This is a double-blind, randomized, placebo-controlled phase I clinical trial with dose-escalation of a synthetic vaccine against Streptococcus pyogenes. The active component of this vaccine candidate is a synthetic polypeptide named StreptInCor designed to elicit humoral and cell-mediated immune responses. The vaccine will be formulated with Aluminium hydroxide in three different doses of StreptInCor (50 µg, 100µg, 200 µg). The proposed vaccination schedule is three doses (0, 1, 6 months). The doses will be escalated for the next group after safety review.

Start Date01 May 2021

Sponsor / Collaborator

Butantan Institute

100 Clinical Results associated with Streptococcus pyogenes vaccine(Butantan Institute)

100 Translational Medicine associated with Streptococcus pyogenes vaccine(Butantan Institute)

100 Patents (Medical) associated with Streptococcus pyogenes vaccine(Butantan Institute)

Literatures (Medical) associated with Streptococcus pyogenes vaccine(Butantan Institute)

18 Sep 2023·Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Safety of Streptococcus pyogenes Vaccines: Anticipating and Overcoming Challenges for Clinical Trials and Post-Marketing Monitoring.

Article

Author: Long, Raj ; Dale, James B ; Kim, Jerome H ; Excler, Jean-Louis ; Fulurija, Alma ; Cavaleri, Marco ; McCulloch, Mignon ; Asturias, Edwin J ; Zühlke, Liesl ; Ackland, James ; Steer, Andrew C ; Sun, Wellington ; Sriskandan, Shiranee

Streptococcus pyogenes (Strep A) infections result in a vastly underestimated burden of acute and chronic disease globally. The Strep A Vaccine Global Consortium's (SAVAC's) mission is to accelerate the development of safe, effective, and affordable S. pyogenes vaccines. The safety of vaccine recipients is of paramount importance. A single S. pyogenes vaccine clinical trial conducted in the 1960s raised important safety concerns. A SAVAC Safety Working Group was established to review the safety assessment methodology and results of more recent early-phase clinical trials and to consider future challenges for vaccine safety assessments across all phases of vaccine development. No clinical or biological safety signals were detected in any of these early-phase trials in the modern era. Improvements in vaccine safety assessments need further consideration, particularly for pediatric clinical trials, large-scale efficacy trials, and preparation for post-marketing pharmacovigilance.

01 Feb 2017·Journal of Applied ToxicologyQ4 · MEDICINE

Preclinical safety study of a recombinant Streptococcus pyogenes vaccine formulated with aluminum adjuvant

Q4 · MEDICINE

Article

Author: Mosley, Yung‐Yi C. ; Dunham, Anisa ; Burlet, Elodie ; HogenEsch, Harm ; Morefield, Garry ; Lu, Fangjia

AbstractA recombinant vaccine composed of a fusion protein formulated with aluminum hydroxide adjuvant is under development for protection against diseases caused by Streptococcus pyogenes. The safety and local reactogenicity of the vaccine was assessed by a comprehensive series of clinical, pathologic and immunologic tests in preclinical experiments. Outbred mice received three intramuscular injections of 1/5th of the human dose (0.1 ml) and rabbits received two injections of the full human dose. Control groups received adjuvant or protein antigen. The vaccine did not cause clinical evidence of systemic toxicity in mice or rabbits. There was a transient increase of peripheral blood neutrophils after the third vaccination of mice. In addition, the concentration of acute phase proteins serum amyloid A and haptoglobin was significantly increased 1 day after injection of the vaccine in mice. There was mild transient swelling and erythema of the injection site in both mice and rabbits. Treatment‐related pathology was limited to inflammation at the injection site and accumulation of adjuvant‐containing macrophages in the draining lymph nodes. In conclusion, the absence of clinical toxicity in two animal species suggest that the vaccine is safe for use in a phase I human clinical trial. Copyright © 2016 John Wiley & Sons, Ltd.

01 Aug 2014·Revista da Sociedade Brasileira de Medicina TropicalQ4 · MEDICINE

Streptococcal acute pharyngitis

Q4 · MEDICINE

ReviewOA

Author: Anjos, Lais Martins Moreira ; Marcondes, Mariana Barros ; Lima, Mariana Ferreira ; Mondelli, Alessandro Lia ; Okoshi, Marina Politi

Acute pharyngitis/tonsillitis, which is characterized by inflammation of the posterior pharynx and tonsils, is a common disease. Several viruses and bacteria can cause acute pharyngitis; however, Streptococcus pyogenes (also known as Lancefield group A β-hemolytic streptococci) is the only agent that requires an etiologic diagnosis and specific treatment. S. pyogenes is of major clinical importance because it can trigger post-infection systemic complications, acute rheumatic fever, and post-streptococcal glomerulonephritis. Symptom onset in streptococcal infection is usually abrupt and includes intense sore throat, fever, chills, malaise, headache, tender enlarged anterior cervical lymph nodes, and pharyngeal or tonsillar exudate. Cough, coryza, conjunctivitis, and diarrhea are uncommon, and their presence suggests a viral cause. A diagnosis of pharyngitis is supported by the patient's history and by the physical examination. Throat culture is the gold standard for diagnosing streptococcus pharyngitis. However, it has been underused in public health services because of its low availability and because of the 1- to 2-day delay in obtaining results. Rapid antigen detection tests have been used to detect S. pyogenes directly from throat swabs within minutes. Clinical scoring systems have been developed to predict the risk of S. pyogenes infection. The most commonly used scoring system is the modified Centor score. Acute S. pyogenes pharyngitis is often a self-limiting disease. Penicillins are the first-choice treatment. For patients with penicillin allergy, cephalosporins can be an acceptable alternative, although primary hypersensitivity to cephalosporins can occur. Another drug option is the macrolides. Future perspectives to prevent streptococcal pharyngitis and post-infection systemic complications include the development of an anti-Streptococcus pyogenes vaccine.

100 Deals associated with Streptococcus pyogenes vaccine(Butantan Institute)

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatic Fever	Phase 1	-	Butantan Institute	01 May 2021

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