Safety, Tolerability, and Immunogenicity Study of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Adults

Pneumococcal Vaccines Clinical Trial

Official title:

A Phase 1/2, Randomized, Observer-Blind, Dose-Finding, Active-Controlled, Parallel-Group, Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Healthy Adults Aged 50 Years and Older

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06151288
• Other study ID #: VAX31-101
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: November 8, 2023
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: Vaxcyte, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to evaluate the safety, tolerability and immunogenicity of a single injection of VAX-31 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 50 to 64 years of age in Stage 1. Stage 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-31 at 3 dose levels compared to PCV20 in adults aged 50 years and older.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1015
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Able and willing to complete the informed consent process.

3. Available for clinical follow-up through the last study visit at 6 months after the study vaccination.

4. In good general health as determined by medical history, vital signs, physical examination, and clinical judgment of the Investigator.

5. Willing to have blood samples collected, stored indefinitely, and used for research purposes.

6. Able to provide proof of identity to the satisfaction of the study staff completing the enrollment process.

7. Women of childbearing potential, defined as premenopausal females capable of becoming pregnant, must have a negative urine pregnancy test immediately prior to randomization and agree to use acceptable contraception

8. 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.

Exclusion Criteria:

1. Previous pneumococcal disease (either confirmed or self-reported).

2. Previous receipt of a licensed or investigational pneumococcal vaccine.

3. 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.

4. Planned or actual administration of any licensed vaccine during the period starting 30 days before enrollment into the study through Month 1.

5. Physical examination indicating any clinically significant medical condition.

6. Body Temperature >38.0°C (>100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescheduled).

7. Previous or existing diagnosis of HIV, Hepatitis B, or Hepatitis C.

8. History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.

9. Female who is pregnant, breastfeeding, or planning to become pregnant during study participation.

10. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) resulting in clinically significant bruising or bleeding difficulties with IM injections or blood draws.

11. 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.

12. 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.

13. Received blood or blood product (including Immune Globulin IV) within 90 days prior to enrollment into the study.

14. Received systemic corticosteroids (except for inhaled, topical, intra-articular) for

=14 consecutive days and has not completed treatment =30 days prior to enrollment into the study.

15. Receiving immunosuppressive therapy.

16. History of malignancy =5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer

Related Conditions & MeSH terms

• Pneumococcal Vaccines

Intervention

Biological:
• 31 valent pneumococcal conjugate vaccine
0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
• 20 valent pneumococcal conjugate vaccine
0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1

Locations

Country	Name	City	State
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Velocity Clinical Research, Cleveland	Cleveland	Ohio
United States	DM Clinical Research - Detroit	Detroit	Michigan
United States	Healthcare Research Network II, LLC	Flossmoor	Illinois
United States	Benchmark Research	Fort Worth	Texas
United States	Research Centers of America	Hollywood	Florida
United States	Health Awareness	Jupiter	Florida
United States	AMR Knoxville	Knoxville	Tennessee
United States	WR-CRCN	Las Vegas	Nevada
United States	Johnson County Clin-Trials	Lenexa	Kansas
United States	Optimal Research	Melbourne	Florida
United States	AMR Mobile	Mobile	Alabama
United States	Health Research of Hampton Roads	Newport News	Virginia
United States	Coastal Carolina Research	North Charleston	South Carolina
United States	Velocity Clinical Research Omaha	Omaha	Nebraska
United States	DM Clinical Research - Philadelphia	Philadelphia	Pennsylvania
United States	AMR Phoenix	Phoenix	Arizona
United States	Rochester Clinical Research	Rochester	New York
United States	CenExel JBR Clinical Research	Salt Lake City	Utah
United States	Benchmark Research	San Angelo	Texas
United States	Velocity Clinical Research, Savannah	Savannah	Georgia
United States	Precision Clinical Research	Sunrise	Florida
United States	Cenexel AMRI	Toms River	New Jersey
United States	Velocity Clinical Research	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Vaxcyte, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants reporting solicited local reactions within 7 days after vaccination (redness, swelling, and pain at injection site) in each age group		7 days after vaccination
Primary	Percentage of subjects reporting solicited systemic events within 7 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain) in each age group vaccination in each age group		7 days after vaccination
Primary	Percentage of subjects reporting unsolicited Adverse Event in each age group		1 month after vaccination
Primary	Percentage of subjects reporting Serious Adverse Event		6 months after vaccination
Primary	Percentage of subjects reporting New Onset of Chronic Illness		6 months after vaccination
Primary	Percentage of subjects reporting Medically Attended Adverse Event		6 months after vaccination
Secondary	Percentage of participants with Adverse Events due to clinically significant laboratory values		1 month after vaccination
Secondary	Percentage of participants with a shift from normal at baseline to abnormal at post-vaccination in safety laboratory parameters (hematology, clinical chemistry, urinalysis)		1 month after vaccination
Secondary	31 VAX-31 Pneumococcal serotype-specific OPA geometric mean titer		1 month after vaccination
Secondary	31 VAX-31 Pneumococcal serotype-specific IgG geometric mean concentration		1 month after vaccination