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

NCT04586673 | Completed Phase 1 Results DMC

• 1 other identifier: HIV-CORE 0052
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

vaccine

Outcome Measures

Primary Outcomes (3)

• Assessement of Safety

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

  140 days

• Assement of Safety

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

  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

  up to day 7

Secondary Outcomes (1)

• Assessment of the Immunogenicity of the ChAdOx1.tHIVconsv1 and MVA.tHIVconsv3 & 4 Vaccines Administered Sequentially.

  Up to 5 months

Study Arms (2)

ChAdOx1.tHIVconsv1 low dose

EXPERIMENTAL

3 participants will receive one dose of ChAdOx1.tHIVconsv1 at 5 x 10\^9 vp

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.

Biological: ChAdOx1.tHIVconsv1 (C1); Biological: MVA.tHIVconsv3 (M3); Biological: MVA.tHIVconsv4 (M4)

Interventions

ChAdOx1.tHIVconsv1 (C1) BIOLOGICAL

ChAdOx1.tHIVconsv1 5 x 10\^9 vp

ChAdOx1.tHIVconsv1 low dose

MVA.tHIVconsv3 (M3) BIOLOGICAL

MVA.tHIVconsv3 1 x 10\^8 pfu

ChADOx1.tHIVconsv1 higher dose

MVA.tHIVconsv4 (M4) BIOLOGICAL

MVA.tHIVconsv4 09. x 10\^8 pfu

ChADOx1.tHIVconsv1 higher dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39612921 DERIVED

Results Point of Contact

• Title: Dr Paola Cicconi
• Organization: University of Oxford

paola.cicconi@ndm.ox.ac.uk

01865611425

Study Officials

• Paola Cicconi

  Dr Paola Cicconi

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 14, 2020
• Study Start: July 3, 2021
• Primary Completion: August 3, 2022
• Study Completion: August 3, 2022
• Last Updated: April 29, 2025
• Results First Posted: September 3, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)