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HIVPhase 1NCT04586673

A Study to Assess Safety and Immunogenicity of Conserved Mosaic HIV-1 Vaccines

A Phase 1 study testing ChAdOx1.tHIVconsv1 (C1), MVA.tHIVconsv3 (M3) and MVA.tHIVconsv4 (M4) in people with HIV, run by University of Oxford at 1 site in United Kingdom.

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 object of the study is to assess the safety profile of candidate vaccines ChAdOx1.tHIVconsv1, MVA.tHIVconsv3 and MVA.tHIVcnsv4 administered sequentially in healthy HIV-1/2 negative adult volunteers. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
HIV
What is being tested?
ChAdOx1.tHIVconsv1 (C1), MVA.tHIVconsv3 (M3) and MVA.tHIVconsv4 (M4)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited Kingdom
Study dates
3 Jul 2021to 3 Aug 2022
Phase
Phase 1
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy adult aged 18-65 years
  • Able and willing (in the Investigator's opinion) to comply with all study requirements
  • Willing to allow the investigators to discuss the volunteer's medical history with their GP
  • Women of child-bearing potential agree to practice continuous effective contraception during the study and test negative for pregnancy on the day(s) of screening and vaccination
  • For sexually active men, willingness to use barrier methods for the purposes of contraception from screening until 4 months after the last vaccination
  • Agreement to refrain from blood donation during the course of the study
  • In the opinion of the Investigators, the volunteer has understood the information provided Written informed consent must be given before any study-related procedures are performed
  • Willing to undergo HCV, HBV, syphilis and HIV testing and counselling and receive test results

Who cannot join

  • Confirmed HIV-1 or HIV-2 infection
  • Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
  • Prior receipt of a recombinant simian adenoviral vaccine prior to enrolment
  • Planned receipt of another adenoviral vectored vaccine within 90 days after the vaccination with the ChAdOx1.tHIVconsv1 IMP
  • Receipt of any investigational HIV-1/2 vaccine
  • Receipt of live attenuated vaccine within the previous 60 days or planned receipt within 60 days after vaccination with the IMP
Show all 28Show fewer
  • Receipt of other vaccine, including influenza vaccine, within the previous 14 days or planned receipt within 14 days after vaccination with the IMP
  • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
  • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV-1/2 infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
  • Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
  • Any history of anaphylaxis in relation to vaccination
  • Pregnancy, lactation or willingness/intention to become pregnant during the study
  • History of cancer (except basal cell carcinoma of the skin)
  • History of serious psychiatric condition likely to affect participation in the study
  • Bleeding disorder (eg. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
  • Any other serious chronic illness requiring hospital specialist supervision
  • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
  • Suspected or known injecting drug abuse in the 5 years preceding enrolment
  • Reported high-risk behaviour for HIV-1/2 infection. High-risk behaviour for HIV-1/2 infection is defined as follows. Within the previous 12 months the volunteer has:
  • Had unprotected vaginal or anal sex with a person infected with HIV and not taking effective treatment, injecting drug users or casual partners (i.e., no continuing, established relationship)
  • Engaged in sex work for money or drugs
  • Used injection drugs
  • Acquired one of the following sexually transmitted infection: chlamydia, gonorrhea and syphilis.
  • Seropositive for hepatitis B surface antigen (HBsAg)
  • Seropositive for hepatitis C virus (antibodies to HCV)
  • Untreated Syphilis: Treponemal IgG/IgM and positive RPR/TPPA AND no documentation of adequate treatment
  • Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

    Oxford, OX3 7LE

Other trials in United Kingdom

About this study

Official title: A Phase I Dose Escalation Open Label Trial to Assess Safety and Immunogenicity of Candidate ChAdOx1- and MVA- Vectored Conserved Mosaic HIV-1 Vaccines Given Sequentially to Healthy HIV-1 Negative Adult Volunteers in Oxford, UK

The object of the study is to assess the safety profile of candidate vaccines ChAdOx1.tHIVconsv1, MVA.tHIVconsv3 and MVA.tHIVcnsv4 administered sequentially in healthy HIV-1/2 negative adult volunteers.

In addition, the study will assess the immune responses generated of the candidate vaccines ChAdOx1.tHIVconsv1, MV.tHIVconsv3 and MVA.tHIVconsv4 administered sequentially in healthy HIV-1/2 negative adult volunteers.

3 healthy, HIV-1 negative adult volunteers will receive one vaccination of low dose ChAdOx1.tHIVconsv1. A further 10 healthy, HIV-1 negative adult volunteers will receive a higher dose of ChAdOx1.tHIVconsv1, followed by one vaccination each of MVA.tHIVconsv3 and MVA.tHIVconsv4 4 weeks later.

Conditions
HIV
Being tested
ChAdOx1.tHIVconsv1 (C1), MVA.tHIVconsv3 (M3), MVA.tHIVconsv4 (M4)
Keywords
vaccine

What participants receive

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

  • ChAdOx1.tHIVconsv1 (C1)Biological

    ChAdOx1.tHIVconsv1 5 x 10^9 vp

  • ChAdOx1.tHIVconsv1 (C1)Biological

    ChAdOx1.tHIVconsv1 5 x 10^10 vp

  • MVA.tHIVconsv3 (M3)Biological

    MVA.tHIVconsv3 1 x 10^8 pfu

  • MVA.tHIVconsv4 (M4)Biological

    MVA.tHIVconsv4 09. x 10^8 pfu

Study groups in NCT04586673
Study groupRoleWhat they receive
ChAdOx1.tHIVconsv1 low doseExperimental3 participants will receive one dose of ChAdOx1.tHIVconsv1 at 5 x 10^9 vp
Receives: Biological: ChAdOx1.tHIVconsv1 (C1)
ChADOx1.tHIVconsv1 higher doseExperimental10 participants will receive one dose of ChAdOx1.tHIVconsv1 at 5 x 10^10 vp and one dose each of MVA.tHIVconsv3 at 1 x 10^8 pfu and MVA.tHIVconsv4 at 0.9 x 10^8 pfu.
Receives: Biological: ChAdOx1.tHIVconsv1 (C1); Biological: MVA.tHIVconsv3 (M3); Biological: MVA.tHIVconsv4 (M4)

What is being measured

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

  1. Assessement of Safety

    • Proportion of volunteers with vaccine related serious adverse events (SAEs) collected up to day 140 after enrollment.

    Measured: 140 days

  2. Assement of Safety

    Proportion of volunteers with Grade 3 or 4 unsolicited adverse events (AEs) through 28 days post final vaccination

    Measured: up to 28 days after each vaccination

  3. Assessment of Safety

    Proportion of volunteers with local and systemic reactogenicity events from Day 0 to Day 6 post vaccination

    Measured: up to day 7

Secondary outcomes (1)

  1. Assessment of the Immunogenicity of the ChAdOx1.tHIVconsv1 and MVA.tHIVconsv3 & 4 Vaccines Administered Sequentially.

    The proportion of participants that develop T-cell responses to tHIVconsvx measured by IFN-gamma ELISpot assay

    Measured: Up to 5 months

Timeline

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

  1. First posted14 Oct 2020
  2. Study start3 Jul 2021
  3. Primary completion3 Aug 2022
  4. Study completion3 Aug 2022

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
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Model description
The first three participants will receive a low dose of ChAdOx1.tHIVconsv1 only. A further ten participants will receive a higher dose of ChAdOx1.tHIVconsv1 and a subsequent vaccination of MVA.tHIVconsv3 and MVA.tHIVconsv4
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04586673
Sponsor's protocol ID
HIV-CORE 0052
Status last verified
Aug 2023
First submitted
1 Oct 2020
Last updated
29 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Borthwick N, Fernandez N, Hayes PJ, Wee EG, Akis Yildirim BM, Baines A, Baker M, Byard N, Conway O, Glaze M, Jenkin D, Larkworthy C, Luciw M, Platt A, Poulton I, Thomas M, Quaddy J, Watson M, Crook A, Cicconi P, Hanke T. Safety and immunogenicity of the ChAdOx1-MVA-vectored conserved mosaic HIVconsvX candidate T-cell vaccines in HIV-CORE 005.2, an open-label, dose-escalation, first-in-human, phase 1 trial in adults living without HIV-1 in the UK. Lancet Microbe. 2025 Mar;6(3):100956. doi: 10.1016/j.lanmic.2024.100956. Epub 2024 Nov 26.

    PubMed 39612921

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ChAdOx1.tHIVconsv1 (C1), MVA.tHIVconsv3 (M3) and MVA.tHIVconsv4 (M4) in people with HIV, run by University of Oxford at 1 site 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 28 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 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

Yes. Results are posted in the registry (first posted 3 Sep 2024). 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?

Assessement of Safety (time frame: 140 days). 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 NCT04586673, 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 29 Apr 2025.

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Clinical Trial NCT04586673 | AzTrials