Healthy VolunteersPhase 1NCT01864876
The Effects of GLA (5 mcg) on Human Volunteers
A Phase 1 study testing GLA-AF, GLA-SE and EM060G (SE) in people with Healthy Volunteers, run by Access to Advanced Health Institute (AAHI) at 1 site in United States.
Trial summary
This protocol is for a phase 1, randomized, single-blinded study to evaluate the safety and tolerability of a single 5 mcg dose of GLA-SE administered intramuscularly and GLA-AF administered subcutaneously. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GLA-AF, GLA-SE and EM060G (SE)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2013
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males and females, as assessed by a medical history, physical exam,and laboratory tests;
- Age of at least 18 years of age on the day of screening and no greater than 50 years at time of administration;
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study (screening plus 4 weeks);
- Willing to undergo HIV testing and counseling and receive HIV test results;
- If a female of child bearing potential, must be willing to use two effective methods of contraception (combined oral contraceptive pill; injectable contraceptive; diaphragm; Intra Uterine Device (IUD); condoms; anatomical sterility in self or partner) until 6 weeks after study drug administration. If a sexually active male, must be willing to use two effective methods of contraception (such as condoms, anatomical sterility) from screening until 6 weeks after study drug administration (same as above) and will be advised not to get his partner(s) pregnant during this time.
Who cannot join
- Positive for hepatitis B surface antigen, positive for hepatitis C antibodies, or active syphilis infection based on clinical evaluation;
- Confirmed HIV-1 or HIV-2 infection;
- Any clinically significant abnormality on medical history or physical examination including history of immunodeficiency or autoimmune disease;
- Any use of systemic corticosteroids immunosuppressive anticancer medications;
- Any clinically significant acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that in the opinion of the investigator would preclude participation;
- Any laboratory value outside of reference range other than CRP, with the exception of any non-clinically significant Grade I elevations of liver function tests (AST, ALT, direct/total bilirubin), electrolytes (Na, K, Cl, CO2), CBC, urinalysis as determined by the Principal Investigator or his designee.
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- Within the 12 months prior to enrollment, the subject self reports excessive daily alcohol use, frequent binge drinking or chronic marijuana abuse (defined as greater than 2 times a week) or any other use of illicit drugs;
- If female, pregnant, planning a pregnancy during the trial period, or lactating;
- Receipt of a live attenuated vaccine within 30 days or other vaccine within 14 days prior to study drug;
- Prior receipt of GLA in another research study;
- Participation in another clinical study of an investigational product currently or within past 16 weeks, or expected participation during this study;
- In the opinion of the investigator, unlikely to comply with protocol due to medical, social or psychiatric reasons;
- Allergy to eggs
- A glomerular filtration rate that is less than 60 mL/min/1.73 m2 as calculated by study team based on laboratory creatinine values.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-Blinded Phase 1 Study to Evaluate the Safety and Immunogenicity of a Single Administration of 5 mcg GLA in Healthy Volunteers
This protocol is for a phase 1, randomized, single-blinded study to evaluate the safety and tolerability of a single 5 mcg dose of GLA-SE administered intramuscularly and GLA-AF administered subcutaneously. The second focus will be to detail the global immune response by measuring systemic cytokines, chemokines, and global gene regulation. The third focus will be to investigate the effects of GLA on the peripheral blood immune cells including monocytes and dendritic cells. The results of this trial will generate supportive human data to use GLA as an adjuvant in a dendritic cell-targeted vaccine strategy.
- Conditions
- Healthy Volunteers
- Being tested
- GLA-AF, GLA-SE, EM060G (SE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLA-AFBiological
Glucopyranosyl Lipid A (GLA) in an aqueous formulation (AF).
GLA-SEBiological
Glucopyranosyl Lipid A (GLA) in a stable oil-in-water emulsion (SE).
EM060G (SE)Biological
The same stable oil-in-water emulsion (SE), but without GLA.
| Study group | Role | What they receive |
|---|---|---|
| GLA-AF | Experimental | 5 mcg GLA-AF given as one subcutaneous injection. Receives: Biological: GLA-AF |
| GLA-SE | Experimental | 5 mcg GLA-SE given as one intramuscular injection. Receives: Biological: GLA-SE |
| EM060G (SE) | Experimental | EM060G (SE) given as one intramuscular injection. Receives: Biological: EM060G (SE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Local reactogenicity events and systemic reactogenicity events will be monitored for 28 days post injection.
- Local reactogenicity events include tenderness, erythema, skin discoloration, edema, vesicle formation or ulceration, induration, pruritus, formation of a crust or scab, or other.
- Systemic reactogenicity events include fever, chills, headache, nausea, vomiting, malaise, myalgia, arthralgia, and rash.
Long term safety will be monitored by follow-up phone calls at 3 months, 6 months, and 1 year post injection.
Measured: 1 year
Secondary outcomes (1)
Immunogenicity
Describe the global immune response by measuring systemic cytokines, chemokines and global gene regulation. Investigate the effects of GLA on the peripheral blood immune cells including monocytes and dendritic cells.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startSep 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access to Advanced Health Institute (AAHI)
- Sponsor type
- University, hospital or other
- Collaborators
- Rockefeller University
- Responsible party
- Sponsor
- Investigators
- Franco Piazza, MD, MPH, Study director, Access to Advanced Health Institute (AAHI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864876
- Sponsor's protocol ID
- MCA-0784
- Status last verified
- Feb 2014
- First submitted
- 24 May 2013
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blinded Phase 1 Study to Evaluate the Safety and Immunogenicity of a Single Administration of 5 mcg GLA in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01864876
- Acronym / sponsor ID
- MCA-0784
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Access to Advanced Health Institute (AAHI)University, hospital or other
- Collaborators
- Rockefeller University
- Study start
- Sep 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 May 2013 (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 protocol is for a phase 1, randomized, single-blinded study to evaluate the safety and tolerability of a single 5 mcg dose of GLA-SE administered intramuscularly and GLA-AF administered subcutaneously. The second focus will be to detail the global immune response by measuring systemic cytokines, chemokines, and global gene regulation. The third focus will be to investigate the effects of GLA on the peripheral blood immune cells including monocytes and dendritic cells. The results of this trial will generate supportive human data to use GLA as an adjuvant in a dendritic cell-targeted vaccine strategy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GLA-AF | Experimental | Biological: GLA-AF5 mcg GLA-AF given as one subcutaneous injection. |
| GLA-SE | Experimental | Biological: GLA-SE5 mcg GLA-SE given as one intramuscular injection. |
| EM060G (SE) | Experimental | Biological: EM060G (SE)EM060G (SE) given as one intramuscular injection. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult males and females, as assessed by a medical history, physical exam,and laboratory tests;
- Age of at least 18 years of age on the day of screening and no greater than 50 years at time of administration;
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study (screening plus 4 weeks);
- Willing to undergo HIV testing and counseling and receive HIV test results;
- If a female of child bearing potential, must be willing to use two effective methods of contraception (combined oral contraceptive pill; injectable contraceptive; diaphragm; Intra Uterine Device (IUD); condoms; anatomical sterility in self or partner) until 6 weeks after study drug administration. If a sexually active male, must be willing to use two effective methods of contraception (such as condoms, anatomical sterility) from screening until 6 weeks after study drug administration (same as above) and will be advised not to get his partner(s) pregnant during this time.
Key exclusion criteria (14 listed)
- Positive for hepatitis B surface antigen, positive for hepatitis C antibodies, or active syphilis infection based on clinical evaluation;
- Confirmed HIV-1 or HIV-2 infection;
- Any clinically significant abnormality on medical history or physical examination including history of immunodeficiency or autoimmune disease;
- Any use of systemic corticosteroids immunosuppressive anticancer medications;
- Any clinically significant acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that in the opinion of the investigator would preclude participation;
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 |
|---|---|---|
| GLA-AFGlucopyranosyl Lipid A (GLA) in an aqueous formulation (AF). | Biological | GLA-AF |
| GLA-SEGlucopyranosyl Lipid A (GLA) in a stable oil-in-water emulsion (SE). | Biological | GLA-SE |
| EM060G (SE)The same stable oil-in-water emulsion (SE), but without GLA. | Biological | EM060G (SE) |
Primary outcome
Safety
Time frame: 1 year
Local reactogenicity events and systemic reactogenicity events will be monitored for 28 days post injection. * Local reactogenicity events include tenderness, erythema, skin discoloration, edema, vesicle formation or ulceration, induration, pruritus, formation of a crust or scab, or other. * Systemic reactogenicity events include fever, chills, headache, nausea, vomiting, malaise, myalgia, arthralgia, and rash. Long term safety will be monitored by follow-up phone calls at 3 months, 6 months, and 1 year post injection.
1 secondary outcome
Immunogenicity
Time frame: 28 days
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 Feb 2014.
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Screening Protocol
Pain
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.
Franco Piazza, MD, MPH study director
Access to Advanced Health Institute (AAHI)
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 GLA-AF, GLA-SE and EM060G (SE) in people with Healthy Volunteers, run by Access to Advanced Health Institute (AAHI) at 1 site in United States.
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 5 inclusion and 14 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 Feb 2014. 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 United States. 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 (time frame: 1 year). 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 Feb 2014.