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HIVPhase 1NCT01712425

Safety and Immunogenicity of ChAdV63.HIVconsv and MVA.HIVconsv Candidate HIV-1 Vaccines in Recently HIV-1 Infected Individuals

A Phase 1 study testing 0-24 week prime/boost regimen and 0-8 week prime/boost regimen in people with HIV, run by IrsiCaixa at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The HIVconsv gene was constructed by assembling the 14 most conserved regions of the HIV-1 proteome into one chimaeric protein. This gene has been inserted into 2 leading non-replicating vaccine vectors: an attenuated chimpanzee adenovirus serotype 63 (ChAdV63) and a modified vaccinia virus Ankara (MVA) to construct… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
HIV
What is being tested?
0-24 week prime/boost regimen and 0-8 week prime/boost regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
2 sitesSpain
Study dates
Oct 2012to Oct 2015
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 documented in the past 6 months (by acute antiretroviral syndrome, p24 antigenemia and/or ELISA seroconversion)
  • Willing and able to give written informed consent for participation in the study
  • Willing and able to adhere to an effective HAART regimen for the duration of the study
  • Cluster of differentiation 4 (CD4)+ T cell count > 350 cells/ml at screening and at the preceding clinic visit
  • No new AIDS-defining diagnosis or progression of HIV-related disease.
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  • Haematological and biochemical laboratory parameters as follows: Haemoglobin > 10g/dl, Platelets > 100.000/dl, alanine aminotransferase (ALT) ≤ 2.5 x ULN, Creatinine ≤ 1.3 x upper limit of normal (ULN)
  • Serology: negative for hepatitis B surface antigen OR HbsAg positive with Hepatitis B Virus (HBV)-DNA < 1000 copies/ml; negative for hepatitis C antibodies OR confirmed clearance of Hepatitis C Virus (HCV) infection (spontaneous or following treatment); negative syphilis serology or documented adequate treatment of syphilis if positive enzimeimmunoassay (EIA) Immonoglobulin G (IgG) or Treponema pallidum hemagglutination assay (TPHA)
  • Available for follow up for duration of study (screening + 72 weeks) and willing to comply with the protocol requirements
  • Women of child-bearing age must not be pregnant, not be 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 second 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 second immunisation.

Who cannot join

  • Confirmed HIV-2 seropositive
  • Positive pregnancy test
  • Presence of Nucleos(t)ide Reverse Transcriptase Inhibitors (NRTI) mutation in the screening genotype
  • Participation in another clinical trial within 12 weeks of study entry
  • History of autoimmune disease other than HIV-related auto-immune disease.
  • History or clinical manifestations of any physical or psychiatric disorder which could impair the subject's ability to complete the study
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  • History of anaphylaxis or severe adverse reaction to vaccines
  • Previous immunisation with any experimental immunogens
  • Receipt of blood products 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.

Spain2 sites

  • Germans Trias i Pujol Hospital

    Badalona, Barcelona, 08916

  • Clinic de Barcelona Hospital

    Barcelona, 08036

Other trials in Spain

About this study

Official title: Safety and Immunogenicity of ChAdV63.HIVconsv and MVA.HIVconsv Candidate HIV-1 Vaccines in Recently HIV-1 Infected Individuals With Early Viral Suppression After Initiation of Antiretroviral Therapy (HAART)

The HIVconsv gene was constructed by assembling the 14 most conserved regions of the HIV-1 proteome into one chimaeric protein. This gene has been inserted into 2 leading non-replicating vaccine vectors: an attenuated chimpanzee adenovirus serotype 63 (ChAdV63) and a modified vaccinia virus Ankara (MVA) to construct the ChAdV63.HIVconsv and MVA.HIVconsv HIV-1 candidate vaccines. The present study is named ChAd-MVA.HIVconsv-BCN01 and it is a phase I, multicenter primary/booster therapeutic vaccination study to evaluate the safety and immunogenicity of ChAdV63.HIVcons and MVA.HIVconsv HIV-1 vaccines, delivered intramuscularly according to a 0-8 weeks or a 0-24 weeks schedule to recently HIV-1 infected individuals with early viral suppression 6 months after initiation of Tenofovir/Emtricitabine plus Raltegravir.

Read the detailed description

It is a Phase I, multicenter primary/booster therapeutic vaccination study to evaluate the safety and immunogenicity of ChAdV63.HIVcons and MVA.HIVconsv HIV-1 vaccines, delivered intramuscularly according to a 0-8 weeks or a 0-24 weeks schedule to recently HIV-1 infected individuals with early viral suppression 6 months after initiation of Tenofovir/Emtricitabine plus Raltegravir.

24 patients who meet all eligibility criteria will be enrolled, first 10 individuals will be assigned in the 0-24 week prime/boost regimen (ARM A). The next 10 volunteers will be assigned in the 0-8 week prime/boost regimen (ARM B).Four additional volunteers will be included as 'back-up' and assigned 2 in ARM A and 2 in ARM B to cover a possible 10% of patients who drop-off during the follow-up. Purpose of staging of 2 study arms is just to shorten overall study duration (from screening of first volunteer to 6 months after last immunisation of last volunteer).

Lastly, 24 patients who also meet all eligibility criteria will be enrolled as controls, will also initiate promptly antiretroviral treatment with Tenofovir/Emtricitabine plus Raltegravir but will not receive the investigational vaccines. Control patients will consecutively be assigned to the 0-24w control arm (ARM C 'long control') or 0-8w control arm (ARM D 'short control') until 12 patients per arm are reached. The purpose of the control arms is to have a study population to compare the viral reservoir decay kinetics in the absence of vaccination.

Conditions
HIV
Being tested
0-24 week prime/boost regimen, 0-8 week prime/boost regimen
Keywords
vaccine, recently HIV-1 infected individuals

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0-24 week prime/boost regimenBiological

    Also called ARM A

    ChAdV63.HIVcons (5x10^10 vp) and MVA.HIVconsv (2x10^8 pfu) HIV-1 vaccines, delivered intramuscularly

  • 0-8 week prime/boost regimenBiological

    Also called ARM B

    ChAdV63.HIVcons (5x10^10 vp) and MVA.HIVconsv (2x10^8 pfu) HIV-1 vaccines, delivered intramuscularly

Study groups in NCT01712425
Study groupRoleWhat they receive
0-24 week prime/boost regimen (ARM A)ExperimentalStart antiretroviral treatment raltegravir + tenofovir/emtricitabine. ChAdV63.HIVcons and MVA.HIVconsv HIV-1 vaccines, delivered intramuscularly, 0-24 week prime/boost regimen
Receives: Biological: 0-24 week prime/boost regimen
0-8 week prime/boost regimen (ARM B)ExperimentalStart antiretroviral treatment raltegravir + tenofovir/emtricitabine. ChAdV63.HIVcons and MVA.HIVconsv HIV-1 vaccines, delivered intramuscularly, 0-8 week prime/boost regimen
Receives: Biological: 0-8 week prime/boost regimen
Arm A control (ARM C)No interventionStart antiretroviral treatment raltegravir + tenofovir/emtricitabine. Follow-up as in Arm A.
Arm B control (ARM D)No interventionStart antiretroviral treatment raltegravir + tenofovir/emtricitabine. Follow-up as in Arm B.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Grade 3 or 4 local reaction

    The proportion of volunteers who develop a grade 3 or 4 local reaction

    Measured: Up to 24 weeks

  2. Grade 3 or 4 systemic reaction

    The proportion of volunteers who develop a grade 3 or 4 systemic reaction

    Measured: Up to 24 weeks

  3. Serious adverse event, including laboratory abnormalities.

    The proportion of volunteers who develop a serious adverse event, including laboratory abnormalities.

    Measured: Up to 24 weeks

Secondary outcomes (5)

  1. HIV-specific CD8+ T cell responses

    Magnitude and phenotype of HIV-1-specific CD8+ T cell populations , in selected volunteers with appropriate human leukocyte antigen (HLA) class I alleles will be assessed according to first immunogenicity results.

    Measured: Change from baseline (pre-HAART) and w24, to +1week, +4weeks, +12weeks and +24weeks post vaccination.

  2. Magnitude and phenotype of HIV-1-specific CD8+ T cell populations

    Magnitude and phenotype of HIV-1-specific CD8+ T cell populations , in selected volunteers with appropriate HLA class I alleles will be assessed according to first immunogenicity results.

    Measured: Change from baseline (pre-HAART) and w24, to +1week, +4weeks, +12weeks and +24weeks post vaccination.

  3. Lymphocyte activation marker HLADR+CD38+

    Lymphocyte activation marker HLA-DR+CD38+ will be assessed at selected timepoints according to first immunogenicity results

    Measured: Change from baseline (pre-HAART) and w24, to +1week, +4weeks, +12weeks and +24weeks post vaccination.

  4. Integrated and unintegrated viral HIV-1 DNA in PBMCs.

    Quantification of integrated and unintegrated viral HIV-1 DNA in peripheral blood mononucleated cells (PBMC)s will be determined at selected timepoints according to first immunogenicity results

    Measured: Change from baseline (pre-HAART) and w24, to +1week, +4weeks, +12weeks and +24weeks post vaccination.

  5. Viral suppressive capacity of CD8+ T cells in vitro

    Viral suppressive capacity of CD8+ T cells in vitro using a flow cytometric assay at selected timepoints according to first immunogenicity results

    Measured: Change from baseline (pre-HAART) and w24, to +1week, +4weeks, +12weeks and +24weeks post vaccination.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01712425
Sponsor's protocol ID
ChAd-MVA.HIVconsv-BCN01
Other IDs
2011-000846-39
Status last verified
May 2024
First submitted
4 Oct 2012
Last updated
7 May 2024
Results posted
No
Data monitoring committee
No

Publications

  • Mothe B, Manzardo C, Sanchez-Bernabeu A, Coll P, Moron-Lopez S, Puertas MC, Rosas-Umbert M, Cobarsi P, Escrig R, Perez-Alvarez N, Ruiz I, Rovira C, Meulbroek M, Crook A, Borthwick N, Wee EG, Yang H, Miro JM, Dorrell L, Clotet B, Martinez-Picado J, Brander C, Hanke T. Therapeutic Vaccination Refocuses T-cell Responses Towards Conserved Regions of HIV-1 in Early Treated Individuals (BCN 01 study). EClinicalMedicine. 2019 Jun 5;11:65-80. doi: 10.1016/j.eclinm.2019.05.009. eCollection 2019 May-Jun.

    PubMed 31312806

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 0-24 week prime/boost regimen and 0-8 week prime/boost regimen in people with HIV, run by IrsiCaixa at 2 sites in Spain.

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 13 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 7 May 2024. 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 Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Grade 3 or 4 local reaction (time frame: Up to 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01712425, 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 7 May 2024.

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