HIV I InfectionPhase 2NCT00659789
Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV
A Phase 2 study testing Vacc-4x and Sterile water in people with HIV I Infection, run by Bionor Immuno AS at 18 sites in 5 countries.
Trial summary
Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- HIV I Infection
- What is being tested?
- Vacc-4x and Sterile water
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 18 sitesin 5 countries
- Study dates
- Aug 2008to Jun 2011
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-55
- HIV positive at least one year
- Clinically stable on ART for at least six months
- Documented viral load less than 50 copies/mL for the last six months
- Documented prestudy CD4 cell count equal or more than 400x10exp6/L
- Nadir CD4 cell count equal or more than 200x10exp6/L
- Signed informed consent
Who cannot join
- Reported pre-study AIDS-defining illness within the previous year
- Malignant disease
- On chronic treatment with immuno-suppressive therapy
- Unacceptable values of hematology and clinical chemistry parameters
- Current chronic infection such as HCV and HBV or active tuberculosis
- Pregnant or breastfeeding women
Show all 9Show fewer
- Not using safe contraceptive methods
- Participation in other clinical trial
- Incapability of compliance
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
Germany6 sites
EPIMED GmbH
Berlin, State of Berlin, 12157
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 13353
Universitätsklinikum Bonn
Bonn, 53127
Klinik I für Innere Medizin Klinikum Der Universität zu Köln
Cologne, 50937
ifi - Studien und Projekte GmbH, an der Asklepios-Klinik St. George
Hamburg, 20099
Universitätsklinikum Hamburg Eppendorf
Hamburg, 20246
United States5 sites
Northwestern University Division of Infectious Diseases
Chicago, Illinois, 60611
UCLA CARE Center
Los Angeles, California, 90035
Cedars-Sinai Medical Center
Los Angeles, California, 90048-8700
University of Miami School of Medicine
Miami, Florida, 33136
UC Davis Medical Center
Sacramento, California, 95817
Spain3 sites
Hospital Germans Trias i Pujol
Badalona, 08916
Hospital Clinic i Provincial
Barcelona, 08036
Unidad de VIH, Hospital de Bellvitge, Calle Feixa Llarga s/n, Hospitalet de Llobregat.
Barcelona, 08907
United Kingdom3 sites
Brighton and Sussex University Hospital, HIV/GUM Research, Elton John Centre
Brighton, BN2 1EE
Chelsea and Westminster Hospital
London
Harrison Wing St Thomas' Hospital
London
About this study
Official title: A Phase II, Randomized, Double-blind, Multicenter, Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV-1 Who Have Maintained an Adequate Response to ART
Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore, ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure.
ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.
Read the detailed description
Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore,ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure.
ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.
- Conditions
- HIV I Infection
- Being tested
- Vacc-4x, Sterile water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacc-4xDrug
Also called Combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13.
Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
Sterile waterDrug
Also called Placebo
Sterile water is used in place of Vacc-4x and in place of Leukine
| Study group | Role | What they receive |
|---|---|---|
| Vacc-4x | Experimental | Vacc-4x reconstituted in sterile water (0.1 mL) at a dose of 1.2mg per intradermal administration. Participants are given a total of 6 immunizations over 18 weeks (weeks 1, 2, 3, 4, 16, 18). Recombinant human granulocyte macrophage colony stimulating factor (rhuGM-CSF) Leukine (0.06mg in 0.1 mL) administered intradermally is used as a local adjuvant. Receives: Drug: Vacc-4x |
| Placebo | Placebo comparator | Placebo injections consisting of sterile water (0.1 mL) in place of Vacc-4x. Placebo injections consisting of sterile water (0.1 mL) in place of Leukine. Receives: Drug: Sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52.
Measured: From Week 28 to Week 52
Secondary outcomes (5)
Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
Brief summary of treatment emergent adverse events or related treatment emergent events and deaths. The intensity of adverse events was described according to the Division of AIDS table for grading severity of adult and pediatric adverse events, 2004.
Measured: Up to week 52
Immunogenicity
Immunogenicity of Vacc-4x evaluated by DTH (Delayed-type Hypersensitivity) reaction. The number of participants showing induration and/or erythema
Measured: Week 1, week 18 and week 52
Effect of Vacc-4x on CD8 Counts
CD8 Count Over Time for subjects who stopped ART at Week 28 and remained off ART until Week 52
Measured: Weeks 6,18,24,28,32,36,40,44,48,52.
Time to Restart of ART for Vacc-4x Subjects Versus Placebo
Kaplan-Meier Estimate of Time to restart ART (from time coming off ART)
Measured: Between Week 28 to Week 52
Effects on Vacc-4x on HIV-1 RNA
Measured: Weeks 24,28,32,36,40,44,48,52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2010
- Study completionJun 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV I 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionor Immuno AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Pollard, MD, Principal investigator, University of California at Davis, USAJürgen Rochstroh, MD, Principal investigator, Universitätsklinikum Bonn, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659789
- Sponsor's protocol ID
- CT-BI Vacc-4x 2007/1
- Other IDs
- 2007-006302-13, 13619
- Status last verified
- Nov 2016
- First submitted
- 14 Apr 2008
- Last updated
- 23 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Participants have not provided informed consent for their anonymized individual data to be made available beyond that described in the patient information sheet.
Publications
Pollard RB, Rockstroh JK, Pantaleo G, Asmuth DM, Peters B, Lazzarin A, Garcia F, Ellefsen K, Podzamczer D, van Lunzen J, Arasteh K, Schurmann D, Clotet B, Hardy WD, Mitsuyasu R, Moyle G, Plettenberg A, Fisher M, Fatkenheuer G, Fischl M, Taiwo B, Baksaas I, Jolliffe D, Persson S, Jelmert O, Hovden AO, Sommerfelt MA, Wendel-Hansen V, Sorensen B. Safety and efficacy of the peptide-based therapeutic vaccine for HIV-1, Vacc-4x: a phase 2 randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2014 Apr;14(4):291-300. doi: 10.1016/S1473-3099(13)70343-8. Epub 2014 Feb 11.
PubMed 24525316
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Multicenter, Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV-1 Who Have Maintained an Adequate Response to ART
- ClinicalTrials.gov ID
- NCT00659789
- Acronym / sponsor ID
- CT-BI Vacc-4x 2007/1
- Conditions
- HIV I Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Bionor Immuno ASIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 Apr 2008 (estimated)
- Results
- Posted 5 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore, ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure.
ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.
Detailed description
Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore,ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure.
ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vacc-4x | Experimental | Drug: Vacc-4xVacc-4x reconstituted in sterile water (0.1 mL) at a dose of 1.2mg per intradermal administration. Participants are given a total of 6 immunizations over 18 weeks (weeks 1, 2, 3, 4, 16, 18). Recombinant human granulocyte macrophage colony stimulating factor (rhuGM-CSF) Leukine (0.06mg in 0.1 mL) administered intradermally is used as a local adjuvant. |
| Placebo | Placebo comparator | Drug: Sterile waterPlacebo injections consisting of sterile water (0.1 mL) in place of Vacc-4x. Placebo injections consisting of sterile water (0.1 mL) in place of Leukine. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-55
- HIV positive at least one year
- Clinically stable on ART for at least six months
- Documented viral load less than 50 copies/mL for the last six months
- Documented prestudy CD4 cell count equal or more than 400x10exp6/L
Key exclusion criteria (9 listed)
- Reported pre-study AIDS-defining illness within the previous year
- Malignant disease
- On chronic treatment with immuno-suppressive therapy
- Unacceptable values of hematology and clinical chemistry parameters
- Current chronic infection such as HCV and HBV or active tuberculosis
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 |
|---|---|---|
| Vacc-4xAlso: Combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13.Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. | Drug | Vacc-4x |
| Sterile waterAlso: PlaceboSterile water is used in place of Vacc-4x and in place of Leukine | Drug | Placebo |
Primary outcome
Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52.
Time frame: From Week 28 to Week 52
5 secondary outcomes
Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
Time frame: Up to week 52
Immunogenicity
Time frame: Week 1, week 18 and week 52
Effect of Vacc-4x on CD8 Counts
Time frame: Weeks 6,18,24,28,32,36,40,44,48,52.
Time to Restart of ART for Vacc-4x Subjects Versus Placebo
Time frame: Between Week 28 to Week 52
Effects on Vacc-4x on HIV-1 RNA
Time frame: Weeks 24,28,32,36,40,44,48,52.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24525316Pollard RB, Rockstroh JK, Pantaleo G, Asmuth DM, Peters B, Lazzarin A, Garcia F, Ellefsen K, Podzamczer D, van Lunzen J, Arasteh K, Schurmann D, Clotet B, Hardy WD, Mitsuyasu R, Moyle G, Plettenberg A, Fisher M, Fatkenheuer G, Fischl M, Taiwo B, Baksaas I, Jolliffe D, Persson S, Jelmert O, Hovden AO, Sommerfelt MA, Wendel-Hansen V, Sorensen B. Safety and efficacy of the peptide-based therapeutic vaccine for HIV-1, Vacc-4x: a phase 2 randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2014 Apr;14(4):291-300. doi: 10.1016/S1473-3099(13)70343-8. Epub 2014 Feb 11.
- Individual participant dataSharing planned: No. Participants have not provided informed consent for their anonymized individual data to be made available beyond that described in the patient information sheet.
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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.
Richard Pollard, MD principal investigator
University of California at Davis, USA
Jürgen Rochstroh, MD principal investigator
Universitätsklinikum Bonn, Germany
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vacc-4x and Sterile water in people with HIV I Infection, run by Bionor Immuno AS at 18 sites in 5 countries.
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 7 inclusion and 9 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany, United States, Spain, United Kingdom, 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 5 Jan 2017). 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?
Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52. (time frame: From Week 28 to Week 52). 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 NCT00659789, 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 23 Feb 2017.