A Controlled Study to Evaluate the Safety and Immunogenicity of StreptAnova™ in Healthy Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02564237
• Date of registration: 29/09/2015
• Prospective Registration: No
• Primary sponsor: Dalhousie University
• Public title: A Controlled Study to Evaluate the Safety and Immunogenicity of StreptAnova™ in Healthy Adults
• Scientific title: A Phase I, Randomized, Observer-blind, Comparator-controlled, Study of the Safety and Immunogenicity of StreptAnova™ Vaccine in Healthy Adults Age = 18 - 50 Years
• Date of first enrolment: August 2015
• Target sample size: 39
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02564237
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Canada

Contacts

• Name: Shelly McNeil, MD
• Affiliation: Dalhousie University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female healthy adults ages 18 to 50 years inclusive;

- Good general health as determined by screening evaluation no greater than 42 days
before the first immunization;

- For women of childbearing age, use of adequate birth control from enrollment until 180
days after the last injection;

- Written informed consent, after reading the consent form and having adequate
opportunity to discuss the study with an investigator or a qualified designee.

Exclusion Criteria:

- Presence of any febrile illness or any known or suspected acute illness on the day of
any first immunization;

- Any chronic illness, whether or not active treatment is required;

- Any immunodeficiency (congenital or acquired);

- Any history of cardiac pathology (acquired or severe/persistent congenital);

- Any history of congenital malformation syndromes associated with congenital heart
disease (syndrome complexes, e.g. VATER association; chromosomal disorders, e.g.
Down's Syndrome; teratogenic agents, e.g. fetal alcohol syndrome; others, e.g.
Noonan's);

- Any history of clinical manifestations of auto-immune or systemic diseases
(inflammatory disorders, e.g. JRA, SLE, Kawasaki disease; inborn errors of metabolism,
e.g. Fabry; connective tissue disorders, e.g. Marfan syndrome; neuromuscular
disorders, e.g. Friedreich ataxia; endocrine-metabolic disorders, e.g. hypothyroidism;
hematologic disorders, e.g. sickle cell anemia);

- Any history of acute rheumatic fever (ARF), post-streptococcal glomerulonephritis
(PSGN), undiagnosed acute self-limiting polyarthritis (swelling, heat, redness or
tenderness or pain and limitation of motion in >2 joints), or chorea (purposeless,
involuntary rapid movements of the trunk and/or extremities);

- Any previous echocardiogram suggestive of cardiac pathology;

- Any immediate family history (parents, siblings) of ARF, PSGN, self-limiting
polyarthritis, chorea, or a collagen-vascular disease such as Lupus or Sjögren's
syndrome;

- Receipt of systemic glucocorticoids (a dose = 20 mg/day prednisone or equivalent)
within one month, or any other cytotoxic or immunosuppressive drug within six months;

- Receipt of any investigational drug within six months, or prior participation in a
clinical trial of a group A streptococcal vaccine;

- Receipt of blood products or immunoglobulin (IVIg or IMIg) within three (3) months of
study entry/baseline serologic evaluation;

- Any physical findings suggestive of acute or chronic illness;

- History of receiving Adriamycin or other chemotherapy;

- Use of any of the following diet pills: fenfluramine, phentermine, or dexfenfluramins
(also known as Pondimin, Redux, Adipex, or Fastin);

- History of sensitivity to any component of study vaccines;

- Evidence of tissue cross-reactive antibodies to human heart, joint cartilage, kidney,
cerebral cortex or basal ganglia by indirect fluorescent antibody assay at
pre-vaccination screening;

- Repeatable clinical laboratory abnormalities (blood or urine), as defined by lab
normal ranges. To exclude transient abnormalities, the investigator may repeat a test
up to twice, and if the repeat test is normal, subject may be enrolled;

- Echocardiographic finding of valvular dysfunction (stenosis, leaflet thickening or
nodules, restricted leaflet mobility, or prolapse), LV dysfunction, atrial or
ventricular enlargement, mild or greater mitral regurgitation or aortic insufficiency,
moderate or greater tricuspid regurgitation or pulmonic insufficiency, pericardial
effusion, or other cardiac pathology as identified by echocardiologist*;

- Receipt of any vaccines within 2 weeks of Dose 1;

- Clinically significant abnormality on screening electrocardiogram*

- Pregnancy or breastfeeding.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Biological: StreptAnova™ (Group A streptococcal (GAS) vaccine)

Biological: Hepatitis B vaccine

Biological: Human Papillomavirus vaccine

Biological: Hepatitis A vaccine

Primary Outcome(s)

Occurrence of adverse events [Time Frame: Injection to Day 360, 6 months post dose 3]

Secondary Outcome(s)

Occurrence of any hematological and biochemical laboratory abnormality [Time Frame: Screening, day 0, day 7, day 30, day 44, day 180 and day 194]

Occurrence of any unsolicited AE [Time Frame: During 28-day follow-up period after injection (i.e. the day of injection and 27 subsequent days), and through to day 360.]

Functional opsonophagocytosis antibody determination for a subset of M protein serotypes [Time Frame: Visit 2 (day 0, pre dose 1), Visit 8 (day 210, 30 days post dose 3) and Visit 9 (day 280, 100 days post dose 3).]

Serum antibodies against M protein and Spa antigens in the vaccine measured by ELISA [Time Frame: Visit 2 (day 0, pre dose 1), Visit 4 (day 30, 30 days post dose 1), Visit 5 (day 44, 14 days post dose 2), Visit 8 (day 210, 30 days post dose 3) and Visit 10 (day 360, 6 months post dose 3)]

Secondary ID(s)

PE1201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors