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

• Sponsor: Vaxcyte, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06151288
• Collaborator: (none)
• Enrollment: 1,000
• Locations: 25
• Arms: 4
• Anticipated Duration (Months): 9.8
• Patients Per Site: 40
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pneumococcal Vaccines	Biological: 31 valent pneumococcal conjugate vaccine; Biological: 20 valent pneumococcal conjugate vaccine	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Nov 8, 2023
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Participants will receive a single low dose of VAX-31 administered as an intramuscular injection at Day 1.	Biological: 31 valent pneumococcal conjugate vaccine; 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
Experimental: Group 2 Participants will receive a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.	Biological: 31 valent pneumococcal conjugate vaccine; 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
Experimental: Group 3 Participants will receive a single high dose of VAX-31 administered as an intramuscular injection at Day 1.	Biological: 31 valent pneumococcal conjugate vaccine; 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1
Active Comparator: Group 4 Participants will receive a single intramuscular injection of the standard dose of PCV20 at Day 1.	Biological: 20 valent pneumococcal conjugate vaccine; 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1; Other Names: PCV20 Prevnar 20™

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

3. Percentage of subjects reporting unsolicited Adverse Event in each age group [1 month after vaccination]

4. Percentage of subjects reporting Serious Adverse Event [6 months after vaccination]

5. Percentage of subjects reporting New Onset of Chronic Illness [6 months after vaccination]

6. Percentage of subjects reporting Medically Attended Adverse Event [6 months after vaccination]

Secondary Outcome Measures

1. Percentage of participants with Adverse Events due to clinically significant laboratory values [1 month after vaccination]

2. 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]

3. 31 VAX-31 Pneumococcal serotype-specific OPA geometric mean titer [1 month after vaccination]

4. 31 VAX-31 Pneumococcal serotype-specific IgG geometric mean concentration [1 month after vaccination]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

1. Receiving immunosuppressive therapy.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AMR Mobile	Mobile	Alabama	United States	36608
2	AMR Phoenix	Phoenix	Arizona	United States	85282
3	Research Centers of America	Hollywood	Florida	United States	33024
4	Health Awareness	Jupiter	Florida	United States	33458
5	Optimal Research	Melbourne	Florida	United States	32934
6	Precision Clinical Research	Sunrise	Florida	United States	33351
7	Velocity Clinical Research, Savannah	Savannah	Georgia	United States	31406
8	Healthcare Research Network II, LLC	Flossmoor	Illinois	United States	60422
9	Johnson County Clin-Trials	Lenexa	Kansas	United States	66219
10	DM Clinical Research - Detroit	Detroit	Michigan	United States	48076
11	Velocity Clinical Research Omaha	Omaha	Nebraska	United States	68134
12	WR-CRCN	Las Vegas	Nevada	United States	89106
13	Cenexel AMRI	Toms River	New Jersey	United States	08755
14	Rochester Clinical Research	Rochester	New York	United States	14609
15	CTI Clinical Research Center	Cincinnati	Ohio	United States	45212
16	Velocity Clinical Research, Cleveland	Cleveland	Ohio	United States	44122
17	DM Clinical Research - Philadelphia	Philadelphia	Pennsylvania	United States	19107
18	Velocity Clinical Research	Warwick	Rhode Island	United States	02886
19	Coastal Carolina Research	North Charleston	South Carolina	United States	29405
20	AMR Knoxville	Knoxville	Tennessee	United States	37909
21	Benchmark Research	Fort Worth	Texas	United States	76135
22	Benchmark Research	San Angelo	Texas	United States	76904
23	CenExel JBR Clinical Research	Salt Lake City	Utah	United States	84107
24	Charlottesville Medical Research	Charlottesville	Virginia	United States	22911
25	Health Research of Hampton Roads	Newport News	Virginia	United States	23606

Sponsors and Collaborators

• Vaxcyte, Inc.

Investigators

• Study Director: Clinical Development, Vaxcyte, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vaxcyte, Inc.
• ClinicalTrials.gov Identifier: NCT06151288
• Other Study ID Numbers: VAX31-101
• First Posted: Nov 30, 2023
• Last Update Posted: Nov 30, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

No Results Posted as of Nov 30, 2023