Pneumococcal Vaccines
Conditions
Brief summary
Phase 2 trial to evaluate safety, tolerability, and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25)
Detailed description
A Phase 2 multicenter, randomized, active-controlled, observer-blind study to evaluate safety, tolerability, and immunogenicity of three formulations of IVT PCV-25, a 25 valent conjugated pneumococcal vaccine with adjuvant. Adult participants will be randomized in a 4:3:2:2 ratio to receive 1 of 3 formulations or control.
Interventions
BIOLOGICALIVT PCV-25 Formulation A
25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
BIOLOGICALIVT PCV-25 Formulation B
25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
BIOLOGICALIVT PCV-25 Formulation C
25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
BIOLOGICALPCV 20
20 valent pneumococcal conjugate vaccine
Sponsors
Inventprise Inc.
Canadian Center for Vaccinology
Vaccine Evaluation Center, Canada
PATH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Multicenter, randomized, active-controlled, observer-blind study to evaluate safety, tolerability, and immunogenicity of three formulations of IVT PCV-25 in which healthy adult participants will be randomized in a 4:3:2:2 ratio to receive 1 of 3 formulations or control.
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults who are 18 through 49 years old on the day of randomization (Day 1). * Participant must provide voluntary written informed consent to participate in the study. * Participant must be able to comprehend and comply with study requirements and procedures and be willing and able to return for all scheduled follow-up visits. * Adult female participants who are not surgically sterile must have a negative pregnancy test at screening and negative pregnancy test prior to vaccination and must agree to employ a highly effective method to avoid pregnancy through Day 57 of the study.
Exclusion criteria
* Use of any investigational medicinal product within 90 days prior to randomization or planned use of such a product during the period of study participation. * Adults who have previously been vaccinated against S. pneumoniae. * History of microbiologically confirmed invasive disease caused by S. pneumoniae. * History of allergic disease (including angioedema) or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines, including PEG. * Any abnormal vital sign deemed clinically relevant by the PI. * Acute illness at time of randomization (moderate or severe) and/or fever (body temperature of ≥ 38.0°C) * History of any non-study vaccine administration within 14 days of study vaccine administration. * No planned vaccines until after Day 29 (Visit 3). * Chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune modifying drugs prior to the administration of the study vaccine (and within the 6 months prior to administration of the study vaccine), including the use of glucocorticoids. The use of topical and inhaled glucocorticoids will be permitted. * Administration of immunoglobulins and/or any blood products within the 6 months prior to administration of the study vaccine or anticipation of such administration during the study period. * Any medical or social condition that in the opinion of the PI , may interfere with the study objectives, pose a risk to the participant, or prevent the participant from completing the study follow-up. * Any screening laboratory test result outside the normal range and with toxicity score ≥ 2, unless allowed by study team. * A positive serologic test for human immunodeficiency virus (HIV)-1 or HIV-2 (HIV 1/2 Ab), hepatitis B (HBsAg) or hepatitis C (HCV Ab). * History of malignancy, excluding non-melanoma skin and cervical carcinoma in situ. * Recent history (within the past year) or signs of alcohol or substance abuse. * History of major psychiatric disorder. * Female adult participants who are pregnant or breastfeeding. * Participant is an employee of, or direct descendant (child or grandchild) of any person employed by the Sponsor, PATH, the Contract Research Organization (CRO), the PI.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Solicited Local Adverse Events (AEs) | 7 days post-vaccination (Day 8) | Number and severity of solicited local AEs (redness, swelling, and pain at the injection site) by group |
| Solicited Systemic AEs | 7 days post-vaccination (Day 8) | Number and severity of solicited systemic AEs within 7 days after vaccination by group |
| Unsolicited AEs | 28 days post-vaccination (Day 29) | Number and severity of unsolicited AEs within 28 days after vaccination by group |
| Severe Adverse Events (SAEs) | 6 months post-vaccination (Day 169) | Number of SAEs within 6 months after vaccination by group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration (GMC) of IgG by Timepoint and Group | Baseline (Day 1) and 28 days post-vaccination (Day 29) | Geometric mean concentrations (GMC) of serotype-specific IgG at Day 1 and Day 29 by group |
| Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group | 28 days post-vaccination (Day 29) | Geometric Mean Fold Rise in serotype specific IgG GMC's from baseline (D1) to Day 29 after vaccination by group |
| Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29 | 28 days post-vaccination (Day 29) | Percentage of participants achieving a \> 4-fold IgG rise from baseline to Day 29 by treatment group |
| OPA Geometric Mean Concentration Titer (GMT) | Baseline (Day 1) and 28 days post-vaccination (Day 29) | Geometric mean titer of serotype-specific OPA antibodies by group and timepoint |
| Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group | From Baseline (Day 1) to 28 days post-vaccination (Day 29) | Geometric mean fold rise (GMFR) of serotype-specific OPA antibodies from baseline to 28 days post-vaccination by group |
Countries
Canada
Contacts
STUDY_DIRECTORSybil Tasker, MD, MPH, FIDSA
Inventprise Inc.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 36.2 years STANDARD_DEVIATION 6.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 203 Participants |
| Region of Enrollment Canada | 40 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 60 | 0 / 80 | 0 / 40 |
| other Total, other adverse events | 17 / 40 | 24 / 60 | 30 / 80 | 16 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 60 | 1 / 80 | 0 / 40 |
Outcome results
None listed