Clinical trial NCT04525599: A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator
Official title: A Phase 1, Randomized, Single Dose, Blinded, Dose-Escalation Study to Assess Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Pneumococcal Disease
Keywords: Pneumococcal Disease
ASP3772
Pneumococcal vaccine
Vaccine
Lead sponsor: Affinivax, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-25
Enrollment: 75
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and tolerability of three dose levels of ASP3772 in comparison to the active comparator Prevnar 13® (PCV13) in toddlers who have previously been administered the routine three-dose series of PCV13.

This study will also evaluate the immunogenicity (production of an immune response) of three different dose levels of ASP3772 in comparison to the active comparator PCV13 in toddlers who have previously been administered the routine three-dose series of PCV13.

Detailed description: After screening, participants will be randomized to ASP3772 or PCV13 on Day 1. A single dose of ASP3772 will be administered on Day 1 as an injection into the right or left thigh muscle at one of three dose levels. The participants randomized to PCV13 will receive a single intramuscular injection of the approved dose of PCV13 into the right or left thigh muscle. All participants will remain at the study site for approximately 30 to 60 minutes following vaccination in order for study site personnel to evaluate any immediate reactions, if needed. The participant's parent/legal guardian will observe for reactions, including daily body temperature measurements and tolerability assessments, from Day 2 through Day 7 and record observed events in the electronic diary device.

All participants will have study visits on Day 7 (+ 1 day) and Day 30 (± 5 days) post-vaccination. The Day 7 visit may be conducted on site or by telephone call.The end-of-study visit will occur on Day 180 (± 14 days), which will be a safety follow-up by telephone call.

Eligibility criteria: Inclusion Criteria:

* Subject is a healthy toddler who has previously completed a 3-dose infant series of PCV13 with the last vaccination greater than 2 months prior to study vaccination.
* Subject is afebrile within the last 48 hours (temperature measured orally is \< 100 °F \[37.8°C\]; measured rectally or tympanic is \< 101 °F \[38.3°C\]; measured in an axillary position or temporal is \< 98.4 °F \[36.9°C\]).
* Subject's parent/legal guardian is able to read, understand and complete study questionnaires (i.e., the electronic subject diary device).
* Subject's parent/legal guardian along with the subject is able and is willing to attend all scheduled visits and to comply with the study procedures.
* Subject's parent/legal guardian has access to a telephone.
* Subject's parent/legal guardian agrees not to enroll subject in another interventional study while participating in the present study.

Exclusion Criteria:

* Subject has a known hypersensitivity to any vaccine.
* Subject has an immune disorder(s) (including autoimmune disease) and/or clinical conditions requiring immunosuppressive drugs, known or suspected impairment of immunological function or a history of congenital or acquired immunodeficiency.
* Subject has or his/her mother has known human immunodeficiency virus infection or known to be hepatitis B surface antigen-positive.
* Subject has functional or anatomic asplenia.
* Subject has known neurological or cognitive behavioral disorders including clinically significant developmental disorder and related disorders.
* Subject has any evidence of any unstable or active clinically significant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease.
* Subject has any active malignancy or history of malignancy.
* Subject has been in receipt of intramuscular, oral, intravenous, inhaled or intranasal corticosteroid treatment within 2 weeks prior to study vaccination or is planned to receive these medications within 4 weeks after study vaccination. Note: Use of topical corticosteroids is permitted.
* Subject has received any live-attenuated vaccines within 4 weeks prior to receipt of the study vaccine or inactivated vaccines within 2 weeks prior to receipt of study vaccine.
* Subject has previously received an approved (other than PCV13) or investigational pneumococcal vaccine.
* Subject has had any prior receipt of a blood transfusion or blood products, including immunoglobulins.
* Subject has received investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening.
* Subject has received a systemically absorbed antibacterial agent within 7 days prior to study vaccination.
* Subject has a history of microbiologically-proven invasive disease caused by S. pneumoniae.
* Subject has received acetaminophen or nonsteroidal anti-inflammatorydrugs (NSAIDs) within 24 hours prior to receipt of study vaccine.
* Subject has a coagulation disorder.
* Subject's parent/legal guardian is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study and the subject cannot be adequately followed for safety according to the protocol.
* Subject who has a condition which makes the subject unsuitable for study participation.
* Subject's parent(s)/legal guardian is an employee of Astellas Pharma Global Development Inc., the study-related contract research organizations (CROs), or the study site.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to Day 30
measure: Number of Participants With Body Temperature Abnormalities and/or Adverse Events
timeFrame: Up to Day 30
measure: Reactogenicity Assessed by Number of Solicited Local Reactions
timeFrame: Up to Day 7
measure: Reactogenicity assessed by Number of Solicited Systemic Reactions
timeFrame: Up to Day 7
Secondary outcomes:
measure: Proportion of Participants Achieving a Serotype-specific Anticapsular Polysaccharide Immunoglobulin G (PS IgG) Concentration of ≥ 0.35 µg/mL for ASP3772
timeFrame: Up to 30 days
measure: Proportion of Participants Achieving a Serotype-specific Anticapsular PS IgG Concentration of ≥ 0.35 µg/mL for PCV13
timeFrame: Up to 30 days
measure: Proportion of Participants Achieving a Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer ≥ 1:8 for ASP3772
timeFrame: Up to 30 days
measure: Proportion of Participants Achieving a Serotype-specific OPA Antibody Titer ≥ 1:8 for PCV13
timeFrame: Up to 30 days
measure: Geometric Mean Titer (GMT) for Serotype-specific OPA for ASP3772
timeFrame: Up to 30 days
measure: Geometric Mean Titer (GMT) for Serotype-specific OPA for PCV13
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Bryant
country: United States
facility: Dermatology Trial Associates
state: Arkansas
city: Jonesboro
country: United States
facility: The Childrens Clinic
state: Arkansas
city: Anaheim
country: United States
facility: Emmaus Research Center, Inc
state: California
city: Madera
country: United States
facility: Madera Family Medical Group
state: California
city: West Covina
country: United States
facility: Ctr Clin Trials San Gabriel
state: California
city: Boynton Beach
country: United States
facility: Gentle Medicine Associates
state: Florida
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research
state: Kentucky
city: Baton Rouge
country: United States
facility: Meridian Clinical Research
state: Louisiana
city: Statesville
country: United States
facility: PMG Research
state: North Carolina
city: Tulsa
country: United States
facility: Oklahoma State University Center for Health Sciences
state: Oklahoma
city: East Norriton
country: United States
facility: Pediatrics Medical Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Coastal Pediatric Associates
state: South Carolina
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research Associates
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: Provo
country: United States
facility: Pediatric Care
state: Utah
city: Spokane
country: United States
facility: MultiCare Institute
state: Washington
Study officials:
affiliation: Astellas Pharma Global Development, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: