HIV InfectionsPhase 1NCT01071031
HIV Vaccine Study in HIV Positive Patients
A Phase 1 study testing HIV-v (Low Dose) and HIV-v (High Dose) in people with HIV Infections, run by PepTcell Limited at 5 sites in United Kingdom.
Trial summary
The purpose of the study is to see whether a single vaccination (injection) with the investigational HIV vaccine is safe and effective in patients who are HIV positive but have not yet begun anti-retroviral therapy. As this is an exploratory study, four different dose formulations of HIV vaccine will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- HIV-v (Low Dose) and HIV-v (High Dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Nov 2009to Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male subjects age 18 - 50 years inclusive with HIV-1 infection
- Documented as HIV positive, with viral loads higher than 5,000 copies per millilitre of blood, but less than 500,000 using either a branched DNA test, or an RT-PCR test
- CD4 T cell count >350/mm3
- Clinically stable in the opinion of the investigator and not expected to require anti-retroviral therapy during the course of the study
- No evidence of any AIDS defining illness
- Subjects with male or female partners must agree to use a barrier method of protection against disease transmission during intercourse (e.g. condom).
- Subjects whose female partners are of child-bearing potential must also agree to use a second contraceptive method (e.g. spermicidal agent, IUD, hormonal contraceptive) in addition to a condom for the duration of the study.
- Provide written informed consent to participate in the study and be willing to comply with all study procedures.
Who cannot join
- Participation in a clinical trial or receipt of an experimental therapy within 30 days prior to study dosing
- Receipt of another vaccine 30 days before or 30 days after HIV-v
- Currently receiving anti-viral, anti-retroviral therapy or any chronic anti-infective therapy
- Receiving, or have received over the previous two weeks, any treatment that might modulate the immune response after vaccination, including, but not limited to, immunosuppressive therapy and systemic corticosteroids
- Suffers from a disease or is undergoing treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (>800µg/day beclometasone or equivalent), radiation treatment or cytotoxic drugs
- Received a blood transfusion or immunoglobulins within 90 days prior to study entry
Show all 15Show fewer
- Patients on inhaled corticosteroids for asthma or other respiratory conditions
- Subjects having an infective exacerbation during the screening process as defined as a requirement of inhaled, oral, or intravenous antibiotics prior to the first study dose will be excluded
- Use of non-steroidal anti-inflammatory drugs (NSAIDs) or any over-the-counter product, herbal product, diet aid, hormone supplement, etc., within 14 days prior to vaccination or any planned administration of these products over the course of the first 28 days after vaccination (unless approved by both the Principal Investigator and the Sponsor)
- Patients with Hepatitis B or C co-infection (though serological evidence of previous hepatitis C infection with no evidence of carrier status is acceptable)
- Suffers from or has a history of significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, haematological or renal disorder
- Subjects with clinically significant out of range laboratory values as stated in Section 8.6 of the protocol
- Patients with a history of significant or allergic reaction to vaccines
- Patients with a known or suspected dependence on illicit drugs or alcohol and those undergoing illicit drug replacement programmes
- Is direct employee of the study site or monitoring CRO
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Elton John Centre, Sussex House,
Brighton, BN2 1ES
Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital
London, London, E1 1BB
St. Stephen's Centre, Chelsea and Westminster Foundation Trust
London, London, SW10 9NH
North Manchester General Hospital, Department for Infectious Diseases
Manchester, M8 5RB
Royal Hallamshire Hospital
Sheffield, S10 2JF
About this study
Official title: A Multicentre, Two Stage, Randomised, Double Blind Study of the Safety, Tolerability and Immunogenicity of a Human Immunodeficiency Virus (HIV) Vaccine Candidate, HIV-v
The purpose of the study is to see whether a single vaccination (injection) with the investigational HIV vaccine is safe and effective in patients who are HIV positive but have not yet begun anti-retroviral therapy. As this is an exploratory study, four different dose formulations of HIV vaccine will be investigated.
This study will evaluate whether or not the HIV vaccine is able to reduce the HIV viral load (number of HIV virus particles in the blood) and increase or slow the decline in CD4 T cell count.
Read the detailed description
The study will consist of a screening period of 3 to 21 days before vaccination on Day 0 and a double-blind treatment period of 28 days with a follow up period of 5 months. Prior to conducting any study-related procedures, subjects will provide written informed consent. During screening, eligibility will be assessed, a medical history will be taken, a complete physical examination will be performed and vital signs will be measured. Blood samples will be taken for the assessment of HCV and HBV status. Further samples will be taken for CD4 and HIV load, haematology, biochemistry, urinalysis and a 12-lead electrocardiographic (ECG) assessment will be carried out. A self-assessment diary card will be used by subjects between Day 0 and Day 28 to record any AEs.
On Days 7, 14, 21 and 28 an AE interview will be conducted, concomitant medications and vital signs will be recorded and a physical examination will be performed. Samples will be collected for haematology, clinical chemistry and urinalysis. In addition, samples will be collected for CD4 T cell count and HIV viral load at days 14 and 28 after vaccination. A sample will be collected for immunogenicity on Day 28.
All patients will attend follow-up visits at Weeks 8, 12, 16, 20 and 24 at which a physical examination and examination of the injection site will be performed and vital signs measured. Samples will be collected for haematology, biochemistry, urinalysis CD4 T-cell count and HIV viral load. Blood samples for immunogenicity testing will be collected at Weeks 12 and 24.
Stage I: Sequential, non-randomised, single blind, parallel group. Five male HIV-1 positive volunteers will be vaccinated in a sequential, non-randomised single blind fashion. They will each receive one of the five possible active study treatments (WFI only, adjuvant only, low dose + WFI, low dose + adjuvant, high dose + WFI and high dose + adjuvant). Each of these five patients will be observed as in-patients for 24 hours after vaccination and vaccinations will be performed in a sequential manner with at least 48 hours observation of each patient before vaccination of the next patient is commenced.
Following completion of the '28 day treatment follow up' by the five Stage I subjects a Safety Committee will review the safety and tolerability data for these subjects and will make a recommendation for continuing or discontinuing recruitment and any changes that may be required in the conduct of the study. Subject to a positive decision from the Safety Committee the remaining subjects will be recruited into Stage II of the study.
Stage II: randomised, double-blind group 50 male HIV-1 positive volunteers will be randomised to one of five possible treatment groups. Following completion of the Day 1 Visit by the first five subjects in Stage II the Safety Committee will review the blinded safety and tolerability data for these subjects. Subject to acceptable safety and tolerability, the centres will be allowed to continue recruitment for the rest of the planned cohort.
After 25 Stage II subjects have completed the Day 1 Visit a Safety Committee will review the blinded data generated and will make a recommendation for continuing or discontinuing recruitment and any changes that may be required in the conduct of the study.
- Conditions
- HIV Infections
- Being tested
- HIV-v (Low Dose), HIV-v (High Dose), HIV-v (Control)
- Keywords
- Safety, Tolerability, Immunogenicity, Human Immunodeficiency Virus, HIV-1, Vaccine, CD4, Viral Load, HIV
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV-v (Low Dose)Biological
Low Dose HIV-v (a sterile lyophilised mixture of polypeptide T-cell epitope sequences) with water for injection or adjuvant
Administration: A single subcutaneous injection
HIV-v (High Dose)Biological
High Dose HIV-v (a sterile lyophilised mixture of polypeptide T-cell epitope sequences with water for injection or adjuvant
Administration: A single subcutaneous injection
HIV-v (Control)Biological
Adjuvant only or Water for injection only
Administration: A single subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Low Dose HIV-v with water for injection Receives: Biological: HIV-v (Low Dose) |
| Group 2 | Experimental | Low Dose HIV-v with adjuvant Receives: Biological: HIV-v (Low Dose) |
| Group 3 | Experimental | High Dose HIV-v with water for injection Receives: Biological: HIV-v (High Dose) |
| Group 4 | Experimental | High Dose HIV-v with adjuvant Receives: Biological: HIV-v (High Dose) |
| Group 5 | Placebo comparator | Control group: adjuvant only or water for injection only Receives: Biological: HIV-v (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the safety and tolerability of the PepTcell HIV vaccine by analysis of safety data including changes in HIV load and CD4 T cell count.
Measured: Pre-vaccination, days 1, 2, 7, 14, 21 and 28 after vaccination and weeks 8, 12, 16, 20 and 24 after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startNov 2009
- Primary completionApr 2011
- Study completionApr 2011
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepTcell Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marta Boffito, MD PhD, Principal investigator, St Stephen's Aids TrustStuart Robinson, Study director, PepTcell Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071031
- Sponsor's protocol ID
- HIV-v-001
- Status last verified
- Sep 2012
- First submitted
- 17 Feb 2010
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Boffito M, Fox J, Bowman C, Fisher M, Orkin C, Wilkins E, Jackson A, Pleguezuelos O, Robinson S, Stoloff GA, Caparros-Wanderley W. Safety, immunogenicity and efficacy assessment of HIV immunotherapy in a multi-centre, double-blind, randomised, Placebo-controlled Phase Ib human trial. Vaccine. 2013 Nov 19;31(48):5680-6. doi: 10.1016/j.vaccine.2013.09.057. Epub 2013 Oct 8.
PubMed 24120550
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Two Stage, Randomised, Double Blind Study of the Safety, Tolerability and Immunogenicity of a Human Immunodeficiency Virus (HIV) Vaccine Candidate, HIV-v
- ClinicalTrials.gov ID
- NCT01071031
- Acronym / sponsor ID
- HIV-v-001
- Conditions
- HIV Infections
- Keywords
- Safety, Tolerability, Immunogenicity, Human Immunodeficiency Virus, HIV-1, Vaccine, CD4, Viral Load
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- PepTcell LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 18 Feb 2010 (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.
The purpose of the study is to see whether a single vaccination (injection) with the investigational HIV vaccine is safe and effective in patients who are HIV positive but have not yet begun anti-retroviral therapy. As this is an exploratory study, four different dose formulations of HIV vaccine will be investigated.
This study will evaluate whether or not the HIV vaccine is able to reduce the HIV viral load (number of HIV virus particles in the blood) and increase or slow the decline in CD4 T cell count.
Detailed description
The study will consist of a screening period of 3 to 21 days before vaccination on Day 0 and a double-blind treatment period of 28 days with a follow up period of 5 months. Prior to conducting any study-related procedures, subjects will provide written informed consent. During screening, eligibility will be assessed, a medical history will be taken, a complete physical examination will be performed and vital signs will be measured. Blood samples will be taken for the assessment of HCV and HBV status. Further samples will be taken for CD4 and HIV load, haematology, biochemistry, urinalysis and a 12-lead electrocardiographic (ECG) assessment will be carried out. A self-assessment diary card will be used by subjects between Day 0 and Day 28 to record any AEs.
On Days 7, 14, 21 and 28 an AE interview will be conducted, concomitant medications and vital signs will be recorded and a physical examination will be performed. Samples will be collected for haematology, clinical chemistry and urinalysis. In addition, samples will be collected for CD4 T cell count and HIV viral load at days 14 and 28 after vaccination. A sample will be collected for immunogenicity on Day 28.
All patients will attend follow-up visits at Weeks 8, 12, 16, 20 and 24 at which a physical examination and examination of the injection site will be performed and vital signs measured. Samples will be collected for haematology, biochemistry, urinalysis CD4 T-cell count and HIV viral load. Blood samples for immunogenicity testing will be collected at Weeks 12 and 24.
Stage I: Sequential, non-randomised, single blind, parallel group. Five male HIV-1 positive volunteers will be vaccinated in a sequential, non-randomised single blind fashion. They will each receive one of the five possible active study treatments (WFI only, adjuvant only, low dose + WFI, low dose + adjuvant, high dose + WFI and high dose + adjuvant). Each of these five patients will be observed as in-patients for 24 hours after vaccination and vaccinations will be performed in a sequential manner with at least 48 hours observation of each patient before vaccination of the next patient is commenced.
Following completion of the '28 day treatment follow up' by the five Stage I subjects a Safety Committee will review the safety and tolerability data for these subjects and will make a recommendation for continuing or discontinuing recruitment and any changes that may be required in the conduct of the study. Subject to a positive decision from the Safety Committee the remaining subjects will be recruited into Stage II of the study.
Stage II: randomised, double-blind group 50 male HIV-1 positive volunteers will be randomised to one of five possible treatment groups. Following completion of the Day 1 Visit by the first five subjects in Stage II the Safety Committee will review the blinded safety and tolerability data for these subjects. Subject to acceptable safety and tolerability, the centres will be allowed to continue recruitment for the rest of the planned cohort.
After 25 Stage II subjects have completed the Day 1 Visit a Safety Committee will review the blinded data generated and will make a recommendation for continuing or discontinuing recruitment and any changes that may be required in the conduct of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: HIV-v (Low Dose)Low Dose HIV-v with water for injection |
| Group 2 | Experimental | Biological: HIV-v (Low Dose)Low Dose HIV-v with adjuvant |
| Group 3 | Experimental | Biological: HIV-v (High Dose)High Dose HIV-v with water for injection |
| Group 4 | Experimental | Biological: HIV-v (High Dose)High Dose HIV-v with adjuvant |
| Group 5 | Placebo comparator | Biological: HIV-v (Control)Control group: adjuvant only or water for injection only |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male subjects age 18 - 50 years inclusive with HIV-1 infection
- Documented as HIV positive, with viral loads higher than 5,000 copies per millilitre of blood, but less than 500,000 using either a branched DNA test, or an RT-PCR test
- CD4 T cell count >350/mm3
- Clinically stable in the opinion of the investigator and not expected to require anti-retroviral therapy during the course of the study
- No evidence of any AIDS defining illness
Key exclusion criteria (15 listed)
- Participation in a clinical trial or receipt of an experimental therapy within 30 days prior to study dosing
- Receipt of another vaccine 30 days before or 30 days after HIV-v
- Currently receiving anti-viral, anti-retroviral therapy or any chronic anti-infective therapy
- Receiving, or have received over the previous two weeks, any treatment that might modulate the immune response after vaccination, including, but not limited to, immunosuppressive therapy and systemic corticosteroids
- Suffers from a disease or is undergoing treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (>800µg/day beclometasone or equivalent), radiation treatment or cytotoxic drugs
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-v (Low Dose)Low Dose HIV-v (a sterile lyophilised mixture of polypeptide T-cell epitope sequences) with water for injection or adjuvant Administration: A single subcutaneous injection | Biological | Group 1, Group 2 |
| HIV-v (High Dose)High Dose HIV-v (a sterile lyophilised mixture of polypeptide T-cell epitope sequences with water for injection or adjuvant Administration: A single subcutaneous injection | Biological | Group 3, Group 4 |
| HIV-v (Control)Adjuvant only or Water for injection only Administration: A single subcutaneous injection | Biological | Group 5 |
Primary outcome
To demonstrate the safety and tolerability of the PepTcell HIV vaccine by analysis of safety data including changes in HIV load and CD4 T cell count.
Time frame: Pre-vaccination, days 1, 2, 7, 14, 21 and 28 after vaccination and weeks 8, 12, 16, 20 and 24 after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2012.
- Derived from this study: PubMed 24120550Boffito M, Fox J, Bowman C, Fisher M, Orkin C, Wilkins E, Jackson A, Pleguezuelos O, Robinson S, Stoloff GA, Caparros-Wanderley W. Safety, immunogenicity and efficacy assessment of HIV immunotherapy in a multi-centre, double-blind, randomised, Placebo-controlled Phase Ib human trial. Vaccine. 2013 Nov 19;31(48):5680-6. doi: 10.1016/j.vaccine.2013.09.057. Epub 2013 Oct 8.
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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.
Marta Boffito, MD PhD principal investigator
St Stephen's Aids Trust
Stuart Robinson study director
PepTcell Limited
5 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-v (Low Dose) and HIV-v (High Dose) in people with HIV Infections, run by PepTcell Limited at 5 sites in United Kingdom.
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 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. 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?
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?
To demonstrate the safety and tolerability of the PepTcell HIV vaccine by analysis of safety data including changes in HIV load and CD4 T cell count. (time frame: Pre-vaccination, days 1, 2, 7, 14, 21 and 28 after vaccination and weeks 8, 12, 16, 20 and 24 after vaccination). 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 NCT01071031, 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 26 Sep 2012.