A Phase 1/2a Open Label Trial to Assess Safety and Immunogenicity of Candidate T-cell Vaccines ChAdOx1.HTI and MVA.HTI Given Sequentially to Healthy HIV-1/2 Negative Adult Volunteers in Oxford, UK

University of Oxford1 site in 1 country10 target enrollmentNovember 1, 2021

ConditionsHealthy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy
Sponsor: University of Oxford
Enrollment: 10
Locations: 1
Primary Endpoint: Collection of data on adverse events.
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 1, 2021

End Date

August 16, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Oxford

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

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
•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

Outcomes

Primary Outcomes

Collection of data on adverse events.

Time Frame: Up to 8 months

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