Clinical trial NCT06151288: Safety, Tolerability, and Immunogenicity Study of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pneumococcal Vaccines
Lead sponsor: Vaxcyte, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-30
Enrollment: 1015
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of participants reporting solicited local reactions within 7 days after vaccination (redness, swelling, and pain at injection site) in each age group
timeFrame: 7 days after vaccination
measure: 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
timeFrame: 7 days after vaccination
measure: Percentage of subjects reporting unsolicited Adverse Event in each age group
timeFrame: 1 month after vaccination
measure: Percentage of subjects reporting Serious Adverse Event
timeFrame: 6 months after vaccination
measure: Percentage of subjects reporting New Onset of Chronic Illness
timeFrame: 6 months after vaccination
measure: Percentage of subjects reporting Medically Attended Adverse Event
timeFrame: 6 months after vaccination
Secondary outcomes:
measure: Percentage of participants with Adverse Events due to clinically significant laboratory values
timeFrame: 1 month after vaccination
measure: Percentage of participants with a shift from normal at baseline to abnormal at post-vaccination in safety laboratory parameters (hematology, clinical chemistry, urinalysis)
timeFrame: 1 month after vaccination
measure: 31 VAX-31 Pneumococcal serotype-specific OPA geometric mean titer
timeFrame: 1 month after vaccination
measure: 31 VAX-31 Pneumococcal serotype-specific IgG geometric mean concentration
timeFrame: 1 month after vaccination
Other outcomes:
Locations:
city: Mobile
country: United States
facility: AMR Mobile
state: Alabama
city: Phoenix
country: United States
facility: AMR Phoenix
state: Arizona
city: Hollywood
country: United States
facility: Research Centers of America
state: Florida
city: Jupiter
country: United States
facility: Health Awareness
state: Florida
city: Melbourne
country: United States
facility: Optimal Research
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: Savannah
country: United States
facility: Velocity Clinical Research, Savannah
state: Georgia
city: Flossmoor
country: United States
facility: Healthcare Research Network II, LLC
state: Illinois
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Detroit
country: United States
facility: DM Clinical Research - Detroit
state: Michigan
city: Omaha
country: United States
facility: Velocity Clinical Research Omaha
state: Nebraska
city: Las Vegas
country: United States
facility: WR-CRCN
state: Nevada
city: Toms River
country: United States
facility: Cenexel AMRI
state: New Jersey
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cleveland
country: United States
facility: Velocity Clinical Research, Cleveland
state: Ohio
city: Philadelphia
country: United States
facility: DM Clinical Research - Philadelphia
state: Pennsylvania
city: Warwick
country: United States
facility: Velocity Clinical Research
state: Rhode Island
city: North Charleston
country: United States
facility: Coastal Carolina Research
state: South Carolina
city: Knoxville
country: United States
facility: AMR Knoxville
state: Tennessee
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research
state: Texas
city: Salt Lake City
country: United States
facility: CenExel JBR Clinical Research
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads
state: Virginia
Study officials:
affiliation: Vaxcyte, Inc.
name: Clinical Development
role: STUDY_DIRECTOR
References: