Pneumococcal InfectionPhase 1NCT03549208
A Study to Evaluate the Safety and Immunogeneicity of Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults
A Phase 1 study testing LBVE01, LBVE02 and Prevnar13 in people with Pneumococcal Infection, run by LG Chem.
Trial summary
phase-1 study pneumococcal conjugate vaccine study in healthy adults Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infection
- What is being tested?
- LBVE01, LBVE02 and Prevnar13
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to 25 Jul 2019
- 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult older than 19 years old and younger than 50 years old
- A subject who was informed of the purpose, method, and efficacy of the clinical study and signed the written informed consent form
Who cannot join
- A subject who participated in other clinical studies within 3 months before screening
- A subject who was vaccinated with other vaccines within 4 weeks before screening, or who is expected to receive other vaccination during the clinical study period
- A subject with medical history of hypersensitive reactions (e.g. anaphylaxis) to the test drug or its ingredients
- A subject who received immunoglobulin or blood-derived materials within 3 months before screening
- A subject with immunologic function disorders including congenital or acquired immunodeficiency disorders
- A subject who is receiving immunosuppressive therapy or drugs that can affect immunological reaction
Show all 10Show fewer
- A subject with pyrexia of over 38 Celsius degrees on the day of the vaccination with the investigational products
- A subject with medical history of Invasive Pneumococcal Disease (IPD) or pneumonia caused by Streptococcus pneumoniae
- A subject who was vaccinated with any pneumococcal vaccine before screening
- A subject who received the vaccine containing diphtheria toxoid within 6 months before screening (e.g. adult Td vaccine)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Single-blind, Single-center, Randomized, Active-controlled, Parallel Group, Phase I Study to Evaluate the Safety and Immunogenicity of Intramuscular Single Injection With Pneumococcal Conjugate Vaccine or Prevnar13 in Healthy Adults
phase-1 study pneumococcal conjugate vaccine study in healthy adults
Read the detailed description
A Study to Evaluate the Safety and Immunogeneicity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy adults
- Conditions
- Pneumococcal Infection
- Being tested
- LBVE01, LBVE02, Prevnar13
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBVE01Biological
Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
LBVE02Biological
Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
Prevnar13Biological
13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
| Study group | Role | What they receive |
|---|---|---|
| LBVE01 | Experimental | Multivalent pneumococcal conjugate vaccine Receives: Biological: LBVE01 |
| LBVE02 | Experimental | Multivalent pneumococcal conjugate vaccine Receives: Biological: LBVE02 |
| Prevnar13 | Active comparator | Multivalent pneumococcal conjugate vaccine Prevnar13 Receives: Biological: Prevnar13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited adverse events
Solicited adverse events
Measured: Baseline(pre-vaccination) up to 7 days after
Unsolicited adverse events
Unsolicited adverse events
Measured: Baseline(pre-vaccination) up to 4 weeks after vaccination
Immediate reactions after vaccination
Immediate reactions after vaccination
Measured: Baseline(pre-vaccination) up to 30 minutes after vaccination
Secondary outcomes (3)
Serotype-Specific Pneumococcal immunoglobulin G antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination
GMC
Measured: 4 weeks After Vaccination
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 4 weeks After Vaccination
GMT
Measured: 4 weeks After Vaccination
Proportion of subjects achieving 4-fold rise in Pneumococcal Opsonophagocytic Activity (OPA) titer at 4 weeks after vaccination
OPA titer
Measured: 4 weeks after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start1 Jul 2018 (estimated)
- Primary completion1 Apr 2019 (estimated)
- Study completion25 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myoung-don Oh, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549208
- Sponsor's protocol ID
- LG-VECL003
- Status last verified
- May 2018
- First submitted
- 25 May 2018
- Last updated
- 13 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-blind, Single-center, Randomized, Active-controlled, Parallel Group, Phase I Study to Evaluate the Safety and Immunogenicity of Intramuscular Single Injection With Pneumococcal Conjugate Vaccine or Prevnar13 in Healthy Adults
- ClinicalTrials.gov ID
- NCT03549208
- Acronym / sponsor ID
- LG-VECL003
- Conditions
- Pneumococcal Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 25 Jul 2019 (estimated)
- First posted
- 7 Jun 2018 (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.
phase-1 study pneumococcal conjugate vaccine study in healthy adults
Detailed description
A Study to Evaluate the Safety and Immunogeneicity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy adults
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LBVE01 | Experimental | Biological: LBVE01Multivalent pneumococcal conjugate vaccine |
| LBVE02 | Experimental | Biological: LBVE02Multivalent pneumococcal conjugate vaccine |
| Prevnar13 | Active comparator | Biological: Prevnar13Multivalent pneumococcal conjugate vaccine Prevnar13 |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult older than 19 years old and younger than 50 years old
- A subject who was informed of the purpose, method, and efficacy of the clinical study and signed the written informed consent form
Key exclusion criteria (10 listed)
- A subject who participated in other clinical studies within 3 months before screening
- A subject who was vaccinated with other vaccines within 4 weeks before screening, or who is expected to receive other vaccination during the clinical study period
- A subject with medical history of hypersensitive reactions (e.g. anaphylaxis) to the test drug or its ingredients
- A subject who received immunoglobulin or blood-derived materials within 3 months before screening
- A subject with immunologic function disorders including congenital or acquired immunodeficiency disorders
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 |
|---|---|---|
| LBVE01Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh | Biological | LBVE01 |
| LBVE02Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh | Biological | LBVE02 |
| Prevnar1313-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh | Biological | Prevnar13 |
Primary outcome
Solicited adverse events
Time frame: Baseline(pre-vaccination) up to 7 days after
Solicited adverse events
Unsolicited adverse events
Time frame: Baseline(pre-vaccination) up to 4 weeks after vaccination
Unsolicited adverse events
Immediate reactions after vaccination
Time frame: Baseline(pre-vaccination) up to 30 minutes after vaccination
Immediate reactions after vaccination
3 secondary outcomes
Serotype-Specific Pneumococcal immunoglobulin G antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination
Time frame: 4 weeks After Vaccination
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 4 weeks After Vaccination
Time frame: 4 weeks After Vaccination
Proportion of subjects achieving 4-fold rise in Pneumococcal Opsonophagocytic Activity (OPA) titer at 4 weeks after vaccination
Time frame: 4 weeks after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
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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.
Myoung-don Oh, M.D. principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LBVE01, LBVE02 and Prevnar13 in people with Pneumococcal Infection, run by LG Chem.
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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soie Park (02-6987-4160, soiep@lgchem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Solicited adverse events (time frame: Baseline(pre-vaccination) up to 7 days after). The study lists 3 primary outcomes in all. 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 13 Jun 2018.