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

NCT05266456 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: VAX24-101
• Study Type: interventional
• Target: 835
• Locations: 1 country
• Sites: 13

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 18 to 49 years of age in Phase 1. The Phase 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-24 at 3 dose levels compared to PCV20 in adults aged 50 to 64 years of age in Phase 2.

Conditions

Pneumococcal Vaccines

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age Group

  Solicited local reactions include redness/erythema, swelling/induration, and pain at injection site within 7 days after vaccination in each age group

  7 days after vaccination

• Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age Group

  Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain

  7 days after vaccination

• Percentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group

  Percentage of participants in each age group with adverse events (AEs) whose date of onset occurs after the study vaccine and within the 28 days after vaccination.

  1 month after vaccination

• Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)

  Percentage of participants with SAEs and NOCIs

  6 months after vaccination

Secondary Outcomes (3)

• Percentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values

  1 month after vaccination

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

  1 month after vaccination

• VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (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: 20 valent pneumococcal 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

20 valent pneumococcal conjugate vaccine BIOLOGICAL

0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1

PCV20

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female age 18 to 49 years (inclusive) for the Phase 1 group, or 50 to 64 years (inclusive) for the Phase 2 group at the time of enrollment into the study.
• 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.
• Screening laboratory values must be within the central laboratory normal limits prior to study enrollment. Minor abnormalities are considered acceptable if not clinically significant.
• 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.
• Negative pregnancy test (urine and serum) for women of childbearing potential.

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).
• Seropositive to HIV, HCV, or HBsAg.
• History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
• Female who is breast-feeding or planning to become pregnant during study participation.
• Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM 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.

Sponsors & Collaborators

• Vaxcyte, Inc.: lead

Study Sites (13)

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

Velocity Clinical Research

Valparaiso, Indiana, 46383, United States

Location

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

Benchmark Research

Metairie, Louisiana, 70006, United States

Location

Alliance for Multispecialty Research

Kansas City, Missouri, 64114, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

Acellacare of Wilmington

Wilmington, North Carolina, 28401, United States

Location

Velocity Clinical Research

Warwick, Rhode Island, 02886, United States

Location

Coastal Carolina Research

North Charleston, South Carolina, 29405, United States

Location

Benchmark Research

San Angelo, Texas, 76904, United States

Location

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Related Publications (1)

• Wassil J, Sisti M, Fairman J, Davis M, Fierro C, Bennett S, Johnson D, Migone TS, Nguyen K, Sauer P, Currie M, Iki S, Simon JK. Evaluating the safety, tolerability, and immunogenicity of a 24-valent pneumococcal conjugate vaccine (VAX-24) in healthy adults aged 18 to 64 years: a phase 1/2, double-masked, dose-finding, active-controlled, randomised clinical trial. Lancet Infect Dis. 2024 Mar;24(3):308-318. doi: 10.1016/S1473-3099(23)00572-8. Epub 2023 Dec 4.

  PMID: 38061367 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, 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 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Investigator, Outcomes Assessor)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 4, 2022
• Study Start: February 22, 2022
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2023
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-03

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 (13)