A Study to Determine the Safety and Immunogenicity of a Candidate MAP Vaccines ChAdOx2 HAV and MVA in Healthy Adult Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03027193
• Date of registration: 19/01/2017
• Prospective Registration: Yes
• Primary sponsor: University of Oxford
• Public title: A Study to Determine the Safety and Immunogenicity of a Candidate MAP Vaccines ChAdOx2 HAV and MVA in Healthy Adult Volunteers
• Scientific title: A Phase I Clinical Trial to Determine the Safety and Immunogenicity of the Candidate Mycobacterium Avium Subspecies Paratuberculosis (MAP) Vaccines ChAdOx2 HAV and MVA HAV in Healthy Adult Volunteers
• Date of first enrolment: March 15, 2017
• Target sample size: 28
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03027193
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Adrian V Hill, DPhill FRCP
• Affiliation: Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hosptal, Oxford, United Kingdom

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Healthy adults aged 18 to 50 years

2. Able and willing (in the Investigator's opinion) to comply with all study requirements

3. Willing to allow the investigators to discuss the volunteer's medical history with
their General Practitioner

4. For females only, willingness to practice continuous effective contraception (see
below) during the study and a negative pregnancy test on the day(s) of screening and
vaccination

5. Agreement to refrain from blood donation during the course of the study

6. Provide written informed consent

Exclusion Criteria:

1. Participation in another research study involving receipt of an investigational
product in the 30 days preceding enrolment, or planned use during the study period

2. Prior receipt of an investigational vaccine likely to impact on interpretation of the
trial data.

3. Prior receipt of an adenoviral vectored vaccine in the last 12 months

4. Administration of immunoglobulins and/or any blood products within the three months
preceding the planned administration of the vaccine candidate

5. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV
infection; asplenia; recurrent, severe infections and chronic (more than 14 days)
immunosuppressant medication within the past 6 months (inhaled and topical steroids
are allowed)

6. History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine

7. Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.

8. Any history of anaphylaxis in relation to vaccination

9. Pregnancy, lactation or willingness/intention to become pregnant during the study

10. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in
situ)

11. History of serious psychiatric condition likely to affect participation in the study

12. Bleeding disorder (eg. Factor deficiency, coagulopathy or platelet disorder), or prior
history of significant bleeding or bruising following IM injections or venepuncture

13. Any other serious chronic illness requiring hospital specialist supervision

14. Suspected or known current alcohol abuse as defined by an alcohol intake of greater
than 42 units every week

15. Suspected or known injecting drug abuse in the 5 years preceding enrolment

16. Seropositive for hepatitis C (antibodies to HCV)

17. Seropositive for hepatitis B surface antigen(HBsAg)

18. Any clinically significant abnormal finding on screening biochemistry or haematology
blood tests or urinalysis

19. 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

20. Inability of the study team to contact the volunteer's GP to confirm medical history
and safety to participate.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Mycobacterium Avium Subspecies Paratuberculosis

Crohn Disease

Intervention(s)

Biological: ChAdOx2 HAV

Biological: MVA HAV

Primary Outcome(s)

Occurrence of solicited and unsolicited local and systemic adverse events [Time Frame: up to 28 days following vaccination]

Secondary Outcome(s)

Measures of Immunogenicity of ChAdOx2 HAV and MVA HAV [Time Frame: Approximately 2 months post each vaccination]

Secondary ID(s)

HAV001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors