Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults (NCT NCT05297578)
NCT ID: NCT05297578
Last Updated: 2024-10-09
Results Overview
Solicited local reactions included redness/erythema, swelling/induration, and pain at injection site
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
207 participants
Primary outcome timeframe
7 days after vaccination
Results posted on
2024-10-09
Participant Flow
230 participants were screened; 21 did not meet eligibility criteria and 2 were excluded for other reasons. 1 participant was randomized to VAX-24 2.2 mcg but was administered and included in the analysis for VAX-24 2.2/4.4 mcg dose. 1 participant in the PCV20 group was lost to follow up at day 1 without any solicited or unsolicited AEs collected. A 66-year-old male did not finish due to sudden cardiac death not considered related to vaccine due to risk factors of hypertension and BMI=47.4
Participant milestones
| Measure |
VAX-24 Low Dose
Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
VAX-24 Mid Dose
Participants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
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.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
PCV20
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.
Pneumococcal 20-valent Conjugate Vaccine: 0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
52
|
51
|
|
Overall Study
Safety Population
|
52
|
52
|
52
|
50
|
|
Overall Study
Immunogenicity Evaluable Population
|
48
|
48
|
47
|
45
|
|
Overall Study
COMPLETED
|
51
|
50
|
49
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
3
|
1
|
Reasons for withdrawal
| Measure |
VAX-24 Low Dose
Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
VAX-24 Mid Dose
Participants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
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.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
PCV20
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.
Pneumococcal 20-valent Conjugate Vaccine: 0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
1
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults
Baseline characteristics by cohort
| Measure |
VAX-24 Low Dose
n=52 Participants
Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
VAX-24 Mid Dose
n=52 Participants
Participants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
VAX-24 Mixed Dose
n=52 Participants
Participants will receive a single dose of VAX-24 2.2 mcg/4.4 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
PCV20Group 4
n=51 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.
Pneumococcal 20-valent Conjugate Vaccine: 0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1
|
Total
n=207 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Age, Continuous
|
67.5 Years
n=5 Participants
|
66.5 Years
n=7 Participants
|
67.0 Years
n=5 Participants
|
67.0 Years
n=4 Participants
|
67.0 Years
n=21 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
140 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
174 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
158 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Height (cm)
|
165.5 cm
n=5 Participants
|
166.6 cm
n=7 Participants
|
167.6 cm
n=5 Participants
|
166.4 cm
n=4 Participants
|
166.6 cm
n=21 Participants
|
|
Weight (kg)
|
75.05 kg
n=5 Participants
|
80.36 kg
n=7 Participants
|
86.11 kg
n=5 Participants
|
81.00 kg
n=4 Participants
|
80.30 kg
n=21 Participants
|
|
Body Mass Index (kg/m^2)
|
27.42 kg/m^2
n=5 Participants
|
28.98 kg/m^2
n=7 Participants
|
29.48 kg/m^2
n=5 Participants
|
28.99 kg/m^2
n=4 Participants
|
28.82 kg/m^2
n=21 Participants
|
PRIMARY outcome
Timeframe: 7 days after vaccinationPopulation: Safety population, defined as all participants exposed to study vaccine
Solicited local reactions included redness/erythema, swelling/induration, and pain at injection site
Outcome measures
| Measure |
VAX-24 Low Dose
n=52 Participants
Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
VAX-24 Mid Dose
n=51 Participants
Participants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
VAX-24 Mixed Dose
n=53 Participants
Participants will receive a single dose of VAX-24 2.2 mcg/4.4 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
PCV20Group 4
n=50 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.
Pneumococcal 20-valent Conjugate Vaccine: 0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination
Any solicited local AE (any grade)
|
42.3 percentage of participants
|
62.7 percentage of participants
|
37.7 percentage of participants
|
48.0 percentage of participants
|
|
Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination
Pain (Local-any grade)
|
38.5 percentage of participants
|
62.7 percentage of participants
|
37.7 percentage of participants
|
48.0 percentage of participants
|
|
Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination
Erythema (redness) at the injection site (any grade)
|
3.8 percentage of participants
|
3.9 percentage of participants
|
3.8 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination
Edema (swelling) at the injection site (any grade)
|
5.8 percentage of participants
|
2.0 percentage of participants
|
3.8 percentage of participants
|
6.0 percentage of participants
|
PRIMARY outcome
Timeframe: 7 days after vaccinationPopulation: Safety population, defined as all participants exposed to study vaccine
Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain within 7 days of vaccination
Outcome measures
| Measure |
VAX-24 Low Dose
n=52 Participants
Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
VAX-24 Mid Dose
n=51 Participants
Participants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
VAX-24 Mixed Dose
n=53 Participants
Participants will receive a single dose of VAX-24 2.2 mcg/4.4 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
PCV20Group 4
n=50 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.
Pneumococcal 20-valent Conjugate Vaccine: 0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination
Any solicited systemic AE (any grade)
|
34.6 Percentage of participants
|
41.2 Percentage of participants
|
28.3 Percentage of participants
|
44.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination
Fever (any grade)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination
Fatigue (any grade)
|
26.9 Percentage of participants
|
31.4 Percentage of participants
|
15.1 Percentage of participants
|
14.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination
Headache (any grade)
|
17.3 Percentage of participants
|
11.8 Percentage of participants
|
11.3 Percentage of participants
|
16.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination
Muscle Pain (any grade)
|
19.2 Percentage of participants
|
27.5 Percentage of participants
|
17.0 Percentage of participants
|
32.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination
Joint pain (any grade)
|
9.6 Percentage of participants
|
11.8 Percentage of participants
|
5.7 Percentage of participants
|
4.0 Percentage of participants
|
PRIMARY outcome
Timeframe: 1 month after vaccinationPopulation: Safety population. defined as all participants exposed to study vaccine
Percentage of participants with at least one Treatment Emergent Adverse Event (unsolicited AEs and SAEs)
Outcome measures
| Measure |
VAX-24 Low Dose
n=52 Participants
Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
VAX-24 Mid Dose
n=51 Participants
Participants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
VAX-24 Mixed Dose
n=53 Participants
Participants will receive a single dose of VAX-24 2.2 mcg/4.4 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
PCV20Group 4
n=50 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.
Pneumococcal 20-valent Conjugate Vaccine: 0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|
|
Percentage of Subjects Reporting Unsolicited Adverse Events Within 1 Month After Vaccination
|
11.5 Percentage of participants
|
7.8 Percentage of participants
|
5.7 Percentage of participants
|
16.0 Percentage of participants
|
PRIMARY outcome
Timeframe: 6 months after vaccinationPopulation: Safety population, defined as all participants exposed to study vaccine
Percentage of participants with serious adverse events (SAEs) and new onset of chronic illness (NOCIs)
Outcome measures
| Measure |
VAX-24 Low Dose
n=52 Participants
Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
VAX-24 Mid Dose
n=51 Participants
Participants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
VAX-24 Mixed Dose
n=53 Participants
Participants will receive a single dose of VAX-24 2.2 mcg/4.4 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
PCV20Group 4
n=50 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.
Pneumococcal 20-valent Conjugate Vaccine: 0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|
|
Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCIs)
Participants with at least 1 SAE
|
1.9 Percentage of participants
|
2.0 Percentage of participants
|
1.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCIs)
Participants with at least 1 NOCI
|
1.9 Percentage of participants
|
2.0 Percentage of participants
|
1.9 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 1 month after vaccinationPopulation: Immunogenicity Evaluable Populations, defined as participants in the exposed population with no major protocol deviation that impacted immunogenicity assessment and provided evaluable serum sample results for baseline, the relevant post-vaccination time points, and within the required time frames.
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.
Outcome measures
| Measure |
VAX-24 Low Dose
n=48 Participants
Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
VAX-24 Mid Dose
n=47 Participants
Participants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
VAX-24 Mixed Dose
n=48 Participants
Participants will receive a single dose of VAX-24 2.2 mcg/4.4 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
PCV20Group 4
n=45 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.
Pneumococcal 20-valent Conjugate Vaccine: 0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
1
|
288.67 Titer
Interval 162.84 to 511.76
|
284.55 Titer
Interval 160.15 to 505.57
|
135.10 Titer
Interval 75.44 to 241.92
|
182.60 Titer
Interval 100.41 to 332.05
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
2
|
1224.83 Titer
Interval 824.49 to 1819.55
|
1865.97 Titer
Interval 1248.74 to 2788.31
|
1060.68 Titer
Interval 703.2 to 1599.89
|
81.26 Titer
Interval 53.5 to 123.41
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
3
|
252.56 Titer
Interval 176.21 to 361.98
|
311.14 Titer
Interval 215.93 to 448.34
|
350.55 Titer
Interval 242.06 to 507.66
|
342.86 Titer
Interval 234.51 to 501.29
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
8
|
1789.95 Titer
Interval 1161.06 to 2759.48
|
1970.88 Titer
Interval 1273.06 to 3051.21
|
1450.17 Titer
Interval 925.72 to 2271.74
|
1498.73 Titer
Interval 951.6 to 2360.43
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
9N
|
7559.19 Titer
Interval 5373.89 to 10633.16
|
7451.59 Titer
Interval 5281.82 to 10512.7
|
7295.23 Titer
Interval 5120.33 to 10393.93
|
1673.49 Titer
Interval 1159.81 to 2414.69
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
9V
|
927.63 Titer
Interval 519.95 to 1654.98
|
1601.84 Titer
Interval 882.94 to 2906.09
|
1858.57 Titer
Interval 1024.51 to 3371.61
|
972.10 Titer
Interval 526.85 to 1793.63
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
10A
|
2544.55 Titer
Interval 1497.94 to 4322.45
|
2921.81 Titer
Interval 1707.58 to 4999.43
|
2484.44 Titer
Interval 1422.17 to 4340.17
|
2490.76 Titer
Interval 1425.51 to 4352.07
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
11A
|
879.43 Titer
Interval 670.8 to 1152.96
|
1068.11 Titer
Interval 811.06 to 1406.63
|
1072.92 Titer
Interval 811.97 to 1417.72
|
814.61 Titer
Interval 610.77 to 1086.49
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
12F
|
1060.55 Titer
Interval 561.14 to 2004.41
|
1153.52 Titer
Interval 604.61 to 2200.78
|
1233.96 Titer
Interval 641.05 to 2375.26
|
718.93 Titer
Interval 367.24 to 1407.42
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
14
|
1972.20 Titer
Interval 1252.37 to 3105.78
|
3253.68 Titer
Interval 2046.65 to 5172.55
|
1607.64 Titer
Interval 1004.25 to 2573.57
|
2491.35 Titer
Interval 1530.09 to 4056.51
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
15B
|
1964.60 Titer
Interval 1099.88 to 3509.16
|
1504.58 Titer
Interval 828.17 to 2733.45
|
1489.75 Titer
Interval 815.6 to 2721.12
|
1759.25 Titer
Interval 946.23 to 3270.81
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
17F
|
2010.33 Titer
Interval 1448.91 to 2789.27
|
2035.09 Titer
Interval 1462.74 to 2831.38
|
1979.30 Titer
Interval 1413.38 to 2771.81
|
267.63 Titer
Interval 187.62 to 381.76
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
18C
|
1553.59 Titer
Interval 963.38 to 2505.39
|
2237.89 Titer
Interval 1377.93 to 3634.56
|
2894.88 Titer
Interval 1770.6 to 4733.03
|
1327.56 Titer
Interval 801.76 to 2198.19
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
19A
|
3608.79 Titer
Interval 2475.63 to 5260.62
|
5805.66 Titer
Interval 3960.51 to 8510.44
|
5124.99 Titer
Interval 3477.83 to 7552.27
|
3808.09 Titer
Interval 2558.49 to 5667.99
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
19F
|
1211.40 Titer
Interval 795.46 to 1844.84
|
1305.32 Titer
Interval 851.81 to 2000.29
|
1723.29 Titer
Interval 1117.99 to 2656.34
|
854.85 Titer
Interval 548.44 to 1332.47
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
20B
|
6871.60 Titer
Interval 4184.11 to 11285.29
|
7368.09 Titer
Interval 4455.6 to 12184.42
|
6621.65 Titer
Interval 3975.31 to 11029.64
|
75.74 Titer
Interval 44.06 to 130.19
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
22F
|
3326.80 Titer
Interval 2010.16 to 5505.82
|
6107.92 Titer
Interval 3663.16 to 10184.29
|
4248.38 Titer
Interval 2530.07 to 7133.68
|
8596.62 Titer
Interval 5051.71 to 14629.07
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
23F
|
808.78 Titer
Interval 410.58 to 1593.16
|
823.11 Titer
Interval 413.68 to 1637.74
|
1182.95 Titer
Interval 588.94 to 2376.1
|
630.71 Titer
Interval 308.41 to 1289.83
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
33F
|
8681.95 Titer
Interval 5543.21 to 13597.95
|
11868.64 Titer
Interval 7495.14 to 18794.13
|
10621.27 Titer
Interval 6694.23 to 16852.03
|
9994.41 Titer
Interval 6225.25 to 16045.67
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
4
|
1386.27 Titer
Interval 854.33 to 2249.42
|
1375.38 Titer
Interval 841.57 to 2247.81
|
1472.75 Titer
Interval 895.08 to 2423.25
|
1031.62 Titer
Interval 618.98 to 1719.34
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
5
|
340.10 Titer
Interval 194.28 to 595.39
|
459.02 Titer
Interval 260.04 to 810.25
|
240.64 Titer
Interval 135.27 to 428.12
|
390.30 Titer
Interval 216.16 to 704.75
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
6A
|
1672.35 Titer
Interval 841.11 to 3325.09
|
3678.45 Titer
Interval 1831.34 to 7388.59
|
2492.54 Titer
Interval 1229.08 to 5054.79
|
1877.87 Titer
Interval 909.27 to 3878.26
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
6B
|
1889.61 Titer
Interval 1008.38 to 3540.94
|
2736.64 Titer
Interval 1446.86 to 5176.17
|
2827.09 Titer
Interval 1481.63 to 5394.35
|
2132.92 Titer
Interval 1094.3 to 4157.19
|
|
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
7F
|
2738.72 Titer
Interval 1786.47 to 4198.55
|
2884.67 Titer
Interval 1869.8 to 4450.37
|
3725.68 Titer
Interval 2400.58 to 5782.22
|
3189.78 Titer
Interval 2032.14 to 5006.89
|
SECONDARY outcome
Timeframe: 1 month after vaccinationPopulation: Immunogenicity evaluable population including all participants as treated.
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.
Outcome measures
| Measure |
VAX-24 Low Dose
n=48 Participants
Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
VAX-24 Mid Dose
n=47 Participants
Participants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
VAX-24 Mixed Dose
n=48 Participants
Participants will receive a single dose of VAX-24 2.2 mcg/4.4 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
PCV20Group 4
n=45 Participants
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.
Pneumococcal 20-valent Conjugate Vaccine: 0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
1
|
4.85 mcg/mL
Interval 3.24 to 7.26
|
5.36 mcg/mL
Interval 3.56 to 8.06
|
4.13 mcg/mL
Interval 2.73 to 6.25
|
4.14 mcg/mL
Interval 2.71 to 6.34
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
2
|
13.42 mcg/mL
Interval 8.97 to 20.07
|
19.04 mcg/mL
Interval 12.65 to 28.65
|
9.20 mcg/mL
Interval 6.08 to 13.93
|
1.59 mcg/mL
Interval 1.04 to 2.44
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
3
|
0.56 mcg/mL
Interval 0.37 to 0.84
|
0.64 mcg/mL
Interval 0.42 to 0.97
|
0.85 mcg/mL
Interval 0.56 to 1.29
|
0.68 mcg/mL
Interval 0.44 to 1.04
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
4
|
2.51 mcg/mL
Interval 1.6 to 3.95
|
2.50 mcg/mL
Interval 1.58 to 3.96
|
2.24 mcg/mL
Interval 1.4 to 3.57
|
2.16 mcg/mL
Interval 1.34 to 3.48
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
5
|
2.39 mcg/mL
Interval 1.44 to 3.96
|
3.20 mcg/mL
Interval 1.91 to 5.34
|
2.03 mcg/mL
Interval 1.21 to 3.42
|
2.67 mcg/mL
Interval 1.57 to 4.56
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
6A
|
5.26 mcg/mL
Interval 2.97 to 9.34
|
8.61 mcg/mL
Interval 4.81 to 15.4
|
6.86 mcg/mL
Interval 3.8 to 12.37
|
4.61 mcg/mL
Interval 2.52 to 8.44
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
6B
|
3.17 mcg/mL
Interval 1.78 to 5.65
|
7.50 mcg/mL
Interval 4.18 to 13.46
|
5.92 mcg/mL
Interval 3.27 to 10.72
|
1.99 mcg/mL
Interval 1.08 to 3.66
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
7F
|
4.88 mcg/mL
Interval 3.25 to 7.35
|
5.50 mcg/mL
Interval 3.64 to 8.33
|
7.67 mcg/mL
Interval 5.04 to 11.67
|
4.52 mcg/mL
Interval 2.94 to 6.96
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
8
|
7.21 mcg/mL
Interval 4.66 to 11.16
|
8.08 mcg/mL
Interval 5.19 to 12.58
|
5.53 mcg/mL
Interval 3.53 to 8.66
|
5.16 mcg/mL
Interval 3.25 to 8.17
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
9N
|
7.93 mcg/mL
Interval 5.68 to 11.06
|
9.83 mcg/mL
Interval 7.01 to 13.78
|
8.32 mcg/mL
Interval 5.9 to 11.72
|
3.22 mcg/mL
Interval 2.27 to 4.58
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
9V
|
4.91 mcg/mL
Interval 3.11 to 7.75
|
5.56 mcg/mL
Interval 3.5 to 8.83
|
7.63 mcg/mL
Interval 4.78 to 12.2
|
3.46 mcg/mL
Interval 2.14 to 5.6
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
10A
|
7.77 mcg/mL
Interval 4.63 to 13.03
|
12.31 mcg/mL
Interval 7.28 to 20.8
|
9.48 mcg/mL
Interval 5.57 to 16.14
|
9.43 mcg/mL
Interval 5.46 to 16.27
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
11A
|
5.33 mcg/mL
Interval 3.67 to 7.73
|
5.46 mcg/mL
Interval 3.75 to 7.97
|
5.73 mcg/mL
Interval 3.91 to 8.4
|
4.70 mcg/mL
Interval 3.18 to 6.96
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
12F
|
1.86 mcg/mL
Interval 1.17 to 2.95
|
2.77 mcg/mL
Interval 1.74 to 4.42
|
2.07 mcg/mL
Interval 1.29 to 3.33
|
0.88 mcg/mL
Interval 0.54 to 1.42
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
14
|
7.93 mcg/mL
Interval 4.71 to 13.33
|
12.21 mcg/mL
Interval 7.2 to 20.69
|
10.41 mcg/mL
Interval 6.08 to 17.81
|
9.08 mcg/mL
Interval 5.25 to 15.73
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
15B
|
12.16 mcg/mL
Interval 7.69 to 19.23
|
17.82 mcg/mL
Interval 11.2 to 28.37
|
13.82 mcg/mL
Interval 8.63 to 22.14
|
12.48 mcg/mL
Interval 7.69 to 20.23
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
17F
|
10.81 mcg/mL
Interval 7.18 to 16.28
|
10.82 mcg/mL
Interval 7.14 to 16.4
|
10.78 mcg/mL
Interval 7.07 to 16.43
|
0.56 mcg/mL
Interval 0.36 to 0.86
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
18C
|
8.17 mcg/mL
Interval 4.94 to 13.53
|
11.92 mcg/mL
Interval 7.15 to 19.88
|
15.03 mcg/mL
Interval 8.95 to 25.23
|
8.25 mcg/mL
Interval 4.85 to 14.04
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
19A
|
10.58 mcg/mL
Interval 6.96 to 16.07
|
13.97 mcg/mL
Interval 9.14 to 21.37
|
13.37 mcg/mL
Interval 8.69 to 20.57
|
7.84 mcg/mL
Interval 5.04 to 12.19
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
19F
|
8.21 mcg/mL
Interval 4.96 to 13.61
|
9.61 mcg/mL
Interval 5.76 to 16.04
|
11.51 mcg/mL
Interval 6.85 to 19.34
|
3.14 mcg/mL
Interval 1.84 to 5.35
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
20B
|
18.18 mcg/mL
Interval 13.27 to 24.9
|
24.61 mcg/mL
Interval 17.88 to 33.88
|
19.51 mcg/mL
Interval 14.12 to 26.98
|
4.77 mcg/mL
Interval 3.42 to 6.65
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
22F
|
3.26 mcg/mL
Interval 2.22 to 4.79
|
6.53 mcg/mL
Interval 4.42 to 9.64
|
4.14 mcg/mL
Interval 2.79 to 6.14
|
7.99 mcg/mL
Interval 5.33 to 11.98
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
23F
|
5.16 mcg/mL
Interval 3.23 to 8.22
|
9.10 mcg/mL
Interval 5.69 to 14.56
|
7.10 mcg/mL
Interval 4.41 to 11.44
|
5.31 mcg/mL
Interval 3.26 to 8.66
|
|
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
33F
|
11.96 mcg/mL
Interval 8.28 to 17.28
|
14.34 mcg/mL
Interval 9.87 to 20.84
|
13.24 mcg/mL
Interval 9.07 to 19.34
|
10.82 mcg/mL
Interval 7.34 to 15.96
|
Adverse Events
VAX-24 Low Dose
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
VAX-24 Mid Dose
Serious events: 1 serious events
Other events: 35 other events
Deaths: 1 deaths
VAX-24 Mixed Dose
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
PCV20Group 4
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VAX-24 Low Dose
n=52 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
VAX-24 Mid Dose
n=51 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
VAX-24 Mixed Dose
n=53 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
PCV20Group 4
n=50 participants at risk
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.
Pneumococcal 20-valent Conjugate Vaccine: 0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|
|
General disorders
Sudden cardiac death
|
0.00%
0/52 • 6 months from vaccination
|
2.0%
1/51 • 6 months from vaccination
|
0.00%
0/53 • 6 months from vaccination
|
0.00%
0/50 • 6 months from vaccination
|
|
Infections and infestations
Pneumonia
|
0.00%
0/52 • 6 months from vaccination
|
0.00%
0/51 • 6 months from vaccination
|
1.9%
1/53 • 6 months from vaccination
|
0.00%
0/50 • 6 months from vaccination
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/52 • 6 months from vaccination
|
0.00%
0/51 • 6 months from vaccination
|
0.00%
0/53 • 6 months from vaccination
|
0.00%
0/50 • 6 months from vaccination
|
|
Investigations
Heart rate irregular
|
0.00%
0/52 • 6 months from vaccination
|
0.00%
0/51 • 6 months from vaccination
|
1.9%
1/53 • 6 months from vaccination
|
0.00%
0/50 • 6 months from vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Cancer
|
1.9%
1/52 • 6 months from vaccination
|
0.00%
0/51 • 6 months from vaccination
|
0.00%
0/53 • 6 months from vaccination
|
0.00%
0/50 • 6 months from vaccination
|
|
Nervous system disorders
Syncope
|
0.00%
0/52 • 6 months from vaccination
|
0.00%
0/51 • 6 months from vaccination
|
1.9%
1/53 • 6 months from vaccination
|
0.00%
0/50 • 6 months from vaccination
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/52 • 6 months from vaccination
|
0.00%
0/51 • 6 months from vaccination
|
1.9%
1/53 • 6 months from vaccination
|
0.00%
0/50 • 6 months from vaccination
|
|
Surgical and medical procedures
Hysterectomy
|
1.9%
1/52 • 6 months from vaccination
|
0.00%
0/51 • 6 months from vaccination
|
0.00%
0/53 • 6 months from vaccination
|
0.00%
0/50 • 6 months from vaccination
|
Other adverse events
| Measure |
VAX-24 Low Dose
n=52 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
VAX-24 Mid Dose
n=51 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
VAX-24 Mixed Dose
n=53 participants at risk
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels.
24-Valent Pneumococcal Conjugate Vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
|
PCV20Group 4
n=50 participants at risk
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.
Pneumococcal 20-valent Conjugate Vaccine: 0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.8%
2/52 • 6 months from vaccination
|
3.9%
2/51 • 6 months from vaccination
|
3.8%
2/53 • 6 months from vaccination
|
10.0%
5/50 • 6 months from vaccination
|
|
Skin and subcutaneous tissue disorders
Pain (Local)
|
38.5%
20/52 • 6 months from vaccination
|
62.7%
32/51 • 6 months from vaccination
|
37.7%
20/53 • 6 months from vaccination
|
48.0%
24/50 • 6 months from vaccination
|
|
Skin and subcutaneous tissue disorders
Edema (local)
|
5.8%
3/52 • 6 months from vaccination
|
2.0%
1/51 • 6 months from vaccination
|
3.8%
2/53 • 6 months from vaccination
|
6.0%
3/50 • 6 months from vaccination
|
|
General disorders
Fatigue
|
26.9%
14/52 • 6 months from vaccination
|
31.4%
16/51 • 6 months from vaccination
|
15.1%
8/53 • 6 months from vaccination
|
14.0%
7/50 • 6 months from vaccination
|
|
General disorders
Headache
|
17.3%
9/52 • 6 months from vaccination
|
11.8%
6/51 • 6 months from vaccination
|
11.3%
6/53 • 6 months from vaccination
|
16.0%
8/50 • 6 months from vaccination
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
19.2%
10/52 • 6 months from vaccination
|
27.5%
14/51 • 6 months from vaccination
|
17.0%
9/53 • 6 months from vaccination
|
32.0%
16/50 • 6 months from vaccination
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
9.6%
5/52 • 6 months from vaccination
|
11.8%
6/51 • 6 months from vaccination
|
5.7%
3/53 • 6 months from vaccination
|
4.0%
2/50 • 6 months from vaccination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor shall review within the ninety (90) day period. Upon receiving any notification from Sponsor requesting deletion of Confidential Information, correction of inaccuracies, or a delay in publication to allow the filing of patent application, Institution or Investigator shall take the requested action of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER