HealthyPhase 1/2NCT04563377
Safety and Immunogenicity of Candidate HIV Vaccines Given Sequentially
A Phase 1/2 study testing ChAdOx1.HTI and MVA.HTI in people with Healthy, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The primary object of the study is to assess the safety profile of candidate vaccines ChAdOx1.HTI and MVA.HTI 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
- Healthy
- What is being tested?
- ChAdOx1.HTI and MVA.HTI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2021to 16 Aug 2022
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults 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 (defined as a fertile woman post-menarche until post-menopausal, unless permanently sterile due to total abdominal hysterectomy, bilateral salpingectomy and bilateral oophorectomy) 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, 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
- 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.HTI IMP
- Receipt of any investigational HIV-1/2 vaccine within the last 6 years
- 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 known HIV-1/2-infected person or a casual partner (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, gonorrhoea 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 1/2a Open Label Trial to Assess Safety and Immunogenicity of Candidate T-cell Vaccines ChAdOx1.HTI and MVA.HTI Given Sequentially to Healthy HIV-1/2 Negative Adult Volunteers in Oxford, UK
The primary object of the study is to assess the safety profile of candidate vaccines ChAdOx1.HTI and MVA.HTI 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.HTI and MVA.HTI administered sequentially in healthy HIV-1/2 negative adult volunteers.
10 healthy, HIV-negative adult volunteers will receive one vaccination of CHAdOx1.HTI followed by a one vaccination of MVA.HTI 8 weeks later.
- Conditions
- Healthy
- Being tested
- ChAdOx1.HTI and MVA.HTI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAdOx1.HTI and MVA.HTIBiological
ChAdOx1. HTI dose 5 x 10^10 vp MVA.HTI dose 2 x 10^8 pfu
| Study group | Role | What they receive |
|---|---|---|
| ChAdOx1.HTI and MVA.HTI vaccination | Experimental | 1x dose of ChAdOx1.HTI at 5 x 10^10 vp
1x dose of MVA.HTI at 2 x 10^8 pfu Receives: Biological: ChAdOx1.HTI and MVA.HTI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of data on adverse events.
Occurrence of reactogenicity signs and symptoms for 7 days following vaccination Change from baseline for safety laboratory measures Occurrence of serious adverse events during the whole study duration
Measured: Up to 8 months
Secondary outcomes (1)
Assessing the immunogenicity of the ChAdOx1.HTI and MVA.HTI vaccines administered sequentially
Proportion of participants that develop T cell responses to HTI-encoded regions as determined by IFN-γ ELISPOT assay
Measured: Up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Nov 2021
- Primary completion16 Aug 2022
- Study completion16 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1/2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT04563377
- Sponsor's protocol ID
- HIV-CORE 0051
- Status last verified
- Aug 2022
- First submitted
- 10 Sep 2020
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Open Label Trial to Assess Safety and Immunogenicity of Candidate T-cell Vaccines ChAdOx1.HTI and MVA.HTI Given Sequentially to Healthy HIV-1/2 Negative Adult Volunteers in Oxford, UK
- ClinicalTrials.gov ID
- NCT04563377
- Acronym / sponsor ID
- HIV-CORE 0051
- Conditions
- Healthy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 16 Aug 2022 (actual)
- First posted
- 24 Sep 2020 (actual)
- 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 primary object of the study is to assess the safety profile of candidate vaccines ChAdOx1.HTI and MVA.HTI 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.HTI and MVA.HTI administered sequentially in healthy HIV-1/2 negative adult volunteers.
10 healthy, HIV-negative adult volunteers will receive one vaccination of CHAdOx1.HTI followed by a one vaccination of MVA.HTI 8 weeks later.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ChAdOx1.HTI and MVA.HTI vaccination | Experimental | Biological: ChAdOx1.HTI and MVA.HTI1x dose of ChAdOx1.HTI at 5 x 10^10 vp 1x dose of MVA.HTI at 2 x 10^8 pfu |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy adults 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 (defined as a fertile woman post-menarche until post-menopausal, unless permanently sterile due to total abdominal hysterectomy, bilateral salpingectomy and bilateral oophorectomy) 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
Key exclusion criteria (28 listed)
- 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
- 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.HTI IMP
- Receipt of any investigational HIV-1/2 vaccine within the last 6 years
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 |
|---|---|---|
| ChAdOx1.HTI and MVA.HTIChAdOx1. HTI dose 5 x 10^10 vp MVA.HTI dose 2 x 10^8 pfu | Biological | ChAdOx1.HTI and MVA.HTI vaccination |
Primary outcome
Collection of data on adverse events.
Time frame: Up to 8 months
Occurrence of reactogenicity signs and symptoms for 7 days following vaccination Change from baseline for safety laboratory measures Occurrence of serious adverse events during the whole study duration
1 secondary outcome
Assessing the immunogenicity of the ChAdOx1.HTI and MVA.HTI vaccines administered sequentially
Time frame: Up to 8 months
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 1 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Paola Cicconi principal investigator
Dr Paola Cicconi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ChAdOx1.HTI and MVA.HTI in people with Healthy, 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 1 Sep 2022. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Collection of data on adverse events. (time frame: Up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2022.