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

NCT05297578 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: VAX24-102
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Pneumococcal Vaccines

Outcome Measures

Primary Outcomes (4)

• 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

  7 days after vaccination

• 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

  7 days after vaccination

• 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)

  1 month after vaccination

• 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)

  6 months after vaccination

Secondary Outcomes (2)

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

  1 month after vaccination

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

  1 month after vaccination

Study Arms (4)

VAX-24 Low Dose

EXPERIMENTAL

Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.

Biological: 24-Valent Pneumococcal Conjugate Vaccine

VAX-24 Mid Dose

EXPERIMENTAL

Participants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1.

Biological: 24-Valent Pneumococcal Conjugate Vaccine

VAX-24 Mixed Dose

EXPERIMENTAL

Participants will receive a single dose of VAX-24 2.2 mcg/4.4 mcg administered as an intramuscular injection on Day 1.

Biological: 24-Valent Pneumococcal Conjugate Vaccine

PCV20

ACTIVE COMPARATOR

Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.

Biological: Pneumococcal 20-valent Conjugate Vaccine

Interventions

24-Valent Pneumococcal Conjugate Vaccine BIOLOGICAL

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

VAX-24 Low Dose; VAX-24 Mid Dose; VAX-24 Mixed Dose

Pneumococcal 20-valent Conjugate Vaccine BIOLOGICAL

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

Also known as: Prevnar 20, PCV20

PCV20

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Vaxcyte, Inc.: lead

Study Sites (20)

Accel Research Sites-Birmingham Clinical Research Unit

Birmingham, Alabama, 35216, United States

Location

Accel Research Sites - DeLand Clinical Research Unit

DeLand, Florida, 32720, United States

Location

CenExel RCA

Hollywood, Florida, 33024, United States

Location

Precision Clinical Research

Sunrise, Florida, 33351, United States

Location

Meridian Clinical Research

Savannah, Georgia, 31406, United States

Location

Pivotal Research Solutions

Stonecrest, Georgia, 30038, United States

Location

Healthcare Research Network II, LLC

Flossmoor, Illinois, 60422, United States

Location

AMR Newton, formerly Heartland Research Associates

Newton, Kansas, 67114, United States

Location

AMR Wichita West

Wichita, Kansas, 67205, United States

Location

AMR New Orleans

New Orleans, Louisiana, 70119, United States

Location

Healthcare Research Network

Hazelwood, Missouri, 63042, United States

Location

Meridian Clinical Research

Omaha, Nebraska, 68134, United States

Location

Accellacare of Rocky Mount

Rocky Mount, North Carolina, 27804, United States

Location

Meridian Clinical Research

Cincinnati, Ohio, 45219, United States

Location

Accellacare of Charleston

Mt. Pleasant, South Carolina, 29464, United States

Location

Coastal Carolina Research

North Charleston, South Carolina, 29405, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States

Location

CenExel JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Related Publications (1)

• 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.

  PMID: 39025698 RESULT

Limitations and Caveats

Some limitations of this clinical study include the lack of a group, such as 3·3 µg or 4·4 µg, for all serotypes, aimed at understanding whether the dose response of polysaccharide can overcome carrier suppression. The relatively low ethnic diversity of participants is also a limitation, and the sample size was relatively small, both of which will be addressed in larger phase 3 clinical trials.

Results Point of Contact

• Title: Vice President of Clinical Development
• Organization: Vaxcyte

clinicaltrialsgov@vaxcyte.com

650-585-0029

Study Officials

• Clinical Development

  Vaxcyte, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Triple (Participant, Investigator, Outcomes Assessor)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: June 15, 2022
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: October 9, 2024
• Results First Posted: April 16, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Individual participant data will be shared after deidentification and made available starting 6 months after initial product approval.
• Access Criteria: Criteria will depend on the specific proposal received and may include qualification of the scientific researchers, potential contribution to the research field, scientific rigor of statistical and analytical methods, and other criteria appropriate for the proposal.

Locations

US (20)