Phase I to Test a New Pneumococcal Vaccine

NCT03303976 | Completed Phase 1

• 1 other identifier: Pneumo1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

To obtain first-in-human data on a new candidate vaccine against Streptococcus pneumoniae in healthy adult and elderly volunteers. The study aims to assess the safety and immunogenicity of a bioconjugate investigational vaccine compared to the control group (Pneumovax23).

Conditions

Pneumococcal Pneumonia; Pneumonia, Bacterial

Keywords

pneumococcal vaccine; bioconjugate

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Safety and tolerability of the candidate vaccine as determined by occurrence, severity, relationship, of solicited and unsolicited advers events (AEs) and serious adverse events (SAEs) after injection of the candidate vaccine compared to the control group throughout the study until one month after injection.

  until one month after injection

Secondary Outcomes (2)

• Clinical laboratory abnormality measure

  change from baseline one week after injection and one month after injection

• Assess immunogenicity of the candidate vaccine

  one month and six months after injection

Study Arms (4)

Pneumo1-low dose

EXPERIMENTAL

Arm A: intramuscular injection monovalent bioconjugate pneumococcal vaccine

Biological: Bioconjugate pneumococcal vaccine

Pneumo1-mid dose

EXPERIMENTAL

Arm B: intramuscular injection monovalent bioconjugate pneumococcal vaccine

Biological: Bioconjugate pneumococcal vaccine

Pneumo1-target dose

EXPERIMENTAL

Arm C: intramuscular injection monovalent bioconjugate pneumococcal vaccine

Biological: Bioconjugate pneumococcal vaccine

Pneumovax23

ACTIVE COMPARATOR

Arm D: intramuscular injection multivalent plain polysaccharide vaccine

Biological: Multivalent plain polysaccharide vaccine

Interventions

Bioconjugate pneumococcal vaccine BIOLOGICAL

Bioconjuagte vaccine against bacterial pneumococcal infection

Pneumo1-low dose; Pneumo1-mid dose; Pneumo1-target dose

Multivalent plain polysaccharide vaccine BIOLOGICAL

Multivalent plain polysaccharide vaccine against bacterial pneumococcal infection

Pneumovax23

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between 60 and 70 (inclusive) years of age at the time of vaccination.
• Subject who is willing and able to comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
• Signed informed consent obtained from the subject.

You may not qualify if:

• Health condition that, in the opinion of the investigator, may interfere with optimal participation in the study or place the volunteer at increased risk of adverse events (AEs). Study clinicians, in consultation with the principal investigator, will use clinical judgment on a case-by-case basis to assess safety risks under this criterion. The PI will consult with the medical monitor as appropriate. • Clinically significant abnormalities on physical examination.
• Clinically significant abnormalities on laboratory screening.
• Acute or chronic, clinically significant cardiovascular, pulmonary, hepatic or renal abnormality, diseases and/or insufficiency as determined by physical examination or laboratory tests, in particular: unstable current or history of coronary artery disease or cardiac insufficiency, uncontrolled hypertension, clinically significant history of myocardial infarction, atrial fibrillation, uncontrolled or clinically significant type 2 diabetes, current or history of rheumatoid arthritis or temporal arteritis, current acute or chronic active pulmonary diseases.
• Planned administration of a vaccine not foreseen by the study protocol within 4 weeks before and after the vaccination.
• Previous vaccination with any licensed or investigational pneumococcal vaccine or planned administration of a pneumococcal vaccination not foreseen by the study protocol and during the study period, as reported by subject.
• History of radiologically documented pneumonia or invasive pneumococcal disease (IPD) within 3 years previous to study start, as reported by subject.
• Known hypersensitivity to any components of the pneumococcal conjugate vaccine.
• Previous vaccination with any pseudomonas investigational vaccine as reported by the subject.
• Known or suspected impairment of immunological function, documented Human Immunodeficiency Virus (HIV) infection, asplenia, or history of autoimmune disease.
• History of regular use (\>2 weeks) in the last 6 months of immunosuppressive drugs including systemic corticosteroids (e.g. corticosteroids ≥0.5 mg/kg BW/day, excluding inhaled and topical steroid).
• Has a coagulation disorder contraindicating intramuscular vaccination..
• Received or receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation or autoimmune disease.
• Received a blood transfusion or previous treatment with blood products, including immunoglobulins within the 3 months preceding the injection, or is scheduled to receive them within 30 days after vaccination.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 3 months preceding the administration of study vaccine, or planned use during the study period.
• BMI (Body Mass Index) \<19 or ≥35.

Sponsors & Collaborators

• LimmaTech Biologics AG: lead

Study Sites (1)

CRS

Mönchengladbach, Germany

Location

MeSH Terms

Conditions

Pneumonia, Pneumococcal; Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

Pneumococcal Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael Leidig, MD

  CRS Mönchengladbach

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 6, 2017
• Study Start: September 7, 2017
• Primary Completion: September 12, 2018
• Study Completion: September 12, 2018
• Last Updated: December 4, 2018

Record last verified: 2018-12

Locations

DE (1)