Trial record 2 of 3 for:
VAX-24
Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05297578 |
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Recruitment Status :
Completed
First Posted : March 28, 2022
Results First Posted : April 16, 2024
Last Update Posted : April 16, 2024
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Sponsor:
Vaxcyte, Inc.
Information provided by (Responsible Party):
Vaxcyte, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pneumococcal Vaccines | Biological: 24-Valent Pneumococcal Conjugate Vaccine Biological: Pneumococcal 20-valent Conjugate Vaccine | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 207 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | A Phase 2, Randomized, Observer-Blind, Dose-Finding, Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Adults 65 Years and Older |
| Actual Study Start Date : | June 15, 2022 |
| Actual Primary Completion Date : | February 15, 2023 |
| Actual Study Completion Date : | February 15, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: VAX-24 Low Dose
Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.
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Biological: 24-Valent Pneumococcal Conjugate Vaccine
0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
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Experimental: VAX-24 Mid Dose
Participants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1.
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Biological: 24-Valent Pneumococcal Conjugate Vaccine
0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
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Experimental: VAX-24 Mixed Dose
Participants will receive a single dose of VAX-24 2.2 mcg/4.4 mcg administered as an intramuscular injection on Day 1.
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Biological: 24-Valent Pneumococcal Conjugate Vaccine
0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
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Active Comparator: PCV20
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.
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Biological: Pneumococcal 20-valent Conjugate Vaccine
0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1
Other Name: Prevnar 20, PCV20 |
Primary Outcome Measures :
- Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination [ Time Frame: 7 days after vaccination ]Solicited local reactions included redness/erythema, swelling/induration, and pain at injection site
- Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination [ Time Frame: 7 days after vaccination ]Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain within 7 days of vaccination
- Percentage of Subjects Reporting Unsolicited Adverse Events Within 1 Month After Vaccination [ Time Frame: 1 month after vaccination ]Percentage of participants with at least one Treatment Emergent Adverse Event (unsolicited AEs and SAEs)
- Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCIs) [ Time Frame: 6 months after vaccination ]Percentage of participants with serious adverse events (SAEs) and new onset of chronic illness (NOCIs)
Secondary Outcome Measures :
- VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs) [ Time Frame: 1 month after vaccination ]The change from baseline to 1 month post-vaccination in the immune response directed against each of the 24 serotypes was evaluated by measuring serotype-specific functional antibody responses with an opsonophagocytic (OPA) assay that assesses the functional capacity of pneumococcal antibodies.
- 24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs) [ Time Frame: 1 month after vaccination ]The change from baseline to 1 month post-vaccination in the immune response directed against each of the 24 serotypes was evaluated by measuring IgG levels using an IgG multiplexed electrochemoluminescent assay (ECLA). Values below the lower limit of quantitation (LLOQ) were analyzed as 0.5*LLOQ. Values above the upper limit of quantitation (ULOQ) were analyzed as 1*ULOQ.
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| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05297578
Locations
Show 20 study locations
Sponsors and Collaborators
Vaxcyte, Inc.
Investigators
| Study Director: | Clinical Development | Vaxcyte, Inc. |
Study Documents (Full-Text)
Documents provided by Vaxcyte, Inc.:
Documents provided by Vaxcyte, Inc.:
Study Protocol [PDF] May 31, 2022
Statistical Analysis Plan [PDF] December 30, 2022
| Responsible Party: | Vaxcyte, Inc. |
| ClinicalTrials.gov Identifier: | NCT05297578 |
| Other Study ID Numbers: |
VAX24-102 |
| First Posted: | March 28, 2022 Key Record Dates |
| Results First Posted: | April 16, 2024 |
| Last Update Posted: | April 16, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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:
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Vaccines Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs |