HIV InfectionPhase 1FLSC-001NCT02756208
A Safety and Immunogenicity Trial of IHV01
A Phase 1 study testing 300 ug FLSC vaccine, 150 ug FLSC vaccine and 75 ug FLSC vaccine in people with HIV Infection, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This study is designed to evaluate the safety of the FLSC vaccine and will be a randomized, placebo-controlled, modified double-blinded dose escalation study in 60 healthy adult volunteers (Human Immunodeficiency Virus-1 uninfected). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- 300 ug FLSC vaccine, 150 ug FLSC vaccine and 75 ug FLSC vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jul 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 to 45 years of age.
- Sex: Male or Female (female volunteers of child bearing potential must have a negative serum beta human chorionic gonadotropin (b-HCG or pregnancy) test at time of screening and entry into the study and provide assurance of the use of effective(as judged by the investigator) birth control methods or abstinence beginning at least 60 days prior to the study and during the study
- Documented HIV-1 negative by ELISA
- Be in good general health without clinically significant medical history, physical examination findings, or clinically significant abnormal laboratory results (i.e., chronic medical conditions as noted in the exclusion criteria such as cancer as well as any conditions that in the opinion of the investigator might pose a risk to the volunteer)
- No identifiable risk factor for acquisition of HIV infection (i.e., intravenous drug use/needle sharing, unprotected sex with multiple partners)
- Negative b-HCG pregnancy test on the day of initial vaccination.
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- Negative screen for Hepatitis B surface antigen (HBsAg);
- Negative screen for antibodies to Hepatitis C virus (Patient may enroll if patient can provide documentation of negative hepatitis C viral load.)
- Participant must have a CD4 count ( a type of white blood cells) within the normal range of the clinical laboratory utilized for the study and a CD4 percentage within 20% of the normal range of the clinical laboratory
- Laboratory parameters must be within pre-specified limits as defined by exclusion criteria.
- Volunteers must be willing and able to provide written informed consent to participate in the study.
- Available for at least 48 weeks of follow-up.
Who cannot join
- High risk behavior for acquisition of HIV within 24 weeks of study entry(i.e., intravenous drug use/needle sharing, unprotected sex with multiple partners)
- Volunteers with an acute and clinically significant medical event (as determined by the investigator) within the past 30 days of screening.
- Have active tuberculosis or other systemic infectious process by review of systems and physical examination
- Have a history of immunodeficiency, autoimmune disease, or use of immunosuppressive medications
- Current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Is pregnant
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- History of any chronic illness that would interfere with conduct or completion of study(as determined by the investigator)
- Have evidence of psychiatric, medical and/or substance abuse problems during the past 24 weeks that the investigator believes would adversely affect the volunteer's ability to participate in the trial
- Have occupational or other responsibilities that would prevent completion of participation in the study
- Have received any live, attenuated vaccine except rabies vaccine within 60 days of study entry
- Vaccine (FDA approved; e.g. influenza, pneumovax, etc) administration within 30 days of immunization with the study vaccine. NOTE: Medically indicated subunit or killed vaccines (e.g., Hepatitis A or Hepatitis B) should be given prior to trial initiation or after completion of the study immunizations. If patient requires immunization, injections should be given more than 2 weeks prior or 2 weeks after study immunization
- Have used experimental therapeutic agents within 30 days of study entry
- Have received blood products or immunoglobulins in the past 12 weeks
- Have a history of anaphylaxis or other serious adverse reactions to vaccines
- Have previously received an HIV vaccine
- Volunteers with any of the following laboratory parameters at the screening visit (within 30 days of immunization): Hemoglobin <10 (without having received a blood or red blood cell transfusion within 30 days prior to laboratory test); neutrophil count <750 cells/mm3; platelet count <50,000/mm3; serum creatinine > 2.0 mg/dL; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limits of normal; total bilirubin > 1.5 mg/dL
- Pregnant women or women who are breast-feeding; female volunteers of childbearing potential who are not using or willing to use an effective (as judged by the investigator) barrier contraceptive methods or abstinence while enrolled in this study.
- Use of any immune modulators or suppressors within 45 days of study entry including but not limited to agents such as interleukins (e.g. IL-2), interferons (e.g. IFN-*), high dose systemic steroids (e.g. ≥ 20 mg prednisone equivalent/day) for > 30 days, thalidomide, filgrastim (G-CSF), sargramostim (GM-CSF), dinitrochlorobenzene (DNCB), thymosin alpha, thymopentin, inosiplex, polyribonucleoside, ditiocarb sodium, cyclosporin, mycophenolate mofetil, methotrexate, and cancer chemotherapy.
- No other investigational agent within 30 days of study entry
- Any other condition which, in the opinion of the investigator, might interfere with completion of the study or evaluation of the results
- Have active Hepatitis B virus infection (positive HBsAg) or Hepatitis C infection(defined as positive antibodies)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201
About this study
Official title: A Phase I Safety and Immunogenicity Trial of IHV01 in HIV-1 Uninfected Volunteers
This study is designed to evaluate the safety of the FLSC vaccine and will be a randomized, placebo-controlled, modified double-blinded dose escalation study in 60 healthy adult volunteers (Human Immunodeficiency Virus-1 uninfected).
Read the detailed description
This is a Phase 1 randomized, placebo-controlled, modified double-blinded dose escalation study in 60 healthy adult volunteers who are Human Immunodeficiency Virus-1 (HIV-1) uninfected. Participants in the study will receive 4 injections at 0, 4, 8 and 24 weeks and will be followed for an additional 24 weeks. The total study duration will be 48 weeks. As this is a Phase 1 trial, the primary objective is to document safety of the Full Length Single Chain (FLSC) gp120-CD4 complex vaccine with a secondary objective to evaluate immune responses induced by the vaccine. This vaccine is being evaluated as it is constructed so that the gp120 and CD4 moieties form a stable intra-chain binding interaction that forms a transition state structure that presents conserved, conformational domains involved in the early HIV replication process. It is hypothesized that antibodies directed to these epitopes would be highly cross-reactive and potentially useful for HIV vaccine development.
- Conditions
- HIV Infection
- Being tested
- 300 ug FLSC vaccine, 150 ug FLSC vaccine, 75 ug FLSC vaccine, Placebo
- Keywords
- vaccine, healthy volunteer
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
300 ug FLSC vaccineBiological
Also called Full length single chain gp120-CD4 complex vaccine
FLSC vaccine 300 ug (1.0 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168
150 ug FLSC vaccineBiological
Also called Full length single chain gp120-CD4 complex vaccine
FLSC vaccine 150 ug (0.5 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168
75 ug FLSC vaccineBiological
Also called Full length single chain gp120-CD4 complex vaccine
FLSC vaccine 75 ug (0.25 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168
PlaceboBiological
Also called sterile saline
Placebo sterile saline (0.25 - 1.0 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168
| Study group | Role | What they receive |
|---|---|---|
| 300 ug FLSC vaccine | Experimental | Subjects will be vaccinated with 300 ug FLSC vaccine (highest vaccine dose) on study days 0, 28, 56 and 168. Receives: Biological: 300 ug FLSC vaccine |
| 150 ug FLSC vaccine | Experimental | Subjects will be vaccinated with 150 ug FLSC vaccine (middle vaccine dose) on study days 0, 28, 56 and 168. Receives: Biological: 150 ug FLSC vaccine |
| 75 ug FLSC vaccine | Experimental | Subjects will be vaccinated with 75 ug FLSC vaccine (lowest vaccine dose) on study days 0, 28, 56 and 168. Receives: Biological: 75 ug FLSC vaccine |
| Placebo | Placebo comparator | Subjects will be vaccinated with placebo (control group) on study days 0, 28, 56 and 168. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Local and Systemic Reactogenicity Signs and Symptoms
Signs and symptoms include pain, tenderness, maximum severity of pain and/or tenderness, erythema, induration, fever, malaise/fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and maximum severity of systemic symptoms.
Measured: 48 weeks
Number of Participants With Related Adverse Events
Treatment emergent adverse events assessed by investigator to be either possibly, probably, or definitely related to study treatment. Medical Dictionary for Regulatory Activities (MedDRA) preferred term, severity, and assessed relationship to study products.
Measured: 48 weeks
Number of Participants With Sustained Decrease in CD4 Count and CD4%.
CD4 count was monitored from baseline and at each study visit through study completion. Baseline CD4 and CD4% levels were calculated by taking the average of the screening and first vaccination visits. The number of individuals who had sustained (2 consecutive time points) 30% decrease in CD4 cell/ul and CD4% from baseline were counted.
Measured: 48 weeks
Secondary outcomes (3)
Binding Antibody Response Rates to FLSC
Percent of participants with anti-FLSC antibodies as assessed by ELISA by 2 weeks after final vaccination
Measured: 2 weeks after 4th (last) vaccination.
Binding Antibody Response Rates to BaL-gp120
Percent of participants with anti-gp120 antibodies as assessed by ELISA
Measured: 2 weeks after 4th (last) vaccination
Competitive Antibody Rates to CD4i Epitopes
Percent of participants with antibodies competing with A32 or 17b as assessed by ELISA.
Measured: 2 weeks after 4th (last) vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startNov 2015
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Auro Vaccines LLC
- Responsible party
- Principal investigator, Mohammad Sajadi, University of Maryland, Baltimore
- Investigators
- Charles E Davis, M.D., Principal investigator, Institute of Human Virology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756208
- Sponsor's protocol ID
- HP-00065547
- Acronym
- FLSC-001
- Status last verified
- Nov 2021
- First submitted
- 17 Apr 2016
- Last updated
- 16 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Safety and Immunogenicity Trial of IHV01 in HIV-1 Uninfected Volunteers
- ClinicalTrials.gov ID
- NCT02756208
- Acronym / sponsor ID
- FLSC-001 / HP-00065547
- Conditions
- HIV Infection
- Keywords
- vaccine, healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Auro Vaccines LLC
- Study start
- Nov 2015 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Posted 16 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the safety of the FLSC vaccine and will be a randomized, placebo-controlled, modified double-blinded dose escalation study in 60 healthy adult volunteers (Human Immunodeficiency Virus-1 uninfected).
Detailed description
This is a Phase 1 randomized, placebo-controlled, modified double-blinded dose escalation study in 60 healthy adult volunteers who are Human Immunodeficiency Virus-1 (HIV-1) uninfected. Participants in the study will receive 4 injections at 0, 4, 8 and 24 weeks and will be followed for an additional 24 weeks. The total study duration will be 48 weeks. As this is a Phase 1 trial, the primary objective is to document safety of the Full Length Single Chain (FLSC) gp120-CD4 complex vaccine with a secondary objective to evaluate immune responses induced by the vaccine. This vaccine is being evaluated as it is constructed so that the gp120 and CD4 moieties form a stable intra-chain binding interaction that forms a transition state structure that presents conserved, conformational domains involved in the early HIV replication process. It is hypothesized that antibodies directed to these epitopes would be highly cross-reactive and potentially useful for HIV vaccine development.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 300 ug FLSC vaccine | Experimental | Biological: 300 ug FLSC vaccineSubjects will be vaccinated with 300 ug FLSC vaccine (highest vaccine dose) on study days 0, 28, 56 and 168. |
| 150 ug FLSC vaccine | Experimental | Biological: 150 ug FLSC vaccineSubjects will be vaccinated with 150 ug FLSC vaccine (middle vaccine dose) on study days 0, 28, 56 and 168. |
| 75 ug FLSC vaccine | Experimental | Biological: 75 ug FLSC vaccineSubjects will be vaccinated with 75 ug FLSC vaccine (lowest vaccine dose) on study days 0, 28, 56 and 168. |
| Placebo | Placebo comparator | Biological: PlaceboSubjects will be vaccinated with placebo (control group) on study days 0, 28, 56 and 168. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Age: 18 to 45 years of age.
- Sex: Male or Female (female volunteers of child bearing potential must have a negative serum beta human chorionic gonadotropin (b-HCG or pregnancy) test at time of screening and entry into the study and provide assurance of the use of effective(as judged by the investigator) birth control methods or abstinence beginning at least 60 days prior to the study and during the study
- Documented HIV-1 negative by ELISA
- Be in good general health without clinically significant medical history, physical examination findings, or clinically significant abnormal laboratory results (i.e., chronic medical conditions as noted in the exclusion criteria such as cancer as well as any conditions that in the opinion of the investigator might pose a risk to the volunteer)
- No identifiable risk factor for acquisition of HIV infection (i.e., intravenous drug use/needle sharing, unprotected sex with multiple partners)
Key exclusion criteria (21 listed)
- High risk behavior for acquisition of HIV within 24 weeks of study entry(i.e., intravenous drug use/needle sharing, unprotected sex with multiple partners)
- Volunteers with an acute and clinically significant medical event (as determined by the investigator) within the past 30 days of screening.
- Have active tuberculosis or other systemic infectious process by review of systems and physical examination
- Have a history of immunodeficiency, autoimmune disease, or use of immunosuppressive medications
- Current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
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 |
|---|---|---|
| 300 ug FLSC vaccineAlso: Full length single chain gp120-CD4 complex vaccineFLSC vaccine 300 ug (1.0 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168 | Biological | 300 ug FLSC vaccine |
| 150 ug FLSC vaccineAlso: Full length single chain gp120-CD4 complex vaccineFLSC vaccine 150 ug (0.5 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168 | Biological | 150 ug FLSC vaccine |
| 75 ug FLSC vaccineAlso: Full length single chain gp120-CD4 complex vaccineFLSC vaccine 75 ug (0.25 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168 | Biological | 75 ug FLSC vaccine |
| PlaceboAlso: sterile salinePlacebo sterile saline (0.25 - 1.0 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168 | Biological | Placebo |
Primary outcome
Number of Participants With Local and Systemic Reactogenicity Signs and Symptoms
Time frame: 48 weeks
Signs and symptoms include pain, tenderness, maximum severity of pain and/or tenderness, erythema, induration, fever, malaise/fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and maximum severity of systemic symptoms.
Number of Participants With Related Adverse Events
Time frame: 48 weeks
Treatment emergent adverse events assessed by investigator to be either possibly, probably, or definitely related to study treatment. Medical Dictionary for Regulatory Activities (MedDRA) preferred term, severity, and assessed relationship to study products.
Number of Participants With Sustained Decrease in CD4 Count and CD4%.
Time frame: 48 weeks
CD4 count was monitored from baseline and at each study visit through study completion. Baseline CD4 and CD4% levels were calculated by taking the average of the screening and first vaccination visits. The number of individuals who had sustained (2 consecutive time points) 30% decrease in CD4 cell/ul and CD4% from baseline were counted.
3 secondary outcomes
Binding Antibody Response Rates to FLSC
Time frame: 2 weeks after 4th (last) vaccination.
Binding Antibody Response Rates to BaL-gp120
Time frame: 2 weeks after 4th (last) vaccination
Competitive Antibody Rates to CD4i Epitopes
Time frame: 2 weeks after 4th (last) vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Charles E Davis, M.D. principal investigator
Institute of Human Virology
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 300 ug FLSC vaccine, 150 ug FLSC vaccine and 75 ug FLSC vaccine in people with HIV Infection, run by University of Maryland, Baltimore 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 12 inclusion and 21 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 16 Dec 2021. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 16 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Local and Systemic Reactogenicity Signs and Symptoms (time frame: 48 weeks). 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 16 Dec 2021.