Safety and Immunogenicity of Candidate HIV Vaccines Given Sequentially

NCT04563377 | Completed Phase 1

• 1 other identifier: HIV-CORE 0051
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The primary object of the study is to assess the safety profile of candidate vaccines ChAdOx1.HTI and MVA.HTI 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.HTI and MVA.HTI administered sequentially in healthy HIV-1/2 negative adult volunteers. 10 healthy, HIV-negative adult volunteers will receive one vaccination of CHAdOx1.HTI followed by a one vaccination of MVA.HTI 8 weeks later.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Collection of data on adverse events.

  Occurrence of reactogenicity signs and symptoms for 7 days following vaccination Change from baseline for safety laboratory measures Occurrence of serious adverse events during the whole study duration

  Up to 8 months

Secondary Outcomes (1)

• Assessing the immunogenicity of the ChAdOx1.HTI and MVA.HTI vaccines administered sequentially

  Up to 8 months

Study Arms (1)

ChAdOx1.HTI and MVA.HTI vaccination

EXPERIMENTAL

1x dose of ChAdOx1.HTI at 5 x 10\^10 vp 1x dose of MVA.HTI at 2 x 10\^8 pfu

Biological: ChAdOx1.HTI and MVA.HTI

Interventions

ChAdOx1.HTI and MVA.HTI BIOLOGICAL

ChAdOx1. HTI dose 5 x 10\^10 vp MVA.HTI dose 2 x 10\^8 pfu

ChAdOx1.HTI and MVA.HTI vaccination

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 adults 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 (defined as a fertile woman post-menarche until post-menopausal, unless permanently sterile due to total abdominal hysterectomy, bilateral salpingectomy and bilateral oophorectomy) 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, 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
• 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.HTI IMP
• Receipt of any investigational HIV-1/2 vaccine within the last 6 years
• 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

Study Officials

• Paola Cicconi

  Dr Paola Cicconi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 24, 2020
• Study Start: November 1, 2021
• Primary Completion: August 16, 2022
• Study Completion: August 16, 2022
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)