Pneumococcal VaccinesPhase 1/2NCT05266456

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

A Phase 1/2 study testing 24 valent pneumococcal conjugate vaccine and 20 valent pneumococcal conjugate vaccine in people with Pneumococcal Vaccines, run by Vaxcyte, Inc. at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Vaccines
What is being tested?: 24 valent pneumococcal conjugate vaccine and 20 valent pneumococcal conjugate vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 835 participants
Where: 13 sitesUnited States
Study dates: 22 Feb 2022to 10 Jan 2023
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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).

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

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

CenExel RCA
Hollywood, Florida, 33024
Alliance for Multispecialty Research
Kansas City, Missouri, 64114
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Benchmark Research
Metairie, Louisiana, 70006
Coastal Carolina Research
North Charleston, South Carolina, 29405
Rochester Clinical Research
Rochester, New York, 14609
JBR Clinical Research
Salt Lake City, Utah, 84107
Benchmark Research
San Angelo, Texas, 76904
Meridian Clinical Research
Savannah, Georgia, 31406
Precision Clinical Research
Sunrise, Florida, 33351
Velocity Clinical Research
Valparaiso, Indiana, 46383
Velocity Clinical Research
Warwick, Rhode Island, 02886
Acellacare of Wilmington
Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Phase 1/2, Randomized, Observer-Blind, Dose-Finding, Controlled, Parallel-Group, Two-Stage Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Adults Aged 18 to 64 Years

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.

Read the detailed description

The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels (Low: 1.1 mcg; Mid: 2.2 mcg; or Mixed: 2.2/4.4 mcg) 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 (Low: 1.1 mcg; Mid: 2.2 mcg; or Mixed: 2.2/4.4 mcg) compared to PCV20 in adults aged 50 to 64 years of age.

Conditions: Pneumococcal Vaccines
Being tested: 24 valent pneumococcal conjugate vaccine, 20 valent pneumococcal conjugate vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

24 valent pneumococcal conjugate vaccineBiological
0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
20 valent pneumococcal conjugate vaccineBiological
0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1

Study groups in NCT05266456
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: 20 valent pneumococcal conjugate vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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.
Measured: 1 month after vaccination
Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)
Percentage of participants with SAEs and NOCIs
Measured: 6 months after vaccination

Secondary outcomes (3)

Percentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values
Shifts from Normal at Baseline to Abnormal on Day 29 in Clinical Chemistry Parameters Occurring in >5% of Subjects Aged 50 to 64 Years
Measured: 1 month after vaccination
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
Antibody geometric mean titers as measured by OPA for the 24 pneumococcal serotypes in VAX-24
Measured: 1 month after vaccination
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
Antibody geometric mean concentrations as measured by IgG for the 24 pneumococcal serotypes in VAX-24
Measured: 1 month after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Feb 202210 Jan 2023

First posted4 Mar 2022
Study start22 Feb 2022
Primary completion10 Jan 2023
Study completion10 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pneumococcal VaccinesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 835 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05266456
Sponsor's protocol ID: VAX24-101
Status last verified: Mar 2024
First submitted: 23 Feb 2022
Last updated: 18 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Vaxcyte is committed to providing access to anonymized data from the company's clinical trials for the purpose of legitimate scientific research. Requests for data may be addressed to datasharing@vaxcyte.com. Requests must be accompanied by a detailed analysis plan and will be reviewed for scientific validity. Data will be made available after initial product approval. Sharing of data may require execution of a data-sharing agreement.

Publications

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.
PubMed 38061367

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingObservational study
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All Pneumococcal Vaccines trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2, Randomized, Observer-Blind, Dose-Finding, Controlled, Parallel-Group, Two-Stage Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Adults Aged 18 to 64 Years
ClinicalTrials.gov ID: NCT05266456
Acronym / sponsor ID: VAX24-101
Conditions: Pneumococcal Vaccines
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 835 participants (actual)
Lead sponsor: Vaxcyte, Inc.Industry (pharma, biotech, devices)
Study start: 22 Feb 2022 (actual)
Primary completion: 10 Jan 2023 (actual)
Study completion: 10 Jan 2023 (actual)
First posted: 4 Mar 2022 (actual)
Results: Posted 18 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
VAX-24 Low Dose	Experimental	Biological: 24 valent pneumococcal conjugate vaccineParticipants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.
VAX-24 Mid Dose	Experimental	Biological: 24 valent pneumococcal conjugate vaccineParticipants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1.
VAX-24 Mixed Dose	Experimental	Biological: 24 valent pneumococcal conjugate vaccineParticipants will receive a single dose of VAX-24 2.2 mcg/4.4 mcg administered as an intramuscular injection on Day 1.
PCV20	Active comparator	Biological: 20 valent pneumococcal conjugate vaccineParticipants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
24 valent pneumococcal conjugate vaccine0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1	Biological	VAX-24 Low Dose, VAX-24 Mid Dose, VAX-24 Mixed Dose
20 valent pneumococcal conjugate vaccine0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1	Biological	PCV20

Primary outcome

Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age Group
Time frame: 7 days after vaccination
Solicited local reactions include redness/erythema, swelling/induration, and pain at injection site within 7 days after vaccination in each age group
Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age Group
Time frame: 7 days after vaccination
Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain
Percentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group
Time frame: 1 month after vaccination
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.
Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)
Time frame: 6 months after vaccination
Percentage of participants with SAEs and NOCIs

3 secondary outcomes

Percentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values
Time frame: 1 month after vaccination
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
Time frame: 1 month after vaccination
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
Time frame: 1 month after vaccination

Results and safety

Results posted to the registry on 18 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VAX-24 Low Dose	16	15
VAX-24 Mid Dose	16	15
VAX-24 Mixed Dose	16	16
PCV20	16	15

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

Time frame: 7 days after vaccination. Number. Unit: percentage of participants

Measure	VAX-24 Low Dose 18-49 Yrs n = 16	VAX-24 Mid Dose 18-49 Yrs n = 16	VAX-24 Mixed Dose 18-49 Yrs n = 16	PCV20 18-49 Yrs n = 16	VAX-24 Low Dose 50-64 Yrs n = 193	VAX-24 Mid Dose 50-64 Yrs n = 191	VAX-24 Mixed Dose 50-64 Yrs n = 191	PCV20 50-64 Yrs n = 196	VAX24 Low Dose 18-64 Yrs n = 209	VAX-24 Mid Dose 18-64 Yrs n = 207	VAX-24 Mixed Dose 18-64 Yrs n = 207	PCV20 18-64 Yrs n = 212
Any solicited local AE; Overall, Any Grade	56.3	81.3	81.3	93.8	73.6	71.7	77.5	71.9	72.2	72.5	77.8	73.6
Pain at injection site; Overall, Any Grade	56.3	75.0	81.3	81.3	71.0	71.2	77.0	69.9	69.9	71.5	77.3	70.8
Erythema (redness) at injection site; Overall, Any Grade	6.3	6.3	18.8	25.0	6.7	7.9	8.9	8.7	6.7	7.7	9.7	9.9
Edema (swelling) at injection site; Overall, Any Grade	18.8	12.5	25.0	18.8	8.8	7.9	7.9	10.7	9.6	8.2	9.2	11.3

Population analysed: Safety population, defined as all patients exposed to study vaccine. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.

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

Time frame: 7 days after vaccination. Number. Unit: Percentage of participants

Measure	VAX-24 Low Dose 18-49 Yrs n = 16	VAX-24 Mid Dose 18-49 Yrs n = 16	VAX-24 Mixed Dose 18-49 Yrs n = 16	PCV20 18-49 Yrs n = 16	VAX-24 Low Dose 50-64 Yrs n = 193	VAX-24 Mid Dose 50-64 Yrs n = 191	VAX-24 Mixed Dose 50-64 Yrs n = 191	PCV20 50-64 Yrs n = 196	VAX-24 Low Dose 18-64 Yrs n = 209	VAX-24 Mid Dose 18-64 Yrs n = 207	VAX-24 Mixed Dose 18-64 Yrs n = 207	PCV20 18-64 Yrs n = 212
Any solicited systemic adverse event	50.0	62.5	56.3	75.0	69.4	69.6	71.2	64.8	67.9	69.1	70.0	65.6
Fever (oral temperature >= 100.4ºF)	6.3	6.3	0.0	12.5	1.0	0.5	2.1	1.0	1.4	1.0	1.9	1.9
Fatigue	37.5	31.3	37.5	50.0	42.5	40.8	40.8	39.8	42.1	40.1	40.6	40.6
Headache	31.3	37.5	25.0	37.5	30.6	28.8	30.4	30.1	30.6	29.5	30.0	30.7
Muscle Pain	37.5	37.5	18.8	56.3	57.0	56.0	60.2	53.1	55.5	54.6	57.0	53.3
Joint Pain	25.0	12.5

Primary outcome: Percentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group

Time frame: 1 month after vaccination. Number. Unit: Percentage of participants

Measure	VAX-24 Low Dose 18-49 Yrs n = 16	VAX-24 Mid Dose 18-49 Yrs n = 16	VAX-24 Mixed Dose 18-49 Yrs n = 16	PCV20 18-49 Yrs n = 16	VAX-24 Low Dose 50-64 Yrs n = 193	VAX-24 Mid Dose 50-64 Yrs n = 191	VAX-24 Mixed Dose 50-64 Yrs n = 191	PCV20 50-64 n = 196	VAX-24 Low Dose 18-64 n = 209	VAX-24 Mid Dose 18-64 Yrs n = 207	VAX-24 Mixed Dose 18-64 Yrs n = 207	PCV20 18-64 Yrs n = 212
Value	12.5	12.5	6.3	6.3	15.5	11.5	13.1	16.8	15.3	11.6	12.6	16.0

Population analysed: Safety population, including all subjects in the Exposed Population who provided safety assessment data. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.

Primary outcome: Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)

Time frame: 6 months after vaccination. Number. Unit: percentage of participants

Measure	VAX-24 Low Dose 18-49 Yrs n = 16	VAX-24 Mid Dose 18-49 Yrs n = 16	VAX-24 Mixed Dose 18-49 Yrs n = 16	PCV20 18-49 Yrs n = 16	VAX-24 Low Dose 50-64 Yrs n = 193	VAX-24 Mid Dose 50-64 Yrs n = 191	VAX-24 Mixed Dose n = 191	PCV20 50-64 Yrs n = 196	VAX-24 Low Dose 18-64 Yrs n = 209	VAX-24 Mid Dose 18-64 Yrs n = 207	VAX-24 Mixed Dose 18-64 Yrs n = 207	PCV20 18-64 Yrs n = 212
Subjects with at least one SAE	0	0	0	0	1.0	1.6	0.5	2.0	1.0	1.4	0.5	1.9
Subjects with at least one NOCI	0	0	0	0	1.6	1.6	3.1	2.6	1.4	1.4	2.9	2.4

Population analysed: Safety population, including all subjects in the exposed population who provided safety assessment data. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VAX-24 Low Dose 18-49 Yrs	0 of 16 (0%)	9 of 16 (56.3%)	0 of 16
VAX-24 Mid Dose 18-49 Yrs	0 of 16 (0%)	13 of 16 (81.3%)	0 of 16
VAX-24 Mixed Dose 18-49 Yrs	0 of 16 (0%)	14 of 16 (87.5%)	0 of 16
PCV20 18-49 Yrs	0 of 16 (0%)	16 of 16 (100%)	0 of 16
VAX-24 Low Dose 50-64 Yrs	2 of 193 (1%)	161 of 193 (83.4%)	0 of 193
VAX-24 Mid Dose 50-64 Yrs	3 of 191 (1.6%)	155 of 191 (81.2%)	0 of 191
VAX-24 Mixed Dose 50-64 Yrs	1 of 191 (0.5%)	164 of 191 (85.9%)	0 of 191
PCV20 50-64 Yrs	4 of 196 (2%)	163 of 196 (83.2%)	0 of 196
VAX-24 Low Dose 18-64 Yrs	2 of 209 (1%)	170 of 209 (81.3%)	0 of 209
VAX-24 Mid Dose 18-64 Yrs	3 of 207 (1.4%)	168 of 207 (81.2%)	0 of 207
VAX-24 Mixed Dose 18-64 Yrs	1 of 207 (0.5%)	178 of 207 (86%)	0 of 207
PCV20 18-64 Yrs	4 of 212 (1.9%)	179 of 212 (84.4%)	0 of 212

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 38061367Wassil 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.
Individual participant dataSharing planned: Yes. Vaxcyte is committed to providing access to anonymized data from the company's clinical trials for the purpose of legitimate scientific research. Requests for data may be addressed to datasharing@vaxcyte.com. Requests must be accompanied by a detailed analysis plan and will be reviewed for scientific validity. Data will be made available after initial product approval. Sharing of data may require execution of a data-sharing agreement.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Development study director

Vaxcyte, Inc.

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age Group (time frame: 7 days after vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05266456, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.