HIV InfectionsPhase 1NCT00412477
A Phase I Study of Safety and Immunogenicity of the WRAIR HIV-1 Vaccine
A Phase 1 study testing HIV LFn-p24 in people with HIV Infections, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
To evaluate the safety of LFn-p24 administered at three different doses with Alhydrogel given intramuscularly To evaluate immune responses to LFn-p24 with Alhydrogel at three different doses given intramuscularly Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- HIV LFn-p24
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2004to 1 Nov 2006
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Citizens of the U.S.A. who are not at high-risk for HIV infection.
- Age: 18 through 45 years of age.
- For women, negative serum pregnancy test will be required within two days prior to any injection, as well as verbal assurance that adequate contraceptive measures are applied.
- Good health as determined by medical history, physical examination, and clinical judgment.
- Clinical laboratory values at screening within the following ranges:
- Hematocrit: Women: > 34%: Men >38% (Mild anemia in any potential trial volunteer who is otherwise healthy attributable by appropriate laboratory studies to thalassemia minor will not be cause for exclusion)
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- White blood cell count: 3,000 to 12,000 cells/mm3
- Platelets: 125,000 to 550,000 per mm3
- Chemistry Panel: Expanded chemistry panel within institutional normal ranges or accompanied by site physician approval.
- Urine dipstick for protein and blood: negative or trace. If either is ≥ 1+, obtain complete urinalysis (UA). If microscopic UA confirms evidence of hematuria or proteinuria ≥ 1+, the volunteer is ineligible unless menstruating, then a repeat UA is required.
- Negative serology for HIV infection (ELISA test).
- Availability for at least 52 weeks
- Successful completion of the Test of Understanding, Commitment for Trial Participation and signature of the approved Trial Consent Form.
Who cannot join
- Acknowledge engaging in highest-risk behavior within 48 weeks of study entry: (i.e., active injecting drug use or having sexual intercourse with a known HIV-1 infected partner).
- Have active tuberculosis or other systemic infectious process by review of systems and physical examination.
- Have a history of immunodeficiency, chronic illness requiring continuous or frequent medical intervention, autoimmune disease, or use of immunosuppressive medications.
- Have evidence of psychiatric, medical and/or substance abuse problems during the past 48 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 within 60 days of study entry.
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- NOTE: Medically indicated subunit or killed vaccines (e.g., Hepatitis A or Hepatitis B) are not exclusionary but should be given at least 2 weeks before or after HIV immunization to avoid potential confusion of adverse reactions.
- Acute or chronic Hepatitis caused by viral or other etiology.
- 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 and/or anthrax vaccine.
- Currently enrolled in other vaccine trials.
- Are pregnant or lactating.
- NOTE: Women of child-bearing potential must be using effective contraception from the date of enrollment into the protocol.
- Have an immediate type hypersensitivity reaction to aminoglyocides, e.g., kanamycin (used to prepare the LFn-p24 vaccine).
- Are study site employees who are involved in the protocol and may have direct access to the immunogenicity results.
- Are receiving ongoing therapy with immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy.
- Are active duty military or reserves.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vaccine Clinical Research Center
Rockville, Maryland, 20850
About this study
Official title: RV 151: A Phase I Study of Safety and Immunogenicity of the WRAIR HIV-1 Vaccine LFn-p24 Administered by the Intramuscular (IM) Route in Healthy Adults, WRAIR #984, HSRRB Log # A-11905.
To evaluate the safety of LFn-p24 administered at three different doses with Alhydrogel given intramuscularly
To evaluate immune responses to LFn-p24 with Alhydrogel at three different doses given intramuscularly
Read the detailed description
The study seeks to enroll healthy, vaccine naïve volunteers, 18 through 45 years old. Recruitment consists of using flyers, newspaper advertising, radio, and direct mailing at local military installations, targeting the general population of the greater Washington D.C. area.
The study's primary objective is the safety and tolerability of Lfn-p24 given IM.
Volunteers will be screened (visit 1) and enrolled within 2 to 12 weeks prior to the first vaccination. Study volunteers will receive a briefing from the Principal Investigator (PI) or a sub investigator. The briefing is followed by an opportunity for questions from the volunteers. The PI or designee will then review the consent form with potential volunteers (visit 1) and answer any questions. After review, an Informed Consent will be signed and a "Test of Understanding" will be completed by all volunteers, prior to enrollment in the study. A second pre-screening visit (visit 2) will occur 3 - 30 days prior to the first vaccination (visit 3) to confirm eligibility for vaccination. During this visit each volunteer will have an opportunity to ask questions about the study.
On the day of vaccination (visits 3, 6, and 10), volunteers will be observed for 30 minutes following injection for acute adverse experiences and will be contacted the day following injection for a brief adverse reaction interview. In addition, volunteers will complete diaries for 7 days following each vaccination and will be evaluated by a clinical investigator if significant symptoms are reported. Adverse effects and laboratory abnormalities will be tabulated. Routine measurements of hematology, serum chemistry, and urinalysis laboratory tests will be performed in subsequent safety and general follow up visits.renee
LFn-p24 with Alhydrogel adjuvant will be delivered IM in the deltoid muscle at the intervals shown below. Groups will be enrolled in staggered fashion beginning with the lowest dose group. The subsequent groups receiving higher doses will then be enrolled by the investigator if the second injection of the immediate lower dose is shown to be safe and well tolerated (< grade II toxicity), after the 2 week post vaccination follow-up visit.
IMMUNIZATION SCHEDULE
Group I Subjects *6 0:150µg LFn-p24 Alhydrogel;4th Week:150µg LFn-p24 Alhydrogel; 16th Week:150µg LFn-p24 Alhydrogel; Group II Subjects *6 0:300µg LFn-p24 Alhydrogel; 4th Week: 300µg LFn-p24 Alhydrogel; 16th Week: 300µg LFn-p24 Alhydrogel; Group III Subjects *6 0: 450µg LFn-p24 Alhydrogel; 4th Week: 450µg LFn-p24 Alhydrogel; 16th Week: 450µg LFn-p24 Alhydrogel
*Six subjects per group includes 4 vaccines and 2 placebos.
- Conditions
- HIV Infections
- Being tested
- HIV LFn-p24
- Keywords
- HIV, Lfn-p24, Anthrax, IM, HIV-1, HIV Preventive Vaccine
- Medical subject headings
- HIV Infections, Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV LFn-p24Biological
HIV LFn-p24 is a combination of an Anthrax derived polypeptide Lethal factor (LFn), from which the toxin domain has been removed, and the HIV-1 gag p24 protein has been fused to LFn. Lfn-p24 is formulated in liquid form, and vialed at 200 µg/ml and 600 µglml. The product will be administered IM in doses ranging from 150µg to 450µg with Alhydrogel.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - LFn-p24 ISOug with Alhydrogel | Experimental | HIV LFn-p24 is a combination of an Anthrax derived polypeptide Lethal factor (LFn), from which the toxin domain has been removed, and the HIV-1 gag p24 protein has been fused to LFn. Lfn-p24 is formulated in liquid form, and vialed. Product is administered IM, 1ml. Six subjects (4 vaccines and 2 placebos).
Placebo recipients will receive a saline preparation in similar volume given IM.
Immunizations given at 0, 4 and 16 weeks Receives: Biological: HIV LFn-p24 |
| Group 2 - LFn-p24 300ug with Alhydrogel | Experimental | HIV LFn-p24 is a combination of an Anthrax derived polypeptide Lethal factor (LFn), from which the toxin domain has been removed, and the HIV-1 gag p24 protein has been fused to LFn. Lfn-p24 is formulated in liquid form, and vialed. Product is administered IM, 1ml. Six subjects (4 vaccines and 2 placebos).
Placebo recipients will receive a saline preparation in similar volume given IM.
Immunizations given at 0, 4 and 16 weeks Receives: Biological: HIV LFn-p24 |
| Group 3 - LFn-p24 450ug with Alhydrogel | Experimental | HIV LFn-p24 is a combination of an Anthrax derived polypeptide Lethal factor (LFn), from which the toxin domain has been removed, and the HIV-1 gag p24 protein has been fused to LFn. Lfn-p24 is formulated in liquid form, and vialed. Product is administered IM, 1ml. Six subjects (4 vaccines and 2 placebos).
Placebo recipients will receive a saline preparation in similar volume given IM.
Immunizations given at 0, 4 and 16 weeks Receives: Biological: HIV LFn-p24 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral: Responders to ELISA and Western Blot antibodies to HIV-1 subtype B gag p24
An HIV-I enzyme linked immunosorbent assay (ELISA) assay will be performed as designated throughout the course of the protocol during Visits 1 through 15. If the ELISA is reactive it will be repeated and an FDA- approved HIV Western blot will be performed. If the Western blot is positive, HIV molecular diagnostics (Roche Amplicor) will be performed
Measured: Days 0, 14, 42, 70, 126, 182, 252 and 364
Cellular: Cytotoxic T-lymphocyte (CTL) responses against subtype B gag antigen target expressed in Epstein Barr Virus (EBV) transformed autologous B cell lines.
Cytotoxic T-lymphocyte (CTL) responses against subtype B gag antigen target expressed in Epstein Barr Virus (EBV) transformed autologous B cell lines. Bulk CTL is currently defined to be positive if the HIV-1 antigen expressing targets relative to control have a specific lysis 10%. CD8+ CTL occurs when lytic activity decreases by 50% after removal of CD8 cells, while removal of CD4 cells maintains specific lysis at 5%. An analogous rule is applied for CD4+ CTL
Measured: Days 3, 14, 42, 70, 126, 182, 252, and 364
IFN-y ELISPOT assay against HIV-gag antigen.
IFN-y ELISPOT assay using a panel of B clade gag peptides. A positive responder will be defined in accordance with other HIV Vaccine Trial Network (HVTN) definitions. For example a positive response may be defined by a significant difference between the number of IFN-g spot forming cell s (SFC)/million peripheral blood mononuclear cells (PBMC) in the presence of HIV gag antigen and no antigen. Other arbitrary definitions may be used.
Measured: Days 3, 14, 42, 70, 126, 182, 252, and 364
IFN- ICS assay against HIV-gag antigen.
For the IFN-gamma intracellular cytokine staining (ICS) assay we will use a panel of B clade gag peptides or other appropriate gag antigens. A positive responder will be defined in accordance with the HIV Vaccine Trial Network (HVTN) definitions or other definitions as appropriate. For example a positive response may be defined as a two-fold difference between the percentage of CD3+CD8+IFN-y+ or CD3+CD4+IFN-y+ T cells in the presence of HIV gag antigen compared with no antigen
Measured: Days 3, 14, 42, 70, 126, 182, 252, and 364
Lymphocyte proliferative responses to HIV-1 subtype B gag
Lymphocyte proliferative responses to HIV- I subtype B gag p24. The data are expressed as a Lymphocyte Stimulation Index (LSI)= (PBMC cpm + antigen/ mitogen) I (PBMC cpm+ medium)] to define antigen specificity. Individuals are arbitrarily designated as responders non-responders if their LSI is greater than or equal to 5.
Measured: Days 3, 14, 42, 70, 126, 182, 252, and 364
Secondary outcomes (3)
Humoral- Binding antibodies to LFn
Expression profile surveillance of 8000 fully annotated genes in peripheral blood mononuclear cells using the Affymetrix Human Focus GeneChip to assess sentinel genes and associated cellular processes that might be correlated with protection by the vaccine.
Measured: Days 3, 14, 42, 70, 126, 182, 252, and 364
Neutralizing antibodies to LFn
Expression profile surveillance of 8000 fully annotated genes in peripheral blood mononuclear cells using the Affymetrix Human Focus GeneChip to assess sentinel genes and associated cellular processes that might be correlated with protection by the vaccine.
Measured: Days 3, 14, 42, 70, 126, 182, 252, and 364
Cellular: Lymphoproliferation to LFn
Expression profile surveillance of 8000 fully annotated genes in peripheral blood mononuclear cells using the Affymetrix Human Focus GeneChip to assess sentinel genes and associated cellular processes that might be correlated with protection by the vaccine.
Measured: Days 3, 14, 42, 70, 126, 182, 252, and 364
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2006 (estimated)
- Study start20 Aug 2004
- Primary completion13 Mar 2006
- Study completion1 Nov 2006
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 HIV 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Sponsor
- Investigators
- CDR Shirley Lee-Lecher, MD, Principal investigator, Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412477
- Sponsor's protocol ID
- WRAIR 984
- Other IDs
- HSRRB Log # A-11905
- Status last verified
- Oct 2018
- First submitted
- 15 Dec 2006
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. UNAIDS/WHO. Report on the global HIV/AIDS epidemic.June 2000. 2. Quinn TC. Global burden of the HIV pandemic. Lancet.1996;348:99-106. 3. Moss B. Genetically engineered poxviruses for recombinant gene expression, vaccination, and safety. PNAS 1996;93; 11341-8. 4. Tartaglia J, Excler JL, El Habib R, Limbach K, Meignier B, Plotkin S, Klein M. Canarypoxvirus-based vaccines : prime-boost strategies to induce cell-mediated and humoral immunity against HIV. AIDS Res Hum Retroviruses 1998;14(supp.3): S291-S298. 5. Girard M, Excler JL. Human Immunodeficiency virus. In Vaccines. Plotkin SA and Mortimer EA Eds. Saunders, Philadelphia,1999, pp.928-967. 6. Excler J-L, Plotkin S. The prime-boost concept applied to HIV preventive vaccines. AIDS 1997;11(suppl A):S127-137. 7. Ogg GS, Jin X, Bonhoeffer S, Dunbar PR, Nowak MA, Mopnard S, Segal JP, Cao Y, 8. Rowland-Jones SL, Cerundolo V, Hurley A, Markowwitz M, Ho DD, Nixon DF, McMichael AJ. Quantitation of HIV-1-specific cytotoxic T lymphocytes and plasma load of viral RNA. Science 1998; 279: 2103-6. 8. Schmitz JE, Kuroda MJ, Santra S, Sasseville VG, Simon MA, Lifton MA, Racz P, Tenner-Racz K, Dalesandro M, Scallon BJ, Ghrayeb J, Forman MA, Montefiori DC, Rieber EP, Letvin NL, Reimann KA. Control of viremia in simian immunodeficiency virus infection by CD8 lymphocytes. Science 1999; 283: 857-60. 9. Brodie SJ, Lewinsohn DA, Patterson BK, Jiyamapa D, Krieger J, Corey L, Greenberg P, Riddell SR. In vivo migration and function of transferred HIV-1-specific cytotoxic T cells. Nature Medicine 1999; 5: 34-41. 10. Letvin NL. Progress in development of an AIDS vaccine. Science 1998; 280: 1875-9.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RV 151: A Phase I Study of Safety and Immunogenicity of the WRAIR HIV-1 Vaccine LFn-p24 Administered by the Intramuscular (IM) Route in Healthy Adults, WRAIR #984, HSRRB Log # A-11905.
- ClinicalTrials.gov ID
- NCT00412477
- Acronym / sponsor ID
- WRAIR 984
- Conditions
- HIV Infections
- Keywords
- HIV, Lfn-p24, Anthrax, IM, HIV-1, HIV Preventive Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Study start
- 20 Aug 2004 (actual)
- Primary completion
- 13 Mar 2006 (actual)
- Study completion
- 1 Nov 2006 (actual)
- First posted
- 18 Dec 2006 (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.
To evaluate the safety of LFn-p24 administered at three different doses with Alhydrogel given intramuscularly
To evaluate immune responses to LFn-p24 with Alhydrogel at three different doses given intramuscularly
Detailed description
The study seeks to enroll healthy, vaccine naïve volunteers, 18 through 45 years old. Recruitment consists of using flyers, newspaper advertising, radio, and direct mailing at local military installations, targeting the general population of the greater Washington D.C. area.
The study's primary objective is the safety and tolerability of Lfn-p24 given IM.
Volunteers will be screened (visit 1) and enrolled within 2 to 12 weeks prior to the first vaccination. Study volunteers will receive a briefing from the Principal Investigator (PI) or a sub investigator. The briefing is followed by an opportunity for questions from the volunteers. The PI or designee will then review the consent form with potential volunteers (visit 1) and answer any questions. After review, an Informed Consent will be signed and a "Test of Understanding" will be completed by all volunteers, prior to enrollment in the study. A second pre-screening visit (visit 2) will occur 3 - 30 days prior to the first vaccination (visit 3) to confirm eligibility for vaccination. During this visit each volunteer will have an opportunity to ask questions about the study.
On the day of vaccination (visits 3, 6, and 10), volunteers will be observed for 30 minutes following injection for acute adverse experiences and will be contacted the day following injection for a brief adverse reaction interview. In addition, volunteers will complete diaries for 7 days following each vaccination and will be evaluated by a clinical investigator if significant symptoms are reported. Adverse effects and laboratory abnormalities will be tabulated. Routine measurements of hematology, serum chemistry, and urinalysis laboratory tests will be performed in subsequent safety and general follow up visits.renee
LFn-p24 with Alhydrogel adjuvant will be delivered IM in the deltoid muscle at the intervals shown below. Groups will be enrolled in staggered fashion beginning with the lowest dose group. The subsequent groups receiving higher doses will then be enrolled by the investigator if the second injection of the immediate lower dose is shown to be safe and well tolerated (< grade II toxicity), after the 2 week post vaccination follow-up visit.
IMMUNIZATION SCHEDULE
Group I Subjects *6 0:150µg LFn-p24 Alhydrogel;4th Week:150µg LFn-p24 Alhydrogel; 16th Week:150µg LFn-p24 Alhydrogel; Group II Subjects *6 0:300µg LFn-p24 Alhydrogel; 4th Week: 300µg LFn-p24 Alhydrogel; 16th Week: 300µg LFn-p24 Alhydrogel; Group III Subjects *6 0: 450µg LFn-p24 Alhydrogel; 4th Week: 450µg LFn-p24 Alhydrogel; 16th Week: 450µg LFn-p24 Alhydrogel
*Six subjects per group includes 4 vaccines and 2 placebos.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - LFn-p24 ISOug with Alhydrogel | Experimental | Biological: HIV LFn-p24HIV LFn-p24 is a combination of an Anthrax derived polypeptide Lethal factor (LFn), from which the toxin domain has been removed, and the HIV-1 gag p24 protein has been fused to LFn. Lfn-p24 is formulated in liquid form, and vialed. Product is administered IM, 1ml. Six subjects (4 vaccines and 2 placebos). Placebo recipients will receive a saline preparation in similar volume given IM. Immunizations given at 0, 4 and 16 weeks |
| Group 2 - LFn-p24 300ug with Alhydrogel | Experimental | Biological: HIV LFn-p24HIV LFn-p24 is a combination of an Anthrax derived polypeptide Lethal factor (LFn), from which the toxin domain has been removed, and the HIV-1 gag p24 protein has been fused to LFn. Lfn-p24 is formulated in liquid form, and vialed. Product is administered IM, 1ml. Six subjects (4 vaccines and 2 placebos). Placebo recipients will receive a saline preparation in similar volume given IM. Immunizations given at 0, 4 and 16 weeks |
| Group 3 - LFn-p24 450ug with Alhydrogel | Experimental | Biological: HIV LFn-p24HIV LFn-p24 is a combination of an Anthrax derived polypeptide Lethal factor (LFn), from which the toxin domain has been removed, and the HIV-1 gag p24 protein has been fused to LFn. Lfn-p24 is formulated in liquid form, and vialed. Product is administered IM, 1ml. Six subjects (4 vaccines and 2 placebos). Placebo recipients will receive a saline preparation in similar volume given IM. Immunizations given at 0, 4 and 16 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Citizens of the U.S.A. who are not at high-risk for HIV infection.
- Age: 18 through 45 years of age.
- For women, negative serum pregnancy test will be required within two days prior to any injection, as well as verbal assurance that adequate contraceptive measures are applied.
- Good health as determined by medical history, physical examination, and clinical judgment.
- Hematocrit: Women: > 34%: Men >38% (Mild anemia in any potential trial volunteer who is otherwise healthy attributable by appropriate laboratory studies to thalassemia minor will not be cause for exclusion)
Key exclusion criteria (19 listed)
- Acknowledge engaging in highest-risk behavior within 48 weeks of study entry: (i.e., active injecting drug use or having sexual intercourse with a known HIV-1 infected partner).
- Have active tuberculosis or other systemic infectious process by review of systems and physical examination.
- Have a history of immunodeficiency, chronic illness requiring continuous or frequent medical intervention, autoimmune disease, or use of immunosuppressive medications.
- Have evidence of psychiatric, medical and/or substance abuse problems during the past 48 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.
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 |
|---|---|---|
| HIV LFn-p24HIV LFn-p24 is a combination of an Anthrax derived polypeptide Lethal factor (LFn), from which the toxin domain has been removed, and the HIV-1 gag p24 protein has been fused to LFn. Lfn-p24 is formulated in liquid form, and vialed at 200 µg/ml and 600 µglml. The product will be administered IM in doses ranging from 150µg to 450µg with Alhydrogel. | Biological | Group 1 - LFn-p24 ISOug with Alhydrogel, Group 2 - LFn-p24 300ug with Alhydrogel, Group 3 - LFn-p24 450ug with Alhydrogel |
Primary outcome
Humoral: Responders to ELISA and Western Blot antibodies to HIV-1 subtype B gag p24
Time frame: Days 0, 14, 42, 70, 126, 182, 252 and 364
An HIV-I enzyme linked immunosorbent assay (ELISA) assay will be performed as designated throughout the course of the protocol during Visits 1 through 15. If the ELISA is reactive it will be repeated and an FDA- approved HIV Western blot will be performed. If the Western blot is positive, HIV molecular diagnostics (Roche Amplicor) will be performed
Cellular: Cytotoxic T-lymphocyte (CTL) responses against subtype B gag antigen target expressed in Epstein Barr Virus (EBV) transformed autologous B cell lines.
Time frame: Days 3, 14, 42, 70, 126, 182, 252, and 364
Cytotoxic T-lymphocyte (CTL) responses against subtype B gag antigen target expressed in Epstein Barr Virus (EBV) transformed autologous B cell lines. Bulk CTL is currently defined to be positive if the HIV-1 antigen expressing targets relative to control have a specific lysis 10%. CD8+ CTL occurs when lytic activity decreases by 50% after removal of CD8 cells, while removal of CD4 cells maintains specific lysis at 5%. An analogous rule is applied for CD4+ CTL
IFN-y ELISPOT assay against HIV-gag antigen.
Time frame: Days 3, 14, 42, 70, 126, 182, 252, and 364
IFN-y ELISPOT assay using a panel of B clade gag peptides. A positive responder will be defined in accordance with other HIV Vaccine Trial Network (HVTN) definitions. For example a positive response may be defined by a significant difference between the number of IFN-g spot forming cell s (SFC)/million peripheral blood mononuclear cells (PBMC) in the presence of HIV gag antigen and no antigen. Other arbitrary definitions may be used.
IFN- ICS assay against HIV-gag antigen.
Time frame: Days 3, 14, 42, 70, 126, 182, 252, and 364
For the IFN-gamma intracellular cytokine staining (ICS) assay we will use a panel of B clade gag peptides or other appropriate gag antigens. A positive responder will be defined in accordance with the HIV Vaccine Trial Network (HVTN) definitions or other definitions as appropriate. For example a positive response may be defined as a two-fold difference between the percentage of CD3+CD8+IFN-y+ or CD3+CD4+IFN-y+ T cells in the presence of HIV gag antigen compared with no antigen
Lymphocyte proliferative responses to HIV-1 subtype B gag
Time frame: Days 3, 14, 42, 70, 126, 182, 252, and 364
Lymphocyte proliferative responses to HIV- I subtype B gag p24. The data are expressed as a Lymphocyte Stimulation Index (LSI)= (PBMC cpm + antigen/ mitogen) I (PBMC cpm+ medium)] to define antigen specificity. Individuals are arbitrarily designated as responders non-responders if their LSI is greater than or equal to 5.
3 secondary outcomes
Humoral- Binding antibodies to LFn
Time frame: Days 3, 14, 42, 70, 126, 182, 252, and 364
Neutralizing antibodies to LFn
Time frame: Days 3, 14, 42, 70, 126, 182, 252, and 364
Cellular: Lymphoproliferation to LFn
Time frame: Days 3, 14, 42, 70, 126, 182, 252, and 364
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 Oct 2018.
- Background1. UNAIDS/WHO. Report on the global HIV/AIDS epidemic.June 2000. 2. Quinn TC. Global burden of the HIV pandemic. Lancet.1996;348:99-106. 3. Moss B. Genetically engineered poxviruses for recombinant gene expression, vaccination, and safety. PNAS 1996;93; 11341-8. 4. Tartaglia J, Excler JL, El Habib R, Limbach K, Meignier B, Plotkin S, Klein M. Canarypoxvirus-based vaccines : prime-boost strategies to induce cell-mediated and humoral immunity against HIV. AIDS Res Hum Retroviruses 1998;14(supp.3): S291-S298. 5. Girard M, Excler JL. Human Immunodeficiency virus. In Vaccines. Plotkin SA and Mortimer EA Eds. Saunders, Philadelphia,1999, pp.928-967. 6. Excler J-L, Plotkin S. The prime-boost concept applied to HIV preventive vaccines. AIDS 1997;11(suppl A):S127-137. 7. Ogg GS, Jin X, Bonhoeffer S, Dunbar PR, Nowak MA, Mopnard S, Segal JP, Cao Y, 8. Rowland-Jones SL, Cerundolo V, Hurley A, Markowwitz M, Ho DD, Nixon DF, McMichael AJ. Quantitation of HIV-1-specific cytotoxic T lymphocytes and plasma load of viral RNA. Science 1998; 279: 2103-6. 8. Schmitz JE, Kuroda MJ, Santra S, Sasseville VG, Simon MA, Lifton MA, Racz P, Tenner-Racz K, Dalesandro M, Scallon BJ, Ghrayeb J, Forman MA, Montefiori DC, Rieber EP, Letvin NL, Reimann KA. Control of viremia in simian immunodeficiency virus infection by CD8 lymphocytes. Science 1999; 283: 857-60. 9. Brodie SJ, Lewinsohn DA, Patterson BK, Jiyamapa D, Krieger J, Corey L, Greenberg P, Riddell SR. In vivo migration and function of transferred HIV-1-specific cytotoxic T cells. Nature Medicine 1999; 5: 34-41. 10. Letvin NL. Progress in development of an AIDS vaccine. Science 1998; 280: 1875-9.
- Individual participant dataSharing planned: No
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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.
CDR Shirley Lee-Lecher, MD principal investigator
Walter Reed Army Institute of Research (WRAIR)
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 HIV LFn-p24 in people with HIV Infections, run by U.S. Army Medical Research and Development Command 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 13 inclusion and 19 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 Oct 2018. 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?
Humoral: Responders to ELISA and Western Blot antibodies to HIV-1 subtype B gag p24 (time frame: Days 0, 14, 42, 70, 126, 182, 252 and 364). The study lists 5 primary outcomes in all. 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 NCT00412477, 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 Oct 2018.