunosuppression.Check my eligibility
What is being tested?
The trial is testing the safety and immune response of VAX-31 (a new vaccine) against Prevnar 20™ (an existing vaccine). Participants will receive one injection of either VAX-31 at different doses or PCV20. The study has two stages based on age groups.See study design
What are the potential side effects?
Potential side effects may include typical reactions at the injection site like pain or swelling, general body reactions such as fever or fatigue, allergic responses ranging from mild rashes to more severe reactions like difficulty breathing if an allergy exists.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 50 and 64 years old for Stage 1, or 50+ for Stage 2.
Select...
I can use a smart device and have internet access for an e-diary.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of participants reporting solicited local reactions within 7 days after vaccination (redness, swelling, and pain at injection site) in each age group
Percentage of subjects reporting Medically Attended Adverse Event
Percentage of subjects reporting New Onset of Chronic Illness
+3 more
Secondary outcome measures
31 VAX-31 Pneumococcal serotype-specific IgG geometric mean concentration
31 VAX-31 Pneumococcal serotype-specific OPA geometric mean titer
Percentage of participants with Adverse Events due to clinically significant laboratory values
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Group 3Experimental Treatment1 Intervention
Participants will receive a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
Group II: Group 2Experimental Treatment1 Intervention
Participants will receive a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
Group III: Group 1Experimental Treatment1 Intervention
Participants will receive a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
Group IV: Group 4Active Control1 Intervention
Participants will receive a single intramuscular injection of the standard dose of PCV20 at Day 1.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vaxcyte, Inc.Lead Sponsor
3 Previous Clinical Trials
1,778 Total Patients Enrolled
Clinical DevelopmentStudy DirectorVaxcyte, Inc.
34 Previous Clinical Trials
87,629 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many sites have been selected to carry out this experiment?

"Velocity Clinical Research in Cleveland, Ohio; WR-CRCN in Las Vegas, Nevada; and Benchmark Research in Fort Worth, Texas are amongst the many clinical trial sites that have opened their doors to participants. Additionally, there are 25 other locations where patients may enrol."

Answered by AI

Are any new participants being sought for this clinical experiment?

"The information accessible on clinicaltrials.gov manifests that enrolment for this medical trial is ongoing. This research project was first advertised to the public on November 8th 2023, with a recent update posted on November 20th of the same year."

Answered by AI

How many participants are included in this research endeavor?

"In order to carry out the research, 1000 participants that meet all criteria must be enlisted. Vaxcyte, Inc., will oversee this trial at Velocity Clinical Research in Cleveland and WR-CRCN located in Las Vegas."

Answered by AI

Who else is applying?

What site did they apply to?
Cenexel AMRI
WR-CRCN
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Want to help plus money is needed.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, and Immunogenicity Study of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Adults
2023. "Safety, Tolerability, and Immunogenicity Study of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06151288.
All > Paid Studies Las Vegas > Knoxville
~451 spots leftby Sep 2024
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