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.
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
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
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- 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
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 group | Role | What they receive |
|---|---|---|
| ChAdOx1.tHIVconsv1 low dose | Experimental | 3 participants will receive one dose of ChAdOx1.tHIVconsv1 at 5 x 10^9 vp Receives: Biological: ChAdOx1.tHIVconsv1 (C1) |
| ChADOx1.tHIVconsv1 higher dose | Experimental | 10 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.
Assessement of Safety
- Proportion of volunteers with vaccine related serious adverse events (SAEs) collected up to day 140 after enrollment.
Measured: 140 days
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
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)
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.
- First posted14 Oct 2020
- Study start3 Jul 2021
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
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 HIVStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paola Cicconi, Principal investigator, Dr Paola Cicconi
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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