Safety and Immunological Response of a Boosting Dose of MVA-B in Healthy Volunteers After 4 Years of Receiving MVA-B

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Biological: Experimental

• Registration Number: NCT01923610
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

24 healthy male and female volunteers who are at low risk of HIV infection and entered into the RISVAC02 study and were randomly allocated to receive 3 intramuscular injections of MVA-B at weeks 0, 4 and 16 will receive a boosting dose 4 years thereafter.

Participants will attend one of two clinical centres on at least 5 occasions over 16 weeks. These visits will comprise:

* Screening

* Trial entry and boosting immunisation

* Early follow-up after immunisation

* Follow-up x 2 including the final visit Participants will have blood and urine collected, and receive 1 immunisation. They will be counselled prior to and following a HIV test, and given health education on prevention of sexually transmitted infections including HIV. T

The two centres which participate are:

* Hospital Clinic, Barcelona and

* Hospital Gregorio Marañón, Madrid The primary objective is to explore the safety and immunogenicity of MVA-B.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-13
• Study First Submitted QC: 2013-08-14
• Study First Posted: 2013-08-15
• Study Start: 2013-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• male or female
• age between 18 and 55 years on the day of screening
• available for follow-up for the duration of the study (52 weeks from screening)
• able to give written informed consent
• at low risk of HIV and willing to remain so for the duration of the study low risk of HIV infection defined as: no history of injecting drug use in the previous ten years no gonorrhoea or syphilis in the last six months no high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months no unprotected anal intercourse in the last six months no unprotected vaginal intercourse outside a relationship with a regular known/presumed HIV negative partner in the last six months
• willing to undergo a HIV test
• willing to undergo a genital infection screen
• if heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable contraceptive; IUCD; consistent record with condoms if using these; physiological or anatomical sterility in self or partner) from 14 days prior to the first vaccination until 4 months after the last, and willing to undergo urine pregnancy tests prior to each vaccination
• if heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination

Exclusion Criteria

• positive for hepatitis B surface antigen, hepatitis C antibody, antibody responses to vaccinia or serology indicating active syphilis requiring treatment
• pregnant or lactating
• clinically relevant abnormality on history or examination including history of grand-mal epilepsy, severe eczema, immunodeficiency or use of immunosuppressives in preceding 3 months
• receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment
• receipt of blood products or immunoglobin within 4 months of screening
• participation in another trial of a medicinal product, completed less than 30 days prior to enrolment
• history of severe local or general reaction to vaccination defined as local: extensive, indurated redness and swelling involving most of the front-lateral thigh or the major circumference of the arm, not resolving within 72 hours general: fever >= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal
• HIV 1/2 positive or indeterminate on screening
• positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
• grade 1 routine laboratory parameters
• unlikely to comply with protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Main	Experimental	MVA HIV-B

Primary Outcome Measures

Name	Time	Method
Grade 3 or above systemic adverse event	12 weeks	Grade 3 or above systemic adverse event (temperature, chills, headache, nausea, vomiting, malaise, and myalgia)
Local adverse event	12 weeks	Grade 3 or above local adverse event (pain, cutaneous reactions including induration)
Primary immunogenicity parameters	12 weeks	The primary immunogenicity parameters will be quantitative or present/absent, and are cellular responses - CD8/CD4+ T cell responses (ELISPOT) at week 2, 4 and 12 following the immunisations
Event attributable to vaccine leading to discontinuation	12 weeks	Any event attributable to vaccine leading to discontinuation of the immunisation regimen
Grade 3 or above other clinical or laboratory adverse event	12 weeks	Grade 3 or above other clinical or laboratory adverse event confirmed at examination or on repeat testing respectively

Secondary Outcome Measures

Name	Time	Method
cellular responses	12 weeks	* CD8/CD4+ T cell responses (ELISPOT) at week 0; * intracellular cytokine analysis at week 0, 2, 4 and 12
All grade 1 and 2 adverse events	28 days of vaccination
Antibody responses	12 weeks	* binding titration to the construct MVAB; * binding titration to and neutralisation of vaccinia

Trial Locations

Locations (2)

Hospital Clínic i Provincial de Barcelona; 🇪🇸 Barcelona, Catalunya, Spain

Hospital Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain