HIV InfectionPhase 1NCT01441193
A Phase I Safety and Immunogenicity Preventive Vaccine Trial Based on the HIV-1 Tat and V2-deleted Env Proteins (ISS P-002)
A Phase 1 study testing HIV-1 Tat/delta-V2 Env combined vaccine, HIV-1 delta-V2 Env vaccine and HIV-1 Tat vaccine 7.5 microg in people with HIV Infection, run by Barbara Ensoli, MD at 3 sites in Italy.
Trial summary
This Phase I study was directed at evaluating the safety profile and the immunogenicity of the vaccination with recombinant HIV-1 Tat and V2-deleted Env (delta-V2 Env) proteins administered in association in healthy, immunologically competent adults, compared to delta-V2 Env or Tat alone. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- HIV-1 Tat/delta-V2 Env combined vaccine, HIV-1 delta-V2 Env vaccine and HIV-1 Tat vaccine 7.5 microg
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesItaly
- Study dates
- Sep 2011to Feb 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 to 55 years;
- Negative blood pregnancy test for women of childbearing potential at screening evaluation (a urine dipstick test will be repeated just before each vaccination), and use of an acceptable mean of contraception by both men and women, since one month prior to immunization (only for women) and until at least 6 months after the last immunization;
- Blood pressure, heart rate and ECG within normal ranges or with mild alterations acknowledged as non clinically significant by the site clinician;
- Haematological and biochemical parameters within the clinical site normal ranges or with mild alterations acknowledged by the site clinician as non clinically significant;
- Normal urine dipstick with esterase and nitrite;
- Normal thyroid function;
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- Negative for HIV infection and for anti-Tat antibodies;
- Good physical and mental health status;
- Availability for the planned study duration;
- Signed informed consent.
Who cannot join
- Concomitant neoplastic diseases;
- History of malignant neoplastic diseases;
- History of encephalopathy, neuropathy or unstable CNS pathology, immunodeficiency, autoimmune disease, angina or cardiac arrhythmias, or any other clinically significant medical problems;
- History of anaphylaxis or serious adverse reactions to vaccines as well as serum IgE levels exceeding 1,000 U.I./mL;
- History of serious allergic reaction to any substance, requiring hospitalization or emergency medical care;
- Chest radiography showing evidence of active or acute cardiac or pulmonary disease;
Show all 19Show fewer
- Any unstable cardiovascular disease;
- Active syphilis by TPHA and RPR tests [NOTE: If the serology is documented to be a false positive or due to an adequately treated infection, the volunteer is eligible];
- Active tuberculosis by cutaneous TB diagnostic test [NOTE: Volunteers with a positive PPD and a normal chest X-ray showing no evidence of TB and not requiring specific therapy are eligible];
- Medical or psychiatric condition or occupational responsibilities which preclude subject compliance with the protocol. Persons with psychotic disorders, major affective disorders or suicidal ideation are specifically excluded;
- Current use of psychotropic drugs;
- Drug and/or alcohol abuse;
- Current or prior therapy with immunomodulators or immunosuppressive drugs and anticoagulant drugs within 30 days prior to study medication administration;
- Live attenuated vaccines within 60 days prior to study entry [NOTE: Medically indicated sub-unit or killed vaccines (e.g, influenza, pneumococcal, hepatitis A and B) are not exclusionary, but should be given at least 4 weeks away from anti-HIV immunizations];
- Use of investigational agents within 90 days prior to study entry;
- Participation in another experimental protocol within 6 months prior to pre-study screening;
- Prior receipt of HIV vaccine in a previous HIV vaccine trial;
- Receipt of blood products or immunoglobulin in the past 6 months;
- Pregnant or lactating women.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Policlinico di Modena, Divisione di Malattie Infettive
Modena, 41100
Azienda Ospedaliera San Gerardo, Divisione di Malattie Infettive
Monza, 20052
IFO - S. Gallicano, Dermatologia Infettiva
Rome, 00153
About this study
Official title: A Phase I, Open Label, Safety and Immunogenicity Vaccine Trial Based on the Association of Recombinant HIV-1 Biologically Active Tat and V2-deleted Env Proteins in HIV Uninfected Healthy Adult Volunteers.
This Phase I study was directed at evaluating the safety profile and the immunogenicity of the vaccination with recombinant HIV-1 Tat and V2-deleted Env (delta-V2 Env) proteins administered in association in healthy, immunologically competent adults, compared to delta-V2 Env or Tat alone.
Read the detailed description
Since the inexorable spreading of HIV pandemic is unabated, the urgency of designing an effective, safe, inexpensive and easily administrable vaccine to protect people from HIV and/or AIDS is an absolute priority. Considering the array of functions sequentially exerted by the regulatory and the structural gene products in supporting the setting of a primary HIV infection, it is expected that vaccines combining early and late viral products (combined vaccines) should be superior to the single antigens approaches since they target multiple viral proteins which are necessary at different key steps of the virus life cycle, including cell-to-cell virus transmission and systemic virus propagation. A combined vaccine strategy based on the early regulatory protein Tat in association with the late structural protein Env modified to increase its immunogenicity (delta-V2Env) has been evaluated in pre-clinical studies in both small animals and monkeys. The results of these studies indicated that the combination of Tat with delta-V2Env is superior in inducing specific immune responses against both Tat and delta-V2Env antigens and in protecting or containing virus replication more efficiently than vaccination with the single antigens alone, confirming that these proteins represent optimal co-antigens for a combined vaccine strategy.
This study was a multicentric, open label, randomized phase I trial, directed to qualify the safety and the immunogenicity of the vaccine based on the association of HIV-1 biologically active Tat and oligomeric ΔV2 Env proteins in healthy, immunologically competent adult volunteers, compared to the single compounds. Tat and delta-V2 Env proteins either in association or as single compounds were administered by a prime-boost regimen, consisting of 3 intradermal priming doses followed by 2 intramuscular boosting injections. Of note, phase I trials have already been successfully conducted with the 2 single components, at the doses proposed in this trial, in healthy individuals.
- Conditions
- HIV Infection
- Being tested
- HIV-1 Tat/delta-V2 Env combined vaccine, HIV-1 delta-V2 Env vaccine, HIV-1 Tat vaccine 7.5 microg, HIV-1 Tat vaccine 30 microg
- Keywords
- HIV, preventive vaccine, Tat, Env
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV-1 Tat/delta-V2 Env combined vaccineBiological
HIV-1 delta-V2 Env vaccineBiological
HIV-1 Tat vaccine 7.5 microgBiological
HIV-1 Tat vaccine 30 microgBiological
| Study group | Role | What they receive |
|---|---|---|
| HIV-1 Tat/delta-V2 Env combined vaccine | Experimental | Tat 7.5 microg and delta-V2 Env 100 microg associated proteins administered i.d. (priming) at week 0, 4 and 8 or i.m. (boosting) at weeks 24 and 36 Receives: Biological: HIV-1 Tat/delta-V2 Env combined vaccine |
| HIV-1 delta-V2 Env vaccine | Active comparator | delta-V2 Env 100 microg administered i.d. (priming) at week 0, 4 and 8 or i.m. (boosting) at week 24 and 36 Receives: Biological: HIV-1 delta-V2 Env vaccine |
| HIV-1 Tat vaccine 7.5 microg | Active comparator | Tat 7.5 microg administered i.d. (priming) at week 0, 4 and 8 or i.m. (boosting) at week 24 and 36 Receives: Biological: HIV-1 Tat vaccine 7.5 microg |
| HIV-1 Tat vaccine 30 microg | Active comparator | Tat 30 microg administered i.d. at week 0, 4 and 8 Receives: Biological: HIV-1 Tat vaccine 30 microg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and immunogenicity
To qualify the vaccine candidate as safe and immunogenic by evaluating the number of local and systemic adverse events, including any significant change in hematological/biochemical/coagulation laboratory parameters, and the frequency of anti-Tat and anti-delta-V2 Env humoral and cellular immune responses
Measured: up to week 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Enrollments were suspended due to delta-V2 Env unavailability, following the EMA/CHMP/BWP/534898/2008 guideline, not allowing the use of a retest date
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies 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
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ensoli, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Vaccines
- Responsible party
- Sponsor-investigator, Barbara Ensoli, MD, Istituto Superiore di Sanità
- Investigators
- Barbara Ensoli, MD, Study director, Istituto Superiore di Sanità
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441193
- Sponsor's protocol ID
- ISS P-002
- Status last verified
- Mar 2016
- First submitted
- 26 Sep 2011
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ensoli B, Bellino S, Tripiciano A, Longo O, Francavilla V, Marcotullio S, Cafaro A, Picconi O, Paniccia G, Scoglio A, Arancio A, Ariola C, Ruiz Alvarez MJ, Campagna M, Scaramuzzi D, Iori C, Esposito R, Mussini C, Ghinelli F, Sighinolfi L, Palamara G, Latini A, Angarano G, Ladisa N, Soscia F, Mercurio VS, Lazzarin A, Tambussi G, Visintini R, Mazzotta F, Di Pietro M, Galli M, Rusconi S, Carosi G, Torti C, Di Perri G, Bonora S, Ensoli F, Garaci E. Therapeutic immunization with HIV-1 Tat reduces immune activation and loss of regulatory T-cells and improves immune function in subjects on HAART. PLoS One. 2010 Nov 11;5(11):e13540. doi: 10.1371/journal.pone.0013540.
PubMed 21085635Bellino S, Francavilla V, Longo O, Tripiciano A, Paniccia G, Arancio A, Fiorelli V, Scoglio A, Collacchi B, Campagna M, Lazzarin A, Tambussi G, Din CT, Visintini R, Narciso P, Antinori A, D'Offizi G, Giulianelli M, Carta M, Di Carlo A, Palamara G, Giuliani M, Laguardia ME, Monini P, Magnani M, Ensoli F, Ensoli B. Parallel conduction of the phase I preventive and therapeutic trials based on the Tat vaccine candidate. Rev Recent Clin Trials. 2009 Sep;4(3):195-204. doi: 10.2174/157488709789957529.
PubMed 20028332Ensoli B, Fiorelli V, Ensoli F, Lazzarin A, Visintini R, Narciso P, Di Carlo A, Tripiciano A, Longo O, Bellino S, Francavilla V, Paniccia G, Arancio A, Scoglio A, Collacchi B, Ruiz Alvarez MJ, Tambussi G, Tassan Din C, Palamara G, Latini A, Antinori A, D'Offizi G, Giuliani M, Giulianelli M, Carta M, Monini P, Magnani M, Garaci E. The preventive phase I trial with the HIV-1 Tat-based vaccine. Vaccine. 2009 Dec 11;28(2):371-8. doi: 10.1016/j.vaccine.2009.10.038. Epub 2009 Oct 29.
PubMed 19879233Caputo A, Gavioli R, Bellino S, Longo O, Tripiciano A, Francavilla V, Sgadari C, Paniccia G, Titti F, Cafaro A, Ferrantelli F, Monini P, Ensoli F, Ensoli B. HIV-1 Tat-based vaccines: an overview and perspectives in the field of HIV/AIDS vaccine development. Int Rev Immunol. 2009;28(5):285-334. doi: 10.1080/08830180903013026.
PubMed 19811313Longo O, Tripiciano A, Fiorelli V, Bellino S, Scoglio A, Collacchi B, Alvarez MJ, Francavilla V, Arancio A, Paniccia G, Lazzarin A, Tambussi G, Din CT, Visintini R, Narciso P, Antinori A, D'Offizi G, Giulianelli M, Carta M, Di Carlo A, Palamara G, Giuliani M, Laguardia ME, Monini P, Magnani M, Ensoli F, Ensoli B. Phase I therapeutic trial of the HIV-1 Tat protein and long term follow-up. Vaccine. 2009 May 26;27(25-26):3306-12. doi: 10.1016/j.vaccine.2009.01.090. Epub 2009 Feb 7.
PubMed 19208456Ensoli B, Fiorelli V, Ensoli F, Cafaro A, Titti F, Butto S, Monini P, Magnani M, Caputo A, Garaci E. Candidate HIV-1 Tat vaccine development: from basic science to clinical trials. AIDS. 2006 Nov 28;20(18):2245-61. doi: 10.1097/QAD.0b013e3280112cd1. No abstract available.
PubMed 17117011Barnett SW, Srivastava IK, Ulmer JB, Donnelly JJ, Rappuoli R. Development of V2-deleted trimeric envelope vaccine candidates from human immunodeficiency virus type 1 (HIV-1) subtypes B and C. Microbes Infect. 2005 Nov;7(14):1386-91. doi: 10.1016/j.micinf.2005.07.018. Epub 2005 Sep 20.
PubMed 16275150Ensoli B, Cafaro A, Caputo A, Fiorelli V, Ensoli F, Gavioli R, Ferrantelli F, Cara A, Titti F, Magnani M. Vaccines based on the native HIV Tat protein and on the combination of Tat and the structural HIV protein variant DeltaV2 Env. Microbes Infect. 2005 Nov;7(14):1392-9. doi: 10.1016/j.micinf.2005.07.016. Epub 2005 Sep 15.
PubMed 16243561Caputo A, Brocca-Cofano E, Castaldello A, Voltan R, Gavioli R, Srivastava IK, Barnett SW, Cafaro A, Ensoli B. Characterization of immune responses elicited in mice by intranasal co-immunization with HIV-1 Tat, gp140 DeltaV2Env and/or SIV Gag proteins and the nontoxicogenic heat-labile Escherichia coli enterotoxin. Vaccine. 2008 Feb 26;26(9):1214-27. doi: 10.1016/j.vaccine.2007.12.030. Epub 2008 Jan 15.
PubMed 18243435Bellino S, Tripiciano A, Picconi O, Francavilla V, Longo O, Sgadari C, Paniccia G, Arancio A, Angarano G, Ladisa N, Lazzarin A, Tambussi G, Nozza S, Torti C, Foca E, Palamara G, Latini A, Sighinolfi L, Mazzotta F, Di Pietro M, Di Perri G, Bonora S, Mercurio VS, Mussini C, Gori A, Galli M, Monini P, Cafaro A, Ensoli F, Ensoli B. The presence of anti-Tat antibodies in HIV-infected individuals is associated with containment of CD4+ T-cell decay and viral load, and with delay of disease progression: results of a 3-year cohort study. Retrovirology. 2014 Jun 24;11:49. doi: 10.1186/1742-4690-11-49.
PubMed 24961156Ensoli B, Cafaro A, Monini P, Marcotullio S, Ensoli F. Challenges in HIV Vaccine Research for Treatment and Prevention. Front Immunol. 2014 Sep 8;5:417. doi: 10.3389/fimmu.2014.00417. eCollection 2014.
PubMed 25250026Ensoli F, Cafaro A, Casabianca A, Tripiciano A, Bellino S, Longo O, Francavilla V, Picconi O, Sgadari C, Moretti S, Cossut MR, Arancio A, Orlandi C, Sernicola L, Maggiorella MT, Paniccia G, Mussini C, Lazzarin A, Sighinolfi L, Palamara G, Gori A, Angarano G, Di Pietro M, Galli M, Mercurio VS, Castelli F, Di Perri G, Monini P, Magnani M, Garaci E, Ensoli B. HIV-1 Tat immunization restores immune homeostasis and attacks the HAART-resistant blood HIV DNA: results of a randomized phase II exploratory clinical trial. Retrovirology. 2015 Apr 29;12:33. doi: 10.1186/s12977-015-0151-y.
PubMed 25924841Cafaro A, Tripiciano A, Sgadari C, Bellino S, Picconi O, Longo O, Francavilla V, Butto S, Titti F, Monini P, Ensoli F, Ensoli B. Development of a novel AIDS vaccine: the HIV-1 transactivator of transcription protein vaccine. Expert Opin Biol Ther. 2015;15 Suppl 1:S13-29. doi: 10.1517/14712598.2015.1021328. Epub 2015 Jun 22.
PubMed 26096836
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Safety and Immunogenicity Vaccine Trial Based on the Association of Recombinant HIV-1 Biologically Active Tat and V2-deleted Env Proteins in HIV Uninfected Healthy Adult Volunteers.
- ClinicalTrials.gov ID
- NCT01441193
- Acronym / sponsor ID
- ISS P-002
- Conditions
- HIV Infection
- Keywords
- HIV, preventive vaccine, Tat, Env
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollments were suspended due to delta-V2 Env unavailability, following the EMA/CHMP/BWP/534898/2008 guideline, not allowing the use of a retest date
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Barbara Ensoli, MDUniversity, hospital or other
- Collaborators
- Novartis Vaccines
- Study start
- Sep 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 27 Sep 2011 (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 Phase I study was directed at evaluating the safety profile and the immunogenicity of the vaccination with recombinant HIV-1 Tat and V2-deleted Env (delta-V2 Env) proteins administered in association in healthy, immunologically competent adults, compared to delta-V2 Env or Tat alone.
Detailed description
Since the inexorable spreading of HIV pandemic is unabated, the urgency of designing an effective, safe, inexpensive and easily administrable vaccine to protect people from HIV and/or AIDS is an absolute priority. Considering the array of functions sequentially exerted by the regulatory and the structural gene products in supporting the setting of a primary HIV infection, it is expected that vaccines combining early and late viral products (combined vaccines) should be superior to the single antigens approaches since they target multiple viral proteins which are necessary at different key steps of the virus life cycle, including cell-to-cell virus transmission and systemic virus propagation. A combined vaccine strategy based on the early regulatory protein Tat in association with the late structural protein Env modified to increase its immunogenicity (delta-V2Env) has been evaluated in pre-clinical studies in both small animals and monkeys. The results of these studies indicated that the combination of Tat with delta-V2Env is superior in inducing specific immune responses against both Tat and delta-V2Env antigens and in protecting or containing virus replication more efficiently than vaccination with the single antigens alone, confirming that these proteins represent optimal co-antigens for a combined vaccine strategy.
This study was a multicentric, open label, randomized phase I trial, directed to qualify the safety and the immunogenicity of the vaccine based on the association of HIV-1 biologically active Tat and oligomeric ΔV2 Env proteins in healthy, immunologically competent adult volunteers, compared to the single compounds. Tat and delta-V2 Env proteins either in association or as single compounds were administered by a prime-boost regimen, consisting of 3 intradermal priming doses followed by 2 intramuscular boosting injections. Of note, phase I trials have already been successfully conducted with the 2 single components, at the doses proposed in this trial, in healthy individuals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIV-1 Tat/delta-V2 Env combined vaccine | Experimental | Biological: HIV-1 Tat/delta-V2 Env combined vaccineTat 7.5 microg and delta-V2 Env 100 microg associated proteins administered i.d. (priming) at week 0, 4 and 8 or i.m. (boosting) at weeks 24 and 36 |
| HIV-1 delta-V2 Env vaccine | Active comparator | Biological: HIV-1 delta-V2 Env vaccinedelta-V2 Env 100 microg administered i.d. (priming) at week 0, 4 and 8 or i.m. (boosting) at week 24 and 36 |
| HIV-1 Tat vaccine 7.5 microg | Active comparator | Biological: HIV-1 Tat vaccine 7.5 microgTat 7.5 microg administered i.d. (priming) at week 0, 4 and 8 or i.m. (boosting) at week 24 and 36 |
| HIV-1 Tat vaccine 30 microg | Active comparator | Biological: HIV-1 Tat vaccine 30 microgTat 30 microg administered i.d. at week 0, 4 and 8 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age: 18 to 55 years;
- Negative blood pregnancy test for women of childbearing potential at screening evaluation (a urine dipstick test will be repeated just before each vaccination), and use of an acceptable mean of contraception by both men and women, since one month prior to immunization (only for women) and until at least 6 months after the last immunization;
- Blood pressure, heart rate and ECG within normal ranges or with mild alterations acknowledged as non clinically significant by the site clinician;
- Haematological and biochemical parameters within the clinical site normal ranges or with mild alterations acknowledged by the site clinician as non clinically significant;
- Normal urine dipstick with esterase and nitrite;
Key exclusion criteria (19 listed)
- Concomitant neoplastic diseases;
- History of malignant neoplastic diseases;
- History of encephalopathy, neuropathy or unstable CNS pathology, immunodeficiency, autoimmune disease, angina or cardiac arrhythmias, or any other clinically significant medical problems;
- History of anaphylaxis or serious adverse reactions to vaccines as well as serum IgE levels exceeding 1,000 U.I./mL;
- History of serious allergic reaction to any substance, requiring hospitalization or emergency medical care;
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-1 Tat/delta-V2 Env combined vaccine | Biological | HIV-1 Tat/delta-V2 Env combined vaccine |
| HIV-1 delta-V2 Env vaccine | Biological | HIV-1 delta-V2 Env vaccine |
| HIV-1 Tat vaccine 7.5 microg | Biological | HIV-1 Tat vaccine 7.5 microg |
| HIV-1 Tat vaccine 30 microg | Biological | HIV-1 Tat vaccine 30 microg |
Primary outcome
Safety and immunogenicity
Time frame: up to week 68
To qualify the vaccine candidate as safe and immunogenic by evaluating the number of local and systemic adverse events, including any significant change in hematological/biochemical/coagulation laboratory parameters, and the frequency of anti-Tat and anti-delta-V2 Env humoral and cellular immune responses
Results and safety
The study was stopped early (reason given: Enrollments were suspended due to delta-V2 Env unavailability, following the EMA/CHMP/BWP/534898/2008 guideline, not allowing the use of a retest date). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
- Background: PubMed 21085635Ensoli B, Bellino S, Tripiciano A, Longo O, Francavilla V, Marcotullio S, Cafaro A, Picconi O, Paniccia G, Scoglio A, Arancio A, Ariola C, Ruiz Alvarez MJ, Campagna M, Scaramuzzi D, Iori C, Esposito R, Mussini C, Ghinelli F, Sighinolfi L, Palamara G, Latini A, Angarano G, Ladisa N, Soscia F, Mercurio VS, Lazzarin A, Tambussi G, Visintini R, Mazzotta F, Di Pietro M, Galli M, Rusconi S, Carosi G, Torti C, Di Perri G, Bonora S, Ensoli F, Garaci E. Therapeutic immunization with HIV-1 Tat reduces immune activation and loss of regulatory T-cells and improves immune function in subjects on HAART. PLoS One. 2010 Nov 11;5(11):e13540. doi: 10.1371/journal.pone.0013540.
- Background: PubMed 20028332Bellino S, Francavilla V, Longo O, Tripiciano A, Paniccia G, Arancio A, Fiorelli V, Scoglio A, Collacchi B, Campagna M, Lazzarin A, Tambussi G, Din CT, Visintini R, Narciso P, Antinori A, D'Offizi G, Giulianelli M, Carta M, Di Carlo A, Palamara G, Giuliani M, Laguardia ME, Monini P, Magnani M, Ensoli F, Ensoli B. Parallel conduction of the phase I preventive and therapeutic trials based on the Tat vaccine candidate. Rev Recent Clin Trials. 2009 Sep;4(3):195-204. doi: 10.2174/157488709789957529.
- Background: PubMed 19879233Ensoli B, Fiorelli V, Ensoli F, Lazzarin A, Visintini R, Narciso P, Di Carlo A, Tripiciano A, Longo O, Bellino S, Francavilla V, Paniccia G, Arancio A, Scoglio A, Collacchi B, Ruiz Alvarez MJ, Tambussi G, Tassan Din C, Palamara G, Latini A, Antinori A, D'Offizi G, Giuliani M, Giulianelli M, Carta M, Monini P, Magnani M, Garaci E. The preventive phase I trial with the HIV-1 Tat-based vaccine. Vaccine. 2009 Dec 11;28(2):371-8. doi: 10.1016/j.vaccine.2009.10.038. Epub 2009 Oct 29.
- Background: PubMed 19811313Caputo A, Gavioli R, Bellino S, Longo O, Tripiciano A, Francavilla V, Sgadari C, Paniccia G, Titti F, Cafaro A, Ferrantelli F, Monini P, Ensoli F, Ensoli B. HIV-1 Tat-based vaccines: an overview and perspectives in the field of HIV/AIDS vaccine development. Int Rev Immunol. 2009;28(5):285-334. doi: 10.1080/08830180903013026.
- Background: PubMed 19208456Longo O, Tripiciano A, Fiorelli V, Bellino S, Scoglio A, Collacchi B, Alvarez MJ, Francavilla V, Arancio A, Paniccia G, Lazzarin A, Tambussi G, Din CT, Visintini R, Narciso P, Antinori A, D'Offizi G, Giulianelli M, Carta M, Di Carlo A, Palamara G, Giuliani M, Laguardia ME, Monini P, Magnani M, Ensoli F, Ensoli B. Phase I therapeutic trial of the HIV-1 Tat protein and long term follow-up. Vaccine. 2009 May 26;27(25-26):3306-12. doi: 10.1016/j.vaccine.2009.01.090. Epub 2009 Feb 7.
- Background: PubMed 17117011Ensoli B, Fiorelli V, Ensoli F, Cafaro A, Titti F, Butto S, Monini P, Magnani M, Caputo A, Garaci E. Candidate HIV-1 Tat vaccine development: from basic science to clinical trials. AIDS. 2006 Nov 28;20(18):2245-61. doi: 10.1097/QAD.0b013e3280112cd1. No abstract available.
- Background: PubMed 16275150Barnett SW, Srivastava IK, Ulmer JB, Donnelly JJ, Rappuoli R. Development of V2-deleted trimeric envelope vaccine candidates from human immunodeficiency virus type 1 (HIV-1) subtypes B and C. Microbes Infect. 2005 Nov;7(14):1386-91. doi: 10.1016/j.micinf.2005.07.018. Epub 2005 Sep 20.
- Background: PubMed 16243561Ensoli B, Cafaro A, Caputo A, Fiorelli V, Ensoli F, Gavioli R, Ferrantelli F, Cara A, Titti F, Magnani M. Vaccines based on the native HIV Tat protein and on the combination of Tat and the structural HIV protein variant DeltaV2 Env. Microbes Infect. 2005 Nov;7(14):1392-9. doi: 10.1016/j.micinf.2005.07.016. Epub 2005 Sep 15.
- Background: PubMed 18243435Caputo A, Brocca-Cofano E, Castaldello A, Voltan R, Gavioli R, Srivastava IK, Barnett SW, Cafaro A, Ensoli B. Characterization of immune responses elicited in mice by intranasal co-immunization with HIV-1 Tat, gp140 DeltaV2Env and/or SIV Gag proteins and the nontoxicogenic heat-labile Escherichia coli enterotoxin. Vaccine. 2008 Feb 26;26(9):1214-27. doi: 10.1016/j.vaccine.2007.12.030. Epub 2008 Jan 15.
- Background: PubMed 24961156Bellino S, Tripiciano A, Picconi O, Francavilla V, Longo O, Sgadari C, Paniccia G, Arancio A, Angarano G, Ladisa N, Lazzarin A, Tambussi G, Nozza S, Torti C, Foca E, Palamara G, Latini A, Sighinolfi L, Mazzotta F, Di Pietro M, Di Perri G, Bonora S, Mercurio VS, Mussini C, Gori A, Galli M, Monini P, Cafaro A, Ensoli F, Ensoli B. The presence of anti-Tat antibodies in HIV-infected individuals is associated with containment of CD4+ T-cell decay and viral load, and with delay of disease progression: results of a 3-year cohort study. Retrovirology. 2014 Jun 24;11:49. doi: 10.1186/1742-4690-11-49.
- Background: PubMed 25250026Ensoli B, Cafaro A, Monini P, Marcotullio S, Ensoli F. Challenges in HIV Vaccine Research for Treatment and Prevention. Front Immunol. 2014 Sep 8;5:417. doi: 10.3389/fimmu.2014.00417. eCollection 2014.
- Background: PubMed 25924841Ensoli F, Cafaro A, Casabianca A, Tripiciano A, Bellino S, Longo O, Francavilla V, Picconi O, Sgadari C, Moretti S, Cossut MR, Arancio A, Orlandi C, Sernicola L, Maggiorella MT, Paniccia G, Mussini C, Lazzarin A, Sighinolfi L, Palamara G, Gori A, Angarano G, Di Pietro M, Galli M, Mercurio VS, Castelli F, Di Perri G, Monini P, Magnani M, Garaci E, Ensoli B. HIV-1 Tat immunization restores immune homeostasis and attacks the HAART-resistant blood HIV DNA: results of a randomized phase II exploratory clinical trial. Retrovirology. 2015 Apr 29;12:33. doi: 10.1186/s12977-015-0151-y.
- Click here for a description of the efforts by the Italian National AIDS Center at the Italian National Institute of Health to develop preventive and therapeutic HIV vaccines based on the HIV-1 Tat proteinLink provided by the sponsor.
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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.
Barbara Ensoli, MD study director
Istituto Superiore di Sanità
3 sites 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-1 Tat/delta-V2 Env combined vaccine, HIV-1 delta-V2 Env vaccine and HIV-1 Tat vaccine 7.5 microg in people with HIV Infection, run by Barbara Ensoli, MD at 3 sites in Italy.
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 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: stopped early, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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 was stopped early (reason given: Enrollments were suspended due to delta-V2 Env unavailability, following the EMA/CHMP/BWP/534898/2008 guideline, not allowing the use of a retest date). Results are not available in the source record.
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 and immunogenicity (time frame: up to week 68). 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 NCT01441193, which also lists 13 linked publications.
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 4 Mar 2016.