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

NCT02564237 | Unknown Phase 1 DMC

• 1 other identifier: PE1201
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-centered trial of a group A streptococcal (GAS) vaccine, StreptAnova™. The study is designed to assess safety and immunogenicity of three doses (0, 1, 6 months) of one dosage (600 µg protein) in healthy adults 18 through 50 years of age.

Conditions

Healthy

Keywords

Group A streptococcal

Outcome Measures

Primary Outcomes (1)

• Occurrence of adverse events

  Injection to Day 360, 6 months post dose 3

Secondary Outcomes (4)

• Occurrence of any hematological and biochemical laboratory abnormality

  Screening, day 0, day 7, day 30, day 44, day 180 and day 194

• Occurrence of any unsolicited AE

  During 28-day follow-up period after injection (i.e. the day of injection and 27 subsequent days), and through to day 360.

• Serum antibodies against M protein and Spa antigens in the vaccine measured by ELISA

  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)

• Functional opsonophagocytosis antibody determination for a subset of M protein serotypes

  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).

Study Arms (2)

Group 1: StreptAnova™

EXPERIMENTAL

Three (3) 0.6 mL doses (600 µg protein) of StreptAnova™ (Group A streptococcal (GAS) vaccine) will be will be administered on days 0, 30 and 180.

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

Group 2: Comparator

ACTIVE COMPARATOR

Three (3) 0.5 mL doses of comparator (Hepatitis B vaccine, Hepatitis A vaccine, OR Human Papillomavirus vaccine) will be administered on days 0, 30 and 180.

Biological: Hepatitis B vaccine; Biological: Hepatitis A vaccine; Biological: Human Papillomavirus vaccine

Interventions

StreptAnova™ (Group A streptococcal (GAS) vaccine) BIOLOGICAL

StreptAnova™ vaccine - 30-valent plus Spa group A Streptococcal vaccine

Group 1: StreptAnova™

Hepatitis B vaccine BIOLOGICAL

Participants will indicate which vaccine they wish to receive (Hepatitis B, Hepatitis A, or Human Papillomavirus vaccine) if they are randomized to a comparator prior to randomization.

Group 2: Comparator

Hepatitis A vaccine BIOLOGICAL

Participants will indicate which vaccine they wish to receive (Hepatitis B, Hepatitis A, or Human Papillomavirus vaccine) if they are randomized to a comparator prior to randomization.

Group 2: Comparator

Human Papillomavirus vaccine BIOLOGICAL

Participants will indicate which vaccine they wish to receive (Hepatitis B, Hepatitis A, or Human Papillomavirus vaccine) if they are randomized to a comparator prior to randomization.

Group 2: Comparator

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Dalhousie University: lead

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related Publications (2)

• Finn MB, Penfound TA, Salehi S, Ogega CO, Dold C, Plante O, Dale JB. Immunogenicity of a 30-valent M protein mRNA group A Streptococcus vaccine. Vaccine. 2024 Sep 17;42(22):126205. doi: 10.1016/j.vaccine.2024.126205. Epub 2024 Aug 13.

  PMID: 39141987 DERIVED

• Pastural E, McNeil SA, MacKinnon-Cameron D, Ye L, Langley JM, Stewart R, Martin LH, Hurley GJ, Salehi S, Penfound TA, Halperin S, Dale JB. Safety and immunogenicity of a 30-valent M protein-based group a streptococcal vaccine in healthy adult volunteers: A randomized, controlled phase I study. Vaccine. 2020 Feb 5;38(6):1384-1392. doi: 10.1016/j.vaccine.2019.12.005. Epub 2019 Dec 13.

  PMID: 31843270 DERIVED

MeSH Terms

Interventions

Vaccines; Hepatitis B Vaccines; Hepatitis A Vaccines; Papillomavirus Vaccines

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures; Viral Hepatitis Vaccines; Viral Vaccines

Study Officials

• Shelly McNeil, MD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head, Division of Infectious Diseases, Dept Medicine

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: September 30, 2015
• Study Start: August 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 19, 2017

Record last verified: 2017-01

Locations

CA (1)