HIV-1Phase 1NCT01024842
Safety and Immunogenicity of MVA.HIVconsv in HIV-1 Seropositive Adults on HAART
A Phase 1 study testing MVA.HIVconsv low dose and MVA.HIVconsv high dose in people with HIV-1, run by University of Oxford at 2 sites in United Kingdom.
Trial summary
In this study, the novel vaccine candidate, MVA.HIVconsv, will be tested for safety, tolerability and immunogenicity in HIV-1-seropositive subjects receiving effective antiretroviral therapy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV-1
- What is being tested?
- MVA.HIVconsv low dose and MVA.HIVconsv high dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Dec 2009to Nov 2013
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, aged 18-60 years
- Confirmed HIV-1 seropositive
- Willing and able to give written informed consent for participation in the study
- Treated continuously with a combination of 3 or more antiretroviral agents for the preceding 12 months
- Willing and able to adhere to an effective ART regimen for the duration of the study (switching from current regimen is allowed if for reasons of tolerability or toxicity)
- CD4 cell count > 350 cells/μl at screening and at the preceding clinic visit
Show all 16Show fewer
- Plasma viral load < 50 copies / ml at screening and at the preceding clinic visit
- No new AIDS-defining diagnosis or progression of HIV-related disease in the preceding 6/12 months
- Haematological and biochemical laboratory parameters as follows:
- Haemoglobin > 10g/dl
- Platelets > 100,000/μl
- ALT ≤ 2.5 x ULN
- Creatinine ≤ 1.3 x ULN
- Serology: negative for hepatitis B surface antigen OR HbsAg positive with HBV DNA < 1000 copies/ml; negative for hepatitis C antibodies OR confirmed clearance of HCV infection (spontaneous or following treatment); negative syphilis serology or documented adequate treatment of syphilis if positive EIA IgG or TPHA
- Available for follow up for duration of study (screening + 38 weeks) and willing to comply with the protocol requirements
- Women of child-bearing age must not be pregnant, planning a pregnancy or breast-feeding. Sexually active women must be willing to use an approved method of contraception from screening until 4 months after the third immunisation. Sexually active men in heterosexual relationships must be willing to use an approved method of contraception with their partners from screening until 4 months after the third immunisation.
Who cannot join
- Confirmed HIV-2 seropositive
- Positive pregnancy test
- Participation in another clinical trial within 12 weeks of study entry
- History of autoimmune disease other than HIV-related auto-immune disease which has resolved with ART
- History or clinical manifestations of any physical or psychiatric disorder which could impair the subject's ability to complete the study
- History of anaphylaxis or severe adverse reaction to vaccines
Show all 14Show fewer
- History of alcohol or drug dependency which could, in the opinion of the investigators, impair the subject's ability to complete the study
- Previous immunisation with a recombinant MVA vaccine
- Immunisation with any experimental immunogens within 6 months of study entry
- Receipt of blood products or immunoglobulins within 6 months of study entry
- Treatment for cancer or lymphoproliferative disease within 1 year of study entry
- Receipt of vaccines other than Hepatitis B vaccine within 2 weeks of study entry or planned receipt within 2 weeks of vaccination
- Any other prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study
- Current or recent use (within last 3 months) of interferon or systemic corticosteroids or other immunosuppressive agents
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Weatherall Institute of Molecular Medicine
Oxford, Oxons, OX3 9DS
Oxford Genitourinary Medicine
Oxford, Oxon, OX3 7LJ
About this study
Official title: HIV-CORE 001 - A Randomised Placebo-controlled Study to Evaluate the Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA.HIVconsv, Delivered by Intramuscular Needle Injection to HIV-1 Seropositive Adult Subjects Receiving Antiretroviral Therapy (ART).
In this study, the novel vaccine candidate, MVA.HIVconsv, will be tested for safety, tolerability and immunogenicity in HIV-1-seropositive subjects receiving effective antiretroviral therapy.
MVA.HIVconsv will be tested as a single vaccine modality, as a prelude to testing in a heterologous viral vector boost regimen which will include a replication-defective simian adenovirus expressing the same immunogen.
- Conditions
- HIV-1
- Being tested
- MVA.HIVconsv low dose, Placebo low dose, MVA.HIVconsv high dose, Placebo high dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA.HIVconsv low doseBiological
Three intramuscular injections of MVA.HIVconsv alone at a dose of 1x10^8 pfu at week 0, 4 and 12.
Placebo low doseOther
Three intramuscular injections of placebo alone (200ul) at week 0, 4 and 12.
MVA.HIVconsv high doseBiological
Three intramuscular injections of MVA.HIVconsv alone at a dose of 4x10^8 pfu at week 0, 4 and 12.
Placebo high doseOther
Three intramuscular injections of placebo alone (800ul) at week 0, 4 and 12.
| Study group | Role | What they receive |
|---|---|---|
| Low dose vaccinees | Experimental | Individuals will receive three intramuscular injections of MVA.HIVconsv alone at a dose of 1x10^8 pfu. Receives: Biological: MVA.HIVconsv low dose |
| High dose vaccinees | Experimental | Individuals will receive three intramuscular injections of MVA.HIVconsv alone at a dose of 4x10^8 pfu. Receives: Biological: MVA.HIVconsv high dose |
| Low dose placebo | Placebo comparator | Individuals will receive three intramuscular injections of low dose placebo Receives: Other: Placebo low dose |
| High dose placebo | Placebo comparator | Individuals will receive three intramuscular injections of high dose placebo Receives: Other: Placebo high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of volunteers who develop a grade 3 or 4 local or systemic reactions
Measured: Actively collected data throughout the study until 6 months after the last vaccination
Secondary outcomes (8)
A descriptive summary of grade 3 or 4 local and systemic events, including laboratory abnormalities
Measured: Actively collected data throughout the study until 6 months after the last vaccination
A descriptive summary of serious adverse events, including laboratory abnormalities
Measured: Actively collected data throughout the study until 6 months after the last vaccination
The proportion of volunteers who develop CD8+ T cell responses to a new HIV-1 epitope, as determined by IFN-γ ELISPOT assay
Measured: Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination)
The proportion of volunteers in whom the magnitude of CD8+ T cell responses to HIVconsv peptides increases by ≥ 3-fold, as determined by IFN-γ ELISPOT assay
Measured: Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination)
Evaluation of the effect of MVA.HIVconsv vaccinations on viral suppressive capacity of CD8+ T cells in vitro, using a novel flow cytometric assay
Measured: Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination)
Magnitude and phenotype, including but not limited to activation status, of HIV-1-specific CD8+ T cell populations identified by tetramer staining before and after vaccination, in selected volunteers with appropriate HLA class I alleles.
Measured: Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination)
PBMC will be stored for other exploratory assays to characterise vaccine-expanded T cell populations such as IL-10 secretion and CFSE proliferation assays.
Measured: Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination)
Serum and plasma will be stored for investigation of binding and neutralising antibodies to vaccinia and of pro-inflammatory cytokines.
Measured: Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Slow recruitment therefore study was stopped after 95% volunteers were enrolled.
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-1Studies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Tomas Hanke, Principal investigator, University of OxfordAndrew McMichael, Principal investigator, University of OxfordLucy Dorrell, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024842
- Sponsor's protocol ID
- HIV-CORE 001
- Status last verified
- Jun 2016
- First submitted
- 1 Dec 2009
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data are presented in a manuscript submitted to a peer-reviewed journal.
Publications
Hancock G, Moron-Lopez S, Kopycinski J, Puertas MC, Giannoulatou E, Rose A, Salgado M, Hayton EJ, Crook A, Morgan C, Angus B, Chen F, Yang H, Martinez-Picado J, Hanke T, Dorrell L. Evaluation of the immunogenicity and impact on the latent HIV-1 reservoir of a conserved region vaccine, MVA.HIVconsv, in antiretroviral therapy-treated subjects. J Int AIDS Soc. 2017 May 19;20(1):21171. doi: 10.7448/IAS.20.1.21171.
PubMed 28537062
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV-CORE 001 - A Randomised Placebo-controlled Study to Evaluate the Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA.HIVconsv, Delivered by Intramuscular Needle Injection to HIV-1 Seropositive Adult Subjects Receiving Antiretroviral Therapy (ART).
- ClinicalTrials.gov ID
- NCT01024842
- Acronym / sponsor ID
- HIV-CORE 001
- Conditions
- HIV-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment therefore study was stopped after 95% volunteers were enrolled.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- Dec 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 3 Dec 2009 (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.
In this study, the novel vaccine candidate, MVA.HIVconsv, will be tested for safety, tolerability and immunogenicity in HIV-1-seropositive subjects receiving effective antiretroviral therapy.
MVA.HIVconsv will be tested as a single vaccine modality, as a prelude to testing in a heterologous viral vector boost regimen which will include a replication-defective simian adenovirus expressing the same immunogen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose vaccinees | Experimental | Biological: MVA.HIVconsv low doseIndividuals will receive three intramuscular injections of MVA.HIVconsv alone at a dose of 1x10^8 pfu. |
| High dose vaccinees | Experimental | Biological: MVA.HIVconsv high doseIndividuals will receive three intramuscular injections of MVA.HIVconsv alone at a dose of 4x10^8 pfu. |
| Low dose placebo | Placebo comparator | Other: Placebo low doseIndividuals will receive three intramuscular injections of low dose placebo |
| High dose placebo | Placebo comparator | Other: Placebo high doseIndividuals will receive three intramuscular injections of high dose placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Male or female, aged 18-60 years
- Confirmed HIV-1 seropositive
- Willing and able to give written informed consent for participation in the study
- Treated continuously with a combination of 3 or more antiretroviral agents for the preceding 12 months
- Willing and able to adhere to an effective ART regimen for the duration of the study (switching from current regimen is allowed if for reasons of tolerability or toxicity)
Key exclusion criteria (14 listed)
- Confirmed HIV-2 seropositive
- Positive pregnancy test
- Participation in another clinical trial within 12 weeks of study entry
- History of autoimmune disease other than HIV-related auto-immune disease which has resolved with ART
- History or clinical manifestations of any physical or psychiatric disorder which could impair the subject's ability to complete 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 |
|---|---|---|
| MVA.HIVconsv low doseThree intramuscular injections of MVA.HIVconsv alone at a dose of 1x10^8 pfu at week 0, 4 and 12. | Biological | Low dose vaccinees |
| Placebo low doseThree intramuscular injections of placebo alone (200ul) at week 0, 4 and 12. | Other | Low dose placebo |
| MVA.HIVconsv high doseThree intramuscular injections of MVA.HIVconsv alone at a dose of 4x10^8 pfu at week 0, 4 and 12. | Biological | High dose vaccinees |
| Placebo high doseThree intramuscular injections of placebo alone (800ul) at week 0, 4 and 12. | Other | High dose placebo |
Primary outcome
The proportion of volunteers who develop a grade 3 or 4 local or systemic reactions
Time frame: Actively collected data throughout the study until 6 months after the last vaccination
8 secondary outcomes
A descriptive summary of grade 3 or 4 local and systemic events, including laboratory abnormalities
Time frame: Actively collected data throughout the study until 6 months after the last vaccination
A descriptive summary of serious adverse events, including laboratory abnormalities
Time frame: Actively collected data throughout the study until 6 months after the last vaccination
The proportion of volunteers who develop CD8+ T cell responses to a new HIV-1 epitope, as determined by IFN-γ ELISPOT assay
Time frame: Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination)
The proportion of volunteers in whom the magnitude of CD8+ T cell responses to HIVconsv peptides increases by ≥ 3-fold, as determined by IFN-γ ELISPOT assay
Time frame: Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination)
Evaluation of the effect of MVA.HIVconsv vaccinations on viral suppressive capacity of CD8+ T cells in vitro, using a novel flow cytometric assay
Time frame: Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination)
Magnitude and phenotype, including but not limited to activation status, of HIV-1-specific CD8+ T cell populations identified by tetramer staining before and after vaccination, in selected volunteers with appropriate HLA class I alleles.
Time frame: Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination)
PBMC will be stored for other exploratory assays to characterise vaccine-expanded T cell populations such as IL-10 secretion and CFSE proliferation assays.
Time frame: Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination)
Serum and plasma will be stored for investigation of binding and neutralising antibodies to vaccinia and of pro-inflammatory cytokines.
Time frame: Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination)
Results and safety
The study was stopped early (reason given: Slow recruitment therefore study was stopped after 95% volunteers were enrolled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
- Derived from this study: PubMed 28537062Hancock G, Moron-Lopez S, Kopycinski J, Puertas MC, Giannoulatou E, Rose A, Salgado M, Hayton EJ, Crook A, Morgan C, Angus B, Chen F, Yang H, Martinez-Picado J, Hanke T, Dorrell L. Evaluation of the immunogenicity and impact on the latent HIV-1 reservoir of a conserved region vaccine, MVA.HIVconsv, in antiretroviral therapy-treated subjects. J Int AIDS Soc. 2017 May 19;20(1):21171. doi: 10.7448/IAS.20.1.21171.
- Individual participant dataSharing planned: Yes. Data are presented in a manuscript submitted to a peer-reviewed journal.
Related trials for HIV-1
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
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.
Tomas Hanke principal investigator
University of Oxford
Andrew McMichael principal investigator
University of Oxford
Lucy Dorrell principal investigator
University of Oxford
2 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 MVA.HIVconsv low dose and MVA.HIVconsv high dose in people with HIV-1, run by University of Oxford at 2 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 16 inclusion and 14 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 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early (reason given: Slow recruitment therefore study was stopped after 95% volunteers were enrolled.). 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?
The proportion of volunteers who develop a grade 3 or 4 local or systemic reactions (time frame: Actively collected data throughout the study until 6 months after the last 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 NCT01024842, 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 8 Jun 2016.