SchistosomiasisPhase 1NCT01154049
Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis
A Phase 1 study testing sm14 antigen plus adjuvant GLA in people with Schistosomiasis, run by Oswaldo Cruz Foundation at 1 site in Brazil.
Trial summary
This is a phase I, open-label, single arm trial, which aims to assess the safety of the vaccine prepared sm14 in healthy subjects. The product immunogenicity will be evaluated by conducting serology (anti-sm14 antibodies) and testing of cellular response to the antigen by the method ELI-SPOT. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Schistosomiasis
- What is being tested?
- sm14 antigen plus adjuvant GLA
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2011to Apr 2014
- 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 49 years.
- Available for follow-up throughout the study period (approximately 120 days).
- Ability to understand and sign the informed consent form (IC).
- HIV serology negative
- Absence of helminth infections in general (nematodes, cestodes and trematodes, among which Schistosoma mansoni) at the inclusion in the study.
- Patients who has not chronic use or have not used in the past 45 days any medication, except trifling as nasal saline and vitamins.
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- Be in good health without significant medical history.
- Screening physical examination without clinical significant abnormalities.
- Screening laboratory tests without significant abnormalities according to normal standards and the evaluation of investigators.
- Additional criteria for females of childbearing potential: Negative pregnancy test at screening; consistent use of contraceptive methods (male or female condom, diaphragm, IUD and oral contraceptives or "patches").
Who cannot join
- Women who are pregnant or breastfeeding.
- Use of cytotoxic or immunosuppressive drugs in the last six months, except for spray nasal corticosteroids for allergic rhinitis or topical corticosteroids for uncomplicated dermatitis.
- Immunoglobulin use 60 days prior to vaccination.
- Use of any type of vaccine 30 days prior to vaccination.
- Plan to receive any other vaccine during the period of participation in the study (four months)
- Use any type of investigational medication in a period of 30 days prior to vaccination
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- Use of allergy shots with antigens within 14 days prior to vaccination.
- Psychiatric illness that hinders adherence to the protocol, such as psychosis, obsessive-compulsive neurosis, bipolar disorder treatment, diseases that require treatment with lithium, and suicide thoughts in the last 5 years prior to inclusion.
- Presence of neurological disease, liver disease or kidney disease (diseases which have led to hospitalization or prolonged treatment).
- History of sickle cell anemia.
- Asplenia (no spleen or its removal).
- History of alcohol use/abuse (CAGE criterion) or illicit drugs.
- Blood pressure above 140/90 mmHg at screening or hypertension requiring drug treatment.
- Coagulopathy diagnosed by a doctor or report of capillary fragility (eg, bruising, bleeding, etc.) after injections or blood sampling.
- Active malignancy (eg, any type of cancer) or treated so it may relapse during the study.
- History of allergy to vaccines containing adjuvants composed of lipids (GLA or MPL)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Pesquisa Clínica Evandro Chagas (IPEC) - Fiocruz
Rio de Janeiro, Rio de Janeiro, 21040900
About this study
Official title: Phase 1 Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis
This is a phase I, open-label, single arm trial, which aims to assess the safety of the vaccine prepared sm14 in healthy subjects. The product immunogenicity will be evaluated by conducting serology (anti-sm14 antibodies) and testing of cellular response to the antigen by the method ELI-SPOT. Each participant will remain in the study for approximately 4 months. The total study duration is 10 months, considering a period of 6 months for inclusion. Will be included in the study subjects male and female, between 18 and 49 years, that manifest their will to participate in the research by signing an Informed Consent Form. Eligible population for the study are subjects who do not present at screening significant changes in renal, cardiac and liver functions, complete blood count, clotting, present no acute or chronic illnesses, are not in the chronic use of any medication, do not have HIV infection or other immunodeficiency. Pregnant or breastfeeding women will not be included. Volunteers will receive three doses of vaccine prepared sm14, in doses containing 50 mcg of the antigen, associated with adjuvant GLA-SE at a dose of 10 mcg, with an interval of 30 days between each application. Twenty volunteers will be included in the study. This is a convenience sample, established for the first test of the product in humans, for the initial safety assessment.
- Conditions
- Schistosomiasis
- Being tested
- sm14 antigen plus adjuvant GLA
- Keywords
- Schistosomiasis, Vaccine, sm14
- Medical subject headings
- Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sm14 antigen plus adjuvant GLABiological
Healthy adults will receive 3 doses of the vaccine, on days 0, 30 and 60.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | 3 doses of the vaccine, on days 0, 30 and 60. Receives: Biological: sm14 antigen plus adjuvant GLA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the vaccine
Safety and tolerability of the vaccine (sm14 antigen plus GLA adjuvant) against schistosomiasis in health adults
Measured: 4 months after the first dose
Secondary outcomes (2)
Proportion of seroconversion
Proportion of seroconversion for sm14 antigen 30 days after the complete vaccinal schedule (3 doses, 30 days apart)
Measured: 30 days after the third vaccine dose
Cellular immune response to sm-14 vaccination in health adults
Determine the cellular immune responses and their correlation to the development and magnitude of humoral responses
Measured: 30 days after the third vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startMar 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchistosomiasisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oswaldo Cruz Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Financiadora de Estudos e Projetos
- Responsible party
- Sponsor
- Investigators
- Marilia S Oliveira, MD, MsC, Principal investigator, Instituto de Pesquisa Clínica Evandro Chagas (IPEC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154049
- Sponsor's protocol ID
- sm14-CT001P1
- Status last verified
- Aug 2016
- First submitted
- 29 Jun 2010
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Santini-Oliveira M, Coler RN, Parra J, Veloso V, Jayashankar L, Pinto PM, Ciol MA, Bergquist R, Reed SG, Tendler M. Schistosomiasis vaccine candidate Sm14/GLA-SE: Phase 1 safety and immunogenicity clinical trial in healthy, male adults. Vaccine. 2016 Jan 20;34(4):586-594. doi: 10.1016/j.vaccine.2015.10.027. Epub 2015 Nov 10.
PubMed 26571311
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis
- ClinicalTrials.gov ID
- NCT01154049
- Acronym / sponsor ID
- sm14-CT001P1
- Conditions
- Schistosomiasis
- Keywords
- Schistosomiasis, Vaccine, sm14
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oswaldo Cruz FoundationUniversity, hospital or other
- Collaborators
- Financiadora de Estudos e Projetos
- Study start
- Mar 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 30 Jun 2010 (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.
This is a phase I, open-label, single arm trial, which aims to assess the safety of the vaccine prepared sm14 in healthy subjects. The product immunogenicity will be evaluated by conducting serology (anti-sm14 antibodies) and testing of cellular response to the antigen by the method ELI-SPOT. Each participant will remain in the study for approximately 4 months. The total study duration is 10 months, considering a period of 6 months for inclusion. Will be included in the study subjects male and female, between 18 and 49 years, that manifest their will to participate in the research by signing an Informed Consent Form. Eligible population for the study are subjects who do not present at screening significant changes in renal, cardiac and liver functions, complete blood count, clotting, present no acute or chronic illnesses, are not in the chronic use of any medication, do not have HIV infection or other immunodeficiency. Pregnant or breastfeeding women will not be included. Volunteers will receive three doses of vaccine prepared sm14, in doses containing 50 mcg of the antigen, associated with adjuvant GLA-SE at a dose of 10 mcg, with an interval of 30 days between each application. Twenty volunteers will be included in the study. This is a convenience sample, established for the first test of the product in humans, for the initial safety assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Biological: sm14 antigen plus adjuvant GLA3 doses of the vaccine, on days 0, 30 and 60. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Aged between 18 and 49 years.
- Available for follow-up throughout the study period (approximately 120 days).
- Ability to understand and sign the informed consent form (IC).
- HIV serology negative
- Absence of helminth infections in general (nematodes, cestodes and trematodes, among which Schistosoma mansoni) at the inclusion in the study.
Key exclusion criteria (16 listed)
- Women who are pregnant or breastfeeding.
- Use of cytotoxic or immunosuppressive drugs in the last six months, except for spray nasal corticosteroids for allergic rhinitis or topical corticosteroids for uncomplicated dermatitis.
- Immunoglobulin use 60 days prior to vaccination.
- Use of any type of vaccine 30 days prior to vaccination.
- Plan to receive any other vaccine during the period of participation in the study (four months)
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 |
|---|---|---|
| sm14 antigen plus adjuvant GLAHealthy adults will receive 3 doses of the vaccine, on days 0, 30 and 60. | Biological | single arm |
Primary outcome
Safety of the vaccine
Time frame: 4 months after the first dose
Safety and tolerability of the vaccine (sm14 antigen plus GLA adjuvant) against schistosomiasis in health adults
2 secondary outcomes
Proportion of seroconversion
Time frame: 30 days after the third vaccine dose
Cellular immune response to sm-14 vaccination in health adults
Time frame: 30 days after the third vaccine dose
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 10 Aug 2016.
- Derived from this study: PubMed 26571311Santini-Oliveira M, Coler RN, Parra J, Veloso V, Jayashankar L, Pinto PM, Ciol MA, Bergquist R, Reed SG, Tendler M. Schistosomiasis vaccine candidate Sm14/GLA-SE: Phase 1 safety and immunogenicity clinical trial in healthy, male adults. Vaccine. 2016 Jan 20;34(4):586-594. doi: 10.1016/j.vaccine.2015.10.027. Epub 2015 Nov 10.
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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.
Marilia S Oliveira, MD, MsC principal investigator
Instituto de Pesquisa Clínica Evandro Chagas (IPEC)
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 sm14 antigen plus adjuvant GLA in people with Schistosomiasis, run by Oswaldo Cruz Foundation at 1 site in Brazil.
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 10 inclusion and 16 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 10 Aug 2016. 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 Brazil. 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?
Safety of the vaccine (time frame: 4 months after the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01154049, which also lists 1 linked publication.
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 10 Aug 2016.