Pneumococcal InfectionsPhase 1NCT02892812
A Phase I Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine and 14-valent Pneumococcal Conjugate Vaccine in Adults
A Phase 1 study testing Pneumococcal conjugate vaccine in people with Pneumococcal Infections, run by LG Life Sciences at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of LBVE013 (Pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) or LBVE014 (Pneumococcal 14-valent conjugate vaccine [diphtheria CRM197 protein]) 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 Infections
- What is being tested?
- Pneumococcal conjugate vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2016to Nov 2016
- 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
1 site in 1 country.
About this study
Official title: A Single-blind, Single-center, Randomized, Active-controlled, Parallel Group, Phase I Study to Evaluate the Safety and Immunogenicity of Intramuscular Single Injection With LBVE013 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), LBVE014 (Pneumococcal 14-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) or Prevnar13 in Healthy Adults
The purpose of this study is to evaluate the safety and immunogenicity of LBVE013 (Pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) or LBVE014 (Pneumococcal 14-valent conjugate vaccine [diphtheria CRM197 protein]) in healthy adults.
- Conditions
- Pneumococcal Infections
- Being tested
- Pneumococcal conjugate vaccine
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal conjugate vaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| LBVE013 | Experimental | 13-valent pneumococcal conjugate vaccine Receives: Biological: Pneumococcal conjugate vaccine |
| LBVE014 | Experimental | 14-valent pneumococcal conjugate vaccine Receives: Biological: Pneumococcal conjugate vaccine |
| Prevnar13 | Active comparator | 13-valent pneumococcal conjugate vaccine Receives: Biological: Pneumococcal conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited adverse events
Measured: Baseline(pre-vaccination) up to 7 days after vaccination
Unsolicited adverse events
Measured: Baseline(pre-vaccination) up to 4 weeks after vaccination
Immediate reactions after vaccination
Measured: Baseline(pre-vaccination) up to 30 minutes after vaccination
Secondary outcomes (3)
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 4 weeks After Vaccination
Measured: 4 weeks after vaccination
Proportion of subjects achieving 4-fold rise in Pneumococcal Opsonophagocytic Activity (OPA) titer at 4 weeks after vaccination
Measured: 4 weeks after vaccination
Serotype-Specific Pneumococcal IgG antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination
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 posted8 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionsStudies 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- 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
- NCT02892812
- Sponsor's protocol ID
- LG-VECL001
- Status last verified
- Jun 2017
- First submitted
- 2 Sep 2016
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Single-center, Randomized, Active-controlled, Parallel Group, Phase I Study to Evaluate the Safety and Immunogenicity of Intramuscular Single Injection With LBVE013 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), LBVE014 (Pneumococcal 14-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) or Prevnar13 in Healthy Adults
- ClinicalTrials.gov ID
- NCT02892812
- Acronym / sponsor ID
- LG-VECL001
- Conditions
- Pneumococcal Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Sep 2016 (estimated)
- 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.
The purpose of this study is to evaluate the safety and immunogenicity of LBVE013 (Pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) or LBVE014 (Pneumococcal 14-valent conjugate vaccine [diphtheria CRM197 protein]) 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 |
|---|---|---|
| LBVE013 | Experimental | Biological: Pneumococcal conjugate vaccine13-valent pneumococcal conjugate vaccine |
| LBVE014 | Experimental | Biological: Pneumococcal conjugate vaccine14-valent pneumococcal conjugate vaccine |
| Prevnar13 | Active comparator | Biological: Pneumococcal conjugate vaccine13-valent pneumococcal conjugate vaccine |
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 |
|---|---|---|
| Pneumococcal conjugate vaccine | Biological | LBVE013, LBVE014, Prevnar13 |
Primary outcome
Solicited adverse events
Time frame: Baseline(pre-vaccination) up to 7 days after vaccination
Unsolicited adverse events
Time frame: Baseline(pre-vaccination) up to 4 weeks after vaccination
Immediate reactions after vaccination
Time frame: Baseline(pre-vaccination) up to 30 minutes after vaccination
3 secondary outcomes
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
Serotype-Specific Pneumococcal IgG antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination
Time frame: 4 weeks after vaccination
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 26 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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
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 Pneumococcal conjugate vaccine in people with Pneumococcal Infections, run by LG Life Sciences at 1 site in South Korea.
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: finished, as of the sponsor's last update on 26 Jun 2017. 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 South Korea. 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?
Solicited adverse events (time frame: Baseline(pre-vaccination) up to 7 days after vaccination). 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 26 Jun 2017.