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

NCT ID: NCT04586673

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-03
• Study Completion Date: 2022-08-03

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ChAdOx1.tHIVconsv1 low dose

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

Group Type: EXPERIMENTAL

ChAdOx1.tHIVconsv1 (C1)

Intervention Type: BIOLOGICAL

ChAdOx1.tHIVconsv1 5 x 10\^9 vp

ChADOx1.tHIVconsv1 higher dose

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.

Group Type: EXPERIMENTAL

ChAdOx1.tHIVconsv1 (C1)

Intervention Type: BIOLOGICAL

ChAdOx1.tHIVconsv1 5 x 10\^10 vp

MVA.tHIVconsv3 (M3)

Intervention Type: BIOLOGICAL

MVA.tHIVconsv3 1 x 10\^8 pfu

MVA.tHIVconsv4 (M4)

Intervention Type: BIOLOGICAL

MVA.tHIVconsv4 09. x 10\^8 pfu

Interventions

ChAdOx1.tHIVconsv1 (C1)

ChAdOx1.tHIVconsv1 5 x 10\^9 vp

Intervention Type: BIOLOGICAL

ChAdOx1.tHIVconsv1 (C1)

ChAdOx1.tHIVconsv1 5 x 10\^10 vp

Intervention Type: BIOLOGICAL

MVA.tHIVconsv3 (M3)

MVA.tHIVconsv3 1 x 10\^8 pfu

Intervention Type: BIOLOGICAL

MVA.tHIVconsv4 (M4)

MVA.tHIVconsv4 09. x 10\^8 pfu

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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 person infected with HIV and not taking effective treatment, injecting drug users or casual partners (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, gonorrhea 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paola Cicconi

Role: PRINCIPAL_INVESTIGATOR

Dr Paola Cicconi

Locations

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

Oxford, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 39612921 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HIV-CORE 0052

Identifier Type: -

Identifier Source: org_study_id