Pneumococcal PneumoniaPhase 1NCT03303976
Phase I to Test a New Pneumococcal Vaccine
A Phase 1 study testing Bioconjugate pneumococcal vaccine and Multivalent plain polysaccharide vaccine in people with Pneumococcal Pneumonia and Pneumonia, Bacterial, run by LimmaTech Biologics AG at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Pneumonia, Pneumonia, Bacterial
- What is being tested?
- Bioconjugate pneumococcal vaccine and Multivalent plain polysaccharide vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 7 Sep 2017to 12 Sep 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 24Show fewer
- 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.
- Positive blood test for HBsAg, hepatitis C virus (HCV), HIV-1/2.
- History of allergy to any vaccine.
- Use of any antibiotic therapy within 1 week preceding injection.
- Subjects with an elective surgical intervention, planned during the study period.
- History of chronic alcohol consumption and/or drug abuse.
- Blood donation of at least 500 mL blood draw within 3 months preceding injection or planned during the study period as reported by subject.
- Pregnancy or intention to become pregnant as reported by subject.
- Female subjects who are not postmenopausal for at least 2 years.
- Man subjects with a female partner in reproductive age refusing to use contraception methods.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Immunogenicity of a Candidate Bioconjugate Vaccine Against Streptococcus Pneumoniae When Administered to Adult and Elderly Healthy Subjects. A Phase I Randomized Study.
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).
Read the detailed description
The study aims to assess the safety and immunogenicity of a new bioconjugate investigational vaccine compared to the control group (Pneumovax23) in a randomised, staggered, 2-steps controlled trial.
- Conditions
- Pneumococcal Pneumonia, Pneumonia, Bacterial
- Being tested
- Bioconjugate pneumococcal vaccine, Multivalent plain polysaccharide vaccine
- Keywords
- pneumococcal vaccine, bioconjugate
- Medical subject headings
- Pneumonia, Pneumococcal, Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioconjugate pneumococcal vaccineBiological
Bioconjuagte vaccine against bacterial pneumococcal infection
Multivalent plain polysaccharide vaccineBiological
Multivalent plain polysaccharide vaccine against bacterial pneumococcal infection
| Study group | Role | What they receive |
|---|---|---|
| Pneumo1-low dose | Experimental | Arm A: intramuscular injection monovalent bioconjugate pneumococcal vaccine Receives: Biological: Bioconjugate pneumococcal vaccine |
| Pneumo1-mid dose | Experimental | Arm B: intramuscular injection monovalent bioconjugate pneumococcal vaccine Receives: Biological: Bioconjugate pneumococcal vaccine |
| Pneumo1-target dose | Experimental | Arm C: intramuscular injection monovalent bioconjugate pneumococcal vaccine Receives: Biological: Bioconjugate pneumococcal vaccine |
| Pneumovax23 | Active comparator | Arm D: intramuscular injection multivalent plain polysaccharide vaccine Receives: Biological: Multivalent plain polysaccharide vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: until one month after injection
Secondary outcomes (2)
Clinical laboratory abnormality measure
Safety of the candidate vaccine by measuring changes in haematological and biochemical safety parameters before injection (baseline) and after vaccine administration, in terms of absolute changes and between groups.
Measured: change from baseline one week after injection and one month after injection
Assess immunogenicity of the candidate vaccine
Evaluation of antigen-specific antibodies levels and functionality at each time point for all groups in terms of change from baseline
Measured: one month and six months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start7 Sep 2017
- Primary completion12 Sep 2018
- Study completion12 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- LimmaTech Biologics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Leidig, MD, Principal investigator, CRS Mönchengladbach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303976
- Sponsor's protocol ID
- Pneumo1
- Status last verified
- Dec 2018
- First submitted
- 25 Sep 2017
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of a Candidate Bioconjugate Vaccine Against Streptococcus Pneumoniae When Administered to Adult and Elderly Healthy Subjects. A Phase I Randomized Study.
- ClinicalTrials.gov ID
- NCT03303976
- Acronym / sponsor ID
- Pneumo1
- Conditions
- Pneumococcal Pneumonia, Pneumonia, Bacterial
- Keywords
- pneumococcal vaccine, bioconjugate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- LimmaTech Biologics AGIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 12 Sep 2018 (actual)
- Study completion
- 12 Sep 2018 (actual)
- First posted
- 6 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The study aims to assess the safety and immunogenicity of a new bioconjugate investigational vaccine compared to the control group (Pneumovax23) in a randomised, staggered, 2-steps controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pneumo1-low dose | Experimental | Biological: Bioconjugate pneumococcal vaccineArm A: intramuscular injection monovalent bioconjugate pneumococcal vaccine |
| Pneumo1-mid dose | Experimental | Biological: Bioconjugate pneumococcal vaccineArm B: intramuscular injection monovalent bioconjugate pneumococcal vaccine |
| Pneumo1-target dose | Experimental | Biological: Bioconjugate pneumococcal vaccineArm C: intramuscular injection monovalent bioconjugate pneumococcal vaccine |
| Pneumovax23 | Active comparator | Biological: Multivalent plain polysaccharide vaccineArm D: intramuscular injection multivalent plain polysaccharide vaccine |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioconjugate pneumococcal vaccineBioconjuagte vaccine against bacterial pneumococcal infection | Biological | Pneumo1-low dose, Pneumo1-mid dose, Pneumo1-target dose |
| Multivalent plain polysaccharide vaccineMultivalent plain polysaccharide vaccine against bacterial pneumococcal infection | Biological | Pneumovax23 |
Primary outcome
Incidence of adverse events
Time frame: until one month after injection
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.
2 secondary outcomes
Clinical laboratory abnormality measure
Time frame: change from baseline one week after injection and one month after injection
Assess immunogenicity of the candidate vaccine
Time frame: one month and six months after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Pneumococcal Pneumonia
RecruitingPhase 4
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Severe Acute Malnutrition in Childhood, Pneumococcal Disease
Active, not recruitingPhase 1
A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months of Age Receiving a Single Booster Dose
Pneumonia, Bacterial
RecruitingObservational study
Urine Pneumococcal Antigen Project
Pneumonia, Pneumonia - Bacterial
Active, not recruitingObservational study
A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia
Community-Acquired Pneumonia (CAP)
Not yet recruitingPhase 1
A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose Primary Dosing Series Followed by a Booster Dose at 12 to 15 Months of Age
Pneumonia, Bacterial
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Leidig, MD principal investigator
CRS Mönchengladbach
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bioconjugate pneumococcal vaccine and Multivalent plain polysaccharide vaccine in people with Pneumococcal Pneumonia and Pneumonia, Bacterial, run by LimmaTech Biologics AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: until one month after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.