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NCT04586673

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

Completed Phase 1 Results posted Last updated 29 April 2025
What this trial tests

Phase 1 trial testing ChAdOx1.tHIVconsv1 (C1) in HIV in 13 participants. Completed in 3 August 2022.

Timeline
3 July 2021
Primary endpoint
3 August 2022
3 August 2022

Quick facts

Lead sponsorUniversity of Oxford
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposeprevention
Enrollment13
Start date3 July 2021
Primary completion3 August 2022
Estimated completion3 August 2022
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

University of Oxford

Who can join

Adults 18 to 65, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Assessement of Safety Primary · 140 days

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

GroupValue95% CI
ChAdOx1.tHIVconsv1 Low Dose0
ChADOx1.tHIVconsv1 Higher Dose0
Assement of Safety Primary · up to 28 days after each vaccination

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

GroupValue95% CI
ChAdOx1.tHIVconsv1 Low Dose0
ChADOx1.tHIVconsv1 Higher Dose6
Assessment of Safety Primary · up to day 7

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

GroupValue95% CI
ChAdOx1.tHIVconsv1 Low Dose3
ChADOx1.tHIVconsv1 Higher Dose10
Assessment of the Immunogenicity of the ChAdOx1.tHIVconsv1 and MVA.tHIVconsv3 & 4 Vaccines Administered Sequentially. Secondary · Up to 5 months

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

GroupValue95% CI
ChAdOx1.tHIVconsv1 Low Dose3
ChADOx1.tHIVconsv1 Higher Dose10

Adverse events — posted to ClinicalTrials.gov

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.

ChAdOx1.tHIVconsv1 Low Dose
Serious: 0/3 (0%)
Deaths: 0/3
ChADOx1.tHIVconsv1 Higher Dose
Serious: 0/10 (0%)
Deaths: 0/10
Other adverse events (21 terms — click to expand)

ReactionSystemChAdOx1.tHIVconsv1 Low DoseChADOx1.tHIVconsv1 Higher …
myalgiaGeneral disorders
HeadacheGeneral disorders
FatigueGeneral disorders
MalaiseGeneral disorders
pain at injection siteSkin and subcutaneous tissue disorders
feverishnessGeneral disorders
arthralgiaGeneral disorders
NauseaGastrointestinal disorders
warmth at injection siteSkin and subcutaneous tissue disorders
redness at injection siteSkin and subcutaneous tissue disorders
VomitingGastrointestinal disorders
lymphopeniaBlood and lymphatic system disorders
feverGeneral disorders
FatigueGeneral disorders
palpitationsCardiac disorders
diarrhoeaGastrointestinal disorders
Rhinitis AllergicRespiratory, thoracic and mediastinal disorders
gastric painGastrointestinal disorders
constipationGastrointestinal disorders
Loss of appetiteGastrointestinal disorders
itch in injection siteSkin and subcutaneous tissue disorders

Data from ClinicalTrials.gov NCT04586673 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. HIV vaccinology: 2021 update.
    Lee JH, Crotty S. · · 2021 · cited 46× · PMID 34272086 · DOI 10.1016/j.smim.2021.101470
  2. Current Status of HIV-1 Vaccines.
    Hargrave A, Mustafa AS, Hanif A, Tunio JH, et al · · 2021 · cited 26× · PMID 34579263 · DOI 10.3390/vaccines9091026
  3. Effect of epitope variant co-delivery on the depth of CD8 T cell responses induced by HIV-1 conserved mosaic vaccines.
    Wee EG, Moyo N, Hannoun Z, Giorgi EE, et al · · 2021 · cited 12× · PMID 34169114 · DOI 10.1016/j.omtm.2021.04.018
  4. 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.
    Borthwick N, Fernandez N, Hayes PJ, Wee EG, et al · · 2025 · cited 9× · PMID 39612921 · DOI 10.1016/j.lanmic.2024.100956
  5. The Question of HIV Vaccine: Why Is a Solution Not Yet Available?
    Libera M, Caputo V, Laterza G, Moudoud L, et al · · 2024 · cited 9× · PMID 38628675 · DOI 10.1155/2024/2147912
  6. Assessment of a diverse panel of transmitted/founder HIV-1 infectious molecular clones in a luciferase based CD8 T-cell mediated viral inhibition assay.
    Fernandez N, Hayes P, Makinde J, Hare J, et al · · 2022 · cited 5× · PMID 36532063 · DOI 10.3389/fimmu.2022.1029029
  7. Adenovirus Transcriptome in Human Cells Infected with ChAdOx1-Vectored Candidate HIV-1 Vaccine Is Dominated by High Levels of Correctly Spliced HIVconsv1&62 Transgene RNA.
    Matthews DA, Milligan R, Wee EG, Hanke T. · · 2023 · cited 2× · PMID 37515003 · DOI 10.3390/vaccines11071187
  8. Prospects for therapeutic T-cell vaccine strategies for HIV cure.
    Mothe B, Brander C. · · 2025 · cited 1× · PMID 40638102 · DOI 10.1097/coh.0000000000000965

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04586673.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing