• Proportion of volunteers with vaccine related serious adverse events (SAEs) collected up to day 140 after enrollment.
| Group | Value | 95% CI |
|---|---|---|
| ChAdOx1.tHIVconsv1 Low Dose | 0 | |
| ChADOx1.tHIVconsv1 Higher Dose | 0 |
Last reviewed · How we verify
A Study to Assess Safety and Immunogenicity of Conserved Mosaic HIV-1 Vaccines
Phase 1 trial testing ChAdOx1.tHIVconsv1 (C1) in HIV in 13 participants. Completed in 3 August 2022.
| Lead sponsor | University of Oxford |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 13 |
| Start date | 3 July 2021 |
| Primary completion | 3 August 2022 |
| Estimated completion | 3 August 2022 |
| Sites | 1 location across United Kingdom |
University of Oxford
Adults 18 to 65, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
• Proportion of volunteers with vaccine related serious adverse events (SAEs) collected up to day 140 after enrollment.
| Group | Value | 95% CI |
|---|---|---|
| ChAdOx1.tHIVconsv1 Low Dose | 0 | |
| ChADOx1.tHIVconsv1 Higher Dose | 0 |
Proportion of volunteers with Grade 3 or 4 unsolicited adverse events (AEs) through 28 days post final vaccination
| Group | Value | 95% CI |
|---|---|---|
| ChAdOx1.tHIVconsv1 Low Dose | 0 | |
| ChADOx1.tHIVconsv1 Higher Dose | 6 |
Proportion of volunteers with local and systemic reactogenicity events from Day 0 to Day 6 post vaccination
| Group | Value | 95% CI |
|---|---|---|
| ChAdOx1.tHIVconsv1 Low Dose | 3 | |
| ChADOx1.tHIVconsv1 Higher Dose | 10 |
The proportion of participants that develop T-cell responses to tHIVconsvx measured by IFN-gamma ELISpot assay
| Group | Value | 95% CI |
|---|---|---|
| ChAdOx1.tHIVconsv1 Low Dose | 3 | |
| ChADOx1.tHIVconsv1 Higher Dose | 10 |
Time frame: Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | ChAdOx1.tHIVconsv1 Low Dose | ChADOx1.tHIVconsv1 Higher … |
|---|---|---|---|
| myalgia | General disorders | — | — |
| Headache | General disorders | — | — |
| Fatigue | General disorders | — | — |
| Malaise | General disorders | — | — |
| pain at injection site | Skin and subcutaneous tissue disorders | — | — |
| feverishness | General disorders | — | — |
| arthralgia | General disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| warmth at injection site | Skin and subcutaneous tissue disorders | — | — |
| redness at injection site | Skin and subcutaneous tissue disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| lymphopenia | Blood and lymphatic system disorders | — | — |
| fever | General disorders | — | — |
| Fatigue | General disorders | — | — |
| palpitations | Cardiac disorders | — | — |
| diarrhoea | Gastrointestinal disorders | — | — |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | — | — |
| gastric pain | Gastrointestinal disorders | — | — |
| constipation | Gastrointestinal disorders | — | — |
| Loss of appetite | Gastrointestinal disorders | — | — |
| itch in injection site | Skin and subcutaneous tissue disorders | — | — |
Data from ClinicalTrials.gov NCT04586673 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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