HIVPhase 2AbVaxNCT07054931
Combination Vaccination and Broadly Neutralising Antibody Therapy in HIV
A Phase 2 study testing ChAdOx1.tHIVconsv1, ChAdOx1.HIVconsv62 and MVA.tHIVconsv4 in people with HIV, run by University of Oxford at 3 sites in United Kingdom.
Trial summary
There is no cure for HIV infection. Antiretroviral therapy (ART) is widely available but requires daily, life-long intake. This can cause issues around side-effects, resistance, adherence and stigma. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- HIV
- What is being tested?
- ChAdOx1.tHIVconsv1, ChAdOx1.HIVconsv62 and MVA.tHIVconsv4
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 5 Sep 2025to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- PWH aged ≥18 to ≤64 years old at screening
- Able to give informed written consent including consent to long-term follow-up
- Willing and able to comply with visit schedule and provide blood sampling
- Willing to consent to their HIV care team being informed of their participation and sharing relevant clinical information
- Stable on oral ART with suppressed undetectable HIV pVL 'target not detected' (TND) using local assays for ≥ 1 years (a single viral load measurement >50 but <500 copies/ml during this time period is allowable)
- No evidence of viral insensitivity to GS-2872 based on proviral sequencing
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- No significant co-morbidities according to the investigator's opinion
- Nadir CD4 >200 cells/µl unless treatment commenced during documented acute seroconversion
- Current CD4 count >500 cells/µl or CD4:CD8 ratio >1.0
- On integrase inhibitor (INSTI) or boosted protease inhibitor (bPI) based regimen at time of randomisation. If previously on non-nucleoside reverse transcriptase inhibitor (NNRTI) must have switched at least 4 weeks prior to randomisation
- Adequate haemoglobin (Hb ≥12 g/dL for males, ≥11 g/dL for females)
- Weight ≥ 50kg
- Has received at least 3 doses of vaccination against coronavirus (COVID-19), at least 4 weeks prior to randomisation
- Has received current seasonal vaccination against Influenza*
- People of childbearing potential must agree to use hormonal contraception, intrauterine device, intrauterine hormone-releasing system, or otherwise practice complete abstinence* from at least two weeks before the first Investigational Medicinal Product (IMP) administration, for at least 20 months after the last IMP administration, and until undetectable viral load on ART
- All participants must agree to take precautions to prevent onward transmission of HIV (such as condoms or PrEP) whilst they are off ART and/or have a detectable viral load * Applicable during Influenza season (September-April inclusive). **Individuals capable of becoming pregnant are defined as those who are fertile, with childbearing reproductive organs, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Permanent sterilisation of the participant's sole partner (e.g. vasectomy) is also accepted.
- A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in those not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- Complete abstinence (defined as refraining from heterosexual intercourse) must be in line with the preferred and usual lifestyle of the participant. Barrier contraception, periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation methods), withdrawal and progestogen-only oral hormonal contraception where inhibition of ovulation is not the primary mode of action are not acceptable methods of contraception.
Who cannot join
- • Previous ischaemic heart disease (ST or non-ST myocardial infarction, Q3-risk >20, stable angina, unstable angina, stroke)
- Any current or past history of malignancy, excluding squamous cell skin cancers
- Concurrent opportunistic infection or other co-morbidity likely to occur during the trial e.g.
- malabsorption syndromes, autoimmune disease
- Any contraindication to receipt of BHIVA recommended combination antiretrovirals
- Current treatment with injectable ART
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- HTLV-1 co-infection
- Any evidence of major antiretroviral resistance mutations
- Evidence of HBV infection requiring treatment (HBsAg+, or HBcAb+ without HBsAb+)
- Evidence of HCV infection (HCVAg+ and/or HCV RNA detected)
- Individuals at high risk from severe Covid-19 disease who may be defined in accordance with NHSE guidance as vulnerable and shielded (as per the view of participant's physician)
- Current or planned systemic immunosuppressive therapy (inhaled and topical corticosteroids are allowed)
- Participation in another research study involving receipt of an investigational medicinal product (IMP) in the 3 months preceding enrolment or 5 half-lives of the investigational medicinal product, whichever is longer, or planned participation during the study period (concurrent observational studies are allowed)
- History of anaphylaxis or severe adverse reaction to antibody infusions, or hypersensitivity to GS-2872 or GS-5423 or to any constituent products or excipients thereof
- History of anaphylaxis or severe adverse reaction to any previous vaccine
- A history of thrombosis with thrombocytopaenia syndrome (TTS) following vaccination with any adenoviral vector vaccines
- A history of anti-phospholipid syndrome
- A history of heparin-induced thrombocytopenia
- A history of cerebral venous sinus thrombosis
- Any history of other bleeding or clotting disorders of clinical significance according to the investigator's discretion
- Known anti-PF4 antibody positivity
- Treatment with IV immunoglobulin or other monoclonal antibody treatments planned during the duration of the trial
- Clinically significant abnormal blood test results at screening including
- Moderate to severe hepatic impairment as defined by significant liver impairment with evidence of advanced fibrosis or cirrhosis with decompensation
- ALT >5 x ULN
- eGFR <601
- uPCR >30 mg/mmol
- INR >1.5
- Evidence of organ dysfunction or any clinically significant deviation from normal in medical history, physical examination and/or vital signs that the investigator believes is a preclusion from enrolment into the study
- Active alcohol or substance use that, in the investigator's opinion, will prevent adequate adherence with study requirements
- Insufficient venous access that will allow scheduled blood draws as per protocol
- Concern regarding likelihood of participant not taking precautions to prevent HIV transmission during treatment interruption period
- Pregnancy, lactation or intending to become pregnant
- Participants unable to be followed closely for geographic, social or psychological reasons
- Participants unable to adequately understand written or verbal English to appropriately consent to the study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom3 sites, 3 recruiting
- Recruiting
Guys and St Thomas' NHS Trust
London, SE1 7EH
Julie Fox, BSc, MBChB, MRCP, MD, 00000, julie.fox@kcl.ac.uk
- Recruiting
St Mary's Clinical Trial Unit
London, W2 1NY
Sarah Fidler, BSc, MBBS, FRCP, PhD, 00000, s.fidler@imperial.ac.uk
- Recruiting
Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)
Oxford, OX3 7LJ
Paola Cicconi, MD, 00 44 1865 611425, paola.cicconi@ndm.ox.ac.uk
About this study
Official title: AbVax: Combination Vaccination and Broadly Neutralising Antibody Therapy in HIV to Induce a Protective T-cell 'Vaccinal Effect' - a Randomised Phase II Clinical Trial
There is no cure for HIV infection. Antiretroviral therapy (ART) is widely available but requires daily, life-long intake. This can cause issues around side-effects, resistance, adherence and stigma. A new therapy, broadly neutralising antibodies, (bNAbs), may work as well as ART and may last longer - one dose can last six months. bNAbs appear to first target HIV viruses, then drive a protective immune response conferring long-term control, called the vaccinal effect. AbVax is a clinical trial to understand this effect and how to enhance it to give the strongest possible long-term protection for people living with HIV (PWH). The investigators are studying whether a combination of vaccines that attack HIV, a short period of treatment interruption induced viraemia (TIIV - stopping ART for a few weeks to allow a small amount of virus to return to the bloodstream) and bNABs will produce the most sustained immune protection.
Read the detailed description
AbVax will recruit 48 otherwise healthy PWH aged 18-64. Participants will be randomised across three groups (arms) to determine the best combination of treatment. In Arm A, participants will undergo a period of TIIV, then receive two bNAb infusions. In Arm B, participants receive a combination of three HIV vaccines (one prime dose followed by two booster doses after 4 and 16 weeks), then are given two bNAb infusions. In Arm C, participants will undergo a period of TIIV, then receive the same vaccination combinations as Arm B, then receive two bNAb infusions. All participants then stop ART for an analytical treatment interruption (ATI) to determine the clinical impact and measure how long before any HIV returns to the blood. This allows the investigators to see if vaccines and TIIV add to the protection provided by bNAbs and by how much.
- Conditions
- HIV
- Being tested
- ChAdOx1.tHIVconsv1, ChAdOx1.HIVconsv62, MVA.tHIVconsv4, GS-5423, GS-2872
- Keywords
- vaccination, broadly neutralising antibodies, HIV treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAdOx1.tHIVconsv1Biological
solution for injection one dose of 2.5 x 10^10 vp/ml Arm B and Arm C
ChAdOx1.HIVconsv62Biological
solution for injection one dose of 2.5 x 10^10 vp/ml Arm B and Arm C
MVA.tHIVconsv4Biological
suspension for injection two doses of 1 x 10^8 vpu/ml Arm B and Arm C
GS-5423Biological
Solution for infusion 2550 mg Arm A, Arm B and Arm C
GS-2872Biological
Solution for infusion 850 mg Arm A, Arm B and Arm C
Treatment interruption induced viraemiaOther
Participants pause ART before receiving vaccines and/or bNAbs Arm A and Arm C
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Participants in Arm A will undergo a period of treatment interruption induced viraemia followed by two infusions of broadly neutralising antibodies (GS-5423 and GS-2872). They will then stop ART for an analytical treatment interruption period to determine the clinical impact and to measure how long before any HIV virus returns to the blood. Receives: Biological: GS-5423; Biological: GS-2872; Other: Treatment interruption induced viraemia |
| Arm B | Active comparator | Participants in Arm B will receive a combination of three HIV vaccines (one prime dose (ChAdOx1.tHIVconsv1 and ChAdOx1.HIVconsv62) followed by two booster doses of MVA.tHIVconsv4 at 4 weeks and 16 weeks), followed by two infusions of broadly neutralising antibodies, GS-5423 and GS-2872. They will then stop ART for an analytical treatment interruption period to determine the clinical impact and to measure how long before any HIV virus returns to the blood. Receives: Biological: ChAdOx1.tHIVconsv1; Biological: ChAdOx1.HIVconsv62; Biological: MVA.tHIVconsv4; Biological: GS-5423; Biological: GS-2872 |
| Arm C | Active comparator | Participants in Arm C will undergo a period of treatment interruption induced viraemia followed by a combination of three HIV vaccines (one prime dose (ChAdOx1.tHIVconsv1 and ChAdOx1.HIVconsv62) followed by two booster doses of MVA.tHIVconsv4 at 4 weeks and 16 weeks), followed by two infusions of broadly neutralising antibodies, GS-5423 and GS-2872. They will then stop ART for an analytical treatment interruption period to determine the clinical impact and to measure how long before any HIV virus returns to the blood. Receives: Biological: ChAdOx1.tHIVconsv1; Biological: ChAdOx1.HIVconsv62; Biological: MVA.tHIVconsv4; Biological: GS-5423; Biological: GS-2872; Other: Treatment interruption induced viraemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fold change in T cell immune response to the HIV Gag protein
The geometric mean of the fold-change (GMFC) will be compared between Arm C compared to Arm A; and Arm C compared to Arm B.
Measured: Baseline and 12 weeks after ATI
Secondary outcomes (11)
Safety Assessment
Occurrence of Serious Adverse Events for the whole study duration.
Measured: From enrollment until 16 weeks after restarting ART after ATI
Safety Assessment
Number of participants with adverse events (not including SAEs)
Measured: From enrollment until 16 weeks after ART restart after ATI
HIV viral control
% of participants with undetectable plasma viral load
Measured: Weeks 12 and weeks 24 after ATI
Immunological correlation of virological remission
CD4 T cell counts and CD8:CD4 ratios
Measured: Week 12 and week 24 after ATI
Immunological correlates of virological remission
HIV specific T cell immune response using multiple assays
Measured: Weeks 12 and 24 after ATI
BNAb plasma concentration
bNAb maximum plasma concentration (Cmax)
Measured: Weeks 12 and 24 after ATI
ART plasma concentration
Maximum plasma concentration (Cmax) of ART
Measured: Week 12 and week 24 after ATI
Vaccine specific response
Proportion of participants that develop T cell response to HIVconsv immunogens
Measured: Weeks 12 and 24 after ATI
HIV reservoir assessment
Measures of HIV reservoirs
Measured: Weeks 12 and 24 after ATI
bNAb escape
Proportion of participants with bNAb resistance
Measured: Weeks 12 and 24 after ATI
T cell escape
Proportion of participants with T cell escape mutations
Measured: Weeks 12 and 24 after ATI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start5 Sep 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomised to one of three arms. Participants in Arm A undergo a period of treatment interruption induced viraemia, followed by two bNAB infusions (GS-5423 and GS-2872). Participants in Arm B receive three HIV vaccines (one prime dose of two vaccines, ChAdOx1.tHIVconsv1 and ChAdOx2.HIVconsv62 and two booster doses of MVA.tHIVconsv4 after 4 and 16 weeks), followed by two bNAb infusions (GS-5423 and GS-2872). Participants in Arm C undergo a period of treatment interruption induced viraemia, followed by three HIV vaccines (one prime dose of two vaccines, ChAdOx1.tHIVconsv1 and ChAdOx2.HIVconsv62 and two booster doses of MVA.tHIVconsv4 after 4 and 16 weeks), followed by two bNAb infusions (GS-5423 and GS-2872). All participants then undergo a period of analytical treatment interruption where there responses to the interventions are measured.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054931
- Sponsor's protocol ID
- AbVax
- Other IDs
- MR/Y008847/1
- Acronym
- AbVax
- Status last verified
- Jun 2026
- First submitted
- 16 May 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The aim is to provide a summary of the results or a link to summary results within the trial registration record. Fully anonymised results will be published in peer reviewed papers and presented at conferences
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AbVax: Combination Vaccination and Broadly Neutralising Antibody Therapy in HIV to Induce a Protective T-cell 'Vaccinal Effect' - a Randomised Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07054931
- Acronym / sponsor ID
- AbVax / AbVax
- Conditions
- HIV
- Keywords
- vaccination, broadly neutralising antibodies, HIV treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 8 Jul 2025 (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.
There is no cure for HIV infection. Antiretroviral therapy (ART) is widely available but requires daily, life-long intake. This can cause issues around side-effects, resistance, adherence and stigma. A new therapy, broadly neutralising antibodies, (bNAbs), may work as well as ART and may last longer - one dose can last six months. bNAbs appear to first target HIV viruses, then drive a protective immune response conferring long-term control, called the vaccinal effect. AbVax is a clinical trial to understand this effect and how to enhance it to give the strongest possible long-term protection for people living with HIV (PWH). The investigators are studying whether a combination of vaccines that attack HIV, a short period of treatment interruption induced viraemia (TIIV - stopping ART for a few weeks to allow a small amount of virus to return to the bloodstream) and bNABs will produce the most sustained immune protection.
Detailed description
AbVax will recruit 48 otherwise healthy PWH aged 18-64. Participants will be randomised across three groups (arms) to determine the best combination of treatment. In Arm A, participants will undergo a period of TIIV, then receive two bNAb infusions. In Arm B, participants receive a combination of three HIV vaccines (one prime dose followed by two booster doses after 4 and 16 weeks), then are given two bNAb infusions. In Arm C, participants will undergo a period of TIIV, then receive the same vaccination combinations as Arm B, then receive two bNAb infusions. All participants then stop ART for an analytical treatment interruption (ATI) to determine the clinical impact and measure how long before any HIV returns to the blood. This allows the investigators to see if vaccines and TIIV add to the protection provided by bNAbs and by how much.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are randomised to one of three arms. Participants in Arm A undergo a period of treatment interruption induced viraemia, followed by two bNAB infusions (GS-5423 and GS-2872). Participants in Arm B receive three HIV vaccines (one prime dose of two vaccines, ChAdOx1.tHIVconsv1 and ChAdOx2.HIVconsv62 and two booster doses of MVA.tHIVconsv4 after 4 and 16 weeks), followed by two bNAb infusions (GS-5423 and GS-2872). Participants in Arm C undergo a period of treatment interruption induced viraemia, followed by three HIV vaccines (one prime dose of two vaccines, ChAdOx1.tHIVconsv1 and ChAdOx2.HIVconsv62 and two booster doses of MVA.tHIVconsv4 after 4 and 16 weeks), followed by two bNAb infusions (GS-5423 and GS-2872). All participants then undergo a period of analytical treatment interruption where there responses to the interventions are measured.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Biological: GS-5423, Biological: GS-2872, Other: Treatment interruption induced viraemiaParticipants in Arm A will undergo a period of treatment interruption induced viraemia followed by two infusions of broadly neutralising antibodies (GS-5423 and GS-2872). They will then stop ART for an analytical treatment interruption period to determine the clinical impact and to measure how long before any HIV virus returns to the blood. |
| Arm B | Active comparator | Biological: ChAdOx1.tHIVconsv1, Biological: ChAdOx1.HIVconsv62, Biological: MVA.tHIVconsv4, Biological: GS-5423, Biological: GS-2872Participants in Arm B will receive a combination of three HIV vaccines (one prime dose (ChAdOx1.tHIVconsv1 and ChAdOx1.HIVconsv62) followed by two booster doses of MVA.tHIVconsv4 at 4 weeks and 16 weeks), followed by two infusions of broadly neutralising antibodies, GS-5423 and GS-2872. They will then stop ART for an analytical treatment interruption period to determine the clinical impact and to measure how long before any HIV virus returns to the blood. |
| Arm C | Active comparator | Biological: ChAdOx1.tHIVconsv1, Biological: ChAdOx1.HIVconsv62, Biological: MVA.tHIVconsv4, Biological: GS-5423, Biological: GS-2872, Other: Treatment interruption induced viraemiaParticipants in Arm C will undergo a period of treatment interruption induced viraemia followed by a combination of three HIV vaccines (one prime dose (ChAdOx1.tHIVconsv1 and ChAdOx1.HIVconsv62) followed by two booster doses of MVA.tHIVconsv4 at 4 weeks and 16 weeks), followed by two infusions of broadly neutralising antibodies, GS-5423 and GS-2872. They will then stop ART for an analytical treatment interruption period to determine the clinical impact and to measure how long before any HIV virus returns to the blood. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- PWH aged ≥18 to ≤64 years old at screening
- A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in those not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- Complete abstinence (defined as refraining from heterosexual intercourse) must be in line with the preferred and usual lifestyle of the participant. Barrier contraception, periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation methods), withdrawal and progestogen-only oral hormonal contraception where inhibition of ovulation is not the primary mode of action are not acceptable methods of contraception.
Key exclusion criteria (35 listed)
- • Previous ischaemic heart disease (ST or non-ST myocardial infarction, Q3-risk >20, stable angina, unstable angina, stroke)
- malabsorption syndromes, autoimmune disease
- Any contraindication to receipt of BHIVA recommended combination antiretrovirals
- Current treatment with injectable ART
- HTLV-1 co-infection
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.tHIVconsv1solution for injection one dose of 2.5 x 10^10 vp/ml Arm B and Arm C | Biological | Arm B, Arm C |
| ChAdOx1.HIVconsv62solution for injection one dose of 2.5 x 10^10 vp/ml Arm B and Arm C | Biological | Arm B, Arm C |
| MVA.tHIVconsv4suspension for injection two doses of 1 x 10^8 vpu/ml Arm B and Arm C | Biological | Arm B, Arm C |
| GS-5423Solution for infusion 2550 mg Arm A, Arm B and Arm C | Biological | Arm A, Arm B, Arm C |
| GS-2872Solution for infusion 850 mg Arm A, Arm B and Arm C | Biological | Arm A, Arm B, Arm C |
| Treatment interruption induced viraemiaParticipants pause ART before receiving vaccines and/or bNAbs Arm A and Arm C | Other | Arm A, Arm C |
Primary outcome
Fold change in T cell immune response to the HIV Gag protein
Time frame: Baseline and 12 weeks after ATI
The geometric mean of the fold-change (GMFC) will be compared between Arm C compared to Arm A; and Arm C compared to Arm B.
11 secondary outcomes
Safety Assessment
Time frame: From enrollment until 16 weeks after restarting ART after ATI
Safety Assessment
Time frame: From enrollment until 16 weeks after ART restart after ATI
HIV viral control
Time frame: Weeks 12 and weeks 24 after ATI
Immunological correlation of virological remission
Time frame: Week 12 and week 24 after ATI
Immunological correlates of virological remission
Time frame: Weeks 12 and 24 after ATI
BNAb plasma concentration
Time frame: Weeks 12 and 24 after ATI
ART plasma concentration
Time frame: Week 12 and week 24 after ATI
Vaccine specific response
Time frame: Weeks 12 and 24 after ATI
HIV reservoir assessment
Time frame: Weeks 12 and 24 after ATI
bNAb escape
Time frame: Weeks 12 and 24 after ATI
T cell escape
Time frame: Weeks 12 and 24 after ATI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. The aim is to provide a summary of the results or a link to summary results within the trial registration record. Fully anonymised results will be published in peer reviewed papers and presented at conferences
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ChAdOx1.tHIVconsv1, ChAdOx1.HIVconsv62 and MVA.tHIVconsv4 in people with HIV, run by University of Oxford at 3 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 18 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola Cicconi, MD, PhD (00 44 1865 611425, paola.cicconi@paediatrics.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fold change in T cell immune response to the HIV Gag protein (time frame: Baseline and 12 weeks after ATI). 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 7 Jul 2026.